Rheumatoid Arthritis
Conditions
Keywords
Musculoskeletal Disease, Arthritis, Joint Diseases, Anti-inflammatory Agents, Antirheumatic agents
Brief summary
The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib.
Detailed description
This is an open-label extension study to assess the long-term safety, tolerability, and efficacy of upadacitinib in adults with RA who have completed Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) Phase 2 randomized controlled trial (RCT) with upadacitinib. All participants received treatment with 6 mg upadacitinib twice a day at the start of the study. Participants may have been up-titrated to 12 mg BID based on protocol-specified criteria. In Protocol Amendment 2 (January 2016) the study treatment was changed to a once daily (QD) formulation. Participants receiving 6 mg BID were transitioned to 15 mg QD and participants receiving 12 mg BID were transitioned to 30 mg QD dosing. An optional 12-week vaccine sub-study was added in Protocol Amendment 3 (November 2017) to assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background methotrexate on immunological responses to pneumococcal 13-valent conjugate vaccine (PCV-13; Prevnar 13®) in RA patients. The vaccine substudy included 111 participants who were enrolled in the main study, the first participant was enrolled on 13 February 2018 and the the last participant completed the sub-study on 9 April 2020. In Protocol Amendment 5 (December 2019), the protocol was revised to allow a decrease in upadacitinib dosing from 30 mg QD to 15 mg QD, as appropriate, based on investigator's medical decision or for safety/tolerability concerns.
Interventions
DRUGUpadacitinib
Tablet taken orally
BIOLOGICALPneumococcal 13-valent conjugate vaccine (PCV-13)
Administered by intramuscular injection
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who have completed Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) with upadacitinib (ABT-494) and did not develop any discontinuation criteria. 2. If the subject has evidence of new latent tuberculosis (TB) infection, the subject must initiate and complete a minimum of 2 weeks (or per local guidelines, whichever is longer) of an ongoing TB prophylaxis before continuing to receive study drug. 3. If female, subject must be postmenopausal, OR permanently surgically sterile, OR for women of childbearing potential practicing at least one protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug. 4. Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures. Substudy: 1. Must currently be enrolled in the main study. 2. Must have been receiving a stable dose of upadacitinib (either 15 mg QD or 30 mg QD) for a minimum of 4 weeks prior to the Vaccination visit. 3. Must have been on a stable dose of background methotrexate (no change in dose or frequency) for a minimum of 4 weeks prior to the Vaccination visit. 4. If subject is on corticosteroids, must remain on a stable dose of ≤ 10 mg/day of prednisone or equivalent corticosteroid therapy for at least 4 weeks after the vaccination visit. 5. Must meet the prescribing specifications as per local label requirements to receive Prevnar 13® vaccine. 6. Willing to receive Prevnar13® vaccine.
Exclusion criteria
1. Pregnant or breastfeeding female. 2. Ongoing infections at Week 0 that have not been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled but not dosed until the infection has been successfully treated. 3. Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug. 4. Laboratory values from the visit immediately prior to Baseline Visit (local requirements may apply) meeting the following criteria: * Serum aspartate transaminase (AST) or alanine transaminase (ALT) \> 3.0 × upper limit of normal (ULN) * Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula \< 40 mL/min/1.73m\^2 * Total white blood cell count (WBC) \< 2,000/μL * Absolute neutrophil count (ANC) \< 1,000/μL * Platelet count \< 50,000/μL * Absolute lymphocytes count \< 500/μL * Hemoglobin \< 8 g/dL 5. Enrollment in another interventional clinical study while participating in this study. 6. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study drug. Substudy: 1. Receiving any conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than methotrexate 2. Receiving \> 10 mg/day of prednisone or equivalent corticosteroid therapy. 3. Receipt of any steroid injection within 4 weeks prior to Vaccination visit. 4. History of severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13®. 5. History of any documented pneumococcal infection within the last 6 months prior to the vaccination visit. 6. Receipt of any vaccine 4 weeks prior to the vaccination visit and/or anticipation of any vaccination for 4 weeks after the vaccination visit. 7. Receipt of any pneumococcal vaccine. 8. Subject is not suitable for the sub-study as per the Investigator's judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP). |
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP). |
| Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP). |
| Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination | Vaccination Baseline (defined as the last non-missing observation on or before the date of receiving PCV-13 vaccination) and 4 weeks after vaccination | Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. LDA is defined as a SDAI score ≤ 11.0. |
| Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. Clinical remission is defined as a SDAI score ≤ 3.3. |
| Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The disease activity score-28-CRP (DAS28 \[CRP\]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity. |
| Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. |
| Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. |
| Change From Baseline in Tender Joint Count (TJC68) Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | Sixty-eight joints were assessed by an evaluator for tenderness or pain. The presence of tenderness was scored as a 1 and absence of tenderness as a 0. The total tender joint count is the sum of the scores, and ranges from 0 to 68 (worst). |
| Change From Baseline in Swollen Joint Count (SJC66) Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | Sixty-six joints were assessed by an evaluator for swelling. The presence of swelling was scored as a 1 and absence of swelling as a 0. The total swollen joint count is the sum of the scores, and ranges from 0 to 66 (worst). |
| Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates no disease activity and 100 mm indicates severe disease activity |
| Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity. |
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. LDA is defined as a DAS28(CRP) score ≤ 3.2. |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. |
| Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | — |
| Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | RA-WIS is a tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23. A score \< 10 means low risk, scores between 10 and 17 indicate medium risk, and scores \> 17 indicate high risk of work instability. A negative change from Baseline indicates improvement in work instability. |
| Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The EQ-5D-5L is a generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which is rated on 5 levels of severity (1: no problem, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems). A health state index score was calculated from individual health profiles using a UK scoring algorithm. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The higher the score the better the health status. A positive change from baseline indicates improvement in health status. |
| Change From Baseline in EuroQoL-5D VAS Score Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The EQ-5D-5L is a generic measure of health status consisting of two parts. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). A positive change from baseline indicates improvement. |
| Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination | Vaccination Baseline and 12 weeks after vaccination | Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). |
| Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Vaccination Baseline and 4 and 12 weeks after vaccination | — |
| Change From Baseline in Patient's Assessment of Pain Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates no pain and a score of 100 mm indicates worst possible pain. |
| Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission is defined as a DAS28(CRP) score \< 2.6. |
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score ≤ 10. |
| Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 | The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Clinical remission is defined as a CDAI score ≤ 2.8. |
Countries
Belgium, Bulgaria, Chile, Czechia, Hungary, Israel, Latvia, Mexico, New Zealand, Poland, Puerto Rico, Russia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants must have completed a preceding rheumatoid arthritis (RA) upadacitinib randomized controlled trial (RCT), Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) to be enrolled in this long-term extension study. Participants were enrolled at 113 study sites located in 17 countries (Belgium, Bulgaria, Chile, Czechia, Hungary, Israel, Latvia, Mexico, New Zealand, Poland, Russian Federation, Slovakia, South Africa, Spain, United Kingdom, Ukraine, and United States/Puerto Rico).
Pre-assignment details
Participants were assigned to upadacitinib 6 mg twice-daily up to 30 days following the Last Visit (Week 12) of the preceding RCT. Participants may have been up-titrated to 12 mg BID and subsequently down-titrated per protocol-specified criteria. Efficacy results are reported by treatment sequence for each participant. Adverse event data are reported according to treatment received at the time of the event. Participants may have enrolled in a vaccine substudy during the main study.
Participants by arm
| Arm | Count |
|---|---|
| Upadacitinib Never Titrated Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib. | 306 |
| Upadacitinib Titrated Up and Not Down Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. | 149 |
| Upadacitinib Titrated Up and Down Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. | 38 |
| Total | 493 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 46 | 25 | 1 |
| Overall Study | Coronavirus Disease-2019 (COVID-19) Infection | 1 | 0 | 0 |
| Overall Study | COVID-19 Logistical Restrictions | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 10 | 26 | 1 |
| Overall Study | Lost to Follow-up | 18 | 5 | 1 |
| Overall Study | Missing | 0 | 1 | 0 |
| Overall Study | Non-Compliance | 15 | 6 | 0 |
| Overall Study | Other | 15 | 13 | 0 |
| Overall Study | Required Alternative / Prohibited Therapy | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 57 | 21 | 5 |
Baseline characteristics
| Characteristic | Upadacitinib Never Titrated | Upadacitinib Titrated Up and Not Down | Upadacitinib Titrated Up and Down | Total |
|---|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 12.62 | 56.0 years STANDARD_DEVIATION 12.56 | 53.7 years STANDARD_DEVIATION 8.54 | 55.7 years STANDARD_DEVIATION 12.33 |
| Age, Customized 45 - < 65 years | 174 Participants | 76 Participants | 28 Participants | 278 Participants |
| Age, Customized < 45 years | 56 Participants | 30 Participants | 5 Participants | 91 Participants |
| Age, Customized ≥ 65 years | 76 Participants | 43 Participants | 5 Participants | 124 Participants |
| Duration of RA | 9.34 years STANDARD_DEVIATION 8.73 | 9.61 years STANDARD_DEVIATION 8.36 | 7.66 years STANDARD_DEVIATION 6.54 | 9.29 years STANDARD_DEVIATION 8.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 76 Participants | 40 Participants | 7 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 230 Participants | 109 Participants | 31 Participants | 370 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | 1.4811 score on a scale STANDARD_DEVIATION 0.6848 | 1.6036 score on a scale STANDARD_DEVIATION 0.6215 | 1.5304 score on a scale STANDARD_DEVIATION 0.4969 | 1.5216 score on a scale STANDARD_DEVIATION 0.655 |
| High-sensitivity reactive Protein (hsCRP) | 12.8968 mg/L STANDARD_DEVIATION 17.8329 | 14.9212 mg/L STANDARD_DEVIATION 20.189 | 17.1232 mg/L STANDARD_DEVIATION 28.1184 | 13.8344 mg/L STANDARD_DEVIATION 19.5179 |
| Patient's Global Assessment of Disease Activity | 62.4 score on a scale STANDARD_DEVIATION 20.78 | 67.4 score on a scale STANDARD_DEVIATION 20.52 | 66.5 score on a scale STANDARD_DEVIATION 16.48 | 64.2 score on a scale STANDARD_DEVIATION 20.51 |
| Patient's Global Assessment of Pain | 63.8 score on a scale STANDARD_DEVIATION 19.73 | 67.2 score on a scale STANDARD_DEVIATION 19.64 | 66.5 score on a scale STANDARD_DEVIATION 13.13 | 65.0 score on a scale STANDARD_DEVIATION 19.32 |
| Physician's Global Assessment of Disease Activity | 64.4 score on a scale STANDARD_DEVIATION 15.82 | 65.6 score on a scale STANDARD_DEVIATION 15.41 | 65.0 score on a scale STANDARD_DEVIATION 15.41 | 64.8 score on a scale STANDARD_DEVIATION 15.64 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 12 Participants | 1 Participants | 22 Participants |
| Race/Ethnicity, Customized Multiple | 2 Participants | 3 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 293 Participants | 132 Participants | 37 Participants | 462 Participants |
| Region Eastern Europe | 144 Participants | 46 Participants | 19 Participants | 209 Participants |
| Region North America | 90 Participants | 78 Participants | 10 Participants | 178 Participants |
| Region Other | 3 Participants | 7 Participants | 1 Participants | 11 Participants |
| Region South/Central America | 42 Participants | 5 Participants | 3 Participants | 50 Participants |
| Region Western Europe | 27 Participants | 13 Participants | 5 Participants | 45 Participants |
| Sex: Female, Male Female | 246 Participants | 117 Participants | 29 Participants | 392 Participants |
| Sex: Female, Male Male | 60 Participants | 32 Participants | 9 Participants | 101 Participants |
| Swollen Joint Count | 16.7 joints STANDARD_DEVIATION 10.45 | 18.8 joints STANDARD_DEVIATION 12.03 | 19.3 joints STANDARD_DEVIATION 9.53 | 17.5 joints STANDARD_DEVIATION 10.92 |
| Tender Joint Count | 25.8 joints STANDARD_DEVIATION 14.49 | 30.4 joints STANDARD_DEVIATION 15.9 | 31.3 joints STANDARD_DEVIATION 15.67 | 27.6 joints STANDARD_DEVIATION 15.17 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 493 | 3 / 187 | 0 / 38 |
| other Total, other adverse events | 233 / 493 | 113 / 187 | 23 / 38 |
| serious Total, serious adverse events | 68 / 493 | 42 / 187 | 5 / 38 |
Outcome results
Primary
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 108 | 94.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 312 | 92.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 216 | 92.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 120 | 96.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 6 | 87.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 204 | 94.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 132 | 93.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 48 | 90.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 192 | 93.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 144 | 94.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 300 | 94.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 180 | 93.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 156 | 92.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 276 | 93.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 168 | 91.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 60 | 95.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 24 | 91.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 264 | 93.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 72 | 93.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 12 | 89.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 252 | 94.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 84 | 94.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 288 | 94.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 240 | 92.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 96 | 92.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 36 | 90.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 228 | 96.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 276 | 84.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 6 | 73.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 12 | 73.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 24 | 73.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 36 | 83.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 48 | 82.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 60 | 83.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 72 | 84.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 84 | 76.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 96 | 86.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 108 | 85.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 120 | 89.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 132 | 87.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 144 | 88.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 156 | 87.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 168 | 88.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 180 | 79.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 192 | 87.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 204 | 81.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 216 | 85.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 228 | 83.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 240 | 85.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 252 | 87.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 264 | 81.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 288 | 88.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 300 | 82.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 312 | 87.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 108 | 87.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 6 | 77.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 216 | 85.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 96 | 90.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 288 | 88.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 228 | 92.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 84 | 96.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 12 | 75.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 240 | 89.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 72 | 90.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 312 | 88.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 252 | 86.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 60 | 85.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 300 | 87.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 264 | 89.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 156 | 92.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 48 | 88.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 168 | 82.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 144 | 88.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 36 | 82.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 180 | 86.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 132 | 96.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 276 | 81.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 192 | 92.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 120 | 96.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 24 | 88.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Week 204 | 86.2 percentage of participants |
Primary
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 108 | 79.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 312 | 84.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 216 | 76.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 120 | 80.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 6 | 63.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 204 | 82.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 132 | 79.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 48 | 74.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 192 | 80.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 144 | 76.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 300 | 75.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 180 | 80.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 156 | 79.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 276 | 84.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 168 | 79.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 60 | 79.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 24 | 75.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 264 | 79.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 72 | 77.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 12 | 73.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 252 | 83.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 84 | 78.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 288 | 82.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 240 | 79.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 96 | 74.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 36 | 73.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 228 | 79.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 276 | 52.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 6 | 37.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 12 | 41.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 24 | 49.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 36 | 51.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 48 | 50.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 60 | 52.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 72 | 49.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 84 | 55.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 96 | 53.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 108 | 54.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 120 | 58.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 132 | 56.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 144 | 65.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 156 | 63.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 168 | 61.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 180 | 64.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 192 | 59.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 204 | 59.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 216 | 55.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 228 | 58.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 240 | 63.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 252 | 55.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 264 | 60.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 288 | 58.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 300 | 61.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 312 | 69.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 108 | 58.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 6 | 48.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 216 | 66.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 96 | 63.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 288 | 61.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 228 | 67.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 84 | 75.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 12 | 45.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 240 | 71.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 72 | 63.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 312 | 69.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 252 | 76.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 60 | 65.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 300 | 56.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 264 | 75.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 156 | 76.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 48 | 55.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 168 | 75.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 144 | 60.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 36 | 55.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 180 | 65.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 132 | 69.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 276 | 66.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 192 | 76.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 120 | 72.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 24 | 60.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Week 204 | 79.3 percentage of participants |
Primary
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 108 | 59.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 312 | 63.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 216 | 59.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 120 | 59.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 6 | 38.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 204 | 65.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 132 | 61.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 48 | 57.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 192 | 62.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 144 | 57.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 300 | 60.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 180 | 59.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 156 | 64.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 276 | 66.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 168 | 62.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 60 | 60.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 24 | 45.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 264 | 58.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 72 | 56.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 12 | 47.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 252 | 62.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 84 | 60.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 288 | 65.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 240 | 66.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 96 | 57.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 36 | 49.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 228 | 60.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 276 | 34.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 6 | 15.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 12 | 18.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 24 | 27.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 36 | 28.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 48 | 26.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 60 | 30.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 72 | 29.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 84 | 29.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 96 | 34.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 108 | 31.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 120 | 30.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 132 | 33.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 144 | 34.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 156 | 38.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 168 | 42.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 180 | 29.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 192 | 31.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 204 | 42.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 216 | 41.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 228 | 39.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 240 | 38.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 252 | 29.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 264 | 37.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 288 | 44.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 300 | 41.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 312 | 39.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 108 | 47.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 6 | 21.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 216 | 46.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 96 | 42.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 288 | 44.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 228 | 60.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 84 | 54.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 12 | 24.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 240 | 46.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 72 | 36.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 312 | 55.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 252 | 50.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 60 | 42.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 300 | 43.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 264 | 57.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 156 | 55.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 48 | 25.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 168 | 58.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 144 | 39.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 36 | 34.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 180 | 48.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 132 | 48.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 276 | 48.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 192 | 48.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 120 | 62.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 24 | 37.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Week 204 | 58.6 percentage of participants |
Primary
Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination
Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
Time frame: Vaccination Baseline (defined as the last non-missing observation on or before the date of receiving PCV-13 vaccination) and 4 weeks after vaccination
Population: The sub-study full analysis set (FAS) included all participants enrolled in the sub-study who received PCV-13 vaccination and at least 1 dose of upadacitinib 15 mg or 30 mg after vaccination during the sub-study. Analysis includes participants with available data at the Week 4 visit of the sub-study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Upadacitinib Never Titrated | Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination | 67.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination | 56.5 percentage of participants |
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at Baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 108 | -34.5 score on a scale | Standard Deviation 11.83 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 312 | -35.9 score on a scale | Standard Deviation 12.43 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 216 | -35.8 score on a scale | Standard Deviation 13.19 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 120 | -34.8 score on a scale | Standard Deviation 11.87 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 6 | -30.0 score on a scale | Standard Deviation 12.49 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 204 | -36.0 score on a scale | Standard Deviation 12.36 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 132 | -35.0 score on a scale | Standard Deviation 12.24 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 48 | -34.0 score on a scale | Standard Deviation 12.84 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 192 | -35.6 score on a scale | Standard Deviation 12.25 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 144 | -35.0 score on a scale | Standard Deviation 12.21 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 300 | -36.0 score on a scale | Standard Deviation 12.17 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 180 | -35.5 score on a scale | Standard Deviation 12.6 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 156 | -35.6 score on a scale | Standard Deviation 12.24 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 276 | -36.5 score on a scale | Standard Deviation 12.59 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 168 | -36.2 score on a scale | Standard Deviation 13.01 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 60 | -34.7 score on a scale | Standard Deviation 12.52 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 24 | -32.6 score on a scale | Standard Deviation 11.81 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 264 | -35.5 score on a scale | Standard Deviation 13.66 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 72 | -34.3 score on a scale | Standard Deviation 11.71 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 12 | -31.6 score on a scale | Standard Deviation 11.82 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 252 | -35.9 score on a scale | Standard Deviation 13.41 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 84 | -34.9 score on a scale | Standard Deviation 12.08 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 288 | -36.9 score on a scale | Standard Deviation 13.22 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 240 | -36.4 score on a scale | Standard Deviation 12.95 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 96 | -33.4 score on a scale | Standard Deviation 11.71 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 36 | -32.2 score on a scale | Standard Deviation 12.43 |
| Upadacitinib Never Titrated | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 228 | -35.6 score on a scale | Standard Deviation 12.68 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 276 | -33.6 score on a scale | Standard Deviation 12.16 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 6 | -27.5 score on a scale | Standard Deviation 13.54 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 12 | -28.4 score on a scale | Standard Deviation 13.87 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 24 | -30.6 score on a scale | Standard Deviation 13.59 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 36 | -31.4 score on a scale | Standard Deviation 12.67 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 48 | -31.8 score on a scale | Standard Deviation 13.35 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 60 | -32.4 score on a scale | Standard Deviation 12.18 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 72 | -32.3 score on a scale | Standard Deviation 13.33 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 84 | -31.0 score on a scale | Standard Deviation 13.36 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 96 | -32.1 score on a scale | Standard Deviation 12.37 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 108 | -32.4 score on a scale | Standard Deviation 12.79 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 120 | -32.3 score on a scale | Standard Deviation 12.94 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 132 | -32.7 score on a scale | Standard Deviation 12.39 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 144 | -33.1 score on a scale | Standard Deviation 12.67 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 156 | -33.6 score on a scale | Standard Deviation 12.25 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 168 | -33.8 score on a scale | Standard Deviation 12.97 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 180 | -34.0 score on a scale | Standard Deviation 12.13 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 192 | -34.0 score on a scale | Standard Deviation 12.89 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 204 | -33.8 score on a scale | Standard Deviation 13.69 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 216 | -33.9 score on a scale | Standard Deviation 11.87 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 228 | -35.5 score on a scale | Standard Deviation 13.31 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 240 | -34.7 score on a scale | Standard Deviation 13.02 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 252 | -35.3 score on a scale | Standard Deviation 12.58 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 264 | -33.2 score on a scale | Standard Deviation 12.38 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 288 | -35.3 score on a scale | Standard Deviation 14.34 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 300 | -32.9 score on a scale | Standard Deviation 11.86 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 312 | -34.4 score on a scale | Standard Deviation 12.63 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 108 | -32.3 score on a scale | Standard Deviation 10.81 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 6 | -27.2 score on a scale | Standard Deviation 11.42 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 216 | -37.3 score on a scale | Standard Deviation 11.62 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 96 | -31.3 score on a scale | Standard Deviation 10.86 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 288 | -33.5 score on a scale | Standard Deviation 10.25 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 228 | -37.9 score on a scale | Standard Deviation 11.55 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 84 | -33.5 score on a scale | Standard Deviation 9.66 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 12 | -27.9 score on a scale | Standard Deviation 11.12 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 240 | -35.8 score on a scale | Standard Deviation 11.07 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 72 | -31.8 score on a scale | Standard Deviation 10.88 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 312 | -34.0 score on a scale | Standard Deviation 11.62 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 252 | -34.3 score on a scale | Standard Deviation 11.71 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 60 | -32.2 score on a scale | Standard Deviation 12.09 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 300 | -34.6 score on a scale | Standard Deviation 11.27 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 264 | -33.5 score on a scale | Standard Deviation 12.49 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 156 | -36.1 score on a scale | Standard Deviation 11.8 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 48 | -29.1 score on a scale | Standard Deviation 10.82 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 168 | -37.6 score on a scale | Standard Deviation 13.08 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 144 | -36.2 score on a scale | Standard Deviation 12.03 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 36 | -29.6 score on a scale | Standard Deviation 11.63 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 180 | -36.9 score on a scale | Standard Deviation 12.07 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 132 | -34.5 score on a scale | Standard Deviation 12.14 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 276 | -34.7 score on a scale | Standard Deviation 11.92 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 192 | -38.6 score on a scale | Standard Deviation 11.76 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 120 | -34.0 score on a scale | Standard Deviation 10.75 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 24 | -29.6 score on a scale | Standard Deviation 11.45 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Week 204 | -37.9 score on a scale | Standard Deviation 12.59 |
Secondary
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
The disease activity score-28-CRP (DAS28 \[CRP\]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at Baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 228 | -3.6 score on a scale | Standard Deviation 1.12 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 108 | -3.5 score on a scale | Standard Deviation 1.09 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 6 | -2.9 score on a scale | Standard Deviation 1.21 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 216 | -3.6 score on a scale | Standard Deviation 1.13 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 120 | -3.5 score on a scale | Standard Deviation 1.08 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 48 | -3.4 score on a scale | Standard Deviation 1.2 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 204 | -3.6 score on a scale | Standard Deviation 1.13 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 132 | -3.5 score on a scale | Standard Deviation 1.02 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 300 | -3.7 score on a scale | Standard Deviation 1 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 192 | -3.6 score on a scale | Standard Deviation 1.15 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 144 | -3.4 score on a scale | Standard Deviation 1.13 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 276 | -3.7 score on a scale | Standard Deviation 1.01 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 180 | -3.6 score on a scale | Standard Deviation 1.1 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 156 | -3.5 score on a scale | Standard Deviation 1.13 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 60 | -3.5 score on a scale | Standard Deviation 1.15 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 168 | -3.6 score on a scale | Standard Deviation 1.17 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 24 | -3.2 score on a scale | Standard Deviation 1.07 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 264 | -3.5 score on a scale | Standard Deviation 1.25 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 72 | -3.5 score on a scale | Standard Deviation 1.03 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 12 | -3.1 score on a scale | Standard Deviation 1.14 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 252 | -3.7 score on a scale | Standard Deviation 1.2 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 84 | -3.5 score on a scale | Standard Deviation 1.06 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 288 | -3.7 score on a scale | Standard Deviation 1.08 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 240 | -3.7 score on a scale | Standard Deviation 1.12 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 36 | -3.2 score on a scale | Standard Deviation 1.2 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 96 | -3.4 score on a scale | Standard Deviation 1.11 |
| Upadacitinib Never Titrated | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 312 | -3.5 score on a scale | Standard Deviation 1.1 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 276 | -3.1 score on a scale | Standard Deviation 1.22 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 6 | -2.4 score on a scale | Standard Deviation 1.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 12 | -2.5 score on a scale | Standard Deviation 1.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 24 | -2.7 score on a scale | Standard Deviation 1.36 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 36 | -2.9 score on a scale | Standard Deviation 1.11 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 48 | -2.9 score on a scale | Standard Deviation 1.2 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 60 | -2.9 score on a scale | Standard Deviation 1.07 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 72 | -2.9 score on a scale | Standard Deviation 1.24 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 84 | -2.9 score on a scale | Standard Deviation 1.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 204 | -3.1 score on a scale | Standard Deviation 1.32 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 96 | -3.1 score on a scale | Standard Deviation 1.21 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 108 | -3.1 score on a scale | Standard Deviation 1.24 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 120 | -3.1 score on a scale | Standard Deviation 1.29 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 132 | -3.1 score on a scale | Standard Deviation 1.23 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 144 | -3.0 score on a scale | Standard Deviation 1.18 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 156 | -3.1 score on a scale | Standard Deviation 1.11 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 168 | -3.2 score on a scale | Standard Deviation 1.23 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 180 | -3.2 score on a scale | Standard Deviation 1.24 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 192 | -3.2 score on a scale | Standard Deviation 1.31 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 216 | -3.2 score on a scale | Standard Deviation 1.15 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 228 | -3.3 score on a scale | Standard Deviation 1.37 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 240 | -3.2 score on a scale | Standard Deviation 1.3 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 252 | -3.3 score on a scale | Standard Deviation 1.18 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 264 | -3.1 score on a scale | Standard Deviation 1.24 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 288 | -3.3 score on a scale | Standard Deviation 1.44 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 300 | -3.0 score on a scale | Standard Deviation 1.38 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 312 | -3.2 score on a scale | Standard Deviation 1.25 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 108 | -3.1 score on a scale | Standard Deviation 0.94 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 6 | -2.5 score on a scale | Standard Deviation 1.01 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 216 | -3.5 score on a scale | Standard Deviation 1.02 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 96 | -3.2 score on a scale | Standard Deviation 0.98 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 288 | -3.2 score on a scale | Standard Deviation 0.75 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 228 | -3.7 score on a scale | Standard Deviation 0.91 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 84 | -3.3 score on a scale | Standard Deviation 0.62 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 12 | -2.5 score on a scale | Standard Deviation 1.03 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 240 | -3.5 score on a scale | Standard Deviation 0.91 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 72 | -3.1 score on a scale | Standard Deviation 0.88 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 312 | -3.2 score on a scale | Standard Deviation 1.04 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 252 | -3.3 score on a scale | Standard Deviation 1.04 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 60 | -3.1 score on a scale | Standard Deviation 0.98 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 300 | -3.4 score on a scale | Standard Deviation 0.81 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 264 | -3.4 score on a scale | Standard Deviation 1.01 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 48 | -2.8 score on a scale | Standard Deviation 0.97 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 156 | -3.6 score on a scale | Standard Deviation 1 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 36 | -3.0 score on a scale | Standard Deviation 1.17 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 168 | -3.6 score on a scale | Standard Deviation 1.08 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 144 | -3.4 score on a scale | Standard Deviation 1.04 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 276 | -3.5 score on a scale | Standard Deviation 0.9 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 180 | -3.5 score on a scale | Standard Deviation 1.13 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 132 | -3.3 score on a scale | Standard Deviation 1.02 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 24 | -2.7 score on a scale | Standard Deviation 1.22 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 192 | -3.6 score on a scale | Standard Deviation 1.06 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 120 | -3.2 score on a scale | Standard Deviation 0.86 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | Week 204 | -3.7 score on a scale | Standard Deviation 1.13 |
Secondary
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
The EQ-5D-5L is a generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which is rated on 5 levels of severity (1: no problem, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems). A health state index score was calculated from individual health profiles using a UK scoring algorithm. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The higher the score the better the health status. A positive change from baseline indicates improvement in health status.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at Baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 288 | 0.3 score on a scale | Standard Deviation 0.27 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 216 | 0.2 score on a scale | Standard Deviation 0.29 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 132 | 0.2 score on a scale | Standard Deviation 0.25 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 12 | 0.2 score on a scale | Standard Deviation 0.23 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 36 | 0.2 score on a scale | Standard Deviation 0.24 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 144 | 0.2 score on a scale | Standard Deviation 0.28 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 276 | 0.2 score on a scale | Standard Deviation 0.3 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 204 | 0.2 score on a scale | Standard Deviation 0.27 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 156 | 0.2 score on a scale | Standard Deviation 0.27 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 48 | 0.2 score on a scale | Standard Deviation 0.25 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 192 | 0.2 score on a scale | Standard Deviation 0.27 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 168 | 0.2 score on a scale | Standard Deviation 0.29 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 6 | 0.2 score on a scale | Standard Deviation 0.24 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 180 | 0.2 score on a scale | Standard Deviation 0.27 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 264 | 0.3 score on a scale | Standard Deviation 0.29 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 72 | 0.2 score on a scale | Standard Deviation 0.24 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 300 | 0.2 score on a scale | Standard Deviation 0.28 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 252 | 0.2 score on a scale | Standard Deviation 0.26 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 96 | 0.2 score on a scale | Standard Deviation 0.25 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 24 | 0.2 score on a scale | Standard Deviation 0.23 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 240 | 0.3 score on a scale | Standard Deviation 0.29 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 108 | 0.2 score on a scale | Standard Deviation 0.26 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 312 | 0.2 score on a scale | Standard Deviation 0.29 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 228 | 0.2 score on a scale | Standard Deviation 0.26 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 120 | 0.2 score on a scale | Standard Deviation 0.26 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 204 | 0.2 score on a scale | Standard Deviation 0.31 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 6 | 0.2 score on a scale | Standard Deviation 0.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 12 | 0.2 score on a scale | Standard Deviation 0.29 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 24 | 0.2 score on a scale | Standard Deviation 0.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 36 | 0.2 score on a scale | Standard Deviation 0.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 48 | 0.2 score on a scale | Standard Deviation 0.31 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 72 | 0.2 score on a scale | Standard Deviation 0.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 96 | 0.2 score on a scale | Standard Deviation 0.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 108 | 0.2 score on a scale | Standard Deviation 0.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 120 | 0.2 score on a scale | Standard Deviation 0.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 132 | 0.2 score on a scale | Standard Deviation 0.26 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 144 | 0.2 score on a scale | Standard Deviation 0.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 156 | 0.2 score on a scale | Standard Deviation 0.26 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 168 | 0.2 score on a scale | Standard Deviation 0.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 180 | 0.2 score on a scale | Standard Deviation 0.33 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 192 | 0.2 score on a scale | Standard Deviation 0.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 216 | 0.2 score on a scale | Standard Deviation 0.3 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 228 | 0.2 score on a scale | Standard Deviation 0.31 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 240 | 0.2 score on a scale | Standard Deviation 0.26 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 252 | 0.2 score on a scale | Standard Deviation 0.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 264 | 0.2 score on a scale | Standard Deviation 0.25 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 276 | 0.2 score on a scale | Standard Deviation 0.26 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 288 | 0.2 score on a scale | Standard Deviation 0.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 300 | 0.2 score on a scale | Standard Deviation 0.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 312 | 0.2 score on a scale | Standard Deviation 0.26 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 216 | 0.2 score on a scale | Standard Deviation 0.18 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 108 | 0.1 score on a scale | Standard Deviation 0.16 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 6 | 0.2 score on a scale | Standard Deviation 0.18 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 228 | 0.1 score on a scale | Standard Deviation 0.22 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 96 | 0.2 score on a scale | Standard Deviation 0.15 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 288 | 0.1 score on a scale | Standard Deviation 0.23 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 240 | 0.1 score on a scale | Standard Deviation 0.22 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 72 | 0.2 score on a scale | Standard Deviation 0.16 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 12 | 0.2 score on a scale | Standard Deviation 0.14 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 252 | 0.2 score on a scale | Standard Deviation 0.22 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 48 | 0.1 score on a scale | Standard Deviation 0.2 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 312 | 0.1 score on a scale | Standard Deviation 0.25 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 264 | 0.1 score on a scale | Standard Deviation 0.23 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 36 | 0.2 score on a scale | Standard Deviation 0.16 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 168 | 0.2 score on a scale | Standard Deviation 0.2 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 300 | 0.1 score on a scale | Standard Deviation 0.19 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 180 | 0.2 score on a scale | Standard Deviation 0.2 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 156 | 0.1 score on a scale | Standard Deviation 0.18 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 276 | 0.1 score on a scale | Standard Deviation 0.22 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 192 | 0.2 score on a scale | Standard Deviation 0.2 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 144 | 0.2 score on a scale | Standard Deviation 0.17 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 132 | 0.2 score on a scale | Standard Deviation 0.15 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 204 | 0.2 score on a scale | Standard Deviation 0.21 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 120 | 0.2 score on a scale | Standard Deviation 0.16 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | Week 24 | 0.2 score on a scale | Standard Deviation 0.16 |
Secondary
Change From Baseline in EuroQoL-5D VAS Score Over Time
The EQ-5D-5L is a generic measure of health status consisting of two parts. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). A positive change from baseline indicates improvement.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at Baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 36 | 27.0 score on a scale | Standard Deviation 26.29 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 216 | 30.0 score on a scale | Standard Deviation 26.93 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 132 | 26.3 score on a scale | Standard Deviation 28.75 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 312 | 31.2 score on a scale | Standard Deviation 25.15 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 6 | 23.7 score on a scale | Standard Deviation 25.21 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 144 | 28.6 score on a scale | Standard Deviation 26.71 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 276 | 32.4 score on a scale | Standard Deviation 23.37 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 204 | 32.0 score on a scale | Standard Deviation 24.41 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 156 | 29.9 score on a scale | Standard Deviation 25.48 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 48 | 25.9 score on a scale | Standard Deviation 26.87 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 192 | 29.7 score on a scale | Standard Deviation 24.65 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 168 | 30.3 score on a scale | Standard Deviation 25.29 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 300 | 30.5 score on a scale | Standard Deviation 24.39 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 180 | 30.0 score on a scale | Standard Deviation 24.3 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 264 | 30.8 score on a scale | Standard Deviation 25.3 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 72 | 28.0 score on a scale | Standard Deviation 24.36 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 24 | 27.5 score on a scale | Standard Deviation 25.24 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 252 | 31.2 score on a scale | Standard Deviation 24.46 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 96 | 27.5 score on a scale | Standard Deviation 26.86 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 12 | 26.0 score on a scale | Standard Deviation 25.62 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 240 | 31.3 score on a scale | Standard Deviation 26.18 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 108 | 28.8 score on a scale | Standard Deviation 25.72 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 288 | 32.3 score on a scale | Standard Deviation 24.66 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 228 | 31.6 score on a scale | Standard Deviation 24.92 |
| Upadacitinib Never Titrated | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 120 | 28.4 score on a scale | Standard Deviation 27.22 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 204 | 23.1 score on a scale | Standard Deviation 27.13 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 6 | 14.4 score on a scale | Standard Deviation 24.94 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 12 | 15.9 score on a scale | Standard Deviation 25.83 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 24 | 16.8 score on a scale | Standard Deviation 27.31 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 36 | 18.6 score on a scale | Standard Deviation 27.1 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 48 | 19.1 score on a scale | Standard Deviation 28.61 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 72 | 21.9 score on a scale | Standard Deviation 26.33 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 96 | 22.4 score on a scale | Standard Deviation 27.73 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 108 | 23.2 score on a scale | Standard Deviation 25.81 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 120 | 23.7 score on a scale | Standard Deviation 25.36 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 132 | 23.5 score on a scale | Standard Deviation 26.23 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 144 | 23.5 score on a scale | Standard Deviation 24.29 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 156 | 22.5 score on a scale | Standard Deviation 24.62 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 168 | 22.6 score on a scale | Standard Deviation 23.74 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 180 | 22.0 score on a scale | Standard Deviation 27.24 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 192 | 23.6 score on a scale | Standard Deviation 26.41 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 216 | 24.0 score on a scale | Standard Deviation 26.4 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 228 | 19.7 score on a scale | Standard Deviation 26.7 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 240 | 21.9 score on a scale | Standard Deviation 25.62 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 252 | 22.8 score on a scale | Standard Deviation 26.74 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 264 | 22.2 score on a scale | Standard Deviation 23.6 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 276 | 20.5 score on a scale | Standard Deviation 25.68 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 288 | 24.6 score on a scale | Standard Deviation 25.54 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 300 | 20.4 score on a scale | Standard Deviation 27.31 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 312 | 25.8 score on a scale | Standard Deviation 24.81 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 216 | 28.0 score on a scale | Standard Deviation 21.73 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 108 | 20.5 score on a scale | Standard Deviation 19.06 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 6 | 21.6 score on a scale | Standard Deviation 20.49 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 228 | 29.5 score on a scale | Standard Deviation 23.85 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 96 | 25.4 score on a scale | Standard Deviation 19.25 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 288 | 25.3 score on a scale | Standard Deviation 22.57 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 240 | 28.4 score on a scale | Standard Deviation 26.55 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 72 | 26.7 score on a scale | Standard Deviation 21.43 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 12 | 19.4 score on a scale | Standard Deviation 25.07 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 252 | 25.6 score on a scale | Standard Deviation 23.74 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 48 | 19.7 score on a scale | Standard Deviation 21.07 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 312 | 24.1 score on a scale | Standard Deviation 25.18 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 264 | 21.9 score on a scale | Standard Deviation 24.81 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 36 | 18.6 score on a scale | Standard Deviation 21.05 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 168 | 28.1 score on a scale | Standard Deviation 24.06 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 300 | 23.6 score on a scale | Standard Deviation 17.27 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 180 | 27.0 score on a scale | Standard Deviation 21.68 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 156 | 22.1 score on a scale | Standard Deviation 23.52 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 276 | 25.4 score on a scale | Standard Deviation 20.62 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 192 | 30.8 score on a scale | Standard Deviation 21.96 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 144 | 24.7 score on a scale | Standard Deviation 25.32 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 132 | 28.1 score on a scale | Standard Deviation 19.62 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 204 | 30.7 score on a scale | Standard Deviation 22.99 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 120 | 27.2 score on a scale | Standard Deviation 23.54 |
| Upadacitinib Titrated Up and Down | Change From Baseline in EuroQoL-5D VAS Score Over Time | Week 24 | 20.7 score on a scale | Standard Deviation 20.67 |
Secondary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at Baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 108 | -0.9 score on a scale | Standard Deviation 0.67 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 36 | -0.7 score on a scale | Standard Deviation 0.66 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 204 | -0.9 score on a scale | Standard Deviation 0.68 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 120 | -0.8 score on a scale | Standard Deviation 0.64 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 6 | -0.7 score on a scale | Standard Deviation 0.62 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 264 | -0.8 score on a scale | Standard Deviation 0.68 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 192 | -0.8 score on a scale | Standard Deviation 0.68 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 132 | -0.9 score on a scale | Standard Deviation 0.66 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 48 | -0.8 score on a scale | Standard Deviation 0.63 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 180 | -0.8 score on a scale | Standard Deviation 0.7 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 144 | -0.8 score on a scale | Standard Deviation 0.72 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 288 | -0.9 score on a scale | Standard Deviation 0.7 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 168 | -0.8 score on a scale | Standard Deviation 0.68 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 156 | -0.8 score on a scale | Standard Deviation 0.69 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 252 | -0.9 score on a scale | Standard Deviation 0.69 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 60 | -0.8 score on a scale | Standard Deviation 0.67 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 276 | -0.8 score on a scale | Standard Deviation 0.69 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 300 | -0.8 score on a scale | Standard Deviation 0.76 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 72 | -0.8 score on a scale | Standard Deviation 0.65 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 24 | -0.8 score on a scale | Standard Deviation 0.6 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 240 | -0.8 score on a scale | Standard Deviation 0.69 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 84 | -0.9 score on a scale | Standard Deviation 0.62 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 12 | -0.7 score on a scale | Standard Deviation 0.64 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 228 | -0.9 score on a scale | Standard Deviation 0.72 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 96 | -0.8 score on a scale | Standard Deviation 0.64 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 312 | -0.8 score on a scale | Standard Deviation 0.71 |
| Upadacitinib Never Titrated | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 216 | -0.8 score on a scale | Standard Deviation 0.69 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 36 | -0.6 score on a scale | Standard Deviation 0.62 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 6 | -0.6 score on a scale | Standard Deviation 0.56 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 12 | -0.6 score on a scale | Standard Deviation 0.63 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 24 | -0.6 score on a scale | Standard Deviation 0.61 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 48 | -0.7 score on a scale | Standard Deviation 0.61 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 60 | -0.7 score on a scale | Standard Deviation 0.66 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 72 | -0.7 score on a scale | Standard Deviation 0.63 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 84 | -0.7 score on a scale | Standard Deviation 0.64 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 96 | -0.8 score on a scale | Standard Deviation 0.69 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 108 | -0.7 score on a scale | Standard Deviation 0.67 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 120 | -0.7 score on a scale | Standard Deviation 0.64 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 252 | -0.7 score on a scale | Standard Deviation 0.77 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 132 | -0.7 score on a scale | Standard Deviation 0.64 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 144 | -0.8 score on a scale | Standard Deviation 0.68 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 156 | -0.7 score on a scale | Standard Deviation 0.57 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 168 | -0.7 score on a scale | Standard Deviation 0.67 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 180 | -0.7 score on a scale | Standard Deviation 0.7 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 192 | -0.7 score on a scale | Standard Deviation 0.69 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 204 | -0.7 score on a scale | Standard Deviation 0.79 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 216 | -0.7 score on a scale | Standard Deviation 0.73 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 228 | -0.7 score on a scale | Standard Deviation 0.77 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 240 | -0.7 score on a scale | Standard Deviation 0.77 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 264 | -0.7 score on a scale | Standard Deviation 0.65 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 300 | -0.7 score on a scale | Standard Deviation 0.7 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 312 | -0.8 score on a scale | Standard Deviation 0.74 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 276 | -0.6 score on a scale | Standard Deviation 0.66 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 288 | -0.7 score on a scale | Standard Deviation 0.74 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 204 | -0.8 score on a scale | Standard Deviation 0.51 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 96 | -0.8 score on a scale | Standard Deviation 0.52 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 264 | -0.7 score on a scale | Standard Deviation 0.59 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 216 | -0.8 score on a scale | Standard Deviation 0.61 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 84 | -0.7 score on a scale | Standard Deviation 0.57 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 312 | -0.7 score on a scale | Standard Deviation 0.69 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 228 | -0.7 score on a scale | Standard Deviation 0.61 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 72 | -0.7 score on a scale | Standard Deviation 0.54 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 12 | -0.7 score on a scale | Standard Deviation 0.55 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 60 | -0.7 score on a scale | Standard Deviation 0.52 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 240 | -0.6 score on a scale | Standard Deviation 0.61 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 48 | -0.7 score on a scale | Standard Deviation 0.58 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 252 | -0.7 score on a scale | Standard Deviation 0.59 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 36 | -0.7 score on a scale | Standard Deviation 0.66 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 288 | -0.8 score on a scale | Standard Deviation 0.61 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 156 | -0.8 score on a scale | Standard Deviation 0.61 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 144 | -0.7 score on a scale | Standard Deviation 0.61 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 276 | -0.7 score on a scale | Standard Deviation 0.61 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 168 | -0.8 score on a scale | Standard Deviation 0.6 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 132 | -0.8 score on a scale | Standard Deviation 0.51 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 300 | -0.7 score on a scale | Standard Deviation 0.68 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 180 | -0.7 score on a scale | Standard Deviation 0.64 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 120 | -0.8 score on a scale | Standard Deviation 0.62 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 24 | -0.7 score on a scale | Standard Deviation 0.58 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 192 | -0.8 score on a scale | Standard Deviation 0.57 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 108 | -0.7 score on a scale | Standard Deviation 0.58 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | Week 6 | -0.6 score on a scale | Standard Deviation 0.47 |
Secondary
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 216 | -11.5 mg/L | Standard Deviation 20.22 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 96 | -10.1 mg/L | Standard Deviation 17.74 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 24 | -9.4 mg/L | Standard Deviation 17.38 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 192 | -9.4 mg/L | Standard Deviation 23.81 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 108 | -9.8 mg/L | Standard Deviation 21.56 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 6 | -7.9 mg/L | Standard Deviation 21.74 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 180 | -10.0 mg/L | Standard Deviation 19.41 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 120 | -8.4 mg/L | Standard Deviation 18.27 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 276 | -10.5 mg/L | Standard Deviation 18.04 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 168 | -7.7 mg/L | Standard Deviation 18.37 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 132 | -8.9 mg/L | Standard Deviation 15.19 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 36 | -9.5 mg/L | Standard Deviation 18.62 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 156 | -8.6 mg/L | Standard Deviation 16.6 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 144 | -7.3 mg/L | Standard Deviation 17.15 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 204 | -8.4 mg/L | Standard Deviation 28.9 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 264 | -11.2 mg/L | Standard Deviation 21.02 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 48 | -8.8 mg/L | Standard Deviation 17.5 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 300 | -11.1 mg/L | Standard Deviation 14.63 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 252 | -10.4 mg/L | Standard Deviation 19.33 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 60 | -9.6 mg/L | Standard Deviation 17.78 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 12 | -9.0 mg/L | Standard Deviation 18.96 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 240 | -10.6 mg/L | Standard Deviation 24.45 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 72 | -9.2 mg/L | Standard Deviation 19.42 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 312 | -10.3 mg/L | Standard Deviation 22.22 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 228 | -11.0 mg/L | Standard Deviation 20.71 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 84 | -8.3 mg/L | Standard Deviation 24.66 |
| Upadacitinib Never Titrated | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 288 | -10.6 mg/L | Standard Deviation 16.09 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 312 | -12.0 mg/L | Standard Deviation 21.14 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 204 | -9.6 mg/L | Standard Deviation 21.29 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 6 | -10.0 mg/L | Standard Deviation 21.95 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 12 | -10.7 mg/L | Standard Deviation 20.94 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 24 | -7.2 mg/L | Standard Deviation 36.97 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 36 | -11.1 mg/L | Standard Deviation 22.03 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 48 | -10.2 mg/L | Standard Deviation 22.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 60 | -10.3 mg/L | Standard Deviation 22.1 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 72 | -9.9 mg/L | Standard Deviation 22.95 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 84 | -10.0 mg/L | Standard Deviation 28.56 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 96 | -10.3 mg/L | Standard Deviation 22.36 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 108 | -10.7 mg/L | Standard Deviation 19.36 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 120 | -10.9 mg/L | Standard Deviation 19.63 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 132 | -9.0 mg/L | Standard Deviation 21.32 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 144 | -9.9 mg/L | Standard Deviation 23.45 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 156 | -6.0 mg/L | Standard Deviation 52.17 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 168 | -7.5 mg/L | Standard Deviation 28.96 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 180 | -10.3 mg/L | Standard Deviation 21.44 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 192 | -9.9 mg/L | Standard Deviation 21.04 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 216 | -10.0 mg/L | Standard Deviation 22.42 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 228 | -12.2 mg/L | Standard Deviation 20.89 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 240 | -9.1 mg/L | Standard Deviation 22.38 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 252 | -9.4 mg/L | Standard Deviation 24.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 264 | -9.9 mg/L | Standard Deviation 23.99 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 276 | -11.2 mg/L | Standard Deviation 20.2 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 288 | -12.9 mg/L | Standard Deviation 21.85 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 300 | -11.4 mg/L | Standard Deviation 21.67 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 204 | -9.0 mg/L | Standard Deviation 19.07 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 84 | -10.2 mg/L | Standard Deviation 16.57 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 12 | -12.8 mg/L | Standard Deviation 26.93 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 216 | -8.4 mg/L | Standard Deviation 19.7 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 72 | -11.2 mg/L | Standard Deviation 20.16 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 192 | -9.3 mg/L | Standard Deviation 20.07 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 228 | -10.0 mg/L | Standard Deviation 17.46 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 60 | -11.0 mg/L | Standard Deviation 21.62 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 288 | -7.5 mg/L | Standard Deviation 14.48 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 240 | -9.2 mg/L | Standard Deviation 17.55 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 48 | -13.3 mg/L | Standard Deviation 22.69 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 6 | -13.0 mg/L | Standard Deviation 29 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 252 | -9.9 mg/L | Standard Deviation 18.83 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 36 | -13.5 mg/L | Standard Deviation 28.34 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 312 | -8.7 mg/L | Standard Deviation 15.19 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 144 | -5.9 mg/L | Standard Deviation 26.82 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 132 | -9.3 mg/L | Standard Deviation 17.53 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 264 | -11.1 mg/L | Standard Deviation 18.19 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 156 | -10.9 mg/L | Standard Deviation 18.2 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 120 | -9.2 mg/L | Standard Deviation 18.62 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 24 | -9.1 mg/L | Standard Deviation 29.38 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 168 | -8.8 mg/L | Standard Deviation 17.88 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 108 | -10.8 mg/L | Standard Deviation 17.39 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 300 | -11.0 mg/L | Standard Deviation 19.69 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 180 | -9.2 mg/L | Standard Deviation 19.16 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 96 | -11.1 mg/L | Standard Deviation 17.61 |
| Upadacitinib Titrated Up and Down | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Week 276 | -10.9 mg/L | Standard Deviation 17.95 |
Secondary
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at Baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 36 | 10.1 score on a scale | Standard Deviation 10.59 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 216 | 11.4 score on a scale | Standard Deviation 11.93 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 132 | 11.4 score on a scale | Standard Deviation 10.13 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 312 | 10.7 score on a scale | Standard Deviation 11.24 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 6 | 9.5 score on a scale | Standard Deviation 10.5 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 144 | 9.9 score on a scale | Standard Deviation 11.36 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 276 | 12.1 score on a scale | Standard Deviation 10.98 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 204 | 11.3 score on a scale | Standard Deviation 10.56 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 156 | 10.6 score on a scale | Standard Deviation 10.94 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 48 | 10.4 score on a scale | Standard Deviation 10.58 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 192 | 10.8 score on a scale | Standard Deviation 10.5 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 168 | 10.8 score on a scale | Standard Deviation 12.27 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 300 | 11.1 score on a scale | Standard Deviation 11.14 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 180 | 11.0 score on a scale | Standard Deviation 11.59 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 264 | 11.6 score on a scale | Standard Deviation 10.95 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 72 | 10.8 score on a scale | Standard Deviation 9.55 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 24 | 10.7 score on a scale | Standard Deviation 10.04 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 252 | 11.5 score on a scale | Standard Deviation 10.83 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 96 | 10.3 score on a scale | Standard Deviation 10.45 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 12 | 9.9 score on a scale | Standard Deviation 10.49 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 240 | 11.9 score on a scale | Standard Deviation 10.93 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 108 | 10.5 score on a scale | Standard Deviation 10.49 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 288 | 11.6 score on a scale | Standard Deviation 10.88 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 228 | 11.0 score on a scale | Standard Deviation 11.25 |
| Upadacitinib Never Titrated | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 120 | 11.0 score on a scale | Standard Deviation 10.76 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 204 | 10.2 score on a scale | Standard Deviation 13.01 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 6 | 9.0 score on a scale | Standard Deviation 9.69 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 12 | 8.7 score on a scale | Standard Deviation 10.87 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 24 | 10.6 score on a scale | Standard Deviation 11.6 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 36 | 10.0 score on a scale | Standard Deviation 11.58 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 48 | 10.8 score on a scale | Standard Deviation 10.44 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 72 | 10.9 score on a scale | Standard Deviation 10.64 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 96 | 11.7 score on a scale | Standard Deviation 12.72 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 108 | 11.9 score on a scale | Standard Deviation 12.08 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 120 | 11.6 score on a scale | Standard Deviation 11.95 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 132 | 10.7 score on a scale | Standard Deviation 11.47 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 144 | 11.2 score on a scale | Standard Deviation 12.09 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 156 | 11.2 score on a scale | Standard Deviation 11.48 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 168 | 10.6 score on a scale | Standard Deviation 12.46 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 180 | 9.6 score on a scale | Standard Deviation 13.56 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 192 | 10.9 score on a scale | Standard Deviation 11.82 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 216 | 10.4 score on a scale | Standard Deviation 13.92 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 228 | 10.8 score on a scale | Standard Deviation 14 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 240 | 11.4 score on a scale | Standard Deviation 13.08 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 252 | 10.2 score on a scale | Standard Deviation 13.68 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 264 | 10.7 score on a scale | Standard Deviation 12.52 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 276 | 9.2 score on a scale | Standard Deviation 13.02 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 288 | 12.3 score on a scale | Standard Deviation 11.83 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 300 | 9.7 score on a scale | Standard Deviation 13.12 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 312 | 11.6 score on a scale | Standard Deviation 12.67 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 216 | 10.1 score on a scale | Standard Deviation 12.87 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 108 | 7.9 score on a scale | Standard Deviation 10.62 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 6 | 8.8 score on a scale | Standard Deviation 9.26 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 228 | 11.1 score on a scale | Standard Deviation 13.18 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 96 | 9.5 score on a scale | Standard Deviation 11.27 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 288 | 9.0 score on a scale | Standard Deviation 13.94 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 240 | 9.2 score on a scale | Standard Deviation 13.81 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 72 | 9.2 score on a scale | Standard Deviation 11.44 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 12 | 8.6 score on a scale | Standard Deviation 10.43 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 252 | 8.4 score on a scale | Standard Deviation 13.48 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 48 | 8.4 score on a scale | Standard Deviation 10.83 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 312 | 8.6 score on a scale | Standard Deviation 14.35 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 264 | 7.8 score on a scale | Standard Deviation 13.94 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 36 | 8.0 score on a scale | Standard Deviation 11.5 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 168 | 11.4 score on a scale | Standard Deviation 13.18 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 300 | 7.0 score on a scale | Standard Deviation 13.46 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 180 | 11.4 score on a scale | Standard Deviation 12.45 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 156 | 8.6 score on a scale | Standard Deviation 12.32 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 276 | 7.3 score on a scale | Standard Deviation 13.02 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 192 | 11.5 score on a scale | Standard Deviation 13.27 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 144 | 9.8 score on a scale | Standard Deviation 11.67 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 132 | 10.7 score on a scale | Standard Deviation 10.36 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 204 | 11.2 score on a scale | Standard Deviation 12.7 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 120 | 10.7 score on a scale | Standard Deviation 11.3 |
| Upadacitinib Titrated Up and Down | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | Week 24 | 8.3 score on a scale | Standard Deviation 9.65 |
Secondary
Change From Baseline in Patient's Assessment of Pain Over Time
Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates no pain and a score of 100 mm indicates worst possible pain.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at Baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 108 | -43.6 score on a scale | Standard Deviation 26.28 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 312 | -44.1 score on a scale | Standard Deviation 25.87 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 216 | -42.2 score on a scale | Standard Deviation 28.01 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 120 | -43.0 score on a scale | Standard Deviation 26.67 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 6 | -38.5 score on a scale | Standard Deviation 27.16 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 204 | -44.4 score on a scale | Standard Deviation 25.26 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 132 | -42.2 score on a scale | Standard Deviation 26.89 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 48 | -42.4 score on a scale | Standard Deviation 26.5 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 192 | -41.6 score on a scale | Standard Deviation 27.9 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 144 | -41.7 score on a scale | Standard Deviation 27.02 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 300 | -43.0 score on a scale | Standard Deviation 25.18 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 180 | -42.7 score on a scale | Standard Deviation 26.54 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 156 | -43.5 score on a scale | Standard Deviation 25.72 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 276 | -46.3 score on a scale | Standard Deviation 24.53 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 168 | -43.6 score on a scale | Standard Deviation 27.19 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 24 | -42.2 score on a scale | Standard Deviation 25.41 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 60 | -41.9 score on a scale | Standard Deviation 27.89 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 264 | -44.0 score on a scale | Standard Deviation 25.43 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 12 | -41.3 score on a scale | Standard Deviation 26.07 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 72 | -42.5 score on a scale | Standard Deviation 24.76 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 252 | -44.4 score on a scale | Standard Deviation 27.49 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 84 | -42.1 score on a scale | Standard Deviation 25.87 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 288 | -46.2 score on a scale | Standard Deviation 25.61 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 240 | -43.4 score on a scale | Standard Deviation 27.78 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 96 | -40.5 score on a scale | Standard Deviation 28.02 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 36 | -40.6 score on a scale | Standard Deviation 26.41 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Assessment of Pain Over Time | Week 228 | -45.1 score on a scale | Standard Deviation 24.96 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 276 | -35.6 score on a scale | Standard Deviation 27.39 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 6 | -29.9 score on a scale | Standard Deviation 24.46 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 12 | -29.9 score on a scale | Standard Deviation 26.2 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 24 | -30.9 score on a scale | Standard Deviation 28.77 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 36 | -34.6 score on a scale | Standard Deviation 26.56 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 48 | -31.9 score on a scale | Standard Deviation 28.73 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 60 | -32.2 score on a scale | Standard Deviation 26.5 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 72 | -32.0 score on a scale | Standard Deviation 25.38 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 84 | -33.3 score on a scale | Standard Deviation 26.52 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 96 | -34.2 score on a scale | Standard Deviation 26.14 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 108 | -33.9 score on a scale | Standard Deviation 27.6 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 120 | -36.2 score on a scale | Standard Deviation 27.69 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 132 | -36.7 score on a scale | Standard Deviation 26.71 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 144 | -36.7 score on a scale | Standard Deviation 27.14 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 156 | -37.4 score on a scale | Standard Deviation 25.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 168 | -38.8 score on a scale | Standard Deviation 27.67 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 180 | -33.6 score on a scale | Standard Deviation 30.24 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 192 | -33.8 score on a scale | Standard Deviation 29.13 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 204 | -33.4 score on a scale | Standard Deviation 33.05 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 216 | -32.5 score on a scale | Standard Deviation 32.06 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 228 | -29.6 score on a scale | Standard Deviation 35.17 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 240 | -34.1 score on a scale | Standard Deviation 31.98 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 252 | -34.3 score on a scale | Standard Deviation 28.12 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 264 | -35.6 score on a scale | Standard Deviation 31.33 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 288 | -37.6 score on a scale | Standard Deviation 28.74 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 300 | -34.7 score on a scale | Standard Deviation 32.36 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 312 | -40.3 score on a scale | Standard Deviation 27.37 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 108 | -36.3 score on a scale | Standard Deviation 23.12 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 6 | -30.0 score on a scale | Standard Deviation 26.37 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 216 | -33.6 score on a scale | Standard Deviation 25.98 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 96 | -37.6 score on a scale | Standard Deviation 20.15 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 288 | -33.3 score on a scale | Standard Deviation 23.3 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 228 | -39.8 score on a scale | Standard Deviation 24.7 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 84 | -43.0 score on a scale | Standard Deviation 20.51 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 12 | -31.9 score on a scale | Standard Deviation 20.23 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 240 | -36.1 score on a scale | Standard Deviation 25.38 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 72 | -31.4 score on a scale | Standard Deviation 22.95 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 312 | -33.4 score on a scale | Standard Deviation 30.11 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 252 | -38.3 score on a scale | Standard Deviation 24.92 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 60 | -38.6 score on a scale | Standard Deviation 23.34 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 300 | -29.9 score on a scale | Standard Deviation 30.21 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 264 | -38.2 score on a scale | Standard Deviation 24.11 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 156 | -34.6 score on a scale | Standard Deviation 24.91 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 48 | -32.6 score on a scale | Standard Deviation 23.67 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 168 | -41.6 score on a scale | Standard Deviation 25.76 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 144 | -33.8 score on a scale | Standard Deviation 24.6 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 36 | -34.8 score on a scale | Standard Deviation 21.83 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 180 | -36.5 score on a scale | Standard Deviation 29.2 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 132 | -34.4 score on a scale | Standard Deviation 27.27 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 276 | -34.1 score on a scale | Standard Deviation 26.8 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 192 | -39.9 score on a scale | Standard Deviation 25.44 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 120 | -41.9 score on a scale | Standard Deviation 21.4 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 24 | -36.0 score on a scale | Standard Deviation 21.73 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Assessment of Pain Over Time | Week 204 | -41.9 score on a scale | Standard Deviation 22.39 |
Secondary
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at Baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 108 | -40.8 score on a scale | Standard Deviation 29.75 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 6 | -35.4 score on a scale | Standard Deviation 29.83 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 216 | -39.0 score on a scale | Standard Deviation 32.18 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 120 | -40.6 score on a scale | Standard Deviation 29.76 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 12 | -37.5 score on a scale | Standard Deviation 29 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 204 | -42.0 score on a scale | Standard Deviation 29.28 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 132 | -40.1 score on a scale | Standard Deviation 29.99 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 48 | -39.2 score on a scale | Standard Deviation 30.36 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 192 | -41.0 score on a scale | Standard Deviation 28.73 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 144 | -37.7 score on a scale | Standard Deviation 30.73 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 300 | -38.8 score on a scale | Standard Deviation 29.04 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 180 | -40.3 score on a scale | Standard Deviation 29.52 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 156 | -39.7 score on a scale | Standard Deviation 32.65 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 276 | -42.4 score on a scale | Standard Deviation 27.53 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 168 | -42.7 score on a scale | Standard Deviation 29.04 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 60 | -40.8 score on a scale | Standard Deviation 28.95 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 24 | -36.9 score on a scale | Standard Deviation 28.97 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 264 | -38.5 score on a scale | Standard Deviation 31.53 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 72 | -40.3 score on a scale | Standard Deviation 27.36 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 312 | -36.5 score on a scale | Standard Deviation 32.1 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 252 | -40.6 score on a scale | Standard Deviation 32.12 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 84 | -40.1 score on a scale | Standard Deviation 30.37 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 288 | -43.3 score on a scale | Standard Deviation 27.99 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 240 | -41.9 score on a scale | Standard Deviation 30.43 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 96 | -38.1 score on a scale | Standard Deviation 30.34 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 36 | -37.1 score on a scale | Standard Deviation 30.36 |
| Upadacitinib Never Titrated | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 228 | -38.4 score on a scale | Standard Deviation 32.29 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 276 | -36.8 score on a scale | Standard Deviation 29.4 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 6 | -27.2 score on a scale | Standard Deviation 27.74 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 12 | -29.2 score on a scale | Standard Deviation 28.05 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 24 | -30.4 score on a scale | Standard Deviation 31.16 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 36 | -32.6 score on a scale | Standard Deviation 28.62 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 48 | -30.7 score on a scale | Standard Deviation 30.46 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 60 | -34.4 score on a scale | Standard Deviation 28.36 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 72 | -32.1 score on a scale | Standard Deviation 30.19 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 84 | -32.0 score on a scale | Standard Deviation 31.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 96 | -33.5 score on a scale | Standard Deviation 33.51 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 108 | -35.0 score on a scale | Standard Deviation 29.93 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 120 | -32.4 score on a scale | Standard Deviation 32.91 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 132 | -37.0 score on a scale | Standard Deviation 28.43 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 144 | -36.8 score on a scale | Standard Deviation 28.24 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 156 | -36.9 score on a scale | Standard Deviation 25.93 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 168 | -37.9 score on a scale | Standard Deviation 29.1 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 180 | -30.7 score on a scale | Standard Deviation 33.34 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 192 | -33.4 score on a scale | Standard Deviation 33.3 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 204 | -33.2 score on a scale | Standard Deviation 34 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 216 | -32.5 score on a scale | Standard Deviation 30.72 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 228 | -28.5 score on a scale | Standard Deviation 37.86 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 240 | -37.6 score on a scale | Standard Deviation 28.56 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 252 | -33.8 score on a scale | Standard Deviation 31.76 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 264 | -31.6 score on a scale | Standard Deviation 34.26 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 288 | -38.5 score on a scale | Standard Deviation 32.21 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 300 | -33.4 score on a scale | Standard Deviation 34.89 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 312 | -39.4 score on a scale | Standard Deviation 30.6 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 204 | -43.7 score on a scale | Standard Deviation 25.6 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 108 | -32.1 score on a scale | Standard Deviation 20.65 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 6 | -26.1 score on a scale | Standard Deviation 27.46 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 96 | -33.5 score on a scale | Standard Deviation 22.08 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 288 | -32.2 score on a scale | Standard Deviation 28.16 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 228 | -40.1 score on a scale | Standard Deviation 24.11 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 84 | -39.4 score on a scale | Standard Deviation 21.35 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 12 | -31.3 score on a scale | Standard Deviation 23.13 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 240 | -33.3 score on a scale | Standard Deviation 29.03 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 72 | -26.3 score on a scale | Standard Deviation 30.7 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 312 | -37.7 score on a scale | Standard Deviation 29.67 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 252 | -33.5 score on a scale | Standard Deviation 35.96 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 60 | -38.3 score on a scale | Standard Deviation 24.46 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 300 | -31.6 score on a scale | Standard Deviation 25.93 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 264 | -32.7 score on a scale | Standard Deviation 34.87 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 156 | -38.6 score on a scale | Standard Deviation 21.61 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 48 | -23.6 score on a scale | Standard Deviation 26.58 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 168 | -39.0 score on a scale | Standard Deviation 32.84 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 144 | -33.9 score on a scale | Standard Deviation 29.68 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 36 | -34.9 score on a scale | Standard Deviation 26 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 180 | -33.3 score on a scale | Standard Deviation 34.03 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 132 | -38.4 score on a scale | Standard Deviation 27.02 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 276 | -26.0 score on a scale | Standard Deviation 33.79 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 192 | -42.1 score on a scale | Standard Deviation 23.97 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 120 | -36.6 score on a scale | Standard Deviation 28.02 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 24 | -32.9 score on a scale | Standard Deviation 25.63 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | Week 216 | -35.6 score on a scale | Standard Deviation 27.03 |
Secondary
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates no disease activity and 100 mm indicates severe disease activity
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at Baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 108 | -55.5 score on a scale | Standard Deviation 16.72 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 312 | -58.7 score on a scale | Standard Deviation 16.12 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 216 | -58.3 score on a scale | Standard Deviation 16.5 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 120 | -55.9 score on a scale | Standard Deviation 16.38 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 6 | -46.8 score on a scale | Standard Deviation 20.58 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 204 | -58.0 score on a scale | Standard Deviation 16.73 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 132 | -56.1 score on a scale | Standard Deviation 16.6 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 48 | -52.8 score on a scale | Standard Deviation 19.12 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 192 | -56.3 score on a scale | Standard Deviation 17.25 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 144 | -56.7 score on a scale | Standard Deviation 15.79 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 300 | -56.8 score on a scale | Standard Deviation 17.93 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 180 | -57.2 score on a scale | Standard Deviation 17.11 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 156 | -57.0 score on a scale | Standard Deviation 16.9 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 276 | -56.9 score on a scale | Standard Deviation 16.79 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 168 | -57.0 score on a scale | Standard Deviation 15.94 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 60 | -54.2 score on a scale | Standard Deviation 16.44 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 24 | -51.2 score on a scale | Standard Deviation 18.71 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 264 | -56.5 score on a scale | Standard Deviation 16.68 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 72 | -53.4 score on a scale | Standard Deviation 17.46 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 12 | -48.9 score on a scale | Standard Deviation 20.45 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 252 | -57.2 score on a scale | Standard Deviation 17.56 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 84 | -54.3 score on a scale | Standard Deviation 16.44 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 288 | -57.3 score on a scale | Standard Deviation 18.97 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 240 | -58.1 score on a scale | Standard Deviation 17.63 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 96 | -52.3 score on a scale | Standard Deviation 17.69 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 36 | -51.6 score on a scale | Standard Deviation 19.08 |
| Upadacitinib Never Titrated | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 228 | -56.3 score on a scale | Standard Deviation 19.63 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 276 | -53.5 score on a scale | Standard Deviation 17.07 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 6 | -35.5 score on a scale | Standard Deviation 21.53 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 12 | -39.1 score on a scale | Standard Deviation 22.99 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 24 | -42.5 score on a scale | Standard Deviation 21.24 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 36 | -42.7 score on a scale | Standard Deviation 20.96 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 48 | -45.6 score on a scale | Standard Deviation 19.29 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 60 | -47.1 score on a scale | Standard Deviation 19.64 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 72 | -45.9 score on a scale | Standard Deviation 18.58 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 84 | -43.4 score on a scale | Standard Deviation 21.41 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 96 | -45.7 score on a scale | Standard Deviation 20.42 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 108 | -45.9 score on a scale | Standard Deviation 18.75 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 120 | -48.6 score on a scale | Standard Deviation 18.23 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 132 | -50.1 score on a scale | Standard Deviation 17.19 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 144 | -48.2 score on a scale | Standard Deviation 18.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 156 | -48.9 score on a scale | Standard Deviation 18.89 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 168 | -51.9 score on a scale | Standard Deviation 20.24 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 180 | -53.0 score on a scale | Standard Deviation 18.04 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 192 | -52.1 score on a scale | Standard Deviation 16.56 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 204 | -52.9 score on a scale | Standard Deviation 18.09 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 216 | -50.8 score on a scale | Standard Deviation 18.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 228 | -53.2 score on a scale | Standard Deviation 17.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 240 | -52.8 score on a scale | Standard Deviation 16.04 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 252 | -53.9 score on a scale | Standard Deviation 17.1 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 264 | -50.4 score on a scale | Standard Deviation 18.09 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 288 | -56.3 score on a scale | Standard Deviation 17.25 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 300 | -52.9 score on a scale | Standard Deviation 17.33 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 312 | -55.2 score on a scale | Standard Deviation 17.19 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 108 | -47.4 score on a scale | Standard Deviation 21.09 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 6 | -38.4 score on a scale | Standard Deviation 24.08 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 216 | -51.3 score on a scale | Standard Deviation 20.42 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 96 | -46.8 score on a scale | Standard Deviation 20.97 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 288 | -49.4 score on a scale | Standard Deviation 16.31 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 228 | -55.0 score on a scale | Standard Deviation 19.69 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 84 | -48.5 score on a scale | Standard Deviation 17.25 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 12 | -37.5 score on a scale | Standard Deviation 21.78 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 240 | -49.6 score on a scale | Standard Deviation 18.67 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 72 | -47.2 score on a scale | Standard Deviation 18.47 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 312 | -49.4 score on a scale | Standard Deviation 17.96 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 252 | -52.2 score on a scale | Standard Deviation 18.12 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 60 | -44.7 score on a scale | Standard Deviation 24.33 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 300 | -53.6 score on a scale | Standard Deviation 17.36 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 264 | -46.4 score on a scale | Standard Deviation 18.6 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 156 | -52.4 score on a scale | Standard Deviation 19.49 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 48 | -40.6 score on a scale | Standard Deviation 20.97 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 168 | -55.6 score on a scale | Standard Deviation 21.25 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 144 | -51.4 score on a scale | Standard Deviation 19.66 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 36 | -39.5 score on a scale | Standard Deviation 24.2 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 180 | -53.1 score on a scale | Standard Deviation 19.34 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 132 | -52.5 score on a scale | Standard Deviation 20.62 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 276 | -50.1 score on a scale | Standard Deviation 17.96 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 192 | -55.1 score on a scale | Standard Deviation 20.69 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 120 | -50.1 score on a scale | Standard Deviation 21.51 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 24 | -40.9 score on a scale | Standard Deviation 22.79 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | Week 204 | -54.7 score on a scale | Standard Deviation 19.5 |
Secondary
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at Baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 108 | -43.6 score on a scale | Standard Deviation 27.35 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 312 | -45.8 score on a scale | Standard Deviation 28.64 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 216 | -47.3 score on a scale | Standard Deviation 27.43 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 120 | -42.7 score on a scale | Standard Deviation 22.25 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 6 | -38.8 score on a scale | Standard Deviation 25.57 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 204 | -44.1 score on a scale | Standard Deviation 35.23 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 132 | -43.4 score on a scale | Standard Deviation 19.92 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 48 | -42.9 score on a scale | Standard Deviation 23.24 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 192 | -44.7 score on a scale | Standard Deviation 30.13 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 144 | -41.7 score on a scale | Standard Deviation 22.6 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 300 | -47.4 score on a scale | Standard Deviation 20.47 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 180 | -45.6 score on a scale | Standard Deviation 26.65 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 156 | -42.8 score on a scale | Standard Deviation 21.64 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 276 | -46.3 score on a scale | Standard Deviation 20.01 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 168 | -43.7 score on a scale | Standard Deviation 23.75 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 60 | -44.3 score on a scale | Standard Deviation 24.21 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 24 | -42.0 score on a scale | Standard Deviation 23.35 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 264 | -44.9 score on a scale | Standard Deviation 24.26 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 72 | -43.4 score on a scale | Standard Deviation 24.62 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 12 | -40.6 score on a scale | Standard Deviation 24.84 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 252 | -45.9 score on a scale | Standard Deviation 25.86 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 84 | -42.7 score on a scale | Standard Deviation 28.14 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 288 | -47.1 score on a scale | Standard Deviation 22.36 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 240 | -46.8 score on a scale | Standard Deviation 31.4 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 96 | -42.0 score on a scale | Standard Deviation 18.5 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 36 | -41.8 score on a scale | Standard Deviation 25.1 |
| Upadacitinib Never Titrated | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 228 | -46.0 score on a scale | Standard Deviation 27.33 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 276 | -44.2 score on a scale | Standard Deviation 26.93 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 6 | -37.2 score on a scale | Standard Deviation 27.36 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 12 | -38.6 score on a scale | Standard Deviation 26.09 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 24 | -36.7 score on a scale | Standard Deviation 43.09 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 36 | -41.6 score on a scale | Standard Deviation 25.59 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 48 | -41.6 score on a scale | Standard Deviation 25.26 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 60 | -42.5 score on a scale | Standard Deviation 24.51 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 72 | -41.9 score on a scale | Standard Deviation 27.31 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 84 | -39.0 score on a scale | Standard Deviation 31.94 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 96 | -42.4 score on a scale | Standard Deviation 27.17 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 108 | -42.9 score on a scale | Standard Deviation 24.31 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 120 | -43.7 score on a scale | Standard Deviation 25.88 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 132 | -41.4 score on a scale | Standard Deviation 27.64 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 144 | -43.0 score on a scale | Standard Deviation 29.91 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 156 | -43.6 score on a scale | Standard Deviation 29.88 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 168 | -43.2 score on a scale | Standard Deviation 28.55 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 180 | -45.0 score on a scale | Standard Deviation 27.57 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 192 | -44.4 score on a scale | Standard Deviation 27.94 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 204 | -43.5 score on a scale | Standard Deviation 28.81 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 216 | -44.2 score on a scale | Standard Deviation 26.69 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 228 | -47.9 score on a scale | Standard Deviation 28.86 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 240 | -44.2 score on a scale | Standard Deviation 29.63 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 252 | -45.7 score on a scale | Standard Deviation 29.98 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 264 | -43.5 score on a scale | Standard Deviation 30.06 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 288 | -48.3 score on a scale | Standard Deviation 30.14 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 300 | -41.6 score on a scale | Standard Deviation 26.38 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 312 | -45.8 score on a scale | Standard Deviation 28.89 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 108 | -44.0 score on a scale | Standard Deviation 21.38 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 6 | -40.8 score on a scale | Standard Deviation 29.76 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 216 | -47.4 score on a scale | Standard Deviation 23.26 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 96 | -43.2 score on a scale | Standard Deviation 22.39 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 288 | -41.6 score on a scale | Standard Deviation 17.15 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 228 | -48.6 score on a scale | Standard Deviation 21.47 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 84 | -44.7 score on a scale | Standard Deviation 20.79 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 12 | -41.7 score on a scale | Standard Deviation 30.24 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 240 | -45.0 score on a scale | Standard Deviation 21.97 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 72 | -41.8 score on a scale | Standard Deviation 21.19 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 312 | -41.2 score on a scale | Standard Deviation 17.55 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 252 | -44.3 score on a scale | Standard Deviation 23.5 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 60 | -41.4 score on a scale | Standard Deviation 22.38 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 300 | -42.7 score on a scale | Standard Deviation 19.05 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 264 | -44.4 score on a scale | Standard Deviation 21.96 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 156 | -48.0 score on a scale | Standard Deviation 23.98 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 48 | -44.6 score on a scale | Standard Deviation 29.09 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 168 | -46.4 score on a scale | Standard Deviation 23.28 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 144 | -46.0 score on a scale | Standard Deviation 25.2 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 36 | -44.5 score on a scale | Standard Deviation 31.98 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 180 | -47.2 score on a scale | Standard Deviation 24.08 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 132 | -44.2 score on a scale | Standard Deviation 23.86 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 276 | -47.4 score on a scale | Standard Deviation 20.53 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 192 | -48.5 score on a scale | Standard Deviation 25.36 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 120 | -43.4 score on a scale | Standard Deviation 23.39 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 24 | -38.2 score on a scale | Standard Deviation 33.62 |
| Upadacitinib Titrated Up and Down | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | Week 204 | -47.6 score on a scale | Standard Deviation 24.55 |
Secondary
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Sixty-six joints were assessed by an evaluator for swelling. The presence of swelling was scored as a 1 and absence of swelling as a 0. The total swollen joint count is the sum of the scores, and ranges from 0 to 66 (worst).
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 108 | -15.2 joints | Standard Deviation 8.72 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 312 | -16.7 joints | Standard Deviation 9.71 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 216 | -16.6 joints | Standard Deviation 10.29 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 120 | -15.6 joints | Standard Deviation 8.77 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 6 | -12.8 joints | Standard Deviation 7.76 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 204 | -16.7 joints | Standard Deviation 10.6 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 132 | -15.7 joints | Standard Deviation 9.23 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 48 | -15.3 joints | Standard Deviation 9.47 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 192 | -16.4 joints | Standard Deviation 9.87 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 144 | -15.9 joints | Standard Deviation 9.03 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 300 | -16.7 joints | Standard Deviation 10.21 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 180 | -16.6 joints | Standard Deviation 10.67 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 156 | -16.1 joints | Standard Deviation 9.74 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 276 | -17.8 joints | Standard Deviation 11.35 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 168 | -16.9 joints | Standard Deviation 11.11 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 60 | -15.6 joints | Standard Deviation 9.52 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 24 | -14.2 joints | Standard Deviation 8.31 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 264 | -17.7 joints | Standard Deviation 11.38 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 72 | -15.1 joints | Standard Deviation 8.5 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 12 | -13.7 joints | Standard Deviation 7.95 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 252 | -16.8 joints | Standard Deviation 10.63 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 84 | -15.6 joints | Standard Deviation 9.18 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 288 | -17.4 joints | Standard Deviation 11.28 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 240 | -16.8 joints | Standard Deviation 10.41 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 96 | -15.3 joints | Standard Deviation 9.27 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 36 | -14.1 joints | Standard Deviation 8.26 |
| Upadacitinib Never Titrated | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 228 | -16.2 joints | Standard Deviation 9.51 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 276 | -17.0 joints | Standard Deviation 10.6 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 6 | -13.5 joints | Standard Deviation 10.89 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 12 | -13.9 joints | Standard Deviation 11.26 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 24 | -14.7 joints | Standard Deviation 10.87 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 36 | -15.1 joints | Standard Deviation 10.39 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 48 | -15.4 joints | Standard Deviation 11.19 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 60 | -15.9 joints | Standard Deviation 11.83 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 72 | -15.5 joints | Standard Deviation 10.47 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 84 | -14.7 joints | Standard Deviation 9.96 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 96 | -14.7 joints | Standard Deviation 9.48 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 108 | -15.2 joints | Standard Deviation 10.17 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 120 | -14.8 joints | Standard Deviation 9.06 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 132 | -14.6 joints | Standard Deviation 9.79 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 144 | -15.3 joints | Standard Deviation 9.81 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 156 | -15.5 joints | Standard Deviation 9.53 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 168 | -15.8 joints | Standard Deviation 10.51 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 180 | -16.2 joints | Standard Deviation 10.61 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 192 | -15.8 joints | Standard Deviation 9.23 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 204 | -15.9 joints | Standard Deviation 9.53 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 216 | -16.1 joints | Standard Deviation 8.86 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 228 | -17.3 joints | Standard Deviation 10.79 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 240 | -17.0 joints | Standard Deviation 10.43 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 252 | -16.9 joints | Standard Deviation 9.37 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 264 | -16.1 joints | Standard Deviation 8.72 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 288 | -17.8 joints | Standard Deviation 11.76 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 300 | -17.1 joints | Standard Deviation 10.31 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 312 | -17.4 joints | Standard Deviation 10.41 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 108 | -16.6 joints | Standard Deviation 6.96 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 6 | -14.5 joints | Standard Deviation 8.7 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 216 | -20.4 joints | Standard Deviation 10.12 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 96 | -16.6 joints | Standard Deviation 6.79 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 288 | -18.7 joints | Standard Deviation 7.67 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 228 | -19.8 joints | Standard Deviation 10.16 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 84 | -17.0 joints | Standard Deviation 6.68 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 12 | -13.5 joints | Standard Deviation 6.72 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 240 | -18.8 joints | Standard Deviation 7.86 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 72 | -17.0 joints | Standard Deviation 6.31 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 312 | -18.6 joints | Standard Deviation 7.51 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 252 | -18.1 joints | Standard Deviation 7.78 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 60 | -17.4 joints | Standard Deviation 9.36 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 300 | -19.3 joints | Standard Deviation 7.72 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 264 | -18.3 joints | Standard Deviation 7.55 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 156 | -17.5 joints | Standard Deviation 7.89 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 48 | -16.0 joints | Standard Deviation 6.1 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 168 | -20.0 joints | Standard Deviation 9.94 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 144 | -18.6 joints | Standard Deviation 7.17 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 36 | -15.6 joints | Standard Deviation 5.94 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 180 | -20.0 joints | Standard Deviation 9.91 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 132 | -17.3 joints | Standard Deviation 7.11 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 276 | -18.9 joints | Standard Deviation 7.74 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 192 | -20.7 joints | Standard Deviation 10.08 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 120 | -17.5 joints | Standard Deviation 7.15 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 24 | -15.7 joints | Standard Deviation 5.67 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Week 204 | -19.6 joints | Standard Deviation 10.22 |
Secondary
Change From Baseline in Tender Joint Count (TJC68) Over Time
Sixty-eight joints were assessed by an evaluator for tenderness or pain. The presence of tenderness was scored as a 1 and absence of tenderness as a 0. The total tender joint count is the sum of the scores, and ranges from 0 to 68 (worst).
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 108 | -23.3 joints | Standard Deviation 12.62 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 36 | -21.7 joints | Standard Deviation 12.58 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 216 | -24.2 joints | Standard Deviation 13.82 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 120 | -23.1 joints | Standard Deviation 13.13 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 24 | -22.0 joints | Standard Deviation 12.96 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 204 | -24.2 joints | Standard Deviation 13.77 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 132 | -23.1 joints | Standard Deviation 12.79 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 48 | -23.1 joints | Standard Deviation 13.61 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 192 | -24.0 joints | Standard Deviation 13.75 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 144 | -23.5 joints | Standard Deviation 13.28 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 6 | -20.6 joints | Standard Deviation 12.81 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 180 | -23.7 joints | Standard Deviation 13.6 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 156 | -23.7 joints | Standard Deviation 13.21 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 276 | -23.6 joints | Standard Deviation 13.55 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 168 | -24.1 joints | Standard Deviation 13.82 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 60 | -23.6 joints | Standard Deviation 13.56 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 312 | -24.1 joints | Standard Deviation 13.82 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 264 | -23.7 joints | Standard Deviation 13.56 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 72 | -23.3 joints | Standard Deviation 13.06 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 288 | -24.9 joints | Standard Deviation 14.42 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 252 | -24.2 joints | Standard Deviation 13.78 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 84 | -23.2 joints | Standard Deviation 12.71 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 12 | -21.3 joints | Standard Deviation 12.47 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 240 | -24.7 joints | Standard Deviation 14.09 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 96 | -23.1 joints | Standard Deviation 12.9 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 300 | -24.3 joints | Standard Deviation 14.04 |
| Upadacitinib Never Titrated | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 228 | -23.9 joints | Standard Deviation 13.57 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 276 | -23.9 joints | Standard Deviation 13.76 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 36 | -24.2 joints | Standard Deviation 14.45 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 24 | -23.9 joints | Standard Deviation 14.6 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 6 | -21.3 joints | Standard Deviation 14.53 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 12 | -22.5 joints | Standard Deviation 14.65 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 48 | -24.1 joints | Standard Deviation 14.43 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 60 | -25.0 joints | Standard Deviation 14.42 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 72 | -24.3 joints | Standard Deviation 14.48 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 84 | -23.4 joints | Standard Deviation 14.23 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 96 | -23.9 joints | Standard Deviation 14.58 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 108 | -23.7 joints | Standard Deviation 14.22 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 120 | -23.9 joints | Standard Deviation 14.17 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 132 | -23.7 joints | Standard Deviation 13.95 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 144 | -23.8 joints | Standard Deviation 13.5 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 156 | -23.9 joints | Standard Deviation 13 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 168 | -24.4 joints | Standard Deviation 13.86 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 180 | -24.9 joints | Standard Deviation 14.12 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 192 | -24.4 joints | Standard Deviation 14.15 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 204 | -23.6 joints | Standard Deviation 14.35 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 216 | -24.1 joints | Standard Deviation 13.87 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 228 | -26.6 joints | Standard Deviation 14.65 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 240 | -25.6 joints | Standard Deviation 14.47 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 252 | -25.6 joints | Standard Deviation 14.14 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 264 | -23.7 joints | Standard Deviation 13.28 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 288 | -25.7 joints | Standard Deviation 14.87 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 300 | -24.5 joints | Standard Deviation 15.18 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 312 | -23.2 joints | Standard Deviation 14.08 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 108 | -25.2 joints | Standard Deviation 12.31 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 36 | -23.4 joints | Standard Deviation 13.56 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 216 | -31.6 joints | Standard Deviation 13.8 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 96 | -24.6 joints | Standard Deviation 11.94 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 288 | -26.6 joints | Standard Deviation 14.42 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 228 | -30.5 joints | Standard Deviation 13.69 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 84 | -27.4 joints | Standard Deviation 13.32 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 24 | -22.9 joints | Standard Deviation 12.17 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 240 | -29.4 joints | Standard Deviation 14.28 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 72 | -26.1 joints | Standard Deviation 13.12 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 312 | -26.8 joints | Standard Deviation 14.48 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 252 | -27.5 joints | Standard Deviation 13.26 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 60 | -25.6 joints | Standard Deviation 13.54 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 300 | -28.2 joints | Standard Deviation 14.1 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 264 | -27.0 joints | Standard Deviation 13.76 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 156 | -28.1 joints | Standard Deviation 13.63 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 48 | -24.0 joints | Standard Deviation 13.13 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 168 | -31.0 joints | Standard Deviation 14.12 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 144 | -29.3 joints | Standard Deviation 13.19 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 12 | -20.5 joints | Standard Deviation 11.18 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 180 | -29.5 joints | Standard Deviation 12.96 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 132 | -26.8 joints | Standard Deviation 13.74 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 276 | -28.0 joints | Standard Deviation 14.41 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 192 | -31.3 joints | Standard Deviation 13.8 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 120 | -26.9 joints | Standard Deviation 12.72 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 6 | -22.1 joints | Standard Deviation 12.9 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Tender Joint Count (TJC68) Over Time | Week 204 | -30.4 joints | Standard Deviation 14.53 |
Secondary
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
RA-WIS is a tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23. A score \< 10 means low risk, scores between 10 and 17 indicate medium risk, and scores \> 17 indicate high risk of work instability. A negative change from Baseline indicates improvement in work instability.
Time frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population who were currently working at Baseline and at each visit visit and with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 36 | -6.8 score on a scale | Standard Deviation 6.29 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 216 | -6.0 score on a scale | Standard Deviation 7.55 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 132 | -7.2 score on a scale | Standard Deviation 6.04 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 312 | -4.2 score on a scale | Standard Deviation 7 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 6 | -6.2 score on a scale | Standard Deviation 5.55 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 144 | -5.9 score on a scale | Standard Deviation 6.51 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 276 | -5.0 score on a scale | Standard Deviation 6.74 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 204 | -6.4 score on a scale | Standard Deviation 7.06 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 156 | -6.2 score on a scale | Standard Deviation 7.13 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 48 | -6.8 score on a scale | Standard Deviation 5.94 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 192 | -5.5 score on a scale | Standard Deviation 6.42 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 168 | -5.8 score on a scale | Standard Deviation 6.01 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 300 | -4.6 score on a scale | Standard Deviation 7.23 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 180 | -5.3 score on a scale | Standard Deviation 6.61 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 264 | -5.0 score on a scale | Standard Deviation 6.53 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 72 | -7.5 score on a scale | Standard Deviation 6.83 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 24 | -7.0 score on a scale | Standard Deviation 6.51 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 252 | -5.8 score on a scale | Standard Deviation 6.43 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 96 | -6.5 score on a scale | Standard Deviation 6.72 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 12 | -6.6 score on a scale | Standard Deviation 6.16 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 240 | -5.9 score on a scale | Standard Deviation 7.05 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 108 | -6.8 score on a scale | Standard Deviation 6.8 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 288 | -5.0 score on a scale | Standard Deviation 7.05 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 228 | -6.5 score on a scale | Standard Deviation 7.16 |
| Upadacitinib Never Titrated | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 120 | -7.6 score on a scale | Standard Deviation 6.66 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 204 | -3.7 score on a scale | Standard Deviation 7.52 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 6 | -3.3 score on a scale | Standard Deviation 5.51 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 12 | -4.0 score on a scale | Standard Deviation 6.32 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 24 | -4.6 score on a scale | Standard Deviation 6.63 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 36 | -4.6 score on a scale | Standard Deviation 6.21 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 48 | -5.0 score on a scale | Standard Deviation 6.47 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 72 | -4.8 score on a scale | Standard Deviation 6.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 96 | -6.3 score on a scale | Standard Deviation 7.55 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 108 | -6.5 score on a scale | Standard Deviation 6.71 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 120 | -5.1 score on a scale | Standard Deviation 7.38 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 132 | -5.6 score on a scale | Standard Deviation 6.99 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 144 | -5.6 score on a scale | Standard Deviation 7.65 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 156 | -4.3 score on a scale | Standard Deviation 7.62 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 168 | -4.3 score on a scale | Standard Deviation 6.96 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 180 | -3.5 score on a scale | Standard Deviation 7.03 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 192 | -3.5 score on a scale | Standard Deviation 7.36 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 216 | -3.4 score on a scale | Standard Deviation 7.11 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 228 | -1.9 score on a scale | Standard Deviation 7.55 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 240 | -3.1 score on a scale | Standard Deviation 7.61 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 252 | -2.0 score on a scale | Standard Deviation 8.05 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 264 | -3.4 score on a scale | Standard Deviation 8 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 276 | -2.7 score on a scale | Standard Deviation 8.27 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 288 | -4.8 score on a scale | Standard Deviation 7.38 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 300 | -4.3 score on a scale | Standard Deviation 8.51 |
| Upadacitinib Titrated Up and Not Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 312 | -3.9 score on a scale | Standard Deviation 8.37 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 216 | -5.0 score on a scale | Standard Deviation 2.92 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 108 | -3.5 score on a scale | Standard Deviation 4.8 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 6 | -4.1 score on a scale | Standard Deviation 3 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 228 | -4.6 score on a scale | Standard Deviation 4.24 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 96 | -4.0 score on a scale | Standard Deviation 4.18 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 288 | -4.8 score on a scale | Standard Deviation 3.45 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 240 | -4.5 score on a scale | Standard Deviation 4.09 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 72 | -4.3 score on a scale | Standard Deviation 4.1 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 12 | -4.2 score on a scale | Standard Deviation 3.35 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 252 | -5.0 score on a scale | Standard Deviation 3.7 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 48 | -3.5 score on a scale | Standard Deviation 4.98 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 312 | -2.9 score on a scale | Standard Deviation 4.45 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 264 | -4.5 score on a scale | Standard Deviation 3.89 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 36 | -3.3 score on a scale | Standard Deviation 6.18 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 168 | -5.1 score on a scale | Standard Deviation 6.69 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 300 | -4.6 score on a scale | Standard Deviation 4.07 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 180 | -4.2 score on a scale | Standard Deviation 3.19 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 156 | -4.9 score on a scale | Standard Deviation 3.72 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 276 | -5.0 score on a scale | Standard Deviation 2.52 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 192 | -4.3 score on a scale | Standard Deviation 2.93 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 144 | -4.3 score on a scale | Standard Deviation 3.41 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 132 | -4.7 score on a scale | Standard Deviation 3.47 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 204 | -5.0 score on a scale | Standard Deviation 3.78 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 120 | -5.7 score on a scale | Standard Deviation 4.44 |
| Upadacitinib Titrated Up and Down | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | Week 24 | -3.6 score on a scale | Standard Deviation 3.53 |
Secondary
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Time frame: Vaccination Baseline and 4 and 12 weeks after vaccination
Population: Sub-study full analysis set with available data at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 1: Week 12 | 8.07 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 9V: Week 4 | 5.69 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 5: Week 4 | 1.90 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 9V: Week 12 | 6.18 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 3: Week 12 | 2.26 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 14: Week 4 | 2.97 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 5: Week 12 | 1.84 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 14: Week 12 | 2.84 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 1: Week 4 | 7.90 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 18C: Week 4 | 4.52 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 18C: Week 12 | 4.42 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 6B: Week 4 | 4.50 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 19A: Week 4 | 1.47 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 4: Week 4 | 5.61 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 19A: Week 12 | 1.44 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 6B: Week 12 | 3.90 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 19F: Week 4 | 2.27 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 3: Week 4 | 2.59 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 19F: Week 12 | 2.17 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 7F: Week 4 | 3.58 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 23F: Week 4 | 4.32 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 4: Week 12 | 5.17 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 23F: Week 12 | 4.06 fold-rise |
| Upadacitinib Never Titrated | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 7F: Week 12 | 3.30 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 23F: Week 12 | 3.29 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 1: Week 4 | 6.53 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 1: Week 12 | 6.54 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 3: Week 4 | 2.30 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 3: Week 12 | 2.24 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 4: Week 4 | 3.82 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 4: Week 12 | 3.39 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 5: Week 4 | 1.60 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 5: Week 12 | 1.57 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 6B: Week 4 | 3.10 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 6B: Week 12 | 3.25 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 7F: Week 4 | 2.83 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 7F: Week 12 | 3.02 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 9V: Week 4 | 2.76 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 9V: Week 12 | 2.91 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 14: Week 4 | 2.42 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 14: Week 12 | 2.41 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 18C: Week 12 | 3.53 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 19A: Week 4 | 1.12 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 19A: Week 12 | 1.15 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 19F: Week 4 | 2.32 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 19F: Week 12 | 1.99 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 23F: Week 4 | 3.11 fold-rise |
| Upadacitinib Titrated Up and Not Down | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Antigen 18C: Week 4 | 3.23 fold-rise |
Secondary
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Clinical remission is defined as a CDAI score ≤ 2.8.
Time frame: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 216 | 46.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 108 | 44.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 312 | 50.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 204 | 51.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 120 | 43.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 276 | 53.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 192 | 46.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 132 | 46.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 48 | 34.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 180 | 48.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 144 | 38.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 300 | 51.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 168 | 48.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 156 | 47.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 264 | 48.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 24 | 28.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 60 | 43.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 12 | 26.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 252 | 52.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 72 | 43.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 6 | 23.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 240 | 51.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 84 | 43.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 288 | 51.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 228 | 44.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 96 | 40.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 36 | 32.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 72 | 12.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 6 | 4.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 12 | 6.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 24 | 12.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 36 | 9.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 48 | 11.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 156 | 14.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 60 | 13.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 84 | 12.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 96 | 15.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 108 | 16.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 120 | 12.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 132 | 18.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 144 | 14.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 168 | 20.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 180 | 15.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 192 | 18.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 204 | 20.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 216 | 21.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 228 | 25.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 240 | 24.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 252 | 19.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 264 | 20.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 276 | 24.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 288 | 25.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 300 | 22.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 312 | 27.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 96 | 21.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 24 | 14.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 216 | 28.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 84 | 18.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 6 | 10.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 228 | 31.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 72 | 9.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 288 | 28.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 240 | 31.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 60 | 22.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 12 | 8.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 252 | 22.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 48 | 11.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 312 | 34.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 156 | 32.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 144 | 28.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 264 | 17.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 168 | 33.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 132 | 33.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 36 | 17.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 180 | 20.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 120 | 22.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 300 | 29.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 192 | 24.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 108 | 18.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 276 | 28.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 204 | 34.5 percentage of participants |
Secondary
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission is defined as a DAS28(CRP) score \< 2.6.
Time frame: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 108 | 74.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 312 | 72.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 216 | 79.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 120 | 74.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 6 | 53.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 204 | 77.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 132 | 73.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 48 | 66.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 192 | 76.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 144 | 71.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 300 | 75.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 180 | 75.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 156 | 74.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 276 | 76.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 168 | 77.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 60 | 72.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 24 | 60.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 264 | 73.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 72 | 69.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 12 | 56.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 252 | 80.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 84 | 72.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 288 | 74.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 240 | 75.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 96 | 71.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 36 | 65.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 228 | 80.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 276 | 50.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 6 | 21.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 12 | 25.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 24 | 31.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 36 | 35.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 48 | 36.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 60 | 38.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 72 | 35.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 84 | 36.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 96 | 45.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 108 | 42.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 120 | 49.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 132 | 40.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 144 | 44.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 156 | 50.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 168 | 49.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 180 | 44.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 192 | 47.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 204 | 47.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 216 | 56.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 228 | 49.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 240 | 50.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 252 | 44.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 264 | 39.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 288 | 47.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 300 | 43.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 312 | 45.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 108 | 47.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 6 | 29.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 216 | 53.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 96 | 52.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 288 | 48.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 228 | 69.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 84 | 52.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 12 | 27.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 240 | 69.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 72 | 51.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 312 | 63.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 252 | 58.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 60 | 50.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 300 | 55.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 264 | 67.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 156 | 65.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 48 | 35.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 168 | 66.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 144 | 60.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 36 | 50.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 180 | 56.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 132 | 61.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 276 | 52.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 192 | 55.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 120 | 45.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 24 | 38.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 204 | 76.7 percentage of participants |
Secondary
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. Clinical remission is defined as a SDAI score ≤ 3.3.
Time frame: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 6 | 15.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 216 | 32.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 120 | 33.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 288 | 35.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 204 | 37.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 132 | 33.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 48 | 25.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 192 | 32.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 144 | 26.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 312 | 30.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 180 | 33.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 156 | 33.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 276 | 35.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 168 | 31.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 60 | 32.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 24 | 18.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 264 | 32.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 72 | 31.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 12 | 17.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 252 | 39.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 84 | 32.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 300 | 34.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 240 | 34.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 96 | 28.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 36 | 23.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 228 | 30.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 108 | 31.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 240 | 14.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 12 | 2.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 24 | 6.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 36 | 4.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 48 | 7.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 60 | 12.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 72 | 9.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 84 | 8.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 96 | 13.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 108 | 10.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 120 | 8.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 132 | 10.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 144 | 5.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 156 | 7.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 168 | 11.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 180 | 10.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 192 | 12.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 204 | 11.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 216 | 10.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 228 | 16.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 6 | 4.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 252 | 12.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 264 | 11.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 276 | 17.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 288 | 19.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 300 | 16.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 312 | 15.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 6 | 2.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 216 | 10.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 96 | 18.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 288 | 8.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 228 | 24.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 84 | 12.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 24 | 11.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 240 | 10.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 72 | 9.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 312 | 26.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 252 | 16.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 60 | 13.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 300 | 26.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 264 | 7.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 156 | 28.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 48 | 8.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 168 | 26.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 144 | 14.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 12 | 5.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 180 | 13.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 132 | 20.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 276 | 20.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 192 | 14.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 120 | 12.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 36 | 8.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 204 | 24.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 108 | 12.1 percentage of participants |
Secondary
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score ≤ 10.
Time frame: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 108 | 85.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 312 | 86.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 216 | 88.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 120 | 87.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 6 | 65.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 204 | 89.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 132 | 87.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 48 | 83.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 192 | 88.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 144 | 88.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 300 | 89.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 180 | 88.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 156 | 88.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 276 | 87.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 168 | 90.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 60 | 85.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 24 | 80.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 264 | 83.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 72 | 85.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 12 | 71.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 252 | 89.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 84 | 84.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 288 | 90.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 240 | 87.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 96 | 81.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 36 | 77.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 228 | 89.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 276 | 67.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 6 | 35.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 12 | 39.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 24 | 46.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 36 | 44.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 48 | 50.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 60 | 58.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 72 | 46.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 84 | 52.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 96 | 63.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 108 | 67.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 120 | 67.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 132 | 72.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 144 | 68.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 156 | 73.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 168 | 82.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 180 | 73.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 192 | 70.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 204 | 71.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 216 | 70.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 228 | 67.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 240 | 72.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 252 | 73.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 264 | 63.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 288 | 74.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 300 | 72.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 312 | 70.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 108 | 54.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 6 | 35.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 216 | 78.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 96 | 57.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 288 | 75.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 228 | 79.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 84 | 75.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 12 | 32.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 240 | 75.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 72 | 60.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 312 | 73.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 252 | 74.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 60 | 63.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 300 | 70.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 264 | 75.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 156 | 71.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 48 | 38.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 168 | 83.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 144 | 78.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 36 | 57.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 180 | 76.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 132 | 76.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 276 | 67.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 192 | 79.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 120 | 77.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 24 | 51.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | Week 204 | 82.8 percentage of participants |
Secondary
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. LDA is defined as a DAS28(CRP) score ≤ 3.2.
Time frame: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 108 | 88.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 312 | 84.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 216 | 89.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 120 | 85.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 6 | 70.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 204 | 88.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 132 | 88.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 48 | 86.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 192 | 89.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 144 | 85.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 300 | 94.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 180 | 90.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 156 | 86.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 276 | 91.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 168 | 90.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 60 | 86.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 24 | 82.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 264 | 86.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 72 | 84.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 12 | 77.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 252 | 91.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 84 | 88.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 288 | 90.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 240 | 89.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 96 | 82.4 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 36 | 80.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 228 | 89.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 276 | 74.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 6 | 43.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 12 | 43.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 24 | 48.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 36 | 50.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 48 | 54.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 60 | 56.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 72 | 51.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 84 | 60.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 96 | 64.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 108 | 66.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 120 | 69.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 132 | 70.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 144 | 68.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 156 | 74.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 168 | 78.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 180 | 69.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 192 | 75.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 204 | 61.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 216 | 70.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 228 | 70.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 240 | 75.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 252 | 67.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 264 | 67.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 288 | 71.7 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 300 | 67.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 312 | 68.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 108 | 70.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 6 | 43.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 216 | 82.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 96 | 79.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 288 | 76.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 228 | 86.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 84 | 85.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 12 | 43.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 240 | 86.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 72 | 69.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 312 | 70.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 252 | 83.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 60 | 66.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 300 | 80.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 264 | 82.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 156 | 86.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 48 | 56.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 168 | 80.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 144 | 82.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 36 | 55.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 180 | 80.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 132 | 87.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 276 | 72.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 192 | 96.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 120 | 77.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 24 | 52.8 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | Week 204 | 83.3 percentage of participants |
Secondary
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. LDA is defined as a SDAI score ≤ 11.0.
Time frame: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Population: Open-label treated population with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 108 | 75.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 312 | 72.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 216 | 79.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 120 | 74.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 6 | 54.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 204 | 71.3 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 132 | 77.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 48 | 73.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 192 | 76.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 144 | 70.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 300 | 78.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 180 | 78.7 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 156 | 75.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 276 | 78.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 168 | 75.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 60 | 72.9 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 24 | 66.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 264 | 71.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 72 | 71.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 12 | 61.1 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 252 | 79.0 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 84 | 74.6 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 288 | 74.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 240 | 74.5 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 96 | 71.2 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 36 | 67.8 percentage of participants |
| Upadacitinib Never Titrated | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 228 | 77.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 276 | 56.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 6 | 25.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 12 | 33.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 24 | 33.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 36 | 34.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 48 | 38.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 60 | 41.1 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 72 | 36.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 84 | 40.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 96 | 45.8 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 108 | 51.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 120 | 55.2 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 132 | 43.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 144 | 44.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 156 | 58.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 168 | 59.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 180 | 55.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 192 | 52.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 204 | 52.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 216 | 56.3 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 228 | 56.4 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 240 | 50.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 252 | 52.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 264 | 51.9 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 288 | 56.5 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 300 | 50.0 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 312 | 48.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 108 | 54.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 6 | 32.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 216 | 57.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 96 | 51.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 288 | 68.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 228 | 69.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 84 | 62.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 12 | 23.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 240 | 69.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 72 | 51.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 312 | 65.4 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 252 | 61.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 60 | 61.1 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 300 | 63.2 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 264 | 67.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 156 | 64.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 48 | 41.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 168 | 66.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 144 | 67.9 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 36 | 48.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 180 | 53.3 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 132 | 66.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 276 | 56.0 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 192 | 66.7 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 120 | 64.5 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 24 | 48.6 percentage of participants |
| Upadacitinib Titrated Up and Down | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | Week 204 | 79.3 percentage of participants |
Secondary
Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination
Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
Time frame: Vaccination Baseline and 12 weeks after vaccination
Population: The sub-study full analysis set (FAS) included all participants enrolled in the sub-study who received PCV-13 vaccination and at least 1 dose of upadacitinib 15 mg or 30 mg after vaccination during the sub-study. Analysis includes participants with available data at the Week 12 visit of the sub-study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Upadacitinib Never Titrated | Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination | 64.6 percentage of participants |
| Upadacitinib Titrated Up and Not Down | Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination | 54.5 percentage of participants |