Table 2.
Selected efficacy endpoints at month 6 by MTX dose category
| Low MTX (≤12.5 mg/week) (N = 242) | Moderate MTX (>12.5 to <17.5 mg/week) (N = 333) | High MTX (≥17.5 mg/week) (N = 222) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 47) | Tofacitinib 5 mg BID (n = 102) | Tofacitinib 10 mg BID (n = 93) | Placebo (n = 73) | Tofacitinib 5 mg BID (n = 131) | Tofacitinib 10 mg BID (n = 129) | Placebo (n = 40) | Tofacitinib 5 mg BID (n = 88) | Tofacitinib 10 mg BID (n = 94) | |
| Disease activity a | |||||||||
| CDAI ≤10, % (95 % CI) | 8.9 (2.5, 21.2) | 42.0* (32.2, 52.3) | 52.2* (41.4, 62.9) | 13.0 (6.1, 23.3) | 32.0* (23.9, 40.9) | 41.1* (32.4, 50.3) | 12.5 (4.2, 26.8) | 35.7* (25.6, 46.9) | 39.4* (29.4, 50.0) |
| CDAI ≤2.8, % (95 % CI) | 2.2 (0.1, 11.8) | 9.0 (4.2, 16.4) | 13.3* (7.1, 22.1) | 1.5 (0.0, 7.8) | 8.8* (4.5, 15.2) | 13.7* (8.2, 21.0) | 0 (0.0, 8.8) | 9.5* (4.2, 17.9) | 16.0* (9.2, 25.0) |
| LSM CFB in DAS28–4(ESR) (SE) | −1.00 (0.26) | −2.15* (0.13) | −2.48* (0.14) | −1.33 (0.18) | −2.28* (0.11) | −2.39* (0.10) | −2.07 (0.27) | -2.14 (0.13) | -2.67* (0.13) |
| Functional status a | |||||||||
| HAQ-DI <0.5, % (95 % CI) | 0 (0.0, 7.9) | 24.0* (16.0, 33.6) | 24.4* (16.0, 34.6) | 5.8 (1.6, 14.2) | 17.6* (11.4, 25.4) | 29.8* (22.0, 38.7) | 10.0 (2.8, 23.7) | 19.1 (11.3, 29.1) | 33.0* (23.6, 43.4) |
BID twice daily, CDAI Clinical Disease Activity Index, CFB change from baseline, CI confidence interval, DAS28–4(ESR) disease activity score in 28 joints, erythrocyte sedimentation rate, HAQ-DI Health Assessment Questionnaire-Disability Index, LSM least squares mean, MTX methotrexate, SE standard error
*p < 0.05 vs placebo plus MTX; aNon-responder imputation; Full Analysis Set