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01.10.2015 | Systematic Review

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

verfasst von: Alice Capogrosso Sansone, Stefania Mantarro, Marco Tuccori, Elisa Ruggiero, Sabrina Montagnani, Irma Convertino, Alessandra Marino, Matteo Fornai, Luca Antonioli, Tiberio Corona, Danila Garibaldi, Corrado Blandizzi

Erschienen in: Drug Safety | Ausgabe 10/2015

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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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Titel: Safety Profile of Certolizumab Pegol in Patients with Immune-Mediated Inflammatory Diseases: A Systematic Review and Meta-Analysis
verfasst von: Alice Capogrosso Sansone
Stefania Mantarro
Marco Tuccori
Elisa Ruggiero
Sabrina Montagnani
Irma Convertino
Alessandra Marino
Matteo Fornai
Luca Antonioli
Tiberio Corona
Danila Garibaldi
Corrado Blandizzi
Publikationsdatum: 01.10.2015
Verlag: Springer International Publishing
Erschienen in: Drug Safety / Ausgabe 10/2015
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI: https://doi.org/10.1007/s40264-015-0336-2

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

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

Abstract

Introduction

Objective

Methods

Results

Conclusion

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

Abstract

Introduction

Objective

Methods

Results

Conclusion

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