Adverse events during the 24 week, placebo-controlled, double-blind phase, by treatment group
| Placebo (n=136) | CZP 200 mg (n=138) | CZP 400 mg (n=135) | |
|---|---|---|---|
| TEAE | n (%)* | n (%) | n (%) |
| Any TEAE | 92 (67.6) | 94 (68.1) | 96 (71.1) |
| TEAEs by intensity | |||
| Mild | 74 (54.4) | 78 (56.5) | 77 (57.0) |
| Moderate | 49 (36.0) | 47 (34.1) | 45 (33.3) |
| Severe | 2 (1.5) | 7 (5.1) | 7 (5.2) |
| Discontinuations due to TEAEs | 2 (1.5) | 4 (2.9) | 6 (4.4) |
| Drug-related TEAEs | 37 (27.2) | 39 (28.3) | 41 (30.4) |
| Serious TEAEs | 6 (4.4) | 8 (5.8) | 13 (9.6) |
| Infections | 52 (38.2) | 60 (43.5) | 54 (40.0) |
| Upper respiratory infections | 21 (15.4) | 38 (27.5) | 38 (28.1) |
| Serious infections | 1 (0.7) | 2 (1.4) | 2 (1.5) |
| Injection-site reactions | 3 (2.2) | 6 (4.3) | 13 (9.6) |
| Injection site pain | 2 (1.5) | 3 (2.2) | 1 (0.7) |
| Death | 0 | 1 (0.7)† | 1 (0.7)‡ |
*Placebo escape at week 16; Data not adjusted for exposure.
†Myocardial infarct.
‡Sudden death of unknown cause.
CZP, certolizumab pegol; PBO, placebo; Q2W, every 2 weeks; Q4W, every 4 weeks; TEAE, treatment emergent adverse events–all events after initial study treatment dose.