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Long‐term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo‐controlled studies
Author(s) -
Blauvelt A.,
Paul C.,
Kerkhof P.,
Warren R.B.,
Gottlieb A.B.,
Langley R.G.,
Brock F.,
Arendt C.,
Boehnlein M.,
Lebwohl M.,
Reich K.
Publication year - 2021
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.19314
Subject(s) - certolizumab pegol , medicine , meddra , adverse effect , placebo , incidence (geometry) , randomized controlled trial , bristol myers , confidence interval , psoriasis , plaque psoriasis , surgery , dermatology , pharmacovigilance , infliximab , tumor necrosis factor alpha , physics , alternative medicine , pathology , optics
Summary Background Certolizumab pegol (CZP) is an Fc‐free, PEGylated anti‐tumour necrosis factor biologic. Objectives To report 3‐year safety data from three phase III trials of CZP in adults with plaque psoriasis. Methods Data were pooled from CIMPASI‐1 (NCT02326298), CIMPASI‐2 (NCT02326272) and CIMPACT (NCT02346240). Included patients had moderate‐to‐severe plaque psoriasis of ≥ 6 months’ duration; had been randomized to CZP 200 mg every 2 weeks (Q2W) (400 mg at weeks 0, 2 and 4) or CZP 400 mg Q2W; and had received at least one dose of CZP with up to 144 weeks of exposure. Treatment‐emergent adverse events (TEAEs) were classified using MedDRA v18·1. Reported incidence rates (IRs) are incidence of new cases per 100 patient‐years (PY). Results Over 144 weeks, 995 patients received at least one dose of CZP (exposure: 2231·3 PY); 731 and 728 received at least one dose of CZP 200 mg Q2W (1211·4 PY) and/or 400 mg Q2W (1019·9 PY), respectively. The IR [95% confidence interval (CI)] of TEAEs was 144·9 (135·3–155·0) for all patients, 134·1 (123·2–145·7) for CZP 200 mg Q2W and 158·3 (145·5–171·9) for CZP 400 mg Q2W. The IR (95% CI) of serious TEAEs for all patients was 7·5 (6·4–8·8); the IRs were 6·7 (5·2–8·3) and 8·7 (6·9–10·8) for CZP 200 mg and 400 mg Q2W, respectively. Overall, 3·2% of patients reported serious infections (2·2% within each of the CZP 200 and 400 mg Q2W groups). Overall, there was one case of active tuberculosis, 16 malignancies in 14 patients and seven deaths (two considered treatment‐related). The cumulative IR of TEAEs did not increase over time. Conclusions No new safety signals were identified compared with previously reported data. Risk did not increase with longer or higher CZP exposure.