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Meta-Analysis
. 2015 Oct;38(10):869-88.
doi: 10.1007/s40264-015-0336-2.

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

Alice Capogrosso Sansone  1 , Stefania Mantarro  1   2 , Marco Tuccori  3   4 , Elisa Ruggiero  5 , Sabrina Montagnani  1 , Irma Convertino  6 , Alessandra Marino  1 , Matteo Fornai  1 , Luca Antonioli  1 , Tiberio Corona  5 , Danila Garibaldi  2 , Corrado Blandizzi  1   6
Affiliations
Meta-Analysis

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

Alice Capogrosso Sansone et al. Drug Saf. 2015 Oct.

Abstract

Introduction: 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.

Objective: The objective of this systematic review was to assess the adverse event (AE) patterns of CZP versus a control in patients with IMIDs.

Methods: 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.

Results: 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% CI 1.21-1.86), ADRs 1.20 (95% CI 1.03-1.39), infectious AEs 1.28 (95% CI 1.13-1.45), infectious SAEs 2.17 (95% CI 1.36-3.47), and upper respiratory tract infections 1.34 (95% CI 1.15-1.57).

Conclusion: Safety data on CZP suggest an overall favorable tolerability profile, with infections being the most common AE. However, CZP-treated patients had a twofold higher risk of infectious SAEs than control patients. Large observational studies and data from national registries are needed to detect rare AEs, which might occur after long-term exposures to CZP.

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References

    1. Rheumatology (Oxford). 2002 Oct;41(10):1133-7 - PubMed
    1. Nat Immunol. 2001 Sep;2(9):771-3 - PubMed
    1. World Health Organ Tech Rep Ser. 1972;498:1-25 - PubMed
    1. J Immunol. 2012 Apr 1;188(7):3169-78 - PubMed
    1. Ann Rheum Dis. 2015 Jan;74(1):96-103 - PubMed

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