Psoriatic Arthritis
Conditions
Keywords
psoriatic arthritis, radiographic changes, active comparator, tofacitinib
Brief summary
This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.
Interventions
Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months
DRUGTofacitinib 10 mg BID
Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
DRUGAdalimumab
Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
DRUGPlacebo
Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females, aged \>= 18 years at time of consent. * Have a diagnosis of Psoriatic arthritis (PsA) of \>= 6 months * Meet the Classification Criteria of PsA (CASPAR) at time of screening * Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD). * Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required * Must not have taken a biologic Tumour Necrosis Factor Inhibitor * Must have 3 or more swollen joints AND 3 or more tender joints * Must have active psoriasis skin lesions
Exclusion criteria
* Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed * Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception * New York Heart Association Class III and IV congestive heart failure * History of hypersensitivity or infusion reaction to biologic agents * Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 | At end of Month 3 | ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP). |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | From Baseline to Month 3 | The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | ACR50 was calculated as a ≥50% improvement from baseline in tender/painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. |
| Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | ACR70 was calculated as a ≥70% improvement from baseline in tender/painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. . |
| Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | At Week 2 and Months 1, 2, 4, 6, 9, and 12 | ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12 | The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. |
| Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels | From Baseline to end of Month 3 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain | From Baseline to end of Month 3 | Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. |
| Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis | From Baseline to end of Month 3 | Participant answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly). |
| Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis | From Baseline to end of Month 3 | The blinded investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor). |
| Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count | From Baseline to end of Month 3 | Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling. |
| Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count | From Baseline to end of Month 3 | Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful. |
| Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count. |
| Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | From Baseline to Months 1, 3, 6, 9, and 12 | The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). |
| Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | At Months 1, 3, 6, 9, and 12 | PASI determines psoriasis severity based on lesion severity & percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, & scaling, evaluated separately for head & neck, upper limbs, trunk, & lower limbs & rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis & is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score & can vary in increments of 0.1 & range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI. |
| Change From Baseline in Dactylitis Severity Score (DSS) | From Baseline to Months 1, 3, 6, 9, and 12 | Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=no tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a patient is 0-60. Higher score indicates greater degree of tenderness. |
| Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | From Baseline to Months 1, 3, 6, 9, and 12 | The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. |
| Change From Baseline in the Leeds Enthesitis Index (LEI) | From Baseline to Months 1, 3, 6, 9, and 12 | Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0-6. Higher score indicates a greater number of sites that are affected by enthesitis. |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | From Baseline to Months 1, 3, 6, 9, and 12 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status. |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | From Baseline to Months 1, 3, 6, 9, and 12 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status. |
| Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis | From Baseline to Month 12 | Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | From Baseline to Months 1, 3, 6, 9, and 12 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning. |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | From Baseline to Months 1, 3, 6, 9, and 12 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain. |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | From Baseline to Months 1, 3, 6, 9, and 12 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions. |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | From Baseline to Months 1, 3, 6, 9, and 12 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality. |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | From Baseline to Months 1, 3, 6, 9, and 12 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning. |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | From Baseline to Months 1, 3, 6, 9, and 12 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning. |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | From Baseline to Months 1, 3, 6, 9, and 12 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning. |
| Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | From Baseline to Months 1, 3, 6, 9, and 12 | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. |
| Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | From Baseline to Months 1, 3, 6, 9, and 12 | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. |
| Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | From Baseline to Months 1, 3, 6, 9, and 12 | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. |
| Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | From Baseline to Months 1, 3, 6, 9, and 12 | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. |
| Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | From Baseline to Months 1, 3, 6, 9, and 12 | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. |
| Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | From Baseline to Months 1, 3, 6, 9, and 12 | The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | From Baseline to Months 1, 3, 6, 9, and 12 | FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (washed out), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | From Baseline to Months 1, 3, 6, 9, and 12 | FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (washed out), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | From Baseline to Months 1, 3, 6, 9, and 12 | FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (washed out), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning. |
| Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | From Baseline to Months 1, 3, 6, 9, and 12 | BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity. |
| Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | From Baseline to Months 1, 3, 6, 9, and 12 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning. |
| Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12 | At Month 12 | Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS \>0.5 from baseline. |
Countries
Australia, Belgium, Bulgaria, Canada, Czechia, France, Germany, Hungary, Mexico, Poland, Russia, Slovakia, Spain, Taiwan, United Kingdom, United States
Participant flow
Pre-assignment details
Of 611 participants screened for entry into the study, 422 received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib, 5 mg, Twice Daily Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks. | 107 |
| Tofacitinib, 10 mg, Twice Daily Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. | 104 |
| Adalimumab, 40 mg, Every 2 Weeks Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks. | 106 |
| Placebo/Tofacitinib, 5 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks. | 52 |
| Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks. | 53 |
| Total | 422 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse event related to study drug | 2 | 2 | 2 | 2 | 1 |
| Overall Study | Adverse event unrelated to study drug | 4 | 1 | 2 | 0 | 1 |
| Overall Study | Death | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Insufficient clinical response | 0 | 1 | 2 | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 1 | 0 | 0 |
| Overall Study | No longer met study criteria | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Other | 1 | 1 | 1 | 1 | 3 |
| Overall Study | Protocol Violation | 1 | 1 | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | Tofacitinib, 5 mg, Twice Daily | Tofacitinib, 10 mg, Twice Daily | Adalimumab, 40 mg, Every 2 Weeks | Placebo/Tofacitinib, 5 mg, Twice Daily | Placebo/Tofacitinib, 10 mg, Twice Daily | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 49.4 Years STANDARD_DEVIATION 12.6 | 46.9 Years STANDARD_DEVIATION 12.4 | 47.4 Years STANDARD_DEVIATION 11.3 | 46.1 Years STANDARD_DEVIATION 10.4 | 49.3 Years STANDARD_DEVIATION 13.8 | 47.9 Years STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 57 Participants | 62 Participants | 50 Participants | 28 Participants | 28 Participants | 225 Participants |
| Sex: Female, Male Male | 50 Participants | 42 Participants | 56 Participants | 24 Participants | 25 Participants | 197 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 31 / 107 | 43 / 104 | 43 / 106 | 15 / 52 | 22 / 53 |
| serious Total, serious adverse events | 8 / 107 | 4 / 104 | 9 / 106 | 3 / 52 | 4 / 53 |
Outcome results
Primary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.
Time frame: From Baseline to Month 3
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | -0.3499 Units on a scale | Standard Error 0.04665 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | -0.3998 Units on a scale | Standard Error 0.04716 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | -0.3808 Units on a scale | Standard Error 0.04767 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | -0.1802 Units on a scale | Standard Error 0.05031 |
p-value: 0.006295% CI: [-0.291, -0.0483]Mixed Models Analysis
p-value: 0.000495% CI: [-0.3411, -0.098]Mixed Models Analysis
p-value: 0.001295% CI: [-0.3213, -0.0797]Mixed Models Analysis
Primary
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3
ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).
Time frame: At end of Month 3
Population: All participants who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 | 50.47 Percentage or participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 | 60.58 Percentage or participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 | 51.89 Percentage or participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 | 33.33 Percentage or participants |
p-value: 0.010295% CI: [4.06, 30.21]Large sample approximation
p-value: <0.000195% CI: [14.22, 40.26]Large sample approximation
p-value: 0.005595% CI: [5.45, 31.66]Large sample approximation
Secondary
Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: From Baseline to end of Month 3
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels | -5.5981 mg/L | Standard Error 0.80656 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels | -6.6004 mg/L | Standard Error 0.80822 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels | -7.8955 mg/L | Standard Error 0.82547 |
| Placebo | Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels | -0.8643 mg/L | Standard Error 0.86304 |
Secondary
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain
Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Time frame: From Baseline to end of Month 3
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain | -21.49 mm | Standard Error 2.325 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain | -27.10 mm | Standard Error 2.342 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain | -21.87 mm | Standard Error 2.389 |
| Placebo | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain | -10.22 mm | Standard Error 2.499 |
Secondary
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis
Participant answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).
Time frame: From Baseline to end of Month 3
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis | -20.08 mm | Standard Error 2.275 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis | -25.50 mm | Standard Error 2.291 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis | -21.47 mm | Standard Error 2.328 |
| Placebo | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis | -11.40 mm | Standard Error 2.439 |
Secondary
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis
The blinded investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Time frame: From Baseline to end of Month 3
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis | -27.44 mm | Standard Error 1.998 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis | -33.74 mm | Standard Error 2.021 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis | -29.02 mm | Standard Error 2.043 |
| Placebo | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis | -22.26 mm | Standard Error 2.121 |
Secondary
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count
Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.
Time frame: From Baseline to end of Month 3
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count | -6.5 Joints | Standard Error 0.58 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count | -7.6 Joints | Standard Error 0.58 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count | -6.5 Joints | Standard Error 0.59 |
| Placebo | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count | -4.8 Joints | Standard Error 0.62 |
Secondary
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count
Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.
Time frame: From Baseline to end of Month 3
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count | -8.7 Joints | Standard Error 1.04 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count | -11.0 Joints | Standard Error 1.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count | -7.6 Joints | Standard Error 1.07 |
| Placebo | Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count | -6.9 Joints | Standard Error 1.1 |
Secondary
Change From Baseline in Dactylitis Severity Score (DSS)
Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=no tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a patient is 0-60. Higher score indicates greater degree of tenderness.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug with baseline DSS\>0 and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 9 (n=57, 59, 53, 27, 25, NA) | -7.0 Units on a scale | Standard Error 0.6 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 3 (n=58, 60 , 56, NA, NA, 55) | -3.5 Units on a scale | Standard Error 0.95 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 1 (n=58, 59, 56, NA, NA, 56) | -1.8 Units on a scale | Standard Error 0.91 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 12 (n=54, 58, 52, 26, 24, NA) | -7.4 Units on a scale | Standard Error 0.65 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 6 (n=58, 59, 55, 28, 25, NA) | -5.2 Units on a scale | Standard Error 1.01 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 3 (n=58, 60 , 56, NA, NA, 55) | -5.5 Units on a scale | Standard Error 0.91 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 9 (n=57, 59, 53, 27, 25, NA) | -7.2 Units on a scale | Standard Error 0.58 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 1 (n=58, 59, 56, NA, NA, 56) | -3.1 Units on a scale | Standard Error 0.87 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 12 (n=54, 58, 52, 26, 24, NA) | -7.5 Units on a scale | Standard Error 0.62 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 6 (n=58, 59, 55, 28, 25, NA) | -6.4 Units on a scale | Standard Error 0.99 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Dactylitis Severity Score (DSS) | Month 3 (n=58, 60 , 56, NA, NA, 55) | -4.0 Units on a scale | Standard Error 0.97 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Dactylitis Severity Score (DSS) | Month 9 (n=57, 59, 53, 27, 25, NA) | -6.5 Units on a scale | Standard Error 0.63 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Dactylitis Severity Score (DSS) | Month 12 (n=54, 58, 52, 26, 24, NA) | -6.1 Units on a scale | Standard Error 0.67 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Dactylitis Severity Score (DSS) | Month 6 (n=58, 59, 55, 28, 25, NA) | -5.4 Units on a scale | Standard Error 1.03 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Dactylitis Severity Score (DSS) | Month 1 (n=58, 59, 56, NA, NA, 56) | -2.1 Units on a scale | Standard Error 0.93 |
| Placebo | Change From Baseline in Dactylitis Severity Score (DSS) | Month 6 (n=58, 59, 55, 28, 25, NA) | -5.9 Units on a scale | Standard Error 1.45 |
| Placebo | Change From Baseline in Dactylitis Severity Score (DSS) | Month 1 (n=58, 59, 56, NA, NA, 56) | NA Units on a scale | — |
| Placebo | Change From Baseline in Dactylitis Severity Score (DSS) | Month 3 (n=58, 60 , 56, NA, NA, 55) | NA Units on a scale | — |
| Placebo | Change From Baseline in Dactylitis Severity Score (DSS) | Month 9 (n=57, 59, 53, 27, 25, NA) | -5.3 Units on a scale | Standard Error 0.87 |
| Placebo | Change From Baseline in Dactylitis Severity Score (DSS) | Month 12 (n=54, 58, 52, 26, 24, NA) | -6.7 Units on a scale | Standard Error 0.93 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 9 (n=57, 59, 53, 27, 25, NA) | -7.9 Units on a scale | Standard Error 0.89 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 1 (n=58, 59, 56, NA, NA, 56) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 12 (n=54, 58, 52, 26, 24, NA) | -7.7 Units on a scale | Standard Error 0.96 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 3 (n=58, 60 , 56, NA, NA, 55) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Dactylitis Severity Score (DSS) | Month 6 (n=58, 59, 55, 28, 25, NA) | -5.2 Units on a scale | Standard Error 1.5 |
| Placebo | Change From Baseline in Dactylitis Severity Score (DSS) | Month 1 (n=58, 59, 56, NA, NA, 56) | 0.6 Units on a scale | Standard Error 1.02 |
| Placebo | Change From Baseline in Dactylitis Severity Score (DSS) | Month 9 (n=57, 59, 53, 27, 25, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Dactylitis Severity Score (DSS) | Month 3 (n=58, 60 , 56, NA, NA, 55) | -2.0 Units on a scale | Standard Error 1.06 |
| Placebo | Change From Baseline in Dactylitis Severity Score (DSS) | Month 12 (n=54, 58, 52, 26, 24, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Dactylitis Severity Score (DSS) | Month 6 (n=58, 59, 55, 28, 25, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score
FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (washed out), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 3.6 Units on a scale | Standard Error 0.42 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 3 (n=102, 102, 101, NA, NA, 102) | 3.3 Units on a scale | Standard Error 0.38 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 1 (n=105, 103, 104, NA, NA, 103) | 2.4 Units on a scale | Standard Error 0.35 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 3.9 Units on a scale | Standard Error 0.44 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 6 (n=100, 100, 99,48, 48, NA) | 3.6 Units on a scale | Standard Error 0.4 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 3 (n=102, 102, 101, NA, NA, 102) | 2.8 Units on a scale | Standard Error 0.38 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 3.3 Units on a scale | Standard Error 0.42 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 1 (n=105, 103, 104, NA, NA, 103) | 2.1 Units on a scale | Standard Error 0.35 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 3.7 Units on a scale | Standard Error 0.44 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 6 (n=100, 100, 99,48, 48, NA) | 3.3 Units on a scale | Standard Error 0.4 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 3 (n=102, 102, 101, NA, NA, 102) | 2.9 Units on a scale | Standard Error 0.39 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 3.3 Units on a scale | Standard Error 0.43 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 3.2 Units on a scale | Standard Error 0.45 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 6 (n=100, 100, 99,48, 48, NA) | 3.2 Units on a scale | Standard Error 0.41 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 1 (n=105, 103, 104, NA, NA, 103) | 2.1 Units on a scale | Standard Error 0.36 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 6 (n=100, 100, 99,48, 48, NA) | 3.0 Units on a scale | Standard Error 0.57 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 3 (n=102, 102, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 2.7 Units on a scale | Standard Error 0.59 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 2.7 Units on a scale | Standard Error 0.63 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 3.9 Units on a scale | Standard Error 0.6 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 3.4 Units on a scale | Standard Error 0.63 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 3 (n=102, 102, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 6 (n=100, 100, 99,48, 48, NA) | 3.3 Units on a scale | Standard Error 0.58 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 1 (n=105, 103, 104, NA, NA, 103) | 1.2 Units on a scale | Standard Error 0.38 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 3 (n=102, 102, 101, NA, NA, 102) | 1.6 Units on a scale | Standard Error 0.41 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score | Month 6 (n=100, 100, 99,48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score
FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (washed out), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 4.3 Units on a scale | Standard Error 0.55 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 3 (n=102, 102, 101, NA, NA, 102) | 3.8 Units on a scale | Standard Error 0.52 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 1 (n=105, 103, 104, NA, NA, 103) | 2.9 Units on a scale | Standard Error 0.47 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 4.6 Units on a scale | Standard Error 0.57 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 6 (n=100, 100, 99,48, 48, NA) | 4.3 Units on a scale | Standard Error 0.53 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 3 (n=102, 102, 101, NA, NA, 102) | 3.2 Units on a scale | Standard Error 0.52 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 4.1 Units on a scale | Standard Error 0.55 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 1 (n=105, 103, 104, NA, NA, 103) | 2.3 Units on a scale | Standard Error 0.48 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 4.7 Units on a scale | Standard Error 0.57 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 6 (n=100, 100, 99,48, 48, NA) | 4.7 Units on a scale | Standard Error 0.53 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 3 (n=102, 102, 101, NA, NA, 102) | 3.2 Units on a scale | Standard Error 0.53 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 3.3 Units on a scale | Standard Error 0.56 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 3.7 Units on a scale | Standard Error 0.58 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 6 (n=100, 100, 99,48, 48, NA) | 3.4 Units on a scale | Standard Error 0.54 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 1 (n=105, 103, 104, NA, NA, 103) | 2.1 Units on a scale | Standard Error 0.49 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 6 (n=100, 100, 99,48, 48, NA) | 3.5 Units on a scale | Standard Error 0.75 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 3 (n=102, 102, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 2.8 Units on a scale | Standard Error 0.78 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 2.9 Units on a scale | Standard Error 0.82 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 4.6 Units on a scale | Standard Error 0.8 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 4.3 Units on a scale | Standard Error 0.82 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 3 (n=102, 102, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 6 (n=100, 100, 99,48, 48, NA) | 4.0 Units on a scale | Standard Error 0.76 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 1 (n=105, 103, 104, NA, NA, 103) | 1.5 Units on a scale | Standard Error 0.52 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 3 (n=102, 102, 101, NA, NA, 102) | 1.8 Units on a scale | Standard Error 0.56 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score | Month 6 (n=100, 100, 99,48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score
FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (washed out), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 1 (n=105, 103, 104, NA, NA, 103) | 5.2 Units on a scale | Standard Error 0.77 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 8.5 Units on a scale | Standard Error 0.95 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 7.9 Units on a scale | Standard Error 0.92 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 6 (n=100, 100, 99,48, 48, NA) | 7.9 Units on a scale | Standard Error 0.89 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 3 (102, 102, 101, NA, NA, 102) | 7.0 Units on a scale | Standard Error 0.85 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 8.4 Units on a scale | Standard Error 0.95 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 1 (n=105, 103, 104, NA, NA, 103) | 4.4 Units on a scale | Standard Error 0.78 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 3 (102, 102, 101, NA, NA, 102) | 6.0 Units on a scale | Standard Error 0.85 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 6 (n=100, 100, 99,48, 48, NA) | 8.0 Units on a scale | Standard Error 0.89 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 7.4 Units on a scale | Standard Error 0.92 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 1 (n=105, 103, 104, NA, NA, 103) | 4.2 Units on a scale | Standard Error 0.79 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 6 (n=100, 100, 99,48, 48, NA) | 6.5 Units on a scale | Standard Error 0.91 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 6.5 Units on a scale | Standard Error 0.94 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 6.9 Units on a scale | Standard Error 0.97 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 3 (102, 102, 101, NA, NA, 102) | 6.0 Units on a scale | Standard Error 0.87 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 3 (102, 102, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 6 (n=100, 100, 99,48, 48, NA) | 6.5 Units on a scale | Standard Error 1.26 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 5.7 Units on a scale | Standard Error 1.36 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 5.5 Units on a scale | Standard Error 1.31 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 6 (n=100, 100, 99,48, 48, NA) | 7.2 Units on a scale | Standard Error 1.28 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 3 (102, 102, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 12 (n=96, 96, 94, 44, 44, NA) | 7.6 Units on a scale | Standard Error 1.38 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 9 (n=99, 97, 96, 47, 46, NA) | 8.4 Units on a scale | Standard Error 1.33 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 3 (102, 102, 101, NA, NA, 102) | 3.3 Units on a scale | Standard Error 0.91 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 6 (n=100, 100, 99,48, 48, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 1 (n=105, 103, 104, NA, NA, 103) | 2.7 Units on a scale | Standard Error 0.84 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.
Time frame: From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 2 (n=106, 102, 103, NA, NA, 102) | -0.1842 Units on a scale | Standard Error 0.04131 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.4471 Units on a scale | Standard Error 0.05136 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.2048 Units on a scale | Standard Error 0.04363 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.5391 Units on a scale | Standard Error 0.05324 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 2 (n=104, 104, 104, NA, NA, 102) | -0.2713 Units on a scale | Standard Error 0.04626 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 9 (n=99, 96, 96, 47, 45, NA) | -0.5119 Units on a scale | Standard Error 0.05038 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 4 (n=102, 100, 102, 50, 50, NA) | -0.4231 Units on a scale | Standard Error 0.04982 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.2676 Units on a scale | Standard Error 0.04426 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 4 (n=102, 100, 102, 50, 50, NA) | -0.4407 Units on a scale | Standard Error 0.05039 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 2 (n=104, 104, 104, NA, NA, 102) | -0.4009 Units on a scale | Standard Error 0.04678 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.4611 Units on a scale | Standard Error 0.05179 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 2 (n=106, 102, 103, NA, NA, 102) | -0.2089 Units on a scale | Standard Error 0.04208 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.5104 Units on a scale | Standard Error 0.05365 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 9 (n=99, 96, 96, 47, 45, NA) | -0.4847 Units on a scale | Standard Error 0.05096 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 2 (n=104, 104, 104, NA, NA, 102) | -0.3736 Units on a scale | Standard Error 0.04719 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.3028 Units on a scale | Standard Error 0.04465 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 2 (n=106, 102, 103, NA, NA, 102) | -0.2129 Units on a scale | Standard Error 0.04246 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.4259 Units on a scale | Standard Error 0.05227 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 9 (n=99, 96, 96, 47, 45, NA) | -0.4304 Units on a scale | Standard Error 0.05143 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 4 (n=102, 100, 102, 50, 50, NA) | -0.3643 Units on a scale | Standard Error 0.05069 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.4478 Units on a scale | Standard Error 0.05426 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 4 (n=102, 100, 102, 50, 50, NA) | -0.2850 Units on a scale | Standard Error 0.07075 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 2 (n=106, 102, 103, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 2 (n=104, 104, 104, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.3142 Units on a scale | Standard Error 0.07315 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 9 (n=99, 96, 96, 47, 45, NA) | -0.3843 Units on a scale | Standard Error 0.07185 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.4104 Units on a scale | Standard Error 0.07646 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 2 (n=104, 104, 104, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.4569 Units on a scale | Standard Error 0.07704 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 2 (n=106, 102, 103, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 9 (n=99, 96, 96, 47, 45, NA) | -0.4839 Units on a scale | Standard Error 0.07276 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 4 (n=102, 100, 102, 50, 50, NA) | -0.3302 Units on a scale | Standard Error 0.07128 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.3841 Units on a scale | Standard Error 0.07369 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 6 (n=100, 100, 99, 48, 48, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 2 (n=104, 104, 104, NA, NA, 102) | -0.1682 Units on a scale | Standard Error 0.04998 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.1224 Units on a scale | Standard Error 0.04755 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 9 (n=99, 96, 96, 47, 45, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 2 (n=106, 102, 103, NA, NA, 102) | -0.0837 Units on a scale | Standard Error 0.04549 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Month 4 (n=102, 100, 102, 50, 50, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response
The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO\>0 and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 9 (n=95, 91, 94, 45, 44, NA) | -1.0 Units on a scale | Standard Error 0.09 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 3 (n=98, 97, 98, NA, NA, 98) | -1.0 Units on a scale | Standard Error 0.08 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 1 (n=100, 96, 100, NA, NA, 99) | -0.7 Units on a scale | Standard Error 0.07 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 12 (n=91, 90, 92, 41, 43, NA) | -1.2 Units on a scale | Standard Error 0.09 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 6 (n=96, 94, 96, 46, 46, NA) | -0.9 Units on a scale | Standard Error 0.09 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 3 (n=98, 97, 98, NA, NA, 98) | -1.2 Units on a scale | Standard Error 0.08 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 9 (n=95, 91, 94, 45, 44, NA) | -1.5 Units on a scale | Standard Error 0.09 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 1 (n=100, 96, 100, NA, NA, 99) | -0.8 Units on a scale | Standard Error 0.08 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 12 (n=91, 90, 92, 41, 43, NA) | -1.5 Units on a scale | Standard Error 0.09 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 6 (n=96, 94, 96, 46, 46, NA) | -1.3 Units on a scale | Standard Error 0.09 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 3 (n=98, 97, 98, NA, NA, 98) | -1.0 Units on a scale | Standard Error 0.09 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 9 (n=95, 91, 94, 45, 44, NA) | -1.2 Units on a scale | Standard Error 0.09 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 12 (n=91, 90, 92, 41, 43, NA) | -1.2 Units on a scale | Standard Error 0.09 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 6 (n=96, 94, 96, 46, 46, NA) | -1.2 Units on a scale | Standard Error 0.09 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 1 (n=100, 96, 100, NA, NA, 99) | -0.5 Units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 6 (n=96, 94, 96, 46, 46, NA) | -0.7 Units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 1 (n=100, 96, 100, NA, NA, 99) | NA Units on a scale | — |
| Placebo | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 3 (n=98, 97, 98, NA, NA, 98) | NA Units on a scale | — |
| Placebo | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 9 (n=95, 91, 94, 45, 44, NA) | -0.7 Units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 12 (n=91, 90, 92, 41, 43, NA) | -0.9 Units on a scale | Standard Error 0.13 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 9 (n=95, 91, 94, 45, 44, NA) | -1.3 Units on a scale | Standard Error 0.13 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 1 (n=100, 96, 100, NA, NA, 99) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 12 (n=91, 90, 92, 41, 43, NA) | -1.3 Units on a scale | Standard Error 0.13 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 3 (n=98, 97, 98, NA, NA, 98) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 6 (n=96, 94, 96, 46, 46, NA) | -0.9 Units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 1 (n=100, 96, 100, NA, NA, 99) | -0.2 Units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 9 (n=95, 91, 94, 45, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 3 (n=98, 97, 98, NA, NA, 98) | -0.4 Units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 12 (n=91, 90, 92, 41, 43, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response | Month 6 (n=96, 94, 96, 46, 46, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression
The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 3 (n=101, 103, 100, NA, NA, 102) | -0.25 Units on a scale | Standard Error 0.055 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.25 Units on a scale | Standard Error 0.051 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 3 (n=101, 103, 100, NA, NA, 102) | -0.17 Units on a scale | Standard Error 0.055 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.4 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.22 Units on a scale | Standard Error 0.052 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.4 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 3 (n=101, 103, 100, NA, NA, 102) | -0.32 Units on a scale | Standard Error 0.056 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.4 Units on a scale | Standard Error 0.06 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.4 Units on a scale | Standard Error 0.06 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.27 Units on a scale | Standard Error 0.053 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.3 Units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 3 (n=101, 103, 100, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.2 Units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.2 Units on a scale | Standard Error 0.08 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.08 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.3 Units on a scale | Standard Error 0.08 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 3 (n=101, 103, 100, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.2 Units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.21 Units on a scale | Standard Error 0.056 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 3 (n=101, 103, 100, NA, NA, 102) | -0.21 Units on a scale | Standard Error 0.059 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression | Month 6 (n=100, 100, 99, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility
The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 3 (n=101, 103, 101, NA, NA, 102) | -0.28 Units on a scale | Standard Error 0.047 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.07 Units on a scale | Standard Error 0.042 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 12 (n=96, 96, 94, 44,44, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 3 (n=101, 103, 101, NA, NA, 102) | -0.27 Units on a scale | Standard Error 0.047 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.19 Units on a scale | Standard Error 0.043 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 12 (n=96, 96, 94, 44,44, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 3 (n=101, 103, 101, NA, NA, 102) | -0.29 Units on a scale | Standard Error 0.048 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 12 (n=96, 96, 94, 44,44, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.2 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.15 Units on a scale | Standard Error 0.043 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 3 (n=101, 103, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 12 (n=96, 96, 94, 44,44, NA) | -0.4 Units on a scale | Standard Error 0.07 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 12 (n=96, 96, 94, 44,44, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 3 (n=101, 103, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.2 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.10 Units on a scale | Standard Error 0.046 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 3 (n=101, 103, 101, NA, NA, 102) | -0.11 Units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 12 (n=96, 96, 94, 44,44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility | Month 6 (n=100, 100, 99, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort
The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 3 (n=101, 103, 101, NA, NA, 102) | -0.25 Units on a scale | Standard Error 0.044 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.14 Units on a scale | Standard Error 0.039 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 3 (n=101, 103, 101, NA, NA, 102) | -0.27 Units on a scale | Standard Error 0.044 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.25 Units on a scale | Standard Error 0.04 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.4 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.4 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 3 (n=101, 103, 101, NA, NA, 102) | -0.28 Units on a scale | Standard Error 0.045 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.19 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 3 (n=101, 103, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.4 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.2 Units on a scale | Standard Error 0.07 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.4 Units on a scale | Standard Error 0.07 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 3 (n=101, 103, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 6 (n=100, 100, 99, 48, 48, NA) | -0.4 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 1 (n=105, 103, 104, NA, NA, 103) | -0.08 Units on a scale | Standard Error 0.043 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 3 (n=101, 103, 101, NA, NA, 102) | -0.08 Units on a scale | Standard Error 0.047 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort | Month 6 (n=100, 100, 99, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today
The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 9 (n=99, 97, 96, 47, 46, NA) | 19.2 mm | Standard Error 2.21 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 3 (n=101, 103, 101, NA, NA, 101) | 14.00 mm | Standard Error 2.1 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 1 (n=105, 103, 104, NA, NA, 103) | 10.75 mm | Standard Error 1.859 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 12 (n=96, 96, 94, 44, 44, NA) | 20.7 mm | Standard Error 2.09 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 6 (n=100, 100, 99, 48, 48, NA) | 19.5 mm | Standard Error 2.08 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 3 (n=101, 103, 101, NA, NA, 101) | 15.83 mm | Standard Error 2.092 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 9 (n=99, 97, 96, 47, 46, NA) | 15.9 mm | Standard Error 2.23 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 1 (n=105, 103, 104, NA, NA, 103) | 10.81 mm | Standard Error 1.88 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 12 (n=96, 96, 94, 44, 44, NA) | 19.8 mm | Standard Error 2.09 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 6 (n=100, 100, 99, 48, 48, NA) | 15.7 mm | Standard Error 2.09 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 3 (n=101, 103, 101, NA, NA, 101) | 13.10 mm | Standard Error 2.138 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 9 (n=99, 97, 96, 47, 46, NA) | 18.2 mm | Standard Error 2.26 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 12 (n=96, 96, 94, 44, 44, NA) | 16.5 mm | Standard Error 2.14 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 6 (n=100, 100, 99, 48, 48, NA) | 15.5 mm | Standard Error 2.12 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 1 (n=105, 103, 104, NA, NA, 103) | 10.27 mm | Standard Error 1.917 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 6 (n=100, 100, 99, 48, 48, NA) | 14.7 mm | Standard Error 2.97 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 1 (n=105, 103, 104, NA, NA, 103) | NA mm | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 3 (n=101, 103, 101, NA, NA, 101) | NA mm | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 9 (n=99, 97, 96, 47, 46, NA) | 12.8 mm | Standard Error 3.16 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 12 (n=96, 96, 94, 44, 44, NA) | 16.0 mm | Standard Error 3.02 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 9 (n=99, 97, 96, 47, 46, NA) | 21.5 mm | Standard Error 3.21 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 1 (n=105, 103, 104, NA, NA, 103) | NA mm | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 12 (n=96, 96, 94, 44, 44, NA) | 19.8 mm | Standard Error 3.05 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 3 (n=101, 103, 101, NA, NA, 101) | NA mm | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 6 (n=100, 100, 99, 48, 48, NA) | 16.6 mm | Standard Error 3 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 1 (n=105, 103, 104, NA, NA, 103) | 6.59 mm | Standard Error 2.027 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 9 (n=99, 97, 96, 47, 46, NA) | NA mm | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 3 (n=101, 103, 101, NA, NA, 101) | 6.37 mm | Standard Error 2.242 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 12 (n=96, 96, 94, 44, 44, NA) | NA mm | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today | Month 6 (n=100, 100, 99, 48, 48, NA) | NA mm | — |
Secondary
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care
The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.2 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 3 (n=101, 102, 101, NA, NA, 102) | -0.19 Units on a scale | Standard Error 0.047 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 1 (n=105, 102, 104, NA, NA, 103) | -0.11 Units on a scale | Standard Error 0.046 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.2 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 6 (n=100, 99, 99, 48, 48, NA) | -0.2 Units on a scale | Standard Error 0.04 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 3 (n=101, 102, 101, NA, NA, 102) | -0.11 Units on a scale | Standard Error 0.047 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.2 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 1 (n=105, 102, 104, NA, NA, 103) | -0.16 Units on a scale | Standard Error 0.047 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 6 (n=100, 99, 99, 48, 48, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 3 (n=101, 102, 101, NA, NA, 102) | -0.18 Units on a scale | Standard Error 0.048 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 6 (n=100, 99, 99, 48, 48, NA) | -0.2 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 1 (n=105, 102, 104, NA, NA, 103) | -0.16 Units on a scale | Standard Error 0.047 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 6 (n=100, 99, 99, 48, 48, NA) | -0.2 Units on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 1 (n=105, 102, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 3 (n=101, 102, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.2 Units on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 1 (n=105, 102, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.2 Units on a scale | Standard Error 0.07 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 3 (n=101, 102, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 6 (n=100, 99, 99, 48, 48, NA) | -0.3 Units on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 1 (n=105, 102, 104, NA, NA, 103) | -0.09 Units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 3 (n=101, 102, 101, NA, NA, 102) | -0.12 Units on a scale | Standard Error 0.051 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care | Month 6 (n=100, 99, 99, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities
The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \[1\], some or moderate problems \[2\], or extreme problems \[3\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 3 (n=101, 102, 101, NA, NA, 102) | -0.24 Units on a scale | Standard Error 0.049 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 6 (n=100, 99, 99, 48, 47, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 1 (n=105, 102, 104, NA, NA, 103) | -0.17 Units on a scale | Standard Error 0.043 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 3 (n=101, 102, 101, NA, NA, 102) | -0.29 Units on a scale | Standard Error 0.049 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.4 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.4 Units on a scale | Standard Error 0.05 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 1 (n=105, 102, 104, NA, NA, 103) | -0.19 Units on a scale | Standard Error 0.043 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 6 (n=100, 99, 99, 48, 47, NA) | -0.3 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.4 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.4 Units on a scale | Standard Error 0.05 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 1 (n=105, 102, 104, NA, NA, 103) | -0.21 Units on a scale | Standard Error 0.044 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 3 (n=101, 102, 101, NA, NA, 102) | -0.29 Units on a scale | Standard Error 0.049 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 6 (n=100, 99, 99, 48, 47, NA) | -0.4 Units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 6 (n=100, 99, 99, 48, 47, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 1 (n=105, 102, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 3 (n=101, 102, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 9 (n=99, 97, 96, 47, 46, NA) | -0.4 Units on a scale | Standard Error 0.07 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 1 (n=105, 102, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 12 (n=96, 96, 94, 44, 44, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 3 (n=101, 102, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 6 (n=100, 99, 99, 48, 47, NA) | -0.3 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 1 (n=105, 102, 104, NA, NA, 103) | -0.06 Units on a scale | Standard Error 0.047 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 3 (n=101, 102, 101, NA, NA, 102) | -0.17 Units on a scale | Standard Error 0.052 |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities | Month 6 (n=100, 99, 99, 48, 47, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)
BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score\>0 cm and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 9 (n=23, 20, 10, 9, 9, NA) | -2.06 cm | Standard Error 0.575 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 3 (n=24, 21, 10, NA, NA, 22) | -1.83 cm | Standard Error 0.579 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 1 (n=24, 21, 10, NA, NA, 22) | -1.23 cm | Standard Error 0.537 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 12 (n=23, 19, 10, 9, 9, NA) | -2.50 cm | Standard Error 0.594 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 6 (n=23, 21, 10, 9, 11, NA) | -2.24 cm | Standard Error 0.58 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 3 (n=24, 21, 10, NA, NA, 22) | -2.78 cm | Standard Error 0.559 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 9 (n=23, 20, 10, 9, 9, NA) | -2.71 cm | Standard Error 0.558 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 1 (n=24, 21, 10, NA, NA, 22) | -1.60 cm | Standard Error 0.508 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 12 (n=23, 19, 10, 9, 9, NA) | -3.30 cm | Standard Error 0.587 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 6 (n=23, 21, 10, 9, 11, NA) | -2.35 cm | Standard Error 0.56 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 3 (n=24, 21, 10, NA, NA, 22) | -2.93 cm | Standard Error 0.753 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 9 (n=23, 20, 10, 9, 9, NA) | 2.66 cm | Standard Error 0.747 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 12 (n=23, 19, 10, 9, 9, NA) | -2.42 cm | Standard Error 0.779 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 6 (n=23, 21, 10, 9, 11, NA) | -3.58 cm | Standard Error 0.758 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 1 (n=24, 21, 10, NA, NA, 22) | -2.30 cm | Standard Error 0.673 |
| Placebo | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 6 (n=23, 21, 10, 9, 11, NA) | -2.85 cm | Standard Error 0.778 |
| Placebo | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 1 (n=24, 21, 10, NA, NA, 22) | NA cm | — |
| Placebo | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 3 (n=24, 21, 10, NA, NA, 22) | NA cm | — |
| Placebo | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 9 (n=23, 20, 10, 9, 9, NA) | -3.00 cm | Standard Error 0.77 |
| Placebo | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 12 (n=23, 19, 10, 9, 9, NA) | -2.31 cm | Standard Error 0.808 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 9 (n=23, 20, 10, 9, 9, NA) | -3.35 cm | Standard Error 0.761 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 1 (n=24, 21, 10, NA, NA, 22) | NA cm | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 12 (n=23, 19, 10, 9, 9, NA) | -2.67 cm | Standard Error 0.806 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 3 (n=24, 21, 10, NA, NA, 22) | NA cm | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 6 (n=23, 21, 10, 9, 11, NA) | -3.31 cm | Standard Error 0.744 |
| Placebo | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 1 (n=24, 21, 10, NA, NA, 22) | -1.27 cm | Standard Error 0.581 |
| Placebo | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 9 (n=23, 20, 10, 9, 9, NA) | NA cm | — |
| Placebo | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 3 (n=24, 21, 10, NA, NA, 22) | -1.60 cm | Standard Error 0.624 |
| Placebo | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 12 (n=23, 19, 10, 9, 9, NA) | NA cm | — |
| Placebo | Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) | Month 6 (n=23, 21, 10, 9, 11, NA) | NA cm | — |
Secondary
Change From Baseline in the Leeds Enthesitis Index (LEI)
Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0-6. Higher score indicates a greater number of sites that are affected by enthesitis.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug with baseline LEI\>0 and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 12 (n=67, 56, 67, 24, 29, NA) | -1.7 Units on a scale | Standard Error 0.19 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 6 (n=72, 61, 71, 27, 31, NA) | -1.3 Units on a scale | Standard Error 0.21 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 3 (n=70, 63, 73, NA, NA, 63) | -0.82 Units on a scale | Standard Error 0.221 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 9 (n=70, 58, 68, 27, 29, NA) | -1.4 Units on a scale | Standard Error 0.2 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 1 (n=74, 63, 75, NA, NA, 65) | -0.41 Units on a scale | Standard Error 0.192 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 6 (n=72, 61, 71, 27, 31, NA) | -1.2 Units on a scale | Standard Error 0.23 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 9 (n=70, 58, 68, 27, 29, NA) | -1.3 Units on a scale | Standard Error 0.23 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 12 (n=67, 56, 67, 24, 29, NA) | -1.6 Units on a scale | Standard Error 0.21 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 3 (n=70, 63, 73, NA, NA, 63) | -1.46 Units on a scale | Standard Error 0.24 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 1 (n=74, 63, 75, NA, NA, 65) | -0.57 Units on a scale | Standard Error 0.213 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 6 (n=72, 61, 71, 27, 31, NA) | -1.3 Units on a scale | Standard Error 0.22 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 12 (n=67, 56, 67, 24, 29, NA) | -1.6 Units on a scale | Standard Error 0.2 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 9 (n=70, 58, 68, 27, 29, NA) | -1.5 Units on a scale | Standard Error 0.21 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 1 (n=74, 63, 75, NA, NA, 65) | -0.42 Units on a scale | Standard Error 0.203 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 3 (n=70, 63, 73, NA, NA, 63) | -1.10 Units on a scale | Standard Error 0.228 |
| Placebo | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 12 (n=67, 56, 67, 24, 29, NA) | -1.4 Units on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 1 (n=74, 63, 75, NA, NA, 65) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 3 (n=70, 63, 73, NA, NA, 63) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 6 (n=72, 61, 71, 27, 31, NA) | -1.0 Units on a scale | Standard Error 0.32 |
| Placebo | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 9 (n=70, 58, 68, 27, 29, NA) | -1.4 Units on a scale | Standard Error 0.31 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 6 (n=72, 61, 71, 27, 31, NA) | -1.3 Units on a scale | Standard Error 0.3 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 9 (n=70, 58, 68, 27, 29, NA) | -1.7 Units on a scale | Standard Error 0.3 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 3 (n=70, 63, 73, NA, NA, 63) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 1 (n=74, 63, 75, NA, NA, 65) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 12 (n=67, 56, 67, 24, 29, NA) | -1.9 Units on a scale | Standard Error 0.28 |
| Placebo | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 6 (n=72, 61, 71, 27, 31, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 3 (n=70, 63, 73, NA, NA, 63) | -0.43 Units on a scale | Standard Error 0.246 |
| Placebo | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 12 (n=67, 56, 67, 24, 29, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 1 (n=74, 63, 75, NA, NA, 65) | -0.26 Units on a scale | Standard Error 0.219 |
| Placebo | Change From Baseline in the Leeds Enthesitis Index (LEI) | Month 9 (n=70, 58, 68, 27, 29, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 9.03 Units on a scale | Standard Error 0.953 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 7.75 Units on a scale | Standard Error 0.838 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 5.53 Units on a scale | Standard Error 0.777 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 12 (n=96, 96, 94, 44, 43, NA) | 9.15 Units on a scale | Standard Error 0.961 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 7.76 Units on a scale | Standard Error 0.985 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 8.05 Units on a scale | Standard Error 0.84 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 10.13 Units on a scale | Standard Error 0.96 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 7.16 Units on a scale | Standard Error 0.786 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 12 (n=96, 96, 94, 44, 43, NA) | 11.38 Units on a scale | Standard Error 0.965 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 10.65 Units on a scale | Standard Error 0.989 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 7.52 Units on a scale | Standard Error 0.859 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 8.59 Units on a scale | Standard Error 0.977 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 12 (n=96, 96, 94, 44, 43, NA) | 9.18 Units on a scale | Standard Error 0.984 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 7.76 Units on a scale | Standard Error 1.004 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 6.42 Units on a scale | Standard Error 0.802 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 8.55 Units on a scale | Standard Error 1.405 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 8.46 Units on a scale | Standard Error 1.362 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 12 (n=96, 96, 94, 44, 43, NA) | 8.59 Units on a scale | Standard Error 1.384 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 10.81 Units on a scale | Standard Error 1.389 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 12 (n=96, 96, 94, 44, 43, NA) | 8.61 Units on a scale | Standard Error 1.413 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 8.98 Units on a scale | Standard Error 1.425 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 3.44 Units on a scale | Standard Error 0.851 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 3.77 Units on a scale | Standard Error 0.903 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 12 (n=96, 96, 94, 44, 43, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 5.93 Units on a scale | Standard Error 0.773 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 3 (n=102, 103,101, NA, NA, 102 ) | 4.09 Units on a scale | Standard Error 0.7 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 3.29 Units on a scale | Standard Error 0.61 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 5.70 Units on a scale | Standard Error 0.811 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 5.96 Units on a scale | Standard Error 0.72 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 3 (n=102, 103,101, NA, NA, 102 ) | 3.95 Units on a scale | Standard Error 0.701 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 5.18 Units on a scale | Standard Error 0.778 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 3.87 Units on a scale | Standard Error 0.616 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 4.63 Units on a scale | Standard Error 0.815 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 4.12 Units on a scale | Standard Error 0.722 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 3 (n=102, 103,101, NA, NA, 102 ) | 4.73 Units on a scale | Standard Error 0.713 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 4.09 Units on a scale | Standard Error 0.788 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 4.21 Units on a scale | Standard Error 0.825 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 4.81 Units on a scale | Standard Error 0.733 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 1.96 Units on a scale | Standard Error 0.625 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 4.39 Units on a scale | Standard Error 1.022 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 3 (n=102, 103,101, NA, NA, 102 ) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 4.72 Units on a scale | Standard Error 1.102 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 4.50 Units on a scale | Standard Error 1.164 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 4.85 Units on a scale | Standard Error 1.117 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 4.12 Units on a scale | Standard Error 1.175 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 3 (n=102, 103,101, NA, NA, 102 ) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 3.92 Units on a scale | Standard Error 1.033 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 2.15 Units on a scale | Standard Error 0.666 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 3 (n=102, 103,101, NA, NA, 102 ) | 2.64 Units on a scale | Standard Error 0.748 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 5.79 Units on a scale | Standard Error 1.022 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 4.45 Units on a scale | Standard Error 0.934 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 1 (n=105, 103, 104, NA, NA, 103) | 3.32 Units on a scale | Standard Error 0.867 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 5.86 Units on a scale | Standard Error 1.019 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 6.11 Units on a scale | Standard Error 0.951 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 4.23 Units on a scale | Standard Error 0.932 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 6.43 Units on a scale | Standard Error 1.028 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 1 (n=105, 103, 104, NA, NA, 103) | 3.87 Units on a scale | Standard Error 0.874 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 6.58 Units on a scale | Standard Error 1.022 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 6.38 Units on a scale | Standard Error 0.953 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 3.95 Units on a scale | Standard Error 0.956 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 4.62 Units on a scale | Standard Error 1.048 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 5.86 Units on a scale | Standard Error 1.044 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 5.35 Units on a scale | Standard Error 0.974 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 1 (n=105, 103, 104, NA, NA, 103) | 2.79 Units on a scale | Standard Error 0.895 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 3.70 Units on a scale | Standard Error 1.354 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 3.57 Units on a scale | Standard Error 1.461 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 4.72 Units on a scale | Standard Error 1.467 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 5.45 Units on a scale | Standard Error 1.483 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 1 (n=105, 103, 104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 4.48 Units on a scale | Standard Error 1.483 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 3.41 Units on a scale | Standard Error 1.372 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 1 (n=105, 103, 104, NA, NA, 103) | 1.57 Units on a scale | Standard Error 0.952 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 2.62 Units on a scale | Standard Error 1.009 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 7.43 Units on a scale | Standard Error 0.902 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 3 (n=102, 103,101, NA, NA, 102) | 5.17 Units on a scale | Standard Error 0.846 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 2.43 Units on a scale | Standard Error 0.768 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 7.67 Units on a scale | Standard Error 0.899 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 7.02 Units on a scale | Standard Error 0.897 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 3 (n=102, 103,101, NA, NA, 102) | 5.23 Units on a scale | Standard Error 0.848 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 6.67 Units on a scale | Standard Error 0.909 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 3.89 Units on a scale | Standard Error 0.776 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 7.11 Units on a scale | Standard Error 0.903 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 6.15 Units on a scale | Standard Error 0.9 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 3 (n=102, 103,101, NA, NA, 102) | 5.22 Units on a scale | Standard Error 0.862 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 7.01 Units on a scale | Standard Error 0.921 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 6.81 Units on a scale | Standard Error 0.917 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 6.36 Units on a scale | Standard Error 0.912 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 2.81 Units on a scale | Standard Error 0.787 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 5.22 Units on a scale | Standard Error 1.276 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 3 (n=102, 103,101, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 5.69 Units on a scale | Standard Error 1.285 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 6.49 Units on a scale | Standard Error 1.292 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 6.25 Units on a scale | Standard Error 1.306 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 4.77 Units on a scale | Standard Error 1.308 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 3 (n=102, 103,101, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 5.22 Units on a scale | Standard Error 1.291 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 1.10 Units on a scale | Standard Error 0.84 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 3 (n=102, 103,101, NA, NA, 102) | 2.06 Units on a scale | Standard Error 0.91 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 9 (n=99, 97, 95, 47, 46, NA) | 5.13 Units on a scale | Standard Error 1.021 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 3 (n=102, 103, 100, NA, NA, 102) | 4.21 Units on a scale | Standard Error 1.01 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 4.77 Units on a scale | Standard Error 0.96 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 5.15 Units on a scale | Standard Error 1.048 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 6 (n=100, 100, 98, 48, 48, NA) | 5.67 Units on a scale | Standard Error 1.024 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 3 (n=102, 103, 100, NA, NA, 102) | 4.82 Units on a scale | Standard Error 1.011 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 9 (n=99, 97, 95, 47, 46, NA) | 6.13 Units on a scale | Standard Error 1.03 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 3.87 Units on a scale | Standard Error 0.971 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 6.73 Units on a scale | Standard Error 1.053 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 6 (n=100, 100, 98, 48, 48, NA) | 4.68 Units on a scale | Standard Error 1.027 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 3 (n=102, 103, 100, NA, NA, 102) | 3.35 Units on a scale | Standard Error 1.04 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 9 (n=99, 97, 95, 47, 46, NA) | 4.87 Units on a scale | Standard Error 1.052 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 6.03 Units on a scale | Standard Error 1.075 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 6 (n=100, 100, 98, 48, 48, NA) | 4.77 Units on a scale | Standard Error 1.051 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 2.93 Units on a scale | Standard Error 0.991 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 6 (n=100, 100, 98, 48, 48, NA) | 6.34 Units on a scale | Standard Error 1.458 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 3 (n=102, 103, 100, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 9 (n=99, 97, 95, 47, 46, NA) | 5.89 Units on a scale | Standard Error 1.456 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 4.77 Units on a scale | Standard Error 1.509 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 9 (n=99, 97, 95, 47, 46, NA) | 6.52 Units on a scale | Standard Error 1.478 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 4.94 Units on a scale | Standard Error 1.525 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 3 (n=102, 103, 100, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 6 (n=100, 100, 98, 48, 48, NA) | 4.56 Units on a scale | Standard Error 1.473 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 4.52 Units on a scale | Standard Error 1.042 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 9 (n=99, 97, 95, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 3 (n=102, 103, 100, NA, NA, 102) | 3.68 Units on a scale | Standard Error 1.083 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain | Month 6 (n=100, 100, 98, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 6.24 Units on a scale | Standard Error 0.853 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 3 (n=102, 103, 100, NA, NA, 102) | 4.45 Units on a scale | Standard Error 0.801 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 4.05 Units on a scale | Standard Error 0.751 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 6.21 Units on a scale | Standard Error 0.888 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 6.02 Units on a scale | Standard Error 0.824 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 3 (n=102, 103, 100, NA, NA, 102) | 4.79 Units on a scale | Standard Error 0.803 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 6.56 Units on a scale | Standard Error 0.861 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 3.72 Units on a scale | Standard Error 0.759 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 7.11 Units on a scale | Standard Error 0.892 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 5.21 Units on a scale | Standard Error 0.828 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 3 (n=102, 103, 100, NA, NA, 102) | 5.21 Units on a scale | Standard Error 0.82 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 5.79 Units on a scale | Standard Error 0.872 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 6.37 Units on a scale | Standard Error 0.906 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 5.48 Units on a scale | Standard Error 0.84 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 4.09 Units on a scale | Standard Error 0.77 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 4.97 Units on a scale | Standard Error 1.172 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 3 (n=102, 103, 100, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 4.68 Units on a scale | Standard Error 1.217 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 2.98 Units on a scale | Standard Error 1.279 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 6.70 Units on a scale | Standard Error 1.234 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 5.03 Units on a scale | Standard Error 1.291 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 3 (n=102, 103, 100, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 5.03 Units on a scale | Standard Error 1.185 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 1.98 Units on a scale | Standard Error 0.82 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 3 (n=102, 103, 100, NA, NA, 102) | 3.63 Units on a scale | Standard Error 0.862 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number pf participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 7.66 Units on a scale | Standard Error 0.947 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 5.95 Units on a scale | Standard Error 0.897 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 4.51 Units on a scale | Standard Error 0.827 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 6.13 Units on a scale | Standard Error 0.989 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 6.97 Units on a scale | Standard Error 0.955 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 5.22 Units on a scale | Standard Error 0.898 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 7.74 Units on a scale | Standard Error 0.957 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 4.46 Units on a scale | Standard Error 0.838 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 8.42 Units on a scale | Standard Error 0.995 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 7.08 Units on a scale | Standard Error 0.959 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 5.26 Units on a scale | Standard Error 0.918 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 5.69 Units on a scale | Standard Error 0.972 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 6.32 Units on a scale | Standard Error 1.012 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 7.10 Units on a scale | Standard Error 0.975 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 3.34 Units on a scale | Standard Error 0.852 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 5.44 Units on a scale | Standard Error 1.362 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 5.95 Units on a scale | Standard Error 1.355 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 6.19 Units on a scale | Standard Error 1.427 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 8.93 Units on a scale | Standard Error 1.373 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 6.41 Units on a scale | Standard Error 1.445 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 6.05 Units on a scale | Standard Error 1.373 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 2.96 Units on a scale | Standard Error 0.901 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 3.63 Units on a scale | Standard Error 0.961 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 6.09 Units on a scale | Standard Error 1.017 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 5.50 Units on a scale | Standard Error 0.889 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 3.64 Units on a scale | Standard Error 0.802 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 7.01 Units on a scale | Standard Error 1.022 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 6.81 Units on a scale | Standard Error 0.969 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 5.90 Units on a scale | Standard Error 0.887 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 7.82 Units on a scale | Standard Error 1.023 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 4.59 Units on a scale | Standard Error 0.806 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 7.02 Units on a scale | Standard Error 1.024 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 7.41 Units on a scale | Standard Error 0.97 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 4.93 Units on a scale | Standard Error 0.909 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 5.27 Units on a scale | Standard Error 1.041 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 5.12 Units on a scale | Standard Error 1.043 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 5.05 Units on a scale | Standard Error 0.989 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 2.42 Units on a scale | Standard Error 0.826 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 5.34 Units on a scale | Standard Error 1.378 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 6.61 Units on a scale | Standard Error 1.451 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 5.62 Units on a scale | Standard Error 1.465 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | 6.39 Units on a scale | Standard Error 1.472 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | 5.15 Units on a scale | Standard Error 1.481 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | 4.62 Units on a scale | Standard Error 1.394 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 1 (n=105, 103,104, NA, NA, 103) | 2.16 Units on a scale | Standard Error 0.877 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 9 (n=99, 97, 96, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 3 (n=102, 103, 101, NA, NA, 102) | 3.05 Units on a scale | Standard Error 0.954 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 12 (n=96, 96, 94, 44, 44, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain | Month 6 (n=100, 100, 99, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 9 (n=99, 97, 95, 47, 46, NA) | 5.07 Units on a scale | Standard Error 0.974 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 3 (n=102, 103,100, NA, NA, 102) | 4.35 Units on a scale | Standard Error 0.909 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 1 (n=105, 103,104,NA, NA, 103) | 4.12 Units on a scale | Standard Error 0.841 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 12 (n=96, 96, 94, 44, 43, NA) | 4.82 Units on a scale | Standard Error 1.012 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 6 (n=100, 100, 98, 48, 48, NA) | 5.70 Units on a scale | Standard Error 0.927 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 3 (n=102, 103,100, NA, NA, 102) | 4.20 Units on a scale | Standard Error 0.909 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 9 (n=99, 97, 95, 47, 46, NA) | 6.20 Units on a scale | Standard Error 0.982 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 1 (n=105, 103,104,NA, NA, 103) | 3.63 Units on a scale | Standard Error 0.849 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 12 (n=96, 96, 94, 44, 43, NA) | 6.26 Units on a scale | Standard Error 1.016 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 6 (n=100, 100, 98, 48, 48, NA) | 5.51 Units on a scale | Standard Error 0.93 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 3 (n=102, 103,100, NA, NA, 102) | 3.13 Units on a scale | Standard Error 0.938 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 9 (n=99, 97, 95, 47, 46, NA) | 3.68 Units on a scale | Standard Error 1.005 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 12 (n=96, 96, 94, 44, 43, NA) | 4.81 Units on a scale | Standard Error 1.039 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 6 (n=100, 100, 98, 48, 48, NA) | 4.58 Units on a scale | Standard Error 0.955 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 1 (n=105, 103,104,NA, NA, 103) | 2.13 Units on a scale | Standard Error 0.871 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 6 (n=100, 100, 98, 48, 48, NA) | 4.50 Units on a scale | Standard Error 1.319 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 1 (n=105, 103,104,NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 3 (n=102, 103,100, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 9 (n=99, 97, 95, 47, 46, NA) | 4.61 Units on a scale | Standard Error 1.391 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 12 (n=96, 96, 94, 44, 43, NA) | 4.51 Units on a scale | Standard Error 1.455 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 9 (n=99, 97, 95, 47, 46, NA) | 6.03 Units on a scale | Standard Error 1.409 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 1 (n=105, 103,104,NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 12 (n=96, 96, 94, 44, 43, NA) | 4.43 Units on a scale | Standard Error 1.474 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 3 (n=102, 103,100, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 6 (n=100, 100, 98, 48, 48, NA) | 3.62 Units on a scale | Standard Error 1.331 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 1 (n=105, 103,104,NA, NA, 103) | 3.19 Units on a scale | Standard Error 0.917 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 9 (n=99, 97, 95, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 3 (n=102, 103,100, NA, NA, 102) | 3.27 Units on a scale | Standard Error 0.976 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 12 (n=96, 96, 94, 44, 43, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score | Month 6 (n=100, 100, 98, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 9 (n=99, 97, 95, 47, 46, NA) | 7.52 Units on a scale | Standard Error 0.781 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 3 (n=102, 103,100, NA, NA, 102) | 5.51 Units on a scale | Standard Error 0.733 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 1 (n=105, 103,104, NA, NA, 103) | 3.39 Units on a scale | Standard Error 0.638 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 12 (n=96, 96, 94, 44, 43, NA) | 7.61 Units on a scale | Standard Error 0.806 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 6 (n=100, 100, 98, 48, 48, NA) | 6.72 Units on a scale | Standard Error 0.773 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 3 (n=102, 103,100, NA, NA, 102) | 5.69 Units on a scale | Standard Error 0.735 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 9 (n=99, 97, 95, 47, 46, NA) | 7.21 Units on a scale | Standard Error 0.787 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 1 (n=105, 103,104, NA, NA, 103) | 4.66 Units on a scale | Standard Error 0.645 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 12 (n=96, 96, 94, 44, 43, NA) | 7.67 Units on a scale | Standard Error 0.81 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 6 (n=100, 100, 98, 48, 48, NA) | 6.70 Units on a scale | Standard Error 0.777 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 3 (n=102, 103,100, NA, NA, 102) | 6.23 Units on a scale | Standard Error 0.748 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 9 (n=99, 97, 95, 47, 46, NA) | 6.91 Units on a scale | Standard Error 0.798 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 12 (n=96, 96, 94, 44, 43, NA) | 6.74 Units on a scale | Standard Error 0.822 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 6 (n=100, 100, 98, 48, 48, NA) | 6.26 Units on a scale | Standard Error 0.788 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 1 (n=105, 103,104, NA, NA, 103) | 4.00 Units on a scale | Standard Error 0.655 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 6 (n=100, 100, 98, 48, 48, NA) | 5.86 Units on a scale | Standard Error 1.101 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 3 (n=102, 103,100, NA, NA, 102) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 9 (n=99, 97, 95, 47, 46, NA) | 6.16 Units on a scale | Standard Error 1.115 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 12 (n=96, 96, 94, 44, 43, NA) | 5.82 Units on a scale | Standard Error 1.16 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 9 (n=99, 97, 95, 47, 46, NA) | 7.15 Units on a scale | Standard Error 1.13 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 1 (n=105, 103,104, NA, NA, 103) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 12 (n=96, 96, 94, 44, 43, NA) | 5.72 Units on a scale | Standard Error 1.177 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 3 (n=102, 103,100, NA, NA, 102) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 6 (n=100, 100, 98, 48, 48, NA) | 6.07 Units on a scale | Standard Error 1.112 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 1 (n=105, 103,104, NA, NA, 103) | 1.54 Units on a scale | Standard Error 0.7 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 9 (n=99, 97, 95, 47, 46, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 3 (n=102, 103,100, NA, NA, 102) | 2.68 Units on a scale | Standard Error 0.785 |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 12 (n=96, 96, 94, 44, 43, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score | Month 6 (n=100, 100, 98, 48, 48, NA) | NA Units on a scale | — |
Secondary
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.
Time frame: From Baseline to Months 1, 3, 6, 9, and 12
Population: All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score\>0 and were evaluable. n=number of participants evaluable at each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 1 (n=79, 80, 80, NA, NA, 78) | -0.83 Units on a scale | Standard Error 0.317 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 9 (n=75, 75, 73, 34, 37, NA) | -2.9 Units on a scale | Standard Error 0.31 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 6 (n=76, 78, 76, 33, 39, NA) | -2.4 Units on a scale | Standard Error 0.34 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 12 (n=72, 73, 72, 31, 37, NA) | -3.2 Units on a scale | Standard Error 0.33 |
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 3 (n=77, 79, 79, NA, NA, 78) | -1.84 Units on a scale | Standard Error 0.363 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 9 (n=75, 75, 73, 34, 37, NA) | -2.6 Units on a scale | Standard Error 0.32 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 6 (n=76, 78, 76, 33, 39, NA) | -2.6 Units on a scale | Standard Error 0.34 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 1 (n=79, 80, 80, NA, NA, 78) | -1.27 Units on a scale | Standard Error 0.321 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 3 (n=77, 79, 79, NA, NA, 78) | -2.41 Units on a scale | Standard Error 0.364 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 12 (n=72, 73, 72, 31, 37, NA) | -3.1 Units on a scale | Standard Error 0.33 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 6 (n=76, 78, 76, 33, 39, NA) | -2.3 Units on a scale | Standard Error 0.35 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 1 (n=79, 80, 80, NA, NA, 78) | -0.95 Units on a scale | Standard Error 0.336 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 12 (n=72, 73, 72, 31, 37, NA) | -2.8 Units on a scale | Standard Error 0.35 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 9 (n=75, 75, 73, 34, 37, NA) | -3.0 Units on a scale | Standard Error 0.33 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 3 (n=77, 79, 79, NA, NA, 78) | -1.90 Units on a scale | Standard Error 0.375 |
| Placebo | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 6 (n=76, 78, 76, 33, 39, NA) | -2.4 Units on a scale | Standard Error 0.5 |
| Placebo | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 3 (n=77, 79, 79, NA, NA, 78) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 1 (n=79, 80, 80, NA, NA, 78) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 9 (n=75, 75, 73, 34, 37, NA) | -2.8 Units on a scale | Standard Error 0.46 |
| Placebo | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 12 (n=72, 73, 72, 31, 37, NA) | -2.5 Units on a scale | Standard Error 0.49 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 6 (n=76, 78, 76, 33, 39, NA) | -2.5 Units on a scale | Standard Error 0.48 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 12 (n=72, 73, 72, 31, 37, NA) | -3.2 Units on a scale | Standard Error 0.46 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 9 (n=75, 75, 73, 34, 37, NA) | -3.2 Units on a scale | Standard Error 0.44 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 1 (n=79, 80, 80, NA, NA, 78) | NA Units on a scale | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 3 (n=77, 79, 79, NA, NA, 78) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 6 (n=76, 78, 76, 33, 39, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 3 (n=77, 79, 79, NA, NA, 78) | -1.17 Units on a scale | Standard Error 0.393 |
| Placebo | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 12 (n=72, 73, 72, 31, 37, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 9 (n=75, 75, 73, 34, 37, NA) | NA Units on a scale | — |
| Placebo | Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Month 1 (n=79, 80, 80, NA, NA, 78) | -0.58 Units on a scale | Standard Error 0.355 |
Secondary
Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis
Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing.
Time frame: From Baseline to Month 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis | 0.01 Units on a scale | Standard Error 0.067 |
| Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis | -0.01 Units on a scale | Standard Error 0.067 |
| Adalimumab, 40 mg, Every 2 Weeks | Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis | -0.07 Units on a scale | Standard Error 0.069 |
| Placebo | Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis | 0.00 Units on a scale | Standard Error 0.094 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis | 0.09 Units on a scale | Standard Error 0.099 |
Secondary
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12
ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.
Time frame: At Week 2 and Months 1, 2, 4, 6, 9, and 12
Population: All participants who were randomized and received at least 1 dose of study drug. n=number of responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Week 2 (n=24, 33, 23, NA, NA, 6) | 22.43 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 6 (n=63, 70, 68, 31, 30, NA) | 58.88 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 1 (n=37, 50, 30, NA, NA, 11) | 34.58 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 12 (n=73, 73, 64, 35, 31, NA) | 68.22 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 2 (n=47, 57, 62, NA, NA, 28) | 43.93 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 9 (n=73, 76, 73, 35, 37, NA) | 68.22 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 4 (n=65, 60, 61, 27, 28, NA) | 60.75 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 1 (n=37, 50, 30, NA, NA, 11) | 48.08 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 4 (n=65, 60, 61, 27, 28, NA) | 57.69 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 2 (n=47, 57, 62, NA, NA, 28) | 54.81 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 6 (n=63, 70, 68, 31, 30, NA) | 67.31 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Week 2 (n=24, 33, 23, NA, NA, 6) | 31.73 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 12 (n=73, 73, 64, 35, 31, NA) | 70.19 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 9 (n=73, 76, 73, 35, 37, NA) | 73.08 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 2 (n=47, 57, 62, NA, NA, 28) | 58.49 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 1 (n=37, 50, 30, NA, NA, 11) | 28.30 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Week 2 (n=24, 33, 23, NA, NA, 6) | 21.70 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 6 (n=63, 70, 68, 31, 30, NA) | 64.15 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 9 (n=73, 76, 73, 35, 37, NA) | 68.87 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 4 (n=65, 60, 61, 27, 28, NA) | 57.55 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 12 (n=73, 73, 64, 35, 31, NA) | 60.38 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 4 (n=65, 60, 61, 27, 28, NA) | 51.92 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Week 2 (n=24, 33, 23, NA, NA, 6) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 1 (n=37, 50, 30, NA, NA, 11) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 2 (n=47, 57, 62, NA, NA, 28) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 6 (n=63, 70, 68, 31, 30, NA) | 59.62 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 9 (n=73, 76, 73, 35, 37, NA) | 67.31 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 12 (n=73, 73, 64, 35, 31, NA) | 67.31 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 2 (n=47, 57, 62, NA, NA, 28) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 1 (n=37, 50, 30, NA, NA, 11) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 12 (n=73, 73, 64, 35, 31, NA) | 58.49 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Week 2 (n=24, 33, 23, NA, NA, 6) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 9 (n=73, 76, 73, 35, 37, NA) | 69.81 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 4 (n=65, 60, 61, 27, 28, NA) | 52.83 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 6 (n=63, 70, 68, 31, 30, NA) | 56.60 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 12 (n=73, 73, 64, 35, 31, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 6 (n=63, 70, 68, 31, 30, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 2 (n=47, 57, 62, NA, NA, 28) | 26.67 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 1 (n=37, 50, 30, NA, NA, 11) | 10.48 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 9 (n=73, 76, 73, 35, 37, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Week 2 (n=24, 33, 23, NA, NA, 6) | 5.71 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 | Month 4 (n=65, 60, 61, 27, 28, NA) | NA Percentage of participants |
Secondary
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
ACR50 was calculated as a ≥50% improvement from baseline in tender/painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.
Time frame: At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Population: All participants who were randomized and received at least 1 dose of study drug. n=number of responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=23, 34, 24, NA, NA, 8) | 21.50 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=13, 20,12, NA, NA, 5) | 12.15 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=7, 7, 5, NA, NA, 1) | 6.54 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=30, 42, 35, NA, NA, 10) | 28.04 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=38, 39, 34, 11, 17, NA) | 35.51 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=41, 48, 45, 17, 14, NA) | 38.32 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=45, 48, 49, 22, 23, NA) | 42.06 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=48, 50, 43, 21, 19, NA) | 44.86 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=30, 42, 35, NA, NA, 10) | 40.38 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=48, 50, 43, 21, 19, NA) | 48.08 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=7, 7, 5, NA, NA, 1) | 6.73 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=45, 48, 49, 22, 23, NA) | 46.15 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=41, 48, 45, 17, 14, NA) | 46.15 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=23, 34, 24, NA, NA, 8) | 32.69 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=13, 20,12, NA, NA, 5) | 19.23 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=38, 39, 34, 11, 17, NA) | 37.50 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=13, 20,12, NA, NA, 5) | 11.32 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=23, 34, 24, NA, NA, 8) | 22.64 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=30, 42, 35, NA, NA, 10) | 33.02 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=48, 50, 43, 21, 19, NA) | 40.57 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=38, 39, 34, 11, 17, NA) | 32.08 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=41, 48, 45, 17, 14, NA) | 42.45 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=45, 48, 49, 22, 23, NA) | 46.23 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=7, 7, 5, NA, NA, 1) | 4.72 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=45, 48, 49, 22, 23, NA) | 42.31 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=41, 48, 45, 17, 14, NA) | 32.69 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=38, 39, 34, 11, 17, NA) | 21.15 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=7, 7, 5, NA, NA, 1) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=23, 34, 24, NA, NA, 8) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=30, 42, 35, NA, NA, 10) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=48, 50, 43, 21, 19, NA) | 40.38 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=13, 20,12, NA, NA, 5) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=48, 50, 43, 21, 19, NA) | 35.85 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=7, 7, 5, NA, NA, 1) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=38, 39, 34, 11, 17, NA) | 32.08 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=41, 48, 45, 17, 14, NA) | 26.42 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=45, 48, 49, 22, 23, NA) | 43.40 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=13, 20,12, NA, NA, 5) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=23, 34, 24, NA, NA, 8) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=30, 42, 35, NA, NA, 10) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=48, 50, 43, 21, 19, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=38, 39, 34, 11, 17, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=23, 34, 24, NA, NA, 8) | 7.62 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=30, 42, 35, NA, NA, 10) | 9.52 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=41, 48, 45, 17, 14, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=13, 20,12, NA, NA, 5) | 4.76 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=45, 48, 49, 22, 23, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=7, 7, 5, NA, NA, 1) | 0.95 Percentage of participants |
Secondary
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
ACR70 was calculated as a ≥70% improvement from baseline in tender/painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. .
Time frame: At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Population: All participants who were randomized and received at least 1 dose of study drug. n=number of responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=10, 14, 13, NA, NA, 2) | 9.35 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=5, 8, 4, NA, NA, 1) | 4.67 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=0, 3, 1, NA, NA, 0) | 0.00 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=18, 15, 20, NA, NA, 5) | 16.82 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=24, 23, 21, 7, 8, NA) | 22.43 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=19, 33, 32, 10, 7, NA) | 17.76 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=21, 31, 30, 15, 12, NA) | 19.63 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=25, 32, 31, 12, 12, NA) | 23.36 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=18, 15, 20, NA, NA, 5) | 14.42 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=25, 32, 31, 12, 12, NA) | 30.77 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=0, 3, 1, NA, NA, 0) | 2.88 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=21, 31, 30, 15, 12, NA) | 29.81 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=19, 33, 32, 10, 7, NA) | 31.73 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=10, 14, 13, NA, NA, 2) | 13.46 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=5, 8, 4, NA, NA, 1) | 7.69 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=24, 23, 21, 7, 8, NA) | 22.12 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=5, 8, 4, NA, NA, 1) | 3.77 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=10, 14, 13, NA, NA, 2) | 12.26 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=18, 15, 20, NA, NA, 5) | 18.87 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=25, 32, 31, 12, 12, NA) | 29.25 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=24, 23, 21, 7, 8, NA) | 19.81 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=19, 33, 32, 10, 7, NA) | 30.19 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=21, 31, 30, 15, 12, NA) | 28.30 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=0, 3, 1, NA, NA, 0) | 0.94 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=21, 31, 30, 15, 12, NA) | 28.85 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=19, 33, 32, 10, 7, NA) | 19.23 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=24, 23, 21, 7, 8, NA) | 13.46 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=0, 3, 1, NA, NA, 0) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=10, 14, 13, NA, NA, 2) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=18, 15, 20, NA, NA, 5) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=25, 32, 31, 12, 12, NA) | 23.08 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=5, 8, 4, NA, NA, 1) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=25, 32, 31, 12, 12, NA) | 22.64 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=0, 3, 1, NA, NA, 0) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=24, 23, 21, 7, 8, NA) | 15.09 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=19, 33, 32, 10, 7, NA) | 13.21 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=21, 31, 30, 15, 12, NA) | 22.64 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=5, 8, 4, NA, NA, 1) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=10, 14, 13, NA, NA, 2) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=18, 15, 20, NA, NA, 5) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=25, 32, 31, 12, 12, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=24, 23, 21, 7, 8, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=10, 14, 13, NA, NA, 2) | 1.90 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=18, 15, 20, NA, NA, 5) | 4.76 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=19, 33, 32, 10, 7, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=5, 8, 4, NA, NA, 1) | 0.95 Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=21, 31, 30, 15, 12, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=0, 3, 1, NA, NA, 0) | 0.00 Percentage of participants |
Secondary
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count.
Time frame: At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Population: All participants who were randomized and received at least 1 dose of study drug. n=number of responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=54, 69, 62, NA, NA, 36) | 50.47 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=45, 51, 43, NA, NA, 23) | 42.06 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=34, 42, 23, NA, NA, 10) | 31.78 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=55, 73, 65, NA, NA, 47) | 51.40 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=68, 68, 71, 32, 30, NA) | 63.55 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=61, 75, 71, 35, 35, NA) | 57.01 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=75, 73, 71, 36, 37, NA) | 70.09 Percentage of participants |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=69, 76, 69, 39, 33, NA) | 64.49 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=55, 73, 65, NA, NA, 47) | 70.19 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=69, 76, 69, 39, 33, NA) | 73.08 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=34, 42, 23, NA, NA, 10) | 40.38 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=75, 73, 71, 36, 37, NA) | 70.19 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=61, 75, 71, 35, 35, NA) | 72.12 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=54, 69, 62, NA, NA, 36) | 66.35 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=45, 51, 43, NA, NA, 23) | 49.04 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=68, 68, 71, 32, 30, NA) | 65.38 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=45, 51, 43, NA, NA, 23) | 40.57 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=54, 69, 62, NA, NA, 36) | 58.49 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=55, 73, 65, NA, NA, 47) | 61.32 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=69, 76, 69, 39, 33, NA) | 65.09 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=68, 68, 71, 32, 30, NA) | 66.98 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=61, 75, 71, 35, 35, NA) | 66.98 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=75, 73, 71, 36, 37, NA) | 66.98 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=34, 42, 23, NA, NA, 10) | 21.70 Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=75, 73, 71, 36, 37, NA) | 69.23 Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=61, 75, 71, 35, 35, NA) | 67.31 Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=68, 68, 71, 32, 30, NA) | 61.54 Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=34, 42, 23, NA, NA, 10) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=54, 69, 62, NA, NA, 36) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=55, 73, 65, NA, NA, 47) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=69, 76, 69, 39, 33, NA) | 75.00 Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=45, 51, 43, NA, NA, 23) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=69, 76, 69, 39, 33, NA) | 62.26 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=34, 42, 23, NA, NA, 10) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=68, 68, 71, 32, 30, NA) | 56.60 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=61, 75, 71, 35, 35, NA) | 66.04 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=75, 73, 71, 36, 37, NA) | 69.81 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=45, 51, 43, NA, NA, 23) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=54, 69, 62, NA, NA, 36) | NA Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=55, 73, 65, NA, NA, 47) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 12 (n=69, 76, 69, 39, 33, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 4 (n=68, 68, 71, 32, 30, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 2 (n=54, 69, 62, NA, NA, 36) | 34.29 Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 3 (n=55, 73, 65, NA, NA, 47) | 44.76 Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 6 (n=61, 75, 71, 35, 35, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 1 (n=45, 51, 43, NA, NA, 23) | 21.90 Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Month 9 (n=75, 73, 71, 36, 37, NA) | NA Percentage of participants |
| Placebo | Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 | Week 2 (n=34, 42, 23, NA, NA, 10) | 9.52 Percentage of participants |
Secondary
Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12
Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS \>0.5 from baseline.
Time frame: At Month 12
Population: All participants who were randomized, received at least 1 dose of study drug and were evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12 | 4.08 Percentage of participants |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12 | 5.05 Percentage of participants |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12 | 2.11 Percentage of participants |
| Placebo | Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12 | 4.17 Percentage of participants |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12 | 8.89 Percentage of participants |
Secondary
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12
PASI determines psoriasis severity based on lesion severity & percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, & scaling, evaluated separately for head & neck, upper limbs, trunk, & lower limbs & rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis & is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score & can vary in increments of 0.1 & range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI.
Time frame: At Months 1, 3, 6, 9, and 12
Population: All participants who were randomized and received at least 1 dose of study drug with PASI\>0 and BSA ≥3% at baseline. n=number of responders.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 9 (n=36, 48, 45, 14, 20, NA) | 43.90 Percentage of participants | 5.448 |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 3 (n=35, 31, 30, NA, NA, 12) | 42.68 Percentage of participants | 5.46 |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 1 (n=19, 19, 11, NA, NA, 4) | 23.17 Percentage of participants | 4.66 |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 12 (n=46, 47, 43, 15, 21, NA) | 56.10 Percentage of participants | 5.48 |
| Tofacitinib, 5 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 6 (n=38, 42, 42, 12, 17, NA) | 46.34 Percentage of participants | 5.51 |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 3 (n=35, 31, 30, NA, NA, 12) | 44.29 Percentage of participants | 5.94 |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 9 (n=36, 48, 45, 14, 20, NA) | 68.57 Percentage of participants | 5.55 |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 1 (n=19, 19, 11, NA, NA, 4) | 27.14 Percentage of participants | 5.32 |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 12 (n=46, 47, 43, 15, 21, NA) | 67.14 Percentage of participants | 5.61 |
| Tofacitinib, 10 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 6 (n=38, 42, 42, 12, 17, NA) | 60.00 Percentage of participants | 5.86 |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 3 (n=35, 31, 30, NA, NA, 12) | 38.96 Percentage of participants | 5.56 |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 9 (n=36, 48, 45, 14, 20, NA) | 58.44 Percentage of participants | 5.62 |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 12 (n=46, 47, 43, 15, 21, NA) | 55.84 Percentage of participants | 5.66 |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 6 (n=38, 42, 42, 12, 17, NA) | 54.55 Percentage of participants | 5.67 |
| Adalimumab, 40 mg, Every 2 Weeks | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 1 (n=19, 19, 11, NA, NA, 4) | 14.29 Percentage of participants | 3.99 |
| Placebo | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 6 (n=38, 42, 42, 12, 17, NA) | 28.57 Percentage of participants | 6.97 |
| Placebo | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 1 (n=19, 19, 11, NA, NA, 4) | NA Percentage of participants | — |
| Placebo | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 3 (n=35, 31, 30, NA, NA, 12) | NA Percentage of participants | — |
| Placebo | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 9 (n=36, 48, 45, 14, 20, NA) | 33.33 Percentage of participants | 7.27 |
| Placebo | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 12 (n=46, 47, 43, 15, 21, NA) | 35.71 Percentage of participants | 7.39 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 9 (n=36, 48, 45, 14, 20, NA) | 50.00 Percentage of participants | 7.91 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 1 (n=19, 19, 11, NA, NA, 4) | NA Percentage of participants | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 12 (n=46, 47, 43, 15, 21, NA) | 52.50 Percentage of participants | 7.9 |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 3 (n=35, 31, 30, NA, NA, 12) | NA Percentage of participants | — |
| Placebo/Tofacitinib, 10 mg, Twice Daily | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 6 (n=38, 42, 42, 12, 17, NA) | 42.50 Percentage of participants | 7.82 |
| Placebo | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 1 (n=19, 19, 11, NA, NA, 4) | 4.88 Percentage of participants | 2.38 |
| Placebo | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 9 (n=36, 48, 45, 14, 20, NA) | NA Percentage of participants | — |
| Placebo | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 3 (n=35, 31, 30, NA, NA, 12) | 14.63 Percentage of participants | 3.9 |
| Placebo | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 12 (n=46, 47, 43, 15, 21, NA) | NA Percentage of participants | — |
| Placebo | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 | Month 6 (n=38, 42, 42, 12, 17, NA) | NA Percentage of participants | — |