Safety overview after 24 weeks according to concomitant cDMARD or MTX use at baseline, subdivided by treatment
| Concomitant treatment | cDMARD | MTX | None (cDMARD-naïve or past use at baseline) | ||||||
| PBO, n=69 | IXEQ4W, n=68 | IXEQ2W, n=63 | PBO, n=59 | IXEQ4W, n=57 | IXEQ2W, n=53 | PBO, n=37 | IXEQ4W, n=39 | IXEQ2W, n=39 | |
| Treatment-emergent AE, n (%) | 30 (43.5) | 42 (61.8)* | 40 (63.5)* | 27 (45.8) | 36 (63.2) | 34 (64.2) | 20 (54.1) | 29 (74.4) | 27 (69.2) |
| Mild | 15 (21.7) | 28 (41.2)* | 23 (36.5) | 13 (22.0) | 25 (43.9)* | 18 (34.0) | 12 (32.4) | 15 (38.5) | 18 (46.2) |
| Moderate | 13 (18.8) | 13 (19.1) | 14 (22.2) | 12 (20.3) | 10 (17.5) | 13 (24.5) | 8 (21.6) | 11 (28.2) | 7 (17.9) |
| Severe | 2 (2.9) | 1 (1.5) | 3 (4.8) | 2 (3.4) | 1 (1.8) | 3 (5.7) | 0 | 3 (7.7) | 2 (5.1) |
| Serious AE, n (%) | 2 (2.9) | 3 (4.4) | 4 (6.3) | 1 (1.7) | 2 (3.5) | 0 | 0 | 3 (7.7) | 3 (7.7) |
| AE leading to discontinuation, n (%) | 2 (2.9) | 1 (1.5) | 4 (7.5) | 2 (3.4) | 1 (1.8) | 4 (7.5) | 0 | 1 (2.6) | 0 |
The study was not designed to test equivalence or non-inferiority of treatment with ixekizumab alone versus treatment with ixekizumab combined with cDMARDs.
*P<0.05 versus PBO.
AE, adverse events; cDMARD, conventional disease-modifying antirheumatic drugs; IXEQ2W, 80 mg ixekizumab once every 2 weeks; IXEQ4W, 80 mg ixekizumab once every 4 weeks; MTX, methotrexate; n, number of patients; PBO, placebo.