Table 2.
Treatment-emergent AEs by SOC and preferred term, as reported in at least 1% of patients (including select AEs of special interest in less than 1% of patients)
| Primary SOC Preferred term (MedDRA) |
axSpA (n = 305) | PsA (n = 254) |
|---|---|---|
| ≥ 1 treatment-emergent AE | 152 (49.8) | 122 (48.0) |
| General disorders and administration-site conditions | 67 (22.0) | 68 (26.8) |
| Drug ineffective | 30 (9.8) | 39 (15.4) |
| Condition aggravated | 8 (2.6) | 9 (3.5) |
| Injection-site erythema | 8 (2.6) | 6 (2.4) |
| Injection-site reaction | 8 (2.6) | 4 (1.6) |
| Infections and infestations | 49 (16.1) | 33 (13.0) |
| Nasopharyngitis | 22 (7.2) | 13 (5.1) |
| Bronchitis | 5 (1.6) | 4 (1.6) |
| Herpes zoster | 1 (0.3) | – |
| Pneumonia | 2 (0.7) | – |
| Urinary tract infection | 1 (0.3) | 2 (0.8) |
| Musculoskeletal and connective tissue disorders | 22 (7.2) | 17 (6.7) |
| Osteoarthritis | 2 (0.7) | 3 (1.2) |
| Skin and subcutaneous tissue disorders | 17 (5.6) | 22 (8.7) |
| Pruritus | 1 (0.3) | 2 (0.8) |
| Gastrointestinal disorders | 17 (5.6) | 5 (2.0) |
| Injury, poisoning, and procedural complications | 9 (3.0) | 3 (1.2) |
| Nervous system disorders | 5 (1.6) | 9 (3.5) |
| Respiratory, thoracic, and mediastinal disorders | 7 (2.3) | 4 (1.6) |
| Cardiac disorders | 7 (2.3) | 2 (0.8) |
| Investigations | 3 (1.0) | 5 (2.0) |
Data are shown as n (%)
AE adverse event, axSpA axial spondyloarthritis, MedDRA Medical Dictionary for Regulatory Activities, PsA psoriatic arthritis, SOC system organ class