Safety Profile of Certolizumab Pegol in Patients with Immune-Mediated Inflammatory Diseases: A Systematic Review and Meta-Analysis

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Alice Capogrosso SansoneCorrado Blandizzi

Abstract

Certolizumab pegol (CZP), an anti-tumor necrosis factor PEGylated Fab' fragment of a humanized monoclonal antibody, is currently approved for treatment of some immune-mediated inflammatory diseases (IMIDs). To our knowledge, no systematic review and meta-analysis evaluating the overall safety profile of CZP has been performed. The objective of this systematic review was to assess the adverse event (AE) patterns of CZP versus a control in patients with IMIDs. A systematic literature search was performed using PubMed/MEDLINE, EMBASE, the Cochrane Library, and the FDA database for clinical trials up to March 2014. Eligible studies were those that compared the safety profile of CZP to a control group in patients with IMIDs. The following data were extracted: number of patients experiencing AEs, serious AEs (SAEs), adverse drug reactions (ADRs), withdrawals due to AEs, fatal AEs, infectious AEs and SAEs, upper respiratory tract infections, injection-site reactions, neoplasms, and tuberculosis. A total of 2023 references were identified and 18 randomized controlled trials were included. The main pooled risk ratios of CZP-treated versus control patients were as follows: AEs 1.09 (95% confidence interval, CI 1.04-1.14), SAEs 1.50 (95% ...Continue Reading

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Citations

Mar 6, 2018·Expert Opinion on Drug Safety·Salvatore D'AngeloCarlo Palazzi
Apr 16, 2019·The American Journal of Gastroenterology·Gary R LichtensteinBruce E Sands
Jun 12, 2020·Clinical Microbiology Reviews·Joshua S DavisMichael Boyle
Mar 6, 2021·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Juan S LasaLaurent Peyrin-Biroulet
Jan 14, 2017·Microbiology Spectrum·Claudia C Dobler

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