Table 1.
Clinical efficacy parameters at month 12 and month 24 by treatment cohort (using imputed or observed data in the full analysis set and a longitudinal model based on the full analysis set)a
| Tofacitinib 5 mg twice daily | Tofacitinib 10 mg twice daily | Placebo switching to tofacitinib 5 mg twice daily | Placebo switching to tofacitinib 10 mg twice daily | |||||
|---|---|---|---|---|---|---|---|---|
| 12 months | 24 months | 12 months | 24 months | 12 months | 24 months | 12 months | 24 months | |
| ACR20/50/70 response | ||||||||
| No. of patients | ||||||||
| NRINAP | 309 | 309 | 309 | 309 | 79 | 79 | 75 | 75 |
| Observed | 252 | 211 | 265 | 218 | 67 | 54 | 63 | 52 |
| ACR20 responseb | ||||||||
| NRINAP | 60.8 (2.8) | 50.5 (2.8) | 65.4 (2.7) | 58.3 (2.8) | 62.0 (5.5) | 58.2 (5.5) | 60.0 (5.6) | 57.3 (5.7) |
| Observed | 75.4 (2.7) | 73.5 (3.0) | 78.5 (2.5) | 82.6 (2.6) | 74.6 (5.3) | 83.3 (5.1) | 74.6 (5.5) | 82.7 (5.2) |
| ACR50 responseb | ||||||||
| NRINAP | 37.2 (2.7) | 33.7 (2.7) | 42.1 (2.8) | 46.3 (2.8) | 43.0 (5.6) | 38.0 (5.5) | 33.3 (5.4) | 37.3 (5.6) |
| Observed | 46.0 (3.1) | 48.8 (3.4) | 50.9 (3.1) | 65.1 (3.2) | 52.2 (6.1) | 53.7 (6.8) | 41.3 (6.2) | 53.9 (6.9) |
| ACR70 responseb | ||||||||
| NRINAP | 20.1 (2.3) | 18.8 (2.2) | 26.9 (2.5) | 28.8 (2.6) | 25.3 (4.9) | 21.5 (4.6) | 22.7 (4.8) | 26.7 (5.1) |
| Observed | 24.6 (2.7) | 27.0 (3.1) | 32.5 (2.9) | 40.4 (3.3) | 31.3 (5.7) | 31.5 (6.3) | 27.0 (5.6) | 38.5 (6.7) |
| Remission | ||||||||
| DAS28‐ESR <2.6b | ||||||||
| No. of patients | ||||||||
| NRINAP | 265 | 265 | 257 | 257 | 65 | 65 | 64 | 64 |
| Observed | 218 | 179 | 221 | 179 | 54 | 41 | 54 | 44 |
| NRINAP | 10.6 (1.9) | 11.3 (1.9) | 14.0 (2.2) | 14.8 (2.2) | 10.8 (3.8) | 7.7 (3.3) | 20.3 (5.0) | 15.6 (4.5) |
| Observed | 12.8 (2.3) | 16.8 (2.8) | 18.6 (2.6) | 20.7 (3.0) | 13.0 (4.6) | 12.2 (5.1) | 25.9 (6.0) | 22.7 (6.3) |
| CDAI ≤2.8c | ||||||||
| No. of patients | ||||||||
| NRINAP | 309 | 309 | 308 | 308 | 79 | 79 | 75 | 75 |
| Observed | 252 | 208 | 265 | 218 | 67 | 54 | 63 | 52 |
| NRINAP | 14.2 (2.0) | 12.0 (1.9) | 16.6 (2.1) | 19.8 (2.3) | 12.7 (3.7) | 12.7 (3.7) | 20.0 (4.6) | 22.7 (4.8) |
| Observed | 17.5 (2.4) | 17.8 (2.7) | 20.0 (2.5) | 27.5 (3.0) | 14.9 (4.4) | 18.5 (5.3) | 23.8 (5.4) | 32.7 (6.5) |
| SDAI ≤3.3c | ||||||||
| No. of patients | ||||||||
| NRINAP | 309 | 309 | 308 | 308 | 79 | 79 | 75 | 75 |
| Observed | 252 | 207 | 263 | 216 | 67 | 54 | 63 | 52 |
| NRINAP | 13.9 (2.0) | 14.2 (2.0) | 17.2 (2.2) | 23.4 (2.4) | 12.7 (3.7) | 16.5 (4.2) | 20.0 (4.6) | 28.0 (5.2) |
| Observed | 17.1 (2.4) | 20.8 (2.8) | 20.9 (2.5) | 32.9 (3.2) | 14.9 (4.4) | 22.2 (5.7) | 23.8 (5.4) | 40.4 (6.8) |
| Boolean remission | ||||||||
| No. of patients | ||||||||
| NRINAP | 309 | 309 | 309 | 309 | 79 | 79 | 75 | 75 |
| Observed | 252 | 210 | 265 | 218 | 67 | 54 | 63 | 52 |
| NRINAP | 10.4 (1.7) | 10.0 (1.7) | 13.6 (2.0) | 14.6 (2.0) | 10.1 (3.4) | 13.9 (3.9) | 16.0 (4.2) | 21.3 (4.7) |
| Observed | 12.7 (2.1) | 14.3 (2.4) | 16.6 (2.3) | 20.2 (2.7) | 11.9 (4.0) | 18.5 (5.3) | 19.0 (5.0) | 30.8 (6.4) |
| Low disease activity or remission | ||||||||
| DAS28‐ESR ≤3.2b | ||||||||
| No. of patients | ||||||||
| NRINAP | 265 | 265 | 257 | 257 | 65 | 65 | 64 | 64 |
| Observed | 218 | 179 | 221 | 179 | 54 | 41 | 54 | 44 |
| NRINAP | 23.4 (2.6) | 23.0 (2.6) | 29.2 (2.8) | 30.4 (2.9) | 21.5 (5.1) | 24.6 (5.3) | 31.3 (5.8) | 25.0 (5.4) |
| Observed | 28.4 (3.1) | 33.5 (3.5) | 36.2 (3.2) | 43.0 (3.7) | 25.9 (6.0) | 39.0 (7.6) | 38.9 (6.6) | 36.4 (7.3) |
| CDAI ≤10c | ||||||||
| No. of patients | ||||||||
| NRINAP | 309 | 309 | 308 | 308 | 79 | 79 | 75 | 75 |
| Observed | 252 | 208 | 265 | 218 | 67 | 54 | 63 | 52 |
| NRINAP | 41.1 (2.8) | 40.5 (2.8) | 50.3 (2.9) | 49.4 (2.9) | 48.1 (5.6) | 46.8 (5.6) | 38.7 (5.6) | 45.3 (5.8) |
| Observed | 51.2 (3.2) | 59.1 (3.4) | 60.4 (3.0) | 69.7 (3.1) | 58.2 (6.0) | 66.7 (6.4) | 47.6 (6.3) | 65.4 (6.6) |
| SDAI ≤11c | ||||||||
| No. of patients | ||||||||
| NRINAP | 309 | 309 | 308 | 308 | 79 | 79 | 75 | 75 |
| Observed | 252 | 207 | 263 | 216 | 67 | 54 | 63 | 52 |
| NRINAP | 43.0 (2.8) | 40.5 (2.8) | 52.6 (2.9) | 49.0 (2.9) | 50.6 (5.6) | 48.1 (5.6) | 41.3 (5.7) | 46.7 (5.8) |
| Observed | 53.2 (3.1) | 58.9 (3.4) | 62.7 (3.0) | 69.4 (3.1) | 61.2 (6.0) | 68.5 (6.3) | 50.8 (6.3) | 67.3 (6.5) |
| Change from baselined | ||||||||
| LSM (SE) change in DAS28‐ESRb | −2.2 (0.1) | −2.3 (0.1) | −2.5 (0.1) | −2.6 (0.1) | −2.1 (0.2) | −2.5 (0.2) | −2.4 (0.2) | −2.6 (0.2) |
| No. of patients | 218 | 179 | 220 | 178 | 54 | 41 | 54 | 44 |
| Mean (SE) change in HAQ DI | −0.5 (0.0) | −0.5 (0.0) | −0.6 (0.0) | −0.7 (0.0) | −0.5 (0.1) | −0.6 (0.1) | −0.5 (0.1) | −0.6 (0.1) |
| No. of patients | 251 | 210 | 265 | 218 | 67 | 54 | 63 | 52 |
Except where indicated otherwise, values are the percent of patients (SE). All patients received background methotrexate, including those in the placebo groups. ACR20 = American College of Rheumatology criteria for 20% improvement; NRINAP = nonresponder imputation with no advancement penalty; DAS28‐ESR = Disease Activity Score in 28 joints (4‐variable) using the erythrocyte sedimentation rate; CDAI = Clinical Disease Activity Index; SDAI = Simplified Disease Activity Index; LSM = least squares mean; HAQ DI = Health Assessment Questionnaire disability index.
Values were significantly improved (P ≤ 0.05) at months 12 and 24 versus baseline within each treatment sequence.
P values were not calculated for these outcomes.
Longitudinal model, observed completely.