Table 2.
Treatment-emergent adverse events (TEAEs) during the 24-week, placebo-controlled, double-blind phase, by treatment group in the axSpA population
| Placebo* n=107 n (%) | CZP 200 mg Q2W n=111 n (%) | CZP 400 mg Q4W n=107 n (%) | |
|---|---|---|---|
| Any TEAEs | 67 (62.6) | 85 (76.6) | 80 (74.8) |
| TEAEs by intensity | |||
| Mild | 52 (48.6) | 65 (58.6) | 64 (59.8) |
| Moderate | 36 (33.6) | 46 (41.4) | 43 (40.2) |
| Severe | 7 (6.5) | 4 (3.6) | 3 (2.8) |
| Drug-related TEAEs | 22 (20.6) | 41 (36.9) | 36 (33.6) |
| Infections† | 25 (23.4) | 43 (38.7) | 41 (38.3) |
| Nasopharyngitis | 7 (6.5) | 11 (9.9) | 11 (10.3) |
| Upper respiratory tract infections | 3 (2.8) | 6 (5.4) | 4 (3.7) |
| Serious infections‡ | 0 | 2 (1.8) | 0 |
| Investigations | |||
| Blood creatine phosphokinase increased | 2 (1.9) | 7 (6.3) | 6 (5.6) |
| Injection site reactions§ | 1 (0.9) | 10 (9.0) | 5 (4.7) |
| Injection site pain‡ | 1 (0.9) | 1 (0.9) | 0 |
| Serious TEAEs by SOC | 5 (4.7) | 4 (3.6) | 7 (6.5) |
| Blood and lymphatic system disorder | 0 | 1 (0.9) | 0 |
| Cardiac disorders | 0 | 0 | 1 (0.9) |
| Eye disorders | 0 | 1 (0.9) | 0 |
| Gastrointestinal disorders | 1 (0.9) | 0 | 1 (0.9) |
| General disorders and administration site conditions¶ | 2 (1.9) | 0 | 0 |
| Hepatobiliary disorders | 0 | 0 | 2 (1.9) |
| Immune system disorders | 1 (0.9) | 0 | 1 (0.9) |
| Infections and infestations | 0 | 2 (1.8) | 0 |
| Investigations¶ | 0 | 1 (0.9) | 0 |
| Renal and urinary disorders | 1 (0.9) | 0 | 1 (0.9) |
| Respiratory, thoracic and mediastinal disorders | 0 | 0 | 1 (0.9) |
| Discontinuations due to TEAEs | 2 (1.9) | 2 (1.8) | 4 (3.7) |
| Death | 0 | 0 | 0 |
*placebo escape at week 16.
†Preferred terms.
‡Serious infections reported: haemophilus infection and laryngitis.
§High-level term.
¶Serious general disorders and administration site conditions was two cases of non-cardiac chest pain; serious investigation TEAE was one case of gamma-glutamyltransferase increased.
CZP, certolizumab pegol.