Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies.

ABSTRACT:

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 patie

SUBMITTER: Blauvelt A 

PROVIDER: S-EPMC8246928 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature