Rheumatoid Arthritis
Conditions
Brief summary
This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96 weeks.
Interventions
DRUGTocilizumab
TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core study on SC or IV TCZ and, based on the Investigator's judgment, may continue to benefit from TCZ treatment in this study investigating the SC formulation * Receiving treatment on an outpatient basis * Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol
Exclusion criteria
* Premature withdrawal from WA22762 (NCT01194414) or NA25220 (NCT01232569) core studies for any reason * History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies * Evidence of serious uncontrolled concomitant disease or disorder * Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections * Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening * History of or currently active primary or secondary immunodeficiency * Oral corticosteroids at greater than (\>) 10 mg per day prednisone or equivalent, or non-steroidal anti-inflammatory drugs (NSAIDs) above the maximum recommended dose * Intra-articular or parenteral corticosteroids within 4 weeks prior to Baseline * Treatment with any investigational or commercially available biologic disease-modifying anti-rheumatic drug (DMARD) other than TCZ at any time between completion of the core study WA22762 (NCT01194414) or NA25220 (NCT01232569) and enrollment in the long-term extension study * Pregnant or breastfeeding women * History of alcohol, drug, or chemical abuse within 1 year prior to Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One Serious Adverse Event (SAE) | From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall) | Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The number of participants with at least one SAE regardless of treatment relationship was reported. |
| Percentage of Participants With at Least One SAE | From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall) | AEs were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The percentage of participants with at least one SAE regardless of treatment relationship was calculated. |
| Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint | From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall) | Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. |
| Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline | Baseline | Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. |
| Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline | From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall) | Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. Positive assay results obtained post-Baseline were further investigated via confirmation assay and a neutralization assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Simplified Disease Activity Index (SDAI) Score | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and high-sensitivity C-reactive protein (hsCRP) level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 milligram per deciliter (mg/dL), scores would be expected to fall within less than or equal to (≤) 77 points. |
| Change From Baseline in SDAI Score | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and hsCRP level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity. |
| Tender Joint Count (TJC) Score | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. |
| Change From Baseline in TJC Score | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of tender joints. |
| Swollen Joint Count (SJC) Score | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. |
| Change From Baseline in SJC Score | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of swollen joints. |
| Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. |
| Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. |
| Percentage of Reasons Given for DMARD Dose Reduction or Interruption | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD dose reduction/interruption ≤60 days were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed. |
| Percentage of Reasons Given for DMARD Discontinuation | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD discontinuation were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed. |
| Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. |
| Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. |
| Percentage of Reasons Given for CCS Dose Reduction | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose reduction were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed. |
| Percentage of Reasons Given for CCS Dose Interruption | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose interruption ≤14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed. |
| Percentage of Reasons Given for CCS Discontinuation | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS discontinuation \>14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed. |
| Percentage of Participants Who Correctly Administered All SC TCZ Doses | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Compliance was assessed using drug dispensing logs, diary cards kept by the participant, and return records, as reviewed by the Investigator at regular visits. Total compliance up to the end of treatment was defined as the percentage of participants who correctly administered all scheduled doses of SC TCZ. Correct administration was defined as proper injection technique, injection of the correct amount (162 mg), device not left at room temperature for greater than (\>) 8 hours, and absence of other medication errors. |
| Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The percentage of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was calculated. |
| Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and thereafter returned to the QW regimen was reported with the reason for returning to the QW regimen. |
| Time to Return to the QW Regimen After Switching to the Q2W Regimen | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. Time to return was defined as the time between switching to the Q2W regimen and returning to the previous QW regimen. |
| Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no disease activity) to 100 mm (maximum disease activity), with higher scores representing an increase in perceived symptoms. |
| Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no disease activity) to 100 mm (maximum disease activity), with higher scores representing an increase in perceived symptoms. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in perceived disease activity. |
| Global Assessment of Pain by the Participant According to VAS Score | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no pain) to 100 mm (unbearable pain), with higher scores representing an increase in pain. |
| Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no pain) to 100 mm (unbearable pain), with higher scores representing an increase in pain. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in pain. |
| Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. |
| Change From Baseline in HAQ-DI Score | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The change from Baseline to each visit was calculated, where positive changes represent an increased need for assistance with daily activities. |
| Percentage of Participants With HAQ-DI Score <0.5 | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The percentage of participants achieving a score \<0.5 was calculated at each visit. |
| Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The number of participants who met criteria for low disease activity was reported at each visit. |
| Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for low disease activity was calculated at each visit. |
| Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | Remission was defined as DAS28 \<2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The number of participants who met criteria for remission was reported at each visit. |
| Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | Remission was defined as DAS28 \<2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for remission was calculated at each visit. |
| Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was reported. |
| Disease Activity Score Based on 28 Joints (DAS28) Score | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | The DAS28 was calculated using the Swollen Joint Count (SJC), Tender Joint Count (TJC), erythrocyte sedimentation rate (ESR), and Global Assessment of Disease Activity by the participant according to Visual Analog Scale (VAS) score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-millimeter (mm) scale to a 10-point score. The DAS28 was calculated as (0.56 multiplied by \[×\] square root of TJC) + (0.28 × square root of SJC) + (0.7 × log natural \[ln\] ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. |
| Change From Baseline in DAS28 Score | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | The DAS28 was calculated using the SJC, TJC, ESR, and Global Assessment of Disease Activity by the participant according to VAS score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity. |
| Clinical Disease Activity Index (CDAI) Score | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. |
| Change From Baseline in CDAI Score | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SC TCZ Q2W Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | 44 |
| SC TCZ QW Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. | 173 |
| Total | 217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event or Intercurrent Illness | 1 | 12 | 0 |
| Overall Study | Lack of Efficacy | 1 | 6 | 0 |
| Overall Study | Lost to Follow-up | 0 | 4 | 0 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 4 | 1 |
Baseline characteristics
| Characteristic | SC TCZ Q2W | SC TCZ QW | Total |
|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 10.18 | 58.1 years STANDARD_DEVIATION 10.38 | 58.4 years STANDARD_DEVIATION 10.33 |
| Sex: Female, Male Female | 33 Participants | 133 Participants | 166 Participants |
| Sex: Female, Male Male | 11 Participants | 40 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 44 | 102 / 173 |
| serious Total, serious adverse events | 4 / 44 | 19 / 173 |
Outcome results
Primary
Number of Participants With at Least One Serious Adverse Event (SAE)
Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The number of participants with at least one SAE regardless of treatment relationship was reported.
Time frame: From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)
Population: Safety Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SC TCZ Q2W | Number of Participants With at Least One Serious Adverse Event (SAE) | 4 participants |
| SC TCZ QW | Number of Participants With at Least One Serious Adverse Event (SAE) | 19 participants |
Primary
Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint
Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.
Time frame: From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)
Population: Safety Population; only participants with a valid assay at Screening were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SC TCZ Q2W | Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint | 4.5 percentage of participants |
| SC TCZ QW | Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint | 7.8 percentage of participants |
Primary
Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline
Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.
Time frame: Baseline
Population: Safety Population; only participants with a valid assay at Screening were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SC TCZ Q2W | Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline | 2.3 percentage of participants |
| SC TCZ QW | Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline | 4.8 percentage of participants |
Primary
Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline
Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. Positive assay results obtained post-Baseline were further investigated via confirmation assay and a neutralization assay.
Time frame: From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)
Population: Safety Population; only participants with a valid assay at Screening were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline | Positive Anti-TCZ Assay | 2.3 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline | Positive Confirmation Assay | 0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline | Positive Neutralizing Assay | 0 percentage of participants |
| SC TCZ QW | Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline | Positive Anti-TCZ Assay | 3.0 percentage of participants |
| SC TCZ QW | Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline | Positive Confirmation Assay | 0.6 percentage of participants |
| SC TCZ QW | Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline | Positive Neutralizing Assay | 0.6 percentage of participants |
Primary
Percentage of Participants With at Least One SAE
AEs were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The percentage of participants with at least one SAE regardless of treatment relationship was calculated.
Time frame: From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)
Population: Safety Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SC TCZ Q2W | Percentage of Participants With at Least One SAE | 9.1 percentage of participants |
| SC TCZ QW | Percentage of Participants With at Least One SAE | 11.0 percentage of participants |
Secondary
Change From Baseline in CDAI Score
The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.
Time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Change From Baseline in CDAI Score | Week 36 (n=39,159) | -7.00 units on a scale | Standard Deviation 12.266 |
| SC TCZ Q2W | Change From Baseline in CDAI Score | Week 60 (n=2,92) | -14.05 units on a scale | Standard Deviation 20.294 |
| SC TCZ Q2W | Change From Baseline in CDAI Score | Week 24 (n=42,166) | -5.23 units on a scale | Standard Deviation 14.134 |
| SC TCZ Q2W | Change From Baseline in CDAI Score | Week 72 (n=1,52) | -16.20 units on a scale | — |
| SC TCZ Q2W | Change From Baseline in CDAI Score | Week 48 (n=18,140) | -6.63 units on a scale | Standard Deviation 13.479 |
| SC TCZ Q2W | Change From Baseline in CDAI Score | Week 84 (n=0,11) | NA units on a scale | — |
| SC TCZ Q2W | Change From Baseline in CDAI Score | Week 12 (n=44,172) | -6.11 units on a scale | Standard Deviation 13.219 |
| SC TCZ QW | Change From Baseline in CDAI Score | Week 84 (n=0,11) | -10.01 units on a scale | Standard Deviation 18.58 |
| SC TCZ QW | Change From Baseline in CDAI Score | Week 12 (n=44,172) | -5.81 units on a scale | Standard Deviation 12.01 |
| SC TCZ QW | Change From Baseline in CDAI Score | Week 24 (n=42,166) | -5.47 units on a scale | Standard Deviation 13.754 |
| SC TCZ QW | Change From Baseline in CDAI Score | Week 36 (n=39,159) | -6.63 units on a scale | Standard Deviation 10.676 |
| SC TCZ QW | Change From Baseline in CDAI Score | Week 48 (n=18,140) | -6.70 units on a scale | Standard Deviation 12.328 |
| SC TCZ QW | Change From Baseline in CDAI Score | Week 60 (n=2,92) | -7.05 units on a scale | Standard Deviation 11.065 |
| SC TCZ QW | Change From Baseline in CDAI Score | Week 72 (n=1,52) | -6.31 units on a scale | Standard Deviation 12.999 |
Secondary
Change From Baseline in DAS28 Score
The DAS28 was calculated using the SJC, TJC, ESR, and Global Assessment of Disease Activity by the participant according to VAS score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.
Time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Change From Baseline in DAS28 Score | Week 36 (n=39,158) | -1.51 units on a scale | Standard Deviation 1.312 |
| SC TCZ Q2W | Change From Baseline in DAS28 Score | Week 60 (n=2,91) | 0.65 units on a scale | Standard Deviation 1.41 |
| SC TCZ Q2W | Change From Baseline in DAS28 Score | Week 24 (n=43,167) | -1.42 units on a scale | Standard Deviation 1.383 |
| SC TCZ Q2W | Change From Baseline in DAS28 Score | Week 72 (n=1,52) | -0.35 units on a scale | — |
| SC TCZ Q2W | Change From Baseline in DAS28 Score | Week 48 (n=18,140) | -1.66 units on a scale | Standard Deviation 1.34 |
| SC TCZ Q2W | Change From Baseline in DAS28 Score | Week 84 (n=0,10) | NA units on a scale | — |
| SC TCZ Q2W | Change From Baseline in DAS28 Score | Week 12 (n=44,171) | -1.38 units on a scale | Standard Deviation 1.522 |
| SC TCZ QW | Change From Baseline in DAS28 Score | Week 84 (n=0,10) | -1.57 units on a scale | Standard Deviation 1.312 |
| SC TCZ QW | Change From Baseline in DAS28 Score | Week 12 (n=44,171) | -1.19 units on a scale | Standard Deviation 1.415 |
| SC TCZ QW | Change From Baseline in DAS28 Score | Week 24 (n=43,167) | -1.23 units on a scale | Standard Deviation 1.692 |
| SC TCZ QW | Change From Baseline in DAS28 Score | Week 36 (n=39,158) | -1.29 units on a scale | Standard Deviation 1.429 |
| SC TCZ QW | Change From Baseline in DAS28 Score | Week 48 (n=18,140) | -1.32 units on a scale | Standard Deviation 1.538 |
| SC TCZ QW | Change From Baseline in DAS28 Score | Week 60 (n=2,91) | -1.29 units on a scale | Standard Deviation 1.286 |
| SC TCZ QW | Change From Baseline in DAS28 Score | Week 72 (n=1,52) | -1.53 units on a scale | Standard Deviation 1.435 |
Secondary
Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score
The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no disease activity) to 100 mm (maximum disease activity), with higher scores representing an increase in perceived symptoms. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in perceived disease activity.
Time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 36 (n=39,159) | -11.59 mm | Standard Deviation 23.736 |
| SC TCZ Q2W | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 60 (n=2,92) | 11.50 mm | Standard Deviation 30.406 |
| SC TCZ Q2W | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 24 (n=43,168) | -6.67 mm | Standard Deviation 18.977 |
| SC TCZ Q2W | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 72 (n=1,52) | 19.00 mm | — |
| SC TCZ Q2W | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 48 (n=18,141) | -5.61 mm | Standard Deviation 21.892 |
| SC TCZ Q2W | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 84 (n=0,11) | NA mm | — |
| SC TCZ Q2W | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 12 (n=44,172) | -7.59 mm | Standard Deviation 22.689 |
| SC TCZ QW | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 84 (n=0,11) | -10.82 mm | Standard Deviation 19.778 |
| SC TCZ QW | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 12 (n=44,172) | -9.59 mm | Standard Deviation 22.348 |
| SC TCZ QW | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 24 (n=43,168) | -9.67 mm | Standard Deviation 26.26 |
| SC TCZ QW | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 36 (n=39,159) | -10.14 mm | Standard Deviation 25.338 |
| SC TCZ QW | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 48 (n=18,141) | -11.47 mm | Standard Deviation 25.839 |
| SC TCZ QW | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 60 (n=2,92) | -9.93 mm | Standard Deviation 22.992 |
| SC TCZ QW | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | Week 72 (n=1,52) | -13.82 mm | Standard Deviation 25.779 |
Secondary
Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score
The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no pain) to 100 mm (unbearable pain), with higher scores representing an increase in pain. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in pain.
Time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 36 (n=39,159) | -10.62 mm | Standard Deviation 22.783 |
| SC TCZ Q2W | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 60 (n=2,92) | 3.00 mm | Standard Deviation 25.456 |
| SC TCZ Q2W | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 24 (n=43,168) | -6.63 mm | Standard Deviation 20.641 |
| SC TCZ Q2W | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 72 (n=1,52) | 3.00 mm | — |
| SC TCZ Q2W | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 48 (n=18,141) | -8.00 mm | Standard Deviation 18.166 |
| SC TCZ Q2W | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 84 (n=0,11) | NA mm | — |
| SC TCZ Q2W | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 12 (n=44,172) | -7.59 mm | Standard Deviation 22.145 |
| SC TCZ QW | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 84 (n=0,11) | -14.64 mm | Standard Deviation 20.911 |
| SC TCZ QW | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 12 (n=44,172) | -12.27 mm | Standard Deviation 21.582 |
| SC TCZ QW | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 24 (n=43,168) | -10.76 mm | Standard Deviation 24.154 |
| SC TCZ QW | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 36 (n=39,159) | -10.91 mm | Standard Deviation 22.747 |
| SC TCZ QW | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 48 (n=18,141) | -12.91 mm | Standard Deviation 24.95 |
| SC TCZ QW | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 60 (n=2,92) | -10.07 mm | Standard Deviation 22.001 |
| SC TCZ QW | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | Week 72 (n=1,52) | -12.47 mm | Standard Deviation 23.522 |
Secondary
Change From Baseline in HAQ-DI Score
The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The change from Baseline to each visit was calculated, where positive changes represent an increased need for assistance with daily activities.
Time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Change From Baseline in HAQ-DI Score | Week 36 (n=39,159) | -0.08 units on a scale | Standard Deviation 0.276 |
| SC TCZ Q2W | Change From Baseline in HAQ-DI Score | Week 60 (n=2,92) | 0.56 units on a scale | Standard Deviation 0.795 |
| SC TCZ Q2W | Change From Baseline in HAQ-DI Score | Week 24 (n=43,167) | -0.01 units on a scale | Standard Deviation 0.272 |
| SC TCZ Q2W | Change From Baseline in HAQ-DI Score | Week 72 (n=1,52) | 0.88 units on a scale | — |
| SC TCZ Q2W | Change From Baseline in HAQ-DI Score | Week 48 (n=18,141) | -0.01 units on a scale | Standard Deviation 0.237 |
| SC TCZ Q2W | Change From Baseline in HAQ-DI Score | Week 84 (n=0,11) | NA units on a scale | — |
| SC TCZ Q2W | Change From Baseline in HAQ-DI Score | Week 12 (n=44,172) | -0.02 units on a scale | Standard Deviation 0.254 |
| SC TCZ QW | Change From Baseline in HAQ-DI Score | Week 84 (n=0,11) | -0.07 units on a scale | Standard Deviation 0.397 |
| SC TCZ QW | Change From Baseline in HAQ-DI Score | Week 12 (n=44,172) | -0.10 units on a scale | Standard Deviation 0.339 |
| SC TCZ QW | Change From Baseline in HAQ-DI Score | Week 24 (n=43,167) | -0.11 units on a scale | Standard Deviation 0.372 |
| SC TCZ QW | Change From Baseline in HAQ-DI Score | Week 36 (n=39,159) | -0.09 units on a scale | Standard Deviation 0.394 |
| SC TCZ QW | Change From Baseline in HAQ-DI Score | Week 48 (n=18,141) | -0.14 units on a scale | Standard Deviation 0.39 |
| SC TCZ QW | Change From Baseline in HAQ-DI Score | Week 60 (n=2,92) | -0.08 units on a scale | Standard Deviation 0.394 |
| SC TCZ QW | Change From Baseline in HAQ-DI Score | Week 72 (n=1,52) | -0.06 units on a scale | Standard Deviation 0.42 |
Secondary
Change From Baseline in SDAI Score
The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and hsCRP level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.
Time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Change From Baseline in SDAI Score | Week 36 (n=39,157) | -7.99 units on a scale | Standard Deviation 12.858 |
| SC TCZ Q2W | Change From Baseline in SDAI Score | Week 60 (n=2,91) | -14.46 units on a scale | Standard Deviation 20.873 |
| SC TCZ Q2W | Change From Baseline in SDAI Score | Week 24 (n=41,163) | -5.71 units on a scale | Standard Deviation 14.217 |
| SC TCZ Q2W | Change From Baseline in SDAI Score | Week 72 (n=1,52) | -17.04 units on a scale | — |
| SC TCZ Q2W | Change From Baseline in SDAI Score | Week 48 (n=18,139) | -8.17 units on a scale | Standard Deviation 14.64 |
| SC TCZ Q2W | Change From Baseline in SDAI Score | Week 84 (n=0,10) | NA units on a scale | — |
| SC TCZ Q2W | Change From Baseline in SDAI Score | Week 12 (n=44,169) | -7.07 units on a scale | Standard Deviation 13.671 |
| SC TCZ QW | Change From Baseline in SDAI Score | Week 84 (n=0,10) | -9.48 units on a scale | Standard Deviation 19.29 |
| SC TCZ QW | Change From Baseline in SDAI Score | Week 12 (n=44,169) | -7.00 units on a scale | Standard Deviation 12.056 |
| SC TCZ QW | Change From Baseline in SDAI Score | Week 24 (n=41,163) | -6.79 units on a scale | Standard Deviation 13.069 |
| SC TCZ QW | Change From Baseline in SDAI Score | Week 36 (n=39,157) | -7.38 units on a scale | Standard Deviation 10.953 |
| SC TCZ QW | Change From Baseline in SDAI Score | Week 48 (n=18,139) | -7.29 units on a scale | Standard Deviation 12.454 |
| SC TCZ QW | Change From Baseline in SDAI Score | Week 60 (n=2,91) | -7.52 units on a scale | Standard Deviation 10.846 |
| SC TCZ QW | Change From Baseline in SDAI Score | Week 72 (n=1,52) | -7.10 units on a scale | Standard Deviation 13.379 |
Secondary
Change From Baseline in SJC Score
Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of swollen joints.
Time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Change From Baseline in SJC Score | Week 36 (n=39,159) | -3.33 swollen joints | Standard Deviation 6.868 |
| SC TCZ Q2W | Change From Baseline in SJC Score | Week 60 (n=2,92) | -8.50 swollen joints | Standard Deviation 12.021 |
| SC TCZ Q2W | Change From Baseline in SJC Score | Week 24 (n=42,167) | -3.45 swollen joints | Standard Deviation 8.434 |
| SC TCZ Q2W | Change From Baseline in SJC Score | Week 72 (n=1,52) | -15.00 swollen joints | — |
| SC TCZ Q2W | Change From Baseline in SJC Score | Week 48 (n=18,141) | -6.56 swollen joints | Standard Deviation 9.332 |
| SC TCZ Q2W | Change From Baseline in SJC Score | Week 84 (n=0,11) | NA swollen joints | — |
| SC TCZ Q2W | Change From Baseline in SJC Score | Week 12 (n=44,172) | -3.45 swollen joints | Standard Deviation 7.026 |
| SC TCZ QW | Change From Baseline in SJC Score | Week 84 (n=0,11) | -2.64 swollen joints | Standard Deviation 13.493 |
| SC TCZ QW | Change From Baseline in SJC Score | Week 12 (n=44,172) | -3.00 swollen joints | Standard Deviation 8.543 |
| SC TCZ QW | Change From Baseline in SJC Score | Week 24 (n=42,167) | -2.31 swollen joints | Standard Deviation 9.162 |
| SC TCZ QW | Change From Baseline in SJC Score | Week 36 (n=39,159) | -3.89 swollen joints | Standard Deviation 8.134 |
| SC TCZ QW | Change From Baseline in SJC Score | Week 48 (n=18,141) | -3.25 swollen joints | Standard Deviation 9.543 |
| SC TCZ QW | Change From Baseline in SJC Score | Week 60 (n=2,92) | -3.20 swollen joints | Standard Deviation 8.702 |
| SC TCZ QW | Change From Baseline in SJC Score | Week 72 (n=1,52) | -1.15 swollen joints | Standard Deviation 10.114 |
Secondary
Change From Baseline in TJC Score
Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of tender joints.
Time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Change From Baseline in TJC Score | Week 36 (n=39,159) | -4.03 tender joints | Standard Deviation 10.559 |
| SC TCZ Q2W | Change From Baseline in TJC Score | Week 60 (n=2,92) | -9.00 tender joints | Standard Deviation 12.728 |
| SC TCZ Q2W | Change From Baseline in TJC Score | Week 24 (n=42,167) | -2.69 tender joints | Standard Deviation 12.546 |
| SC TCZ Q2W | Change From Baseline in TJC Score | Week 72 (n=1,52) | -3.00 tender joints | — |
| SC TCZ Q2W | Change From Baseline in TJC Score | Week 48 (n=18,141) | -4.00 tender joints | Standard Deviation 12.902 |
| SC TCZ Q2W | Change From Baseline in TJC Score | Week 84 (n=0,11) | NA tender joints | — |
| SC TCZ Q2W | Change From Baseline in TJC Score | Week 12 (n=44,172) | -3.98 tender joints | Standard Deviation 12.082 |
| SC TCZ QW | Change From Baseline in TJC Score | Week 84 (n=0,11) | -6.27 tender joints | Standard Deviation 13.835 |
| SC TCZ QW | Change From Baseline in TJC Score | Week 12 (n=44,172) | -5.17 tender joints | Standard Deviation 12.175 |
| SC TCZ QW | Change From Baseline in TJC Score | Week 24 (n=42,167) | -5.12 tender joints | Standard Deviation 14.817 |
| SC TCZ QW | Change From Baseline in TJC Score | Week 36 (n=39,159) | -5.60 tender joints | Standard Deviation 12.402 |
| SC TCZ QW | Change From Baseline in TJC Score | Week 48 (n=18,141) | -5.95 tender joints | Standard Deviation 13.899 |
| SC TCZ QW | Change From Baseline in TJC Score | Week 60 (n=2,92) | -6.23 tender joints | Standard Deviation 10.672 |
| SC TCZ QW | Change From Baseline in TJC Score | Week 72 (n=1,52) | -4.98 tender joints | Standard Deviation 11.514 |
Secondary
Clinical Disease Activity Index (CDAI) Score
The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population; only those participants who provided evaluable data (n) were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Clinical Disease Activity Index (CDAI) Score | Baseline (n=44,173) | 20.10 units on a scale | Standard Deviation 15.467 |
| SC TCZ Q2W | Clinical Disease Activity Index (CDAI) Score | Week 12 (n=44,172) | 13.99 units on a scale | Standard Deviation 13.058 |
| SC TCZ Q2W | Clinical Disease Activity Index (CDAI) Score | Week 24 (n=42,166) | 14.86 units on a scale | Standard Deviation 13.232 |
| SC TCZ Q2W | Clinical Disease Activity Index (CDAI) Score | Week 36 (n=39,159) | 13.26 units on a scale | Standard Deviation 11.839 |
| SC TCZ Q2W | Clinical Disease Activity Index (CDAI) Score | Week 48 (n=18,140) | 15.81 units on a scale | Standard Deviation 16.479 |
| SC TCZ Q2W | Clinical Disease Activity Index (CDAI) Score | Week 60 (n=2,92) | 13.60 units on a scale | Standard Deviation 2.828 |
| SC TCZ Q2W | Clinical Disease Activity Index (CDAI) Score | Week 72 (n=1,52) | 27.80 units on a scale | — |
| SC TCZ Q2W | Clinical Disease Activity Index (CDAI) Score | Week 84 (n=0,11) | NA units on a scale | — |
| SC TCZ QW | Clinical Disease Activity Index (CDAI) Score | Week 84 (n=0,11) | 12.82 units on a scale | Standard Deviation 9.154 |
| SC TCZ QW | Clinical Disease Activity Index (CDAI) Score | Baseline (n=44,173) | 23.91 units on a scale | Standard Deviation 16.346 |
| SC TCZ QW | Clinical Disease Activity Index (CDAI) Score | Week 48 (n=18,140) | 16.55 units on a scale | Standard Deviation 13.559 |
| SC TCZ QW | Clinical Disease Activity Index (CDAI) Score | Week 12 (n=44,172) | 18.19 units on a scale | Standard Deviation 14.145 |
| SC TCZ QW | Clinical Disease Activity Index (CDAI) Score | Week 72 (n=1,52) | 16.04 units on a scale | Standard Deviation 15.476 |
| SC TCZ QW | Clinical Disease Activity Index (CDAI) Score | Week 24 (n=42,166) | 18.03 units on a scale | Standard Deviation 13.665 |
| SC TCZ QW | Clinical Disease Activity Index (CDAI) Score | Week 60 (n=2,92) | 14.71 units on a scale | Standard Deviation 11.954 |
| SC TCZ QW | Clinical Disease Activity Index (CDAI) Score | Week 36 (n=39,159) | 16.92 units on a scale | Standard Deviation 12.598 |
Secondary
Disease Activity Score Based on 28 Joints (DAS28) Score
The DAS28 was calculated using the Swollen Joint Count (SJC), Tender Joint Count (TJC), erythrocyte sedimentation rate (ESR), and Global Assessment of Disease Activity by the participant according to Visual Analog Scale (VAS) score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-millimeter (mm) scale to a 10-point score. The DAS28 was calculated as (0.56 multiplied by \[×\] square root of TJC) + (0.28 × square root of SJC) + (0.7 × log natural \[ln\] ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 48 (n=18,141) | 3.15 units on a scale | Standard Deviation 1.392 |
| SC TCZ Q2W | Disease Activity Score Based on 28 Joints (DAS28) Score | Baseline (n=44,172) | 4.55 units on a scale | Standard Deviation 1.732 |
| SC TCZ Q2W | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 60 (n=2,92) | 4.10 units on a scale | Standard Deviation 0.515 |
| SC TCZ Q2W | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 24 (n=43,168) | 3.08 units on a scale | Standard Deviation 1.351 |
| SC TCZ Q2W | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 72 (n=1,52) | 5.76 units on a scale | — |
| SC TCZ Q2W | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 36 (n=39,159) | 3.07 units on a scale | Standard Deviation 1.425 |
| SC TCZ Q2W | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 84 (n=0,11) | NA units on a scale | — |
| SC TCZ Q2W | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 12 (n=44,172) | 3.17 units on a scale | Standard Deviation 1.443 |
| SC TCZ QW | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 84 (n=0,11) | 2.78 units on a scale | Standard Deviation 1.434 |
| SC TCZ QW | Disease Activity Score Based on 28 Joints (DAS28) Score | Baseline (n=44,172) | 4.60 units on a scale | Standard Deviation 1.869 |
| SC TCZ QW | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 12 (n=44,172) | 3.42 units on a scale | Standard Deviation 1.728 |
| SC TCZ QW | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 36 (n=39,159) | 3.29 units on a scale | Standard Deviation 1.624 |
| SC TCZ QW | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 48 (n=18,141) | 3.25 units on a scale | Standard Deviation 1.639 |
| SC TCZ QW | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 60 (n=2,92) | 3.12 units on a scale | Standard Deviation 1.626 |
| SC TCZ QW | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 72 (n=1,52) | 3.05 units on a scale | Standard Deviation 1.97 |
| SC TCZ QW | Disease Activity Score Based on 28 Joints (DAS28) Score | Week 24 (n=43,168) | 3.35 units on a scale | Standard Deviation 1.786 |
Secondary
Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score
The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no disease activity) to 100 mm (maximum disease activity), with higher scores representing an increase in perceived symptoms.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population; only those participants who provided evaluable data (n) were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 24 (n=43,168) | 31.86 mm | Standard Deviation 25.639 |
| SC TCZ Q2W | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Baseline (n=44,173) | 39.39 mm | Standard Deviation 24.483 |
| SC TCZ Q2W | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 12 (n=44,172) | 31.80 mm | Standard Deviation 23.878 |
| SC TCZ Q2W | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 36 (n=39,159) | 30.13 mm | Standard Deviation 23.345 |
| SC TCZ Q2W | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 48 (n=18,141) | 37.95 mm | Standard Deviation 24.878 |
| SC TCZ Q2W | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 60 (n=2,92) | 54.00 mm | Standard Deviation 24.042 |
| SC TCZ Q2W | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 72 (n=1,52) | 57.00 mm | — |
| SC TCZ Q2W | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 84 (n=0,11) | NA mm | — |
| SC TCZ QW | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 84 (n=0,11) | 30.00 mm | Standard Deviation 26.348 |
| SC TCZ QW | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 48 (n=18,141) | 34.63 mm | Standard Deviation 27.136 |
| SC TCZ QW | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Baseline (n=44,173) | 47.25 mm | Standard Deviation 29.868 |
| SC TCZ QW | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 72 (n=1,52) | 30.83 mm | Standard Deviation 28.425 |
| SC TCZ QW | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 12 (n=44,172) | 37.84 mm | Standard Deviation 28.13 |
| SC TCZ QW | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 24 (n=43,168) | 37.51 mm | Standard Deviation 27.536 |
| SC TCZ QW | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 60 (n=2,92) | 32.86 mm | Standard Deviation 27.932 |
| SC TCZ QW | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | Week 36 (n=39,159) | 37.44 mm | Standard Deviation 27.519 |
Secondary
Global Assessment of Pain by the Participant According to VAS Score
The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no pain) to 100 mm (unbearable pain), with higher scores representing an increase in pain.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population; only those participants who provided evaluable data (n) were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Global Assessment of Pain by the Participant According to VAS Score | Week 24 (n=43,168) | 29.42 mm | Standard Deviation 24.509 |
| SC TCZ Q2W | Global Assessment of Pain by the Participant According to VAS Score | Baseline (n=44,173) | 36.89 mm | Standard Deviation 23.044 |
| SC TCZ Q2W | Global Assessment of Pain by the Participant According to VAS Score | Week 36 (n=39,159) | 28.38 mm | Standard Deviation 20.607 |
| SC TCZ Q2W | Global Assessment of Pain by the Participant According to VAS Score | Week 60 (n=2,92) | 50.00 mm | Standard Deviation 14.142 |
| SC TCZ Q2W | Global Assessment of Pain by the Participant According to VAS Score | Week 48 (n=18,141) | 33.44 mm | Standard Deviation 21.742 |
| SC TCZ Q2W | Global Assessment of Pain by the Participant According to VAS Score | Week 12 (n=44,172) | 29.30 mm | Standard Deviation 22.782 |
| SC TCZ Q2W | Global Assessment of Pain by the Participant According to VAS Score | Week 84 (n=0,11) | NA mm | — |
| SC TCZ Q2W | Global Assessment of Pain by the Participant According to VAS Score | Week 72 (n=1,52) | 42.00 mm | — |
| SC TCZ QW | Global Assessment of Pain by the Participant According to VAS Score | Week 84 (n=0,11) | 25.36 mm | Standard Deviation 25.598 |
| SC TCZ QW | Global Assessment of Pain by the Participant According to VAS Score | Week 48 (n=18,141) | 31.52 mm | Standard Deviation 25.892 |
| SC TCZ QW | Global Assessment of Pain by the Participant According to VAS Score | Baseline (n=44,173) | 45.42 mm | Standard Deviation 29.448 |
| SC TCZ QW | Global Assessment of Pain by the Participant According to VAS Score | Week 12 (n=44,172) | 33.27 mm | Standard Deviation 25.984 |
| SC TCZ QW | Global Assessment of Pain by the Participant According to VAS Score | Week 24 (n=43,168) | 34.48 mm | Standard Deviation 24.841 |
| SC TCZ QW | Global Assessment of Pain by the Participant According to VAS Score | Week 36 (n=39,159) | 34.40 mm | Standard Deviation 25.149 |
| SC TCZ QW | Global Assessment of Pain by the Participant According to VAS Score | Week 72 (n=1,52) | 29.20 mm | Standard Deviation 26.733 |
| SC TCZ QW | Global Assessment of Pain by the Participant According to VAS Score | Week 60 (n=2,92) | 30.94 mm | Standard Deviation 27.635 |
Secondary
Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score
The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population; only those participants who provided evaluable data (n) were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline (n=44,173) | 0.98 units on a scale | Standard Deviation 0.682 |
| SC TCZ Q2W | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 (n=44,172) | 0.95 units on a scale | Standard Deviation 0.688 |
| SC TCZ Q2W | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 24 (n=43,167) | 0.94 units on a scale | Standard Deviation 0.717 |
| SC TCZ Q2W | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 36 (n=39,159) | 0.95 units on a scale | Standard Deviation 0.682 |
| SC TCZ Q2W | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 48 (n=18,141) | 0.97 units on a scale | Standard Deviation 0.596 |
| SC TCZ Q2W | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 60 (n=2,92) | 2.13 units on a scale | Standard Deviation 0.53 |
| SC TCZ Q2W | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 72 (n=1,52) | 2.25 units on a scale | — |
| SC TCZ Q2W | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 84 (n=0,11) | NA units on a scale | — |
| SC TCZ QW | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 84 (n=0,11) | 1.14 units on a scale | Standard Deviation 0.73 |
| SC TCZ QW | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline (n=44,173) | 1.20 units on a scale | Standard Deviation 0.729 |
| SC TCZ QW | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 48 (n=18,141) | 1.04 units on a scale | Standard Deviation 0.745 |
| SC TCZ QW | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 (n=44,172) | 1.11 units on a scale | Standard Deviation 0.75 |
| SC TCZ QW | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 72 (n=1,52) | 0.97 units on a scale | Standard Deviation 0.844 |
| SC TCZ QW | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 24 (n=43,167) | 1.09 units on a scale | Standard Deviation 0.725 |
| SC TCZ QW | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 60 (n=2,92) | 1.01 units on a scale | Standard Deviation 0.779 |
| SC TCZ QW | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 36 (n=39,159) | 1.10 units on a scale | Standard Deviation 0.741 |
Secondary
Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen
Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and thereafter returned to the QW regimen was reported with the reason for returning to the QW regimen.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population; only participants who switched from the QW to Q2W regimen were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen | Any Reason | 1 participants |
| SC TCZ Q2W | Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen | Investigator Recommendation | 1 participants |
Secondary
Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen
Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was reported.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SC TCZ Q2W | Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen | 14 participants |
Secondary
Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation
Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation | Any Dose Reduction/Interruption/Discontinuation | 6 participants |
| SC TCZ Q2W | Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation | Dose Reduction | 5 participants |
| SC TCZ Q2W | Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation | Dose Interruption ≤14 Days | 0 participants |
| SC TCZ Q2W | Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation | Discontinuation >14 Days | 2 participants |
| SC TCZ QW | Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation | Discontinuation >14 Days | 19 participants |
| SC TCZ QW | Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation | Any Dose Reduction/Interruption/Discontinuation | 33 participants |
| SC TCZ QW | Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation | Dose Interruption ≤14 Days | 2 participants |
| SC TCZ QW | Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation | Dose Reduction | 24 participants |
Secondary
Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation
Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population; only participants receiving at least one DMARD at Baseline were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation | Dose Reduction | 1 participants |
| SC TCZ Q2W | Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation | Dose Reduction/Interruption ≤60 Days | 1 participants |
| SC TCZ Q2W | Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation | Dose Interruption ≤60 Days | 1 participants |
| SC TCZ Q2W | Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation | Discontinuation >60 Days | 2 participants |
| SC TCZ Q2W | Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation | Any Dose Reduction/Interruption/Discontinuation | 3 participants |
| SC TCZ QW | Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation | Discontinuation >60 Days | 15 participants |
| SC TCZ QW | Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation | Any Dose Reduction/Interruption/Discontinuation | 37 participants |
| SC TCZ QW | Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation | Dose Reduction | 14 participants |
| SC TCZ QW | Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation | Dose Interruption ≤60 Days | 15 participants |
| SC TCZ QW | Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation | Dose Reduction/Interruption ≤60 Days | 27 participants |
Secondary
Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria
Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The number of participants who met criteria for low disease activity was reported at each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population; only those participants who provided evaluable data (n) were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 24, DAS28 (n=43,168) | 23 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline, SDAI (n=44,170) | 14 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline, CDAI (n=44,173) | 13 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 12, DAS28 (n=44,172) | 21 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 12, SDAI (n=44,172) | 22 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 12, CDAI (n=44,172) | 20 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline, DAS28 (n=44,172) | 11 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 24, SDAI (n=41,166) | 19 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 24, CDAI (n=42,166) | 20 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 36, DAS28 (n=39,159) | 21 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 36, SDAI (n=39,159) | 20 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 36, CDAI (n=39,159) | 21 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 48, DAS28 (n=18,141) | 10 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 48, SDAI (n=18,140) | 8 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 48, CDAI (n=18,140) | 7 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 60, DAS28 (n=2,92) | 0 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 60, SDAI (n=2,92) | 0 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 60, CDAI (n=2,92) | 0 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 72, DAS28 (n=1,52) | 0 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 72, SDAI (n=1,52) | 0 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 72, CDAI (n=1,52) | 0 participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 84, DAS28 (n=0,11) | NA participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 84, SDAI (n=0,11) | NA participants |
| SC TCZ Q2W | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 84, CDAI (n=0,11) | NA participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 84, SDAI (n=0,11) | 4 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline, DAS28 (n=44,172) | 46 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 48, DAS28 (n=18,141) | 69 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline, SDAI (n=44,170) | 43 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 72, DAS28 (n=1,52) | 28 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline, CDAI (n=44,173) | 41 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 48, SDAI (n=18,140) | 63 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 12, DAS28 (n=44,172) | 81 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 84, DAS28 (n=0,11) | 6 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 12, SDAI (n=44,172) | 65 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 48, CDAI (n=18,140) | 59 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 12, CDAI (n=44,172) | 63 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 72, SDAI (n=1,52) | 26 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 24, DAS28 (n=43,168) | 82 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 60, DAS28 (n=2,92) | 52 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 24, SDAI (n=41,166) | 67 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 84, CDAI (n=0,11) | 4 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 24, CDAI (n=42,166) | 60 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 60, SDAI (n=2,92) | 40 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 36, DAS28 (n=39,159) | 75 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 72, CDAI (n=1,52) | 25 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 36, SDAI (n=39,159) | 61 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 60, CDAI (n=2,92) | 37 participants |
| SC TCZ QW | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 36, CDAI (n=39,159) | 60 participants |
Secondary
Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria
Remission was defined as DAS28 \<2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The number of participants who met criteria for remission was reported at each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 24, DAS28 (n=43,168) | 18 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline, SDAI (n=44,170) | 2 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline, Boolean (n=44,172) | 1 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 12, DAS28 (n=44,172) | 14 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 12, SDAI (n=44,172) | 7 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 12, Boolean (n=44,172) | 4 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline, DAS28 (n=44,172) | 6 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 24, SDAI (n=41,166) | 8 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 24, Boolean (n=43,170) | 5 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 36, DAS28 (n=39,159) | 15 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 36, SDAI (n=39,159) | 7 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 36, Boolean (n=39,161) | 3 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 48, DAS28 (n=18,141) | 9 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 48, SDAI (n=18,140) | 1 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 48, Boolean (n=18,143) | 1 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 60, DAS28 (n=2,92) | 0 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 60, SDAI (n=2,92) | 0 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 60, Boolean (n=2,93) | 0 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 72, DAS28 (n=1,52) | 0 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 72, SDAI (n=1,52) | 0 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 72, Boolean (n=1,54) | 0 participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 84, DAS28 (n=0,11) | NA participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 84, SDAI (n=0,11) | NA participants |
| SC TCZ Q2W | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 84, Boolean (n=0,11) | NA participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 84, SDAI (n=0,11) | 2 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline, DAS28 (n=44,172) | 33 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 48, DAS28 (n=18,141) | 51 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline, SDAI (n=44,170) | 15 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 72, DAS28 (n=1,52) | 22 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline, Boolean (n=44,172) | 14 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 48, SDAI (n=18,140) | 15 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 12, DAS28 (n=44,172) | 61 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 84, DAS28 (n=0,11) | 6 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 12, SDAI (n=44,172) | 20 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 48, Boolean (n=18,143) | 14 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 12, Boolean (n=44,172) | 15 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 72, SDAI (n=1,52) | 11 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 24, DAS28 (n=43,168) | 61 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 60, DAS28 (n=2,92) | 39 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 24, SDAI (n=41,166) | 23 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 84, Boolean (n=0,11) | 2 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 24, Boolean (n=43,170) | 16 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 60, SDAI (n=2,92) | 17 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 36, DAS28 (n=39,159) | 57 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 72, Boolean (n=1,54) | 10 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 36, SDAI (n=39,159) | 21 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 60, Boolean (n=2,93) | 14 participants |
| SC TCZ QW | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 36, Boolean (n=39,161) | 17 participants |
Secondary
Percentage of Participants Who Correctly Administered All SC TCZ Doses
Compliance was assessed using drug dispensing logs, diary cards kept by the participant, and return records, as reviewed by the Investigator at regular visits. Total compliance up to the end of treatment was defined as the percentage of participants who correctly administered all scheduled doses of SC TCZ. Correct administration was defined as proper injection technique, injection of the correct amount (162 mg), device not left at room temperature for greater than (\>) 8 hours, and absence of other medication errors.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: Intent-to-Treat (ITT) Population: All participants who received at least one dose of study medication and had at least one post-dose efficacy assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SC TCZ Q2W | Percentage of Participants Who Correctly Administered All SC TCZ Doses | 97.7 percentage of participants |
| SC TCZ QW | Percentage of Participants Who Correctly Administered All SC TCZ Doses | 97.7 percentage of participants |
Secondary
Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen
Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The percentage of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was calculated.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SC TCZ Q2W | Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen | 6.5 percentage of participants |
Secondary
Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation
Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation | Any Dose Reduction/Interruption/Discontinuation | 40.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation | Dose Reduction | 33.3 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation | Dose Interruption ≤14 Days | 0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation | Discontinuation >14 Days | 13.3 percentage of participants |
| SC TCZ QW | Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation | Discontinuation >14 Days | 21.3 percentage of participants |
| SC TCZ QW | Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation | Any Dose Reduction/Interruption/Discontinuation | 37.1 percentage of participants |
| SC TCZ QW | Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation | Dose Interruption ≤14 Days | 2.2 percentage of participants |
| SC TCZ QW | Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation | Dose Reduction | 27.0 percentage of participants |
Secondary
Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation
Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population; only participants receiving at least one DMARD at Baseline were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation | Dose Reduction | 2.4 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation | Dose Reduction/Interruption ≤60 Days | 2.4 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation | Dose Interruption ≤60 Days | 2.4 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation | Discontinuation >60 Days | 4.9 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation | Any Dose Reduction/Interruption/Discontinuation | 7.3 percentage of participants |
| SC TCZ QW | Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation | Discontinuation >60 Days | 9.3 percentage of participants |
| SC TCZ QW | Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation | Any Dose Reduction/Interruption/Discontinuation | 23.0 percentage of participants |
| SC TCZ QW | Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation | Dose Reduction | 8.7 percentage of participants |
| SC TCZ QW | Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation | Dose Interruption ≤60 Days | 9.3 percentage of participants |
| SC TCZ QW | Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation | Dose Reduction/Interruption ≤60 Days | 16.8 percentage of participants |
Secondary
Percentage of Participants With HAQ-DI Score <0.5
The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The percentage of participants achieving a score \<0.5 was calculated at each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population; only those participants who provided evaluable data (n) were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Percentage of Participants With HAQ-DI Score <0.5 | Baseline (n=44,173) | 31.8 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With HAQ-DI Score <0.5 | Week 12 (n=44,172) | 27.3 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With HAQ-DI Score <0.5 | Week 24 (n=43,167) | 32.6 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With HAQ-DI Score <0.5 | Week 36 (n=39,159) | 38.5 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With HAQ-DI Score <0.5 | Week 48 (n=18,141) | 27.8 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With HAQ-DI Score <0.5 | Week 60 (n=2,92) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With HAQ-DI Score <0.5 | Week 72 (n=1,52) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With HAQ-DI Score <0.5 | Week 84 (n=0,11) | NA percentage of participants |
| SC TCZ QW | Percentage of Participants With HAQ-DI Score <0.5 | Week 84 (n=0,11) | 9.1 percentage of participants |
| SC TCZ QW | Percentage of Participants With HAQ-DI Score <0.5 | Baseline (n=44,173) | 17.9 percentage of participants |
| SC TCZ QW | Percentage of Participants With HAQ-DI Score <0.5 | Week 48 (n=18,141) | 24.8 percentage of participants |
| SC TCZ QW | Percentage of Participants With HAQ-DI Score <0.5 | Week 12 (n=44,172) | 20.9 percentage of participants |
| SC TCZ QW | Percentage of Participants With HAQ-DI Score <0.5 | Week 72 (n=1,52) | 34.6 percentage of participants |
| SC TCZ QW | Percentage of Participants With HAQ-DI Score <0.5 | Week 24 (n=43,167) | 23.4 percentage of participants |
| SC TCZ QW | Percentage of Participants With HAQ-DI Score <0.5 | Week 60 (n=2,92) | 29.3 percentage of participants |
| SC TCZ QW | Percentage of Participants With HAQ-DI Score <0.5 | Week 36 (n=39,159) | 24.5 percentage of participants |
Secondary
Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria
Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for low disease activity was calculated at each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population; only those participants who provided evaluable data (n) were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 24, DAS28 (n=43,168) | 53.5 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline, SDAI (n=44,170) | 31.8 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline, CDAI (n=44,173) | 29.5 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 12, DAS28 (n=44,172) | 47.7 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 12, SDAI (n=44,172) | 50.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 12, CDAI (n=44,172) | 45.5 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline, DAS28 (n=44,172) | 25.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 24, SDAI (n=41,166) | 46.3 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 24, CDAI (n=42,166) | 47.6 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 36, DAS28 (n=39,159) | 53.8 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 36, SDAI (n=39,159) | 51.3 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 36, CDAI (n=39,159) | 53.8 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 48, DAS28 (n=18,141) | 55.6 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 48, SDAI (n=18,140) | 44.4 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 48, CDAI (n=18,140) | 38.9 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 60, DAS28 (n=2,92) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 60, SDAI (n=2,92) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 60, CDAI (n=2,92) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 72, DAS28 (n=1,52) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 72, SDAI (n=1,52) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 72, CDAI (n=1,52) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 84, DAS28 (n=0,11) | NA percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 84, SDAI (n=0,11) | NA percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 84, CDAI (n=0,11) | NA percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 84, SDAI (n=0,11) | 36.4 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline, DAS28 (n=44,172) | 26.7 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 48, DAS28 (n=18,141) | 48.9 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline, SDAI (n=44,170) | 25.3 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 72, DAS28 (n=1,52) | 53.8 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Baseline, CDAI (n=44,173) | 23.7 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 48, SDAI (n=18,140) | 45.0 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 12, DAS28 (n=44,172) | 47.1 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 84, DAS28 (n=0,11) | 54.5 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 12, SDAI (n=44,172) | 37.8 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 48, CDAI (n=18,140) | 42.1 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 12, CDAI (n=44,172) | 36.6 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 72, SDAI (n=1,52) | 50.0 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 24, DAS28 (n=43,168) | 48.8 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 60, DAS28 (n=2,92) | 56.5 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 24, SDAI (n=41,166) | 40.4 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 84, CDAI (n=0,11) | 36.4 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 24, CDAI (n=42,166) | 36.1 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 60, SDAI (n=2,92) | 43.5 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 36, DAS28 (n=39,159) | 47.2 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 72, CDAI (n=1,52) | 48.1 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 36, SDAI (n=39,159) | 38.4 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 60, CDAI (n=2,92) | 40.2 percentage of participants |
| SC TCZ QW | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Week 36, CDAI (n=39,159) | 37.7 percentage of participants |
Secondary
Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria
Remission was defined as DAS28 \<2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for remission was calculated at each visit.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 60, DAS28 (n=2,92) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 36, SDAI (n=39,159) | 17.9 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 36, Boolean (n=39,161) | 7.7 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 48, DAS28 (n=18,141) | 50.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 48, SDAI (n=18,140) | 5.6 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 48, Boolean (n=18,143) | 5.6 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 36, DAS28 (n=39,159) | 38.5 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 60, SDAI (n=2,92) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 60, Boolean (n=2,93) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 72, DAS28 (n=1,52) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 72, SDAI (n=1,52) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 72, Boolean (n=1,54) | 0.0 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 84, DAS28 (n=0,11) | NA percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 84, SDAI (n=0,11) | NA percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 84, Boolean (n=0,11) | NA percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline, DAS28 (n=44,172) | 13.6 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline, SDAI (n=44,170) | 4.5 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline, Boolean (n=44,172) | 2.3 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 12, DAS28 (n=44,172) | 31.8 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 12, SDAI (n=44,172) | 15.9 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 12, Boolean (n=44,172) | 9.1 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 24, DAS28 (n=43,168) | 41.9 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 24, SDAI (n=41,166) | 19.5 percentage of participants |
| SC TCZ Q2W | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 24, Boolean (n=43,170) | 11.6 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 24, SDAI (n=41,166) | 13.9 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 36, DAS28 (n=39,159) | 35.8 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 84, DAS28 (n=0,11) | 54.5 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 36, SDAI (n=39,159) | 13.2 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 12, DAS28 (n=44,172) | 35.5 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 36, Boolean (n=39,161) | 10.6 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 84, SDAI (n=0,11) | 18.2 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 48, DAS28 (n=18,141) | 36.2 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 24, DAS28 (n=43,168) | 36.3 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 48, SDAI (n=18,140) | 10.7 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 84, Boolean (n=0,11) | 18.2 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 48, Boolean (n=18,143) | 9.8 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 12, SDAI (n=44,172) | 11.6 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 60, DAS28 (n=2,92) | 42.4 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline, DAS28 (n=44,172) | 19.2 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 60, SDAI (n=2,92) | 18.5 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 24, Boolean (n=43,170) | 9.4 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 60, Boolean (n=2,93) | 15.1 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline, SDAI (n=44,170) | 8.8 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 72, DAS28 (n=1,52) | 42.3 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 12, Boolean (n=44,172) | 8.7 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 72, SDAI (n=1,52) | 21.2 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Baseline, Boolean (n=44,172) | 8.1 percentage of participants |
| SC TCZ QW | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Week 72, Boolean (n=1,54) | 18.5 percentage of participants |
Secondary
Percentage of Reasons Given for CCS Discontinuation
Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS discontinuation \>14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population; only participants with a CCS discontinuation \>14 days were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Percentage of Reasons Given for CCS Discontinuation | AEs | 50.0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for CCS Discontinuation | Steroid Tapering | 50.0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for CCS Discontinuation | AE Resolution | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for CCS Discontinuation | Participant Request | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for CCS Discontinuation | RA Improvement | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for CCS Discontinuation | Not Specified | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for CCS Discontinuation | Prescription End | 0 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Discontinuation | Not Specified | 14.8 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Discontinuation | Prescription End | 14.8 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Discontinuation | AE Resolution | 18.5 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Discontinuation | AEs | 11.1 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Discontinuation | RA Improvement | 14.8 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Discontinuation | Steroid Tapering | 18.5 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Discontinuation | Participant Request | 7.4 percentage of reasons |
Secondary
Percentage of Reasons Given for CCS Dose Interruption
Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose interruption ≤14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population; only participants with a CCS dose interruption ≤14 days were included. Results were only reported for the QW arm because no participants in the Q2W arm had a CCS dose interruption.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Percentage of Reasons Given for CCS Dose Interruption | Hospitalization | 33.3 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for CCS Dose Interruption | Steroid Tapering | 66.7 percentage of reasons |
Secondary
Percentage of Reasons Given for CCS Dose Reduction
Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose reduction were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population; only participants with a CCS dose reduction were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Percentage of Reasons Given for CCS Dose Reduction | AEs | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for CCS Dose Reduction | Steroid Tapering | 50.0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for CCS Dose Reduction | Participant Request | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for CCS Dose Reduction | RA Treatment | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for CCS Dose Reduction | Not Specified | 7.1 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for CCS Dose Reduction | Medical History | 42.9 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Dose Reduction | Not Specified | 1.2 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Dose Reduction | AEs | 3.6 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Dose Reduction | Steroid Tapering | 91.7 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Dose Reduction | Medical History | 0 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Dose Reduction | RA Treatment | 2.4 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for CCS Dose Reduction | Participant Request | 1.2 percentage of reasons |
Secondary
Percentage of Reasons Given for DMARD Discontinuation
Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD discontinuation were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population; only participants with a DMARD discontinuation \>60 days were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Discontinuation | Investigator Recommendation | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Discontinuation | Participant Request | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Discontinuation | Efficacy | 33.3 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Discontinuation | Too Expensive | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Discontinuation | RA Improvement | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Discontinuation | Not Specified | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Discontinuation | AEs | 66.7 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Discontinuation | Not Specified | 6.3 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Discontinuation | AEs | 43.8 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Discontinuation | Efficacy | 0 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Discontinuation | Investigator Recommendation | 6.3 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Discontinuation | RA Improvement | 31.3 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Discontinuation | Participant Request | 6.3 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Discontinuation | Too Expensive | 6.3 percentage of reasons |
Secondary
Percentage of Reasons Given for DMARD Dose Reduction or Interruption
Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD dose reduction/interruption ≤60 days were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population; only participants with a DMARD dose reduction/interruption ≤60 days were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Efficacy | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | RA Treatment | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Medical History | 100.0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Replace Previous Drug | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Joint Surgery | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Participant Request | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | RA Improvement | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Not Specified | 0 percentage of reasons |
| SC TCZ Q2W | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | AEs | 0 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Not Specified | 7.3 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | AEs | 70.7 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Efficacy | 2.4 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Joint Surgery | 2.4 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Medical History | 2.4 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | RA Improvement | 7.3 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | RA Treatment | 2.4 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Replace Previous Drug | 2.4 percentage of reasons |
| SC TCZ QW | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Participant Request | 2.4 percentage of reasons |
Secondary
Simplified Disease Activity Index (SDAI) Score
The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and high-sensitivity C-reactive protein (hsCRP) level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 milligram per deciliter (mg/dL), scores would be expected to fall within less than or equal to (≤) 77 points.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Simplified Disease Activity Index (SDAI) Score | Baseline (n=44,170) | 21.54 units on a scale | Standard Deviation 15.717 |
| SC TCZ Q2W | Simplified Disease Activity Index (SDAI) Score | Week 12 (n=44,172) | 14.48 units on a scale | Standard Deviation 13.058 |
| SC TCZ Q2W | Simplified Disease Activity Index (SDAI) Score | Week 24 (n=41,166) | 15.42 units on a scale | Standard Deviation 13.266 |
| SC TCZ Q2W | Simplified Disease Activity Index (SDAI) Score | Week 36 (n=39,159) | 13.75 units on a scale | Standard Deviation 11.841 |
| SC TCZ Q2W | Simplified Disease Activity Index (SDAI) Score | Week 48 (n=18,140) | 15.85 units on a scale | Standard Deviation 16.49 |
| SC TCZ Q2W | Simplified Disease Activity Index (SDAI) Score | Week 60 (n=2,92) | 13.63 units on a scale | Standard Deviation 2.841 |
| SC TCZ Q2W | Simplified Disease Activity Index (SDAI) Score | Week 72 (n=1,52) | 27.82 units on a scale | — |
| SC TCZ Q2W | Simplified Disease Activity Index (SDAI) Score | Week 84 (n=0,11) | NA units on a scale | — |
| SC TCZ QW | Simplified Disease Activity Index (SDAI) Score | Week 84 (n=0,11) | 12.90 units on a scale | Standard Deviation 9.163 |
| SC TCZ QW | Simplified Disease Activity Index (SDAI) Score | Baseline (n=44,170) | 25.10 units on a scale | Standard Deviation 16.972 |
| SC TCZ QW | Simplified Disease Activity Index (SDAI) Score | Week 48 (n=18,140) | 16.76 units on a scale | Standard Deviation 13.603 |
| SC TCZ QW | Simplified Disease Activity Index (SDAI) Score | Week 12 (n=44,172) | 18.32 units on a scale | Standard Deviation 14.199 |
| SC TCZ QW | Simplified Disease Activity Index (SDAI) Score | Week 72 (n=1,52) | 16.23 units on a scale | Standard Deviation 15.73 |
| SC TCZ QW | Simplified Disease Activity Index (SDAI) Score | Week 24 (n=41,166) | 18.18 units on a scale | Standard Deviation 13.779 |
| SC TCZ QW | Simplified Disease Activity Index (SDAI) Score | Week 60 (n=2,92) | 14.90 units on a scale | Standard Deviation 12.045 |
| SC TCZ QW | Simplified Disease Activity Index (SDAI) Score | Week 36 (n=39,159) | 17.06 units on a scale | Standard Deviation 12.621 |
Secondary
Swollen Joint Count (SJC) Score
Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population; only those participants who provided evaluable data (n) were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Swollen Joint Count (SJC) Score | Baseline (n=44,173) | 9.07 swollen joints | Standard Deviation 8.877 |
| SC TCZ Q2W | Swollen Joint Count (SJC) Score | Week 12 (n=44,172) | 5.61 swollen joints | Standard Deviation 7.144 |
| SC TCZ Q2W | Swollen Joint Count (SJC) Score | Week 24 (n=42,167) | 5.98 swollen joints | Standard Deviation 8.587 |
| SC TCZ Q2W | Swollen Joint Count (SJC) Score | Week 36 (n=39,159) | 5.51 swollen joints | Standard Deviation 8.398 |
| SC TCZ Q2W | Swollen Joint Count (SJC) Score | Week 48 (n=18,141) | 4.78 swollen joints | Standard Deviation 9.078 |
| SC TCZ Q2W | Swollen Joint Count (SJC) Score | Week 60 (n=2,92) | 2.00 swollen joints | Standard Deviation 2.828 |
| SC TCZ Q2W | Swollen Joint Count (SJC) Score | Week 72 (n=1,52) | 2.00 swollen joints | — |
| SC TCZ Q2W | Swollen Joint Count (SJC) Score | Week 84 (n=0,11) | NA swollen joints | — |
| SC TCZ QW | Swollen Joint Count (SJC) Score | Week 84 (n=0,11) | 8.64 swollen joints | Standard Deviation 8.857 |
| SC TCZ QW | Swollen Joint Count (SJC) Score | Baseline (n=44,173) | 10.83 swollen joints | Standard Deviation 10.855 |
| SC TCZ QW | Swollen Joint Count (SJC) Score | Week 48 (n=18,141) | 7.23 swollen joints | Standard Deviation 7.87 |
| SC TCZ QW | Swollen Joint Count (SJC) Score | Week 12 (n=44,172) | 7.87 swollen joints | Standard Deviation 8.839 |
| SC TCZ QW | Swollen Joint Count (SJC) Score | Week 72 (n=1,52) | 7.98 swollen joints | Standard Deviation 8.873 |
| SC TCZ QW | Swollen Joint Count (SJC) Score | Week 24 (n=42,167) | 8.57 swollen joints | Standard Deviation 8.783 |
| SC TCZ QW | Swollen Joint Count (SJC) Score | Week 60 (n=2,92) | 6.52 swollen joints | Standard Deviation 7.184 |
| SC TCZ QW | Swollen Joint Count (SJC) Score | Week 36 (n=39,159) | 6.92 swollen joints | Standard Deviation 7.055 |
Secondary
Tender Joint Count (TJC) Score
Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
Population: ITT Population; only those participants who provided evaluable data (n) were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SC TCZ Q2W | Tender Joint Count (TJC) Score | Week 48 (n=18,141) | 10.61 tender joints | Standard Deviation 14.825 |
| SC TCZ Q2W | Tender Joint Count (TJC) Score | Week 24 (n=42,167) | 10.95 tender joints | Standard Deviation 14.221 |
| SC TCZ Q2W | Tender Joint Count (TJC) Score | Week 60 (n=2,92) | 5.50 tender joints | Standard Deviation 0.707 |
| SC TCZ Q2W | Tender Joint Count (TJC) Score | Week 12 (n=44,172) | 9.86 tender joints | Standard Deviation 11.727 |
| SC TCZ Q2W | Tender Joint Count (TJC) Score | Week 72 (n=1,52) | 21.00 tender joints | — |
| SC TCZ Q2W | Tender Joint Count (TJC) Score | Week 36 (n=39,159) | 9.10 tender joints | Standard Deviation 11.392 |
| SC TCZ Q2W | Tender Joint Count (TJC) Score | Week 84 (n=0,11) | NA tender joints | — |
| SC TCZ Q2W | Tender Joint Count (TJC) Score | Baseline (n=44,173) | 13.84 tender joints | Standard Deviation 13.883 |
| SC TCZ QW | Tender Joint Count (TJC) Score | Week 84 (n=0,11) | 9.36 tender joints | Standard Deviation 10.984 |
| SC TCZ QW | Tender Joint Count (TJC) Score | Week 12 (n=44,172) | 14.06 tender joints | Standard Deviation 14.874 |
| SC TCZ QW | Tender Joint Count (TJC) Score | Week 24 (n=42,167) | 13.86 tender joints | Standard Deviation 15.176 |
| SC TCZ QW | Tender Joint Count (TJC) Score | Week 36 (n=39,159) | 13.45 tender joints | Standard Deviation 14.398 |
| SC TCZ QW | Tender Joint Count (TJC) Score | Week 48 (n=18,141) | 12.85 tender joints | Standard Deviation 16.192 |
| SC TCZ QW | Tender Joint Count (TJC) Score | Week 60 (n=2,92) | 10.47 tender joints | Standard Deviation 12.589 |
| SC TCZ QW | Tender Joint Count (TJC) Score | Week 72 (n=1,52) | 11.38 tender joints | Standard Deviation 15.444 |
| SC TCZ QW | Tender Joint Count (TJC) Score | Baseline (n=44,173) | 19.14 tender joints | Standard Deviation 18.469 |
Secondary
Time to Return to the QW Regimen After Switching to the Q2W Regimen
Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. Time to return was defined as the time between switching to the Q2W regimen and returning to the previous QW regimen.
Time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
Population: ITT Population; only participants who switched from the QW to Q2W regimen and returned to the QW regimen were included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SC TCZ Q2W | Time to Return to the QW Regimen After Switching to the Q2W Regimen | 20 weeks |