Radiographic and clinical endpoints (evaluable set, LOCF)
| Tofacitinib 10 mg twice daily + MTX | Tofacitinib 10 mg twice daily monotherapy | MTX monotherapy | |
|---|---|---|---|
| LS mean change from baseline (SE) | |||
| van der Heijde mTSS | |||
| Month 6† | 0.44 (0.50) | −0.14 (0.51) | 0.93 (0.52) |
| Month 12‡ | 0.85 (0.51) | −0.15 (0.52)* | 1.36 (0.54) |
| JSN component score | |||
| Month 6† | 0.29 (0.34) | −0.06 (0.35) | 0.35 (0.36) |
| Month 12‡ | 0.43 (0.35) | −0.12 (0.36) | 0.71 (0.37) |
| Erosion component score | |||
| Month 6† | 0.16 (0.24) | −0.10 (0.25) | 0.58 (0.25) |
| Month 12‡ | 0.42 (0.25) | −0.05 (0.26) | 0.65 (0.27) |
| Responders, % (SE) | |||
| ACR20 | N=35 | N=36 | N=37 |
| Month 3 | 77.1 (7.1) | 66.7 (7.9) | 56.8 (8.1) |
| Month 6 | 77.1 (7.1)* | 72.2 (7.5) | 54.1 (8.2) |
| Month 12 | 82.9 (6.4) | 66.7 (7.9) | 56.8 (8.1) |
| ACR50 | N=35 | N=36 | N=37 |
| Month 3 | 48.6 (8.4) | 55.6 (8.3)* | 29.7 (7.5) |
| Month 6 | 57.1 (8.4)** | 52.8 (8.3)* | 27.0 (7.3) |
| Month 12 | 65.7 (8.0)** | 50.0 (8.3) | 35.1 (7.8) |
| ACR70 | N=35 | N=36 | N=37 |
| Month 3 | 25.7 (7.4) | 27.8 (7.5) | 13.5 (5.6) |
| Month 6 | 34.3 (8.0) | 30.6 (7.7) | 24.3 (7.1) |
| Month 12 | 28.6 (7.6) | 33.3 (7.9) | 24.3 (7.1) |
| DAS28-4(ESR) <2.6 | N=34 | N=36 | N=37 |
| Month 3 | 23.5 (7.3) | 2.8 (2.7) | 13.5 (5.6) |
| Month 6 | 29.4 (7.8) | 13.9 (5.8) | 13.5 (5.6) |
| Month 12 | 35.3 (8.2)* | 19.4 (6.6) | 13.5 (5.6) |
| DAS28-4(ESR) ≤3.2 | N=34 | N=36 | N=37 |
| Month 3 | 32.4 (8.0) | 30.6 (7.7) | 16.2 (6.1) |
| Month 6 | 41.2 (8.4) | 27.8 (7.5) | 21.6 (6.8) |
| Month 12 | 58.8 (8.4)*** | 30.6 (7.7) | 18.9 (6.4) |
| HAQ-DI improvement ≥0.22§ | N=34 | N=36 | N=37 |
| Month 3 | 73.5 (7.6) | 75.0 (7.2) | 81.1 (6.4) |
| Month 6 | 76.5 (7.3) | 75.0 (7.2) | 70.3 (7.5) |
| Month 12 | 73.5 (7.6) | 72.2 (7.5) | 73.0 (7.3) |
*p<0.05, **p<0.01, ***p<0.001 vs MTX monotherapy.
†The numbers of patients evaluable at Month 6 were 29, 27 and 28 in the tofacitinib with MTX, tofacitinib monotherapy and MTX monotherapy groups, respectively.
‡The numbers of patients evaluable at Month 12 were 26, 25 and 22 in the tofacitinib with MTX, tofacitinib monotherapy and MTX monotherapy groups, respectively.
§Improvement vs baseline.
ACR, American College of Rheumatology response criteria; DAS28-4(ESR), Disease Activity Score in 28 joints with 4 variables including erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; JSN, joint space narrowing; LOCF, last observation carried forward; LS, least squares; mTSS, van der Heijde modification of the total Sharp score; MTX, methotrexate; N, number of patients with values at baseline and time point of interest.