Placebo (N=716) n (%) | Baricitinib 4 mg (N=714) n (%) | |
Age group (years) | ||
<65 | 603 (84.2) | 578 (81.0) |
≥65 | 113 (15.8) | 136 (19.0) |
Gender | ||
Female | 571 (79.7) | 562 (78.7) |
Male | 145 (20.3) | 152 (21.3) |
Race | ||
Asian | 208 (29.1) | 202 (28.3) |
White | 455 (63.6) | 460 (64.4) |
Other | 52 (7.3) | 51 (7.1) |
Weight (kg) | ||
<60 | 219 (30.6) | 191 (26.8) |
≥60 to <100 | 436 (60.9) | 461 (64.6) |
≥ 100 | 61 (8.5) | 62 (8.7) |
BMI | ||
≤Median | 368 (51.4) | 345 (48.3) |
>Median | 348 (48.6) | 368 (51.5) |
Tobacco use | ||
Smoker | 139 (19.4) | 151 (21.2) |
Non-smoker | 577 (80.6) | 562 (78.8) |
Time from RA diagnosis (years) | ||
<1 | 106 (14.8) | 114 (16.0) |
≥1 and <5 | 234 (32.7) | 233 (32.6) |
≥5 and <10 | 166 (23.2) | 166 (23.3) |
≥10 | 210 (29.3) | 201 (28.2) |
Serology | ||
RF and ACPA (−) | 70 (9.8) | 71 (9.9) |
RF or ACPA (+) | 646 (90.2) | 643 (90.1) |
Previous csDMARD use | ||
≤1 | 302 (42.2) | 342 (47.9) |
=2 | 250 (34.9) | 206 (28.9) |
≥3 | 164 (22.9) | 166 (23.2) |
DAS28-hsCRP score | ||
≤5.1 | 210 (29.3) | 182 (25.5) |
>5.1 | 502 (70.1) | 530 (74.2) |
SDAI | ||
Lowest tertile | 242 (33.8) | 223 (31.2) |
Middle tertile | 240 (33.5) | 246 (34.5) |
Highest tertile | 225 (31.4) | 235 (32.9) |
HAQ-DI | ||
Lowest tertile | 250 (34.9) | 256 (35.9) |
Middle tertile | 262 (36.6) | 238 (33.3) |
Highest tertile | 200 (27.9) | 218 (30.5) |
ACPA, anticitrullinated peptide antibody; BMI, body mass index; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28-hsCRP, Disease Activity Score for 28 joint counts based on the level of high-sensitivity C reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; N, number of modified intent-to-treat patients in the specified treatment population; n, number of patients in specified category; RA, rheumatoid arthritis; RF, rheumatoid factor; SDAI, Simplified Disease Activity Index.