Table 3.
Treatment‐emergent adverse events (TEAEs) by system organ class in ≥ 2% of the safety population
| System organ class | FAEs (N = 52)a | MTX (N = 52) | IXE (N = 54) |
|---|---|---|---|
| Patients with at least one TEAE | 46 (88) | 43 (83) | 46 (85) |
| Infections and infestations | 14 (27) | 25 (48) | 30 (56) |
| Gastrointestinal disorders | 35 (67) | 17 (33) | 7 (13) |
| General disorders and administration‐site conditions | 5 (10) | 9 (17) | 16 (30) |
| Nervous system disorders | 7 (13) | 11 (21) | 11 (20) |
| Musculoskeletal and connective tissue disorders | 4 (8) | 12 (23) | 9 (17) |
| Skin and subcutaneous tissue disorders | 6 (12) | 6 (12) | 7 (13) |
| Vascular disorders | 14 (27) | 1 (2) | 2 (4) |
| Investigations | 7 (13) | 3 (6) | 6 (11) |
| Respiratory, thoracic and mediastinal disorders | 3 (6) | 3 (6) | 6 (11) |
| Injury, poisoning and procedural complications | 1 (2) | 6 (12) | 5 (9) |
| Ear and labyrinth disorders | 3 (6) | 3 (6) | 2 (4) |
| Blood and lymphatic system disorders | 5 (10) | 3 (6) | 0 |
| Metabolism and nutrition disorders | 1 (2) | 0 | 3 (6) |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 0 | 1 (2) | 2 (4) |
| Renal and urinary disorders | 0 | 0 | 2 (4) |
| Eye disorders | 0 | 2 (4) | 0 |
The data are presented as n (%). FAEs, fumaric acid esters; IXE, ixekizumab; MTX, methotrexate. aDue to the high discontinuation rates observed in the FAE group, post hoc analyses for safety events (exposure‐adjusted incidence rates and rate ratios from Poisson regression models with a term for treatment and using an offset) were deemed necessary.