Evaluation of disease activity in patients with rheumatoid arthritis treated with tofacitinib by RAPID3: post hoc analyses from two phase 3 trials

Fig. 1. Rates of RAPID3 remission and LDA (including remission) at months 6 and 24 in a ORAL Start and b ORAL Scan. *p < 0.05 for tofacitinib versus MTX (ORAL Start—months 6 and 24) or placebo (ORAL Scan—at month 6). aPatients received tofacitinib in combination with MTX. Non-responder imputation was used for missing values. Placebo data are not shown at month 24 for ORAL Scan, as those patients initially receiving placebo advanced to tofacitinib at month 3 or month 6. Statistical analysis for month 24 data was therefore not plausible. BID twice daily, IR inadequate response, LDA low disease activity, MTX methotrexate, PBO placebo, RAPID3 Routine Assessment of Patient Index Data 3

Fig. 2. a Month 24 RAPID3 response stratified by RAPID3 responses at month 6. b Mean changes from baseline in RAPID3 at month 24 stratified by RAPID3 responses at month 6. Disease activity levels for RAPID3 score were defined as remission (≤ 3), LDA (> 3 to ≤ 6; excluding remission), MDA (> 6 to ≤ 12), and HDA (> 12). BID twice daily, CI confidence interval, HDA high disease activity, LDA low disease activity, MDA moderate disease activity, MTX methotrexate, RAPID3 Routine Assessment of Patient Index Data 3

Fig. 3. a Proportion of patients achieving CDAI responses at month 24 stratified by RAPID3 responses at month 6. b Mean changes from baseline in CDAI scores at month 24 stratified by RAPID3 responses at month 6. Disease activity levels for RAPID3 score were defined as remission (≤ 3), LDA (> 3 to ≤ 6; excluding remission), MDA (> 6 to ≤ 12), and HDA (> 12). Disease activity levels according to CDAI were defined as remission (CDAI ≤ 2.8), LDA (excluding remission; CDAI > 2.8 to ≤ 10), MDA (CDAI > 10 to ≤ 22), and HDA (CDAI > 22). BID twice daily, CDAI Clinical Disease Activity Index, CI confidence interval, HDA high disease activity, LDA low disease activity, MDA moderate disease activity, MTX methotrexate, RAPID3 Routine Assessment of Patient Index Data 3

Fig. 4. Patients reporting normative HAQ-DI scores (< 0.5) at month 24 stratified by RAPID3 responses at month 6. Disease activity levels for RAPID3 score were defined as remission (≤ 3), LDA (> 3 to ≤ 6; excluding remission), MDA (> 6 to ≤ 12), and HDA (> 12). BID twice daily, CI confidence interval, HAQ-DI Health Assessment Questionnaire-Disability Index, HDA high disease activity, LDA low disease activity, MDA moderate disease activity, MTX methotrexate, RAPID3 Routine Assessment of Patient Index Data 3

Fig. 5. Patients reporting normative HAQ-DI scores and defined with no radiographic progression stratified by RAPID3 responses at month 6. Disease activity levels for RAPID3 score were defined as remission (≤ 3), LDA (> 3 to ≤ 6; excluding remission), MDA (> 6 to ≤ 12), and HDA (> 12). No radiographic progression was defined as a change from baseline in mTSS ≤ 0. BID twice daily, CI confidence interval, HAQ-DI Health Assessment Questionnaire-Disability Index, HDA high disease activity, LDA low disease activity, MDA moderate disease activity, mTSS modified Total Sharp Score, MTX methotrexate, RAPID3 Routine Assessment of Patient Index Data 3