Safety of Anti-Tumor Necrosis Factor Therapies in Arthritis Patients

Authors

  • Radu M Nanau In Vitro Drug Safety and Biotechnology
  • Manuela G Neuman In Vitro Drug Safety and Biotechnology and Department of Pharmacology and Toxicology, University of Toronto

DOI:

https://doi.org/10.18433/J3WP4F

Abstract

Purpose. Inflammatory and rheumatic arthritis remain leading causes of disability worldwide. The arthritis therapeutic area commands the largest market for the prescription of biological and non-steroidal anti-inflammatory drugs (NSAID). Yet biotechnology and pharmaceutical companies conducting research and providing therapeutics in this area frequently face challenges in patient safety.  The purpose of our study was to assess safety of anti-tumor necrosis factor therapies in arthritis patients.  Methods: The present study systematically reviews adverse events of biologicals alone or in the presence of NSAIDs and other immunosuppressant therapeutics such as disease-modifying antirheumatic drugs (DMARD). We assessed the rheumatology literature that included clinical trials with anti-tumor necrosis factor (TNF) biologicals and case reports published between 2010 and 2014.  Results: Currently approved anti-TNF biologicals in arthritis include the monoclonal antibodies infliximab, adalimumab, certolizumab pegol and golimumab, and the fusion protein etanercept. The most frequently-reported adverse event was infection. We grouped the adverse reactions as immune-mediated, hypersensitivity syndrome reactions including cutaneous and hepatic manifestation, neurological, hematological, and malignancy.  Discussion: Most adverse events are due to the failure of host immunological control, which involves susceptibility to the drug itself, or de novo infection or reactivation of a latent bacterial or viral infection, often with a different expression of disease. Drug-induced liver injury associated with anti-TNF biologicals must be kept in mind when evaluating patients with increased liver enzymes.  Conclusion: Risk assessment in individuals undergoing treatment with biologicals represents a step towards achieving a personalized medicine approach to identify those patients that will safely benefit from this therapeutic approach. Patients and physicians must be alert of anti-TNF agents as potential causes of drug-induced liver injury and monitor the therapies. Personalizing therapeutic pharmacovigilance promises to optimize benefits while minimizing side effects.

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Author Biography

Manuela G Neuman, In Vitro Drug Safety and Biotechnology and Department of Pharmacology and Toxicology, University of Toronto

CEO In Vitro Drug Safety and Biotechnology

Ass. Prof. Pharmacology and Toxicology

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Published

2014-07-30

How to Cite

Nanau, R. M., & Neuman, M. G. (2014). Safety of Anti-Tumor Necrosis Factor Therapies in Arthritis Patients. Journal of Pharmacy & Pharmaceutical Sciences, 17(3), 324–361. https://doi.org/10.18433/J3WP4F

Issue

Section

Review Articles