Efficacy responses at month 3 for bDMARD-naive versus bDMARD-IR in the P2/P3 cohort
| bDMARD-naive | bDMARD-IR | |||||
|---|---|---|---|---|---|---|
| Parameter, % (95% CI) | Placebo N=638 | Tofacitinib 5 mg twice daily N=1043 | Tofacitinib 10 mg twice daily N=1066 | Placebo N=191 | Tofacitinib 5 mg twice daily N=258 | Tofacitinib 10 mg twice daily N=251 |
| CDAI ≤10† | 14.3 (11.5 to 17.4) | 32.4*** (29.5 to 35.4) | 39.8*** (36.8 to 42.9) | 14.4 (9.4 to 20.6) | 29.5** (23.8 to 35.8) | 35.9*** (29.7 to 42.5) |
| CDAI ≤2.8‡ | 0.7 (0.2 to 1.8) | 6.4*** (5.0 to 8.2) | 9.0*** (7.3 to 11.0) | 1.2 (0.1 to 4.3) | 5.9* (3.3 to 9.7) | 6.5* (3.7 to 10.5) |
| SDAI ≤11† | 14.2 (11.4 to 17.3) | 34.6*** (31.6 to 37.6) | 41.1*** (38.0 to 44.2) | 13.8 (8.9 to 19.9) | 29.8*** (24.0 to 36.1) | 38.3*** (32.0 to 44.9) |
| SDAI ≤3.3‡ | 0.7 (0.2 to 1.8) | 6.4*** (4.9 to 8.1) | 9.3*** (7.6 to 11.3) | 0.6 (0.0 to 3.3) | 6.8** (3.9 to 10.8) | 8.3*** (5.0 to 12.6) |
| DAS28-4 (ESR) ≤3.2† | 4.5 (3.0 to 6.5) | 16.6*** (14.3 to 19.2) | 22.9*** (20.3 to 25.8) | 5.1 (2.4 to 9.5) | 12.7* (8.6 to 17.7) | 17.8*** (13.0 to 23.4) |
| DAS28-4 (ESR) <2.6‡ | 2.3 (1.2 to 3.8) | 7.3*** (5.7 to 9.2) | 11.5*** (9.5 to 13.7) | 2.3 (0.6 to 5.7) | 6.6* (3.7 to 10.6) | 8.4* (5.2 to 12.9) |
| HAQ-DI improvement ≥0.22 | 28.7 (24.5 to 33.1) | 52.9*** (49.5 to 56.3) | 59.8*** (56.4 to 63.0) | 36.9 (29.8 to 44.4) | 45.7 (39.4 to 52.2) | 55.3** (48.7 to 61.7) |
| HAQ-DI improvement ≥0.5 | 18.2 (14.8 to 22.1) | 40.3*** (37.0 to 43.6) | 46.1*** (42.8 to 49.5) | 20.1 (14.5 to 26.7) | 31.0* (25.3 to 37.2) | 39.2*** (33.0 to 45.8) |
*p<0.05; **p<0.001; ***p<0.0001 versus placebo. No preservation of type I error or multiple-comparisons correction was applied to p values as statistical significance defined as p<0.05 was exploratory in nature; 95% CIs are exact binomial CIs for single proportions.
†Low-disease activity.
‡Disease remission. DAS28-4(ESR) and HAQ-DI data were FAS, NRI; CDAI and SDAI data were FAS, observed case; percentages were based on the number of patients available for each parameter analysis.
bDMARD, biological disease-modifying antirheumatic drug; CDAI, Clinical Disease Activity Index; DAS, disease activity score; ESR, erythrocyte sedimentation rate; FAS, full analysis set; HAQ-DI, Health Assessment Questionnaire-Disability Index; IR, inadequate responders; N, number of patients with available ACR data at month 3; NRI, non-responder imputation; P2/P3, phase II/phase III; SDAI, Simplified Disease Activity Index.