Percentage of patients achieving ACR20/50/70 responses and CDAI LDA (≤ 10) and remission (≤ 2.8), and LSM changes from baseline in CDAI, HAQ-DI, DAS28-4-ESR, and pain VAS in patients receiving tofacitinib 5 or 10 mg BID ± GC at Month 3 in pooled studies of tofacitinib plus csDMARD.
| Variables | Placebo + csDMARD | Tofacitinib 5 mg BID + csDMARD | Tofacitinib 10 mg BID + csDMARD | |||
|---|---|---|---|---|---|---|
| + GC, n = 315a | − GC, n = 231a | + GC, n = 561a | − GC, n = 384a | + GC, n = 535a | − GC, n = 410a | |
| Patients, FAS, NRI, % (95% CI) | ||||||
| ACR20 | 29.2 (24.2–34.6) | 22.5 (17.3–28.5) | 53.8*** (49.6–58.0) | 57.0*** (51.9–62.0) | 60.4*** (56.1–64.5) | 63.2*** (58.3–67.9) |
| ACR50 | 9.2 (6.3–13.0) | 6.9 (4.0–11.0) | 28.3*** (24.7–32.3) | 30.2*** (25.7–35.1) | 32.2*** (28.2–36.3) | 32.9*** (28.4–37.7) |
| ACR70 | 2.2 (0.9–4.5) | 1.7 (0.5–4.4) | 10.3*** (7.9–13.2) | 11.2*** (8.2–14.8) | 14.6*** (11.7–17.9) | 15.1*** (11.8–19.0) |
| CDAI ≤ 10 | 11.5 (7.7–16.3) | 7.8 (4.3–12.7) | 27.7*** (23.8–32.0) | 29.4*** (24.6–34.6) | 32.4*** (28.2–36.9) | 36.3*** (31.2–41.6) |
| CDAI ≤ 2.8 | 0.0 (0.0–1.6) | 0.6 (0.0–3.1) | 5.0*** (3.2–7.4) | 5.7** (3.5–8.8) | 5.2*** (3.4–7.6) | 7.8*** (5.2–11.1) |
| LSM change from baseline (95% CI) | ||||||
| CDAI | −9.8 (−11.2 to −8.4) | −8.6 (−10.3 to −7.0) | −17.9*** (−18.9 to −16.8) | −18.2*** (−19.4 to −16.9) | −19.8*** (−20.9 to −18.8) | −19.9*** (−21.1 to −18.7) |
| HAQ–DI | −0.2 (−0.2 to −0.1) | −0.2 (−0.2 to −0.1) | −0.4*** (−0.5 to −0.4) | −0.5*** (−0.5 to −0.4) | −0.5*** (−0.6 to −0.5) | −0.5*** (−0.6 to −0.5) |
| DAS28-4-ESR | −0.8 (−1.0 to −0.7) | −0.7 (−0.9 to −0.5) | −1.8*** (−1.9 to −1.7) | −1.8*** (−1.9 to −1.7) | −2.0*** (−2.1 to −1.9) | −2.0*** (−2.2 to −1.9) |
| Pain VAS | −8.7 (−11.3 to −6.1) | −9.6 (−12.6 to −6.6) | −23.8*** (−25.8 to −21.8) | −23.8*** (−26.1 to −21.4) | −25.7*** (−27.7 to −23.7) | −27.3*** (−29.5 to −25.1) |
↵* p < 0.05;
↵** p < 0.001;
↵*** p < 0.0001 (without multiplicity adjustment for exploratory analysis) vs placebo within the respective subgroup.
↵a Note: patient numbers given are from the FAS for ACR responses; however, patient numbers varied among outcome measures. Percentages are based on available data for each outcome measure. ACR20/50/70: an improvement of ≥ 20%, ≥ 50%, and ≥ 70%, respectively, in American College of Rheumatology criteria; BID: twice daily; CDAI: Clinical Disease Activity Index; csDMARD: conventional synthetic disease-modifying antirheumatic drugs; DAS28-4-ESR: 28-joint Disease Activity Score using the erythrocyte sedimentation rate; FAS: full analysis set; GC: glucocorticoids; HAQ-DI: Health Assessment Questionnaire–Disability Index; LDA: low disease activity; LSM: least squares mean; NRI: nonresponder imputation; VAS: visual analog scale.