A drug safety review of treating eosinophilic asthma with monoclonal antibodies

ABSTRACT

Introduction: The last two decades have seen significant progress in the treatment of severe asthma especially the severe eosinophilic phenotype. This review article serves to update the reader on the known safety profiles of these medications. It does not serve as a review of their clinical efficacies.

Areas covered: All four of the currently approved monoclonal antibodies (biologics) used in the treatment of severe asthma are discussed with reference to the known safety data garnered from clinical trials and real world evidence. A fifth, approved by The European Commission and FDA, but not yet by NICE or Health Canada, is also discussed.

Expert opinion: For each of the five biologics the authors shall summarize the known safety profiles and also the potential adverse effects as their usage is extended long term with suggestions for real world studies to help us develop our knowledge base.

KEYWORDS:

• Asthma
• biologics
• safety
• omalizumab
• mepolizumab
• reslizumab
• benralizumab
• dupilumab
• real world evidence

Article highlights

• Summary of safety data from phase III clinical trials, product monographs and real world evidence publications on the currently available biologics for the treatment of asthma

• Safety review of cardiovascular, neoplastic, anaphylaxis risk profile of omalizumab

• Safety review of the use of omalizumab in pregnancy

• Safety review of the anti-IL 5 monoclonal antibodies, mepolizumab, reslizumab, and benralizumab

• Safety review of the anti-IL 4/13 monoclonal antibody, dupilumab

This box summarizes key points contained in the article.

Author contributions

PDM authored the paper. RL coauthored the paper and provide expert feedback.

Declaration of interest

P Mitchell has received speaker fees from GlaxoSmithKline, AstraZeneca, Teva and Novartis, and has received grants from AstraZeneca and Teva. R Leigh has received consulting fees from AstraZeneca and speakers fees from Novartis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper is not funded.