Treatment-emergent AE up to Week 6a (safety population) of the RCT and for all patients treated with CZP in both the RCT and OLE periods.
| PBO, n = 114 | CZP, n = 110 | All CZP RCT + OLEb, n = 219 | |
|---|---|---|---|
| Duration of exposure, days, mean (SD) | 43.0 (4.9) | 43.2 (5.5) | 190c |
| Any AE, n (%d) | 71 (62.3) | 70 (63.6) | 202 (92.2) |
| Any AE by maximum intensity, n (%d) | |||
| Mild | 42 (36.8) | 44 (40.0) | 76 (34.7) |
| Moderate | 25 (21.9) | 23 (20.9) | 102 (46.6) |
| Severe | 4 (3.5) | 3 (2.7) | 24 (11.0) |
| Drug-related AEe, n (%d) | 25 (21.9) | 27 (24.5) | 101 (46.1) |
| Most frequent AEf | |||
| Nasopharyngitis | 6 (5.3) | 10 (9.1) | 31 (14.2) |
| Headache | 15 (13.2) | 8 (7.3) | 28 (12.8) |
| Discontinuations due to AE, n (%d) | 1 (0.9) | 3 (2.7) | 18 (8.2) |
| Serious AE, n (%d) | 1 (0.9) | 2 (1.8) | 15 (6.8) |
| Serious infections and infestations, n (%d) | 0 | 0 | 8 (3.7) |
| Tuberculosis | 0 | 0 | 2 (0.9) |
| No. deaths, n (%d) | 0 | 1 (0.9) | 1 (0.5) |
↵a Four weeks postvaccination.
↵b The data from the OLE phase includes events experienced by PBO patients who entered the OLE phase.
↵c Median exposure to CZP throughout SB and OLE periods.
↵d Percent of patients in group.
↵e AE considered related or possibly related to study drug by the investigator.
↵f AE occurring in ≥ 5% of patients in CZP group. AE: adverse event; RCT: randomized controlled trial; CZP: certolizumab pegol; SB: single-blind phase; OLE: open-label period; PBO: placebo.