Treatment-emergent adverse events during the C-OPTIMISE maintenance period (Weeks 48 to 96)
| N (%), unless otherwise specified | CZP 200 mg Q2W (n=104) | CZP 200 mg Q4W (n=105) | Placebo (n=104) |
| CZP exposure duration (days) | |||
| Mean (SD) | 306.9 (78.9) | 300.5 (77.7) | 171 (104.7) |
| Median (range) | 336.0 (14 to 346) | 336.0 (44 to 350) | 126.0 (14 to 345) |
| Total patient-years at risk | 101.0 | 96.4 | 52.7 |
| Any TEAE | 60 (57.7) | 64 (61.0) | 56 (54.4) |
| Event rate per 100 PY | 177.2 | 140.0 | 237.1 |
| Serious TEAEs | 5 (4.8) | 0 | 0 |
| Discontinuation due to TEAEs | 1 (1.0) | 3 (2.9) | 0 |
| Drug-related TEAEs | 14 (13.5) | 20 (19.0) | 14 (13.6) |
| Severe TEAEs | 1 (1.0) | 0 | 2 (1.9) |
| TEAEs of Interest | |||
| Opportunistic infections | 1 (1.0) | 3 (2.9) | 2 (1.9) |
| Oral candidiasis | 0 | 1 (1.0) | 0 |
| Malignant or unspecified tumours* | 0 | 0 | 0 |
| Serious cardiovascular events† | 0 | 0 | 0 |
| Serious haematopoietic cytopenia | 0 | 0 | 0 |
| Serious bleeding events‡ | 0 | 0 | 0 |
| Hepatic events§ | 3 (2.9) | 5 (4.8) | 3 (2.9) |
| Liver function analyses¶ | 3 (2.9) | 4 (3.8) | 2 (1.9) |
| Hypersensitivity and anaphylactic reactions** | 0 | 0 | 0 |
| Demyelinating disorders | 0 | 0 | 0 |
| Deaths | 0 | 0 | 0 |
*Identified using SMQs ‘malignant or unspecified tumours’ and ‘malignant tumours’; also include incidence of ‘any malignancy’.
†Identified using study sponsor-defined search criteria based on a two-step process using identification via a predefined list of preferred terms in addition to manual review by the study physician.
‡Identified using SMQ ‘haemorrhage terms (excluding laboratory terms)’ in the subset of serious TEAEs.
§Identified using SMQs ‘cholestasis and jaundice of hepatic origin’, ‘hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions’, ‘hepatitis, non-infectious’, ‘liver-related investigations, signs and symptoms’ and ‘liver-related coagulation and bleeding disturbances’.
¶Includes increased levels of alanine aminotransferase, aspartate aminotransferase, hepatic enzyme, blood bilirubin or transaminases.
**Includes incidence of ‘any hypersensitivity and anaphylactic reactions’, ‘any hypersensitivity reactions’ and ‘any anaphylactic reactions’. Safety events are reported for the Safety Set (n=736) according to MedDRA Version 19.0.
CZP, certolizumab pegol; MedDRA, Medical Dictionary for Regulatory Activities; PY, patient-years; Q2W, every 2 weeks; Q4W, every 4 weeks; SD, standard deviation; SMQ, standard MedDRA query; TEAE, treatment-emergent adverse event.