Table 3

Treatment-emergent adverse events during the C-OPTIMISE maintenance period (Weeks 48 to 96)

N (%), unless otherwise specifiedCZP 200 mg Q2W
CZP 200 mg Q4W
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 risk101.096.452.7
Any TEAE60 (57.7)64 (61.0)56 (54.4)
 Event rate per 100 PY177.2140.0237.1
Serious TEAEs5 (4.8)00
Discontinuation due to TEAEs1 (1.0)3 (2.9)0
Drug-related TEAEs14 (13.5)20 (19.0)14 (13.6)
Severe TEAEs1 (1.0)02 (1.9)
TEAEs of Interest
 Opportunistic infections1 (1.0)3 (2.9)2 (1.9)
 Oral candidiasis01 (1.0)0
 Malignant or unspecified tumours*000
 Serious cardiovascular events†000
 Serious haematopoietic cytopenia000
 Serious bleeding events‡000
 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**000
 Demyelinating disorders000
  • *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.