Table 2.
Safety overview of ixekizumab after 24 weeks of treatment when subdivided according to background cDMARD or MTX use at baseline
| Any background cDMARD | Background MTX only | No background cDMARDs | |||||||
| PBO n=52 | IXEQ4W n=60 | IXEQ2W n=73 | PBO n=40 | IXEQ4W n=48 | IXEQ2W n=61 | PBO n=66 | IXEQ4W n=62 | IXEQ2W n=50 | |
| TEAE (≥1), n (%) | 33 (63.5) | 43 (71.7) | 51 (69.9) | 25 (62.5) | 35 (72.9) | 40 (65.6) | 43 (65.2) | 40 (64.5) | 39 (78.0) |
| TEAE (≥1), by severity, n (%) | |||||||||
| Mild | 18 (34.6) | 27 (45.0) | 27 (37.0) | 13 (32.5) | 21 (43.8) | 23 (37.7) | 14 (21.2) | 21 (33.9) | 16 (32.0) |
| Moderate | 15 (28.8) | 15 (25.0) | 20 (27.4) | 12 (30.0) | 13 (27.1) | 14 (23.0) | 27 (40.9) | 16 (25.8) | 18 (36.0) |
| Severe | 0 | 1 (1.7) | 4 (5.5) | 0 | 1 (2.1) | 3 (4.9) | 2 (3.0) | 3 (4.8) | 5 (10.0) |
| Serious AE, n (%) | 2 (3.8) | 1 (1.7) | 4 (5.5) | 2 (5.0) | 1 (2.1) | 3 (4.9) | 2 (3.0) | 2 (3.2) | 4 (8.0) |
| Serious infections, n (%)* | 0 | 0 | 2 (2.7) | 0 | 0 | 2 (3.3) | 0 | 0 | 1 (2.0) |
| Discontinuations due to AE, n (%) | 4 (7.7) | 3 (5.0) | 3 (4.1) | 4 (10.0) | 1 (2.1) | 3 (4.9) | 2 (3.0) | 2 (3.2) | 5 (10.0) |
*None of the reported serious infections were related to Candida or Tuberculosis.
AE, adverse event; cDMARD, conventional disease-modifying antirheumatic drug; IXEQ2W, ixekizumab every 2 weeks;IXEQ4W, ixekizumab every 4 weeks; MTX, methotrexate; n, number of patients; PBO, placebo; TEAE, treatment-emergent adverse event.