| Variables | Placebo, n = 48 | Baricitinib | |||
|---|---|---|---|---|---|
| 1 mg, n = 27 | 2 mg, n = 29 | 4 mg, n = 26 | 8 mg, n = 24 | ||
| Week 12 | |||||
| ACR20, n (%) | 17 (35) | 15 (56) | 17 (59)* | 20 (77)*** | 20 (83)*** |
| DAS28-hsCRP | −0.9 (1.3) | −1.4 (1.4) | −1.6 (1.0)* | −2.2 (1.1)*** | −2.0 (1.3)*** |
| HAQ-DI | −0.13 (0.42) | −0.30 (0.57) | −0.23 (0.52) | −0.33 (0.48) | −0.38 (0.58)* |
| Swollen joint count, 66 | −6.0 (7.9) | −8.1 (7.5) | −7.5 (8.1) | −10.7 (5.0)*** | −10.3 (6.6)** |
| Week 24 | |||||
| ACR20, n (%) | – | – | 21 (72) | 21 (81) | 19 (79) |
| DAS28-hsCRP | – | – | −1.7 (0.9) | −2.5 (0.9) | −2.3 (1.2) |
| HAQ-DI | – | – | −0.24 (0.47) | −0.37 (0.47) | −0.50 (0.52) |
| Swollen joint count, 66 | – | – | −9.4 (7.6) | −12.0 (5.6) | −12.1 (5.3) |
Data are LSM change from baseline (SD) unless otherwise indicated. Only patients in baricitinib 2-, 4-, and 8-mg treatment groups continued treatment for an additional 12 weeks. Significance values for ACR20 are based on 1-sided Fisher’s exact test; significance values for DAS28-hsCRP, HAQ-DI, and swollen joint count (66) are based on ANCOVA.
↵* P < 0.05 vs placebo.
↵** P < 0.01 vs placebo.
↵*** P < 0.001 vs placebo. ACR20: American College of Rheumatology criteria 20% improvement; DAS28-hsCRP: 28-joint count Disease Activity Score based on high-sensitivity C-reactive protein; HAQ-DI: Health Assessment Questionnaire–Disability Index; LSM: least squares mean.