Table 1.
Baseline characteristics | RA-BEGIN DMARD-naïve |
RA-BEAM MTX-IR |
RA-BUILD csDMARD-IR |
||||||
MTX | Bari 4 mg | Bari 4 mg+MTX | Placebo | Bari 4 mg | ADA | Placebo | Bari 2 mg | Bari 4 mg | |
N=138 | N=121 | N=151 | N=361 | N=385 | N=263 | N=157 | N=165 | N=152 | |
Age, years | 49.9 (12.9) | 51.0 (12.8) | 47.5 (13.4) | 52.3 (11.5) | 52.9 (11.8) | 52.7 (11.9) | 51.9 (12.3) | 52.1 (12.1) | 52.3 (11.5) |
Female, n (%) | 97 (70.3) | 90 (74.4) | 108 (71.5) | 280 (77.6) | 301 (78.2) | 200 (76.0) | 132 (84.1) | 130 (78.8) | 124 (81.6) |
White, n (%) | 82 (59.4) | 76 (62.8) | 86 (57.0) | 223 (61.9) | 243 (63.1) | 161 (61.2) | 113 (72.0) | 115 (69.7) | 99 (65.6) |
Duration of RA*, years, median | 0.2 | 0.2 | 0.2 | 6.4 | 5.6 | 5.8 | 3.0 | 3.4 | 4.5 |
Swollen joint count, of 66 | 15.6 (10.1) | 15.3 (8.6) | 16.2 (9.5) | 14.8 (8.5) | 14.9 (8.4) | 15.0 (8.7) | 13.0 (6.7)† | 13.1 (8.0) | 13.4 (7.2) |
Tender joint count, of 68 | 26.7 (15.1) | 24.8 (12.7) | 27.9 (14.5) | 22.6 (13.0) | 23.2 (12.9) | 22.8 (13.6) | 24.5 (15.0)† | 22.1 (13.7) | 23.1 (13.6) |
CDAI | 38.88 (12.54) | 38.74 (12.58) | 40.65 (13.13) | 37.00 (12.47) | 37.73 (12.07) | 37.39 (13.05) | 35.89 (11.72) | 35.47 (12.85) | 35.73 (11.86) |
SDAI | 41.09 (12.92) | 41.20 (13.50) | 43.19 (13.62) | 38.82 (12.67) | 39.99 (12.80) | 39.54 (13.42) | 37.55 (11.89) | 37.23 (13.22) | 37.12 (12.20) |
HAQ-DI | 1.64 (0.66) | 1.60 (0.74) | 1.62 (0.67) | 1.50 (0.68) | 1.55 (0.68) | 1.54 (0.70) | 1.51 (0.60) | 1.48 (0.62) | 1.48 (0.61) |
DAS28-hsCRP | 5.86 (0.92) | 5.83 (0.98) | 5.95 (0.92) | 5.64 (0.92) | 5.74 (0.93) | 5.71 (0.95) | 5.56 (0.87) | 5.49 (0.95) | 5.49 (0.90) |
Corticosteroid use† n (%) | 55 (39.9) | 35 (28.9) | 61 (40.4) | 224 (62.0) | 217 (56.4) | 154 (58.6) | 78 (49.7) | 91 (55.2) | 73 (48.0) |
Data reported as mean (SD) unless otherwise indicated.
*Time from RA diagnosis.
†At time of first baricitinib dose.
ADA, adalimumab; Bari, baricitinib; CDAI, Clinical Disease Activity Index; csDMARD-IR, inadequate responders to conventional synthetic DMARDs; DAS28-hsCRP, Disease Activity Score modified to include the 28 diarthrodial joint count based on the hsCRP level; DMARD, disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire–Disability Index; hsCRP, high-sensitivity C-reactive protein; MTX, methotrexate; MTX-IR, inadequate responders to methotrexate; n, number of patients in indicated category; N, number of patients in the analysis population; RA, rheumatoid arthritis; SDAI, Simplified Disease Activity Index.