Change from baseline in DAS28-hsCRP and proportion of patients achieving SDAI≤11 at week 12
| DAS28-hsCRP Change from baseline LSM (SE) | Patients achieving SDAI≤11 n/N-obs (%) | |||||
| Placebo (N=716) | Baricitinib 4 mg (N=714) | Interaction P value | Placebo (N=716) | Baricitinib 4 mg (N=714) | Interaction P value | |
| Age group (years) | ||||||
| <65 | −1.0 (0.05) | −2.1 (0.05) | 0.561 | 102/603 (16.9) | 221/578 (38.2) | 0.407 |
| ≥65 | −1.2 (0.11) | −2.4 (0.10) | 20/113 (17.7) | 63/136 (46.3) | ||
| Gender | ||||||
| Female | −1.1 (0.05) | −2.2 (0.05) | 0.290 | 97/571 (17.0) | 226/562 (40.2) | 0.735 |
| Male | −1.1 (0.10) | −2.3 (0.10) | 25/145 (17.2) | 58/152 (38.2) | ||
| Race | ||||||
| Asian | −0.9 (0.08) | −2.2 (0.08) | 0.030 | 29/208 (13.9) | 82/202 (40.6) | 0.029 |
| White | −1.1 (0.06) | −2.2 (0.06) | 78/455 (17.1) | 186/460 (40.4) | ||
| Other | −1.3 (0.19) | −2.0 (0.19) | 15/52 (28.8) | 16/51 (31.4) | ||
| Weight (kg) | ||||||
| <60 | −1.1 (0.08) | −2.3 (0.09) | 0.022 | 35/219 (16.0) | 80/191 (41.9) | 0.064 |
| ≥60 to <100 | −1.0 (0.06) | −2.2 (0.06) | 73/436 (16.7) | 187/461 (40.6) | ||
| ≥100 | −1.3 (0.15) | −1.9 (0.15) | 14/61 (23.0) | 17/62 (27.4) | ||
| BMI | ||||||
| ≤Median | −1.0 (0.06) | −2.3 (0.06) | 0.001 | 58/368 (15.8) | 148/345 (42.9) | 0.077 |
| >Median | −1.2 (0.07) | −2.1 (0.06) | 64/348 (18.4) | 135/368 (36.7) | ||
| Tobacco use | ||||||
| Smoker | −0.9 (0.10) | −2.3 (0.10) | 0.136 | 21/139 (15.1) | 65/151 (43.0) | 0.269 |
| Non-smoker | −1.1 (0.05) | −2.2 (0.05) | 101/577 (17.5) | 218/562 (38.8) | ||
| Time from RA diagnosis (years) | ||||||
| < 1 | −0.9 (0.11) | −2.0 (0.11) | 0.488 | 12/105 (11.4) | 31/113 (27.4) | 0.560 |
| ≥1 and < 5 | −1.1 (0.08) | −2.2 (0.08) | 46/234 (19.7) | 97/233 (41.6) | ||
| ≥ 5 and < 10 | −1.0 (0.10) | −2.3 (0.09) | 28/166 (16.9) | 79/166 (47.6) | ||
| ≥ 10 | −1.1 (0.09) | −2.2 (0.09) | 36/210 (17.1) | 77/201 (38.3) | ||
| Serology | ||||||
| RF and ACPA (-) | −1.1 (0.15) | −1.8 (0.15) | 0.010 | 13/70 (18.6) | 17/71 (23.9) | 0.033 |
| RF or ACPA (+) | −1.1 (0.05) | −2.2 (0.05) | 109/646 (16.9) | 267/643 (41.5) | ||
| Previous csDMARD use | ||||||
| ≤1 | −1.1 (0.07) | −2.2 (0.07) | 0.443 | 56/302 (18.5) | 139/342 (40.6) | 0.653 |
| =2 | −1.1 (0.08) | −2.2 (0.08) | 47/250 (18.8) | 87/206 (42.2) | ||
| ≥3 | −0.9 (0.09) | −2.2 (0.09) | 19/164 (11.6) | 58/166 (34.9) | ||
| DAS28-hsCRP score | ||||||
| ≤ 5.1 | −0.7 (0.07) | −1.7 (0.07) | 0.511 | 58/210 (27.6) | 105/182 (57.7) | 0.941 |
| > 5.1 | −1.2 (0.06) | −2.4 (0.06) | 63/502 (12.5) | 177/530 (33.4) | ||
| SDAI | ||||||
| Lowest tertile | −0.8 (0.06) | −1.8 (0.07) | 0.539 | 68/242 (28.1) | 129/223 (57.8) | 0.925 |
| Middle tertile | −1.0 (0.08) | −2.2 (0.08) | 33/240 (13.8) | 92/246 (37.4) | ||
| Highest tertile | −1.3 (0.09) | −2.6 (0.09) | 20/225 (8.9) | 57/235 (24.3) | ||
| HAQ-DI | ||||||
| Lowest tertile | −1.0 (0.07) | −2.1 (0.07) | 0.489 | 64/250 (25.6) | 130/256 (50.8) | 0.612 |
| Middle tertile | −1.0 (0.07) | −2.2 (0.08) | 32/262 (12.2) | 85/238 (35.7) | ||
| Highest tertile | −1.2 (0.09) | −2.3 (0.09) | 25/200 (12.5) | 67/218 (30.7) | ||
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; LSM, least squares mean; N, number of modified intent-to-treat patients in the specified treatment population; n, number of patients in specified category; N-obs, number of patients in the analysis; RA, rheumatoid arthritis; RF, rheumatoid factor; SDAI, Simplified Disease Activity Index.