Hypersensitivity and adverse reactions to biologics for asthma and allergic diseases

ABSTRACT

Introduction: The development of new biologic agents has provided definite therapeutic advances but, like with any new medications, safety remains a concern.

Areas covered: Using PubMed, we reviewed the literature on the adverse effects (AE) to five biologics approved for asthma and/or allergic diseases: one anti-IgE (omalizumab), three anti-IL5 (mepolizumab, reslizumab, benralizumab), and one anti-IL4 (dupilumab).

Expert opinion: Biologic agents approved for asthma and allergic diseases are generally safe. Most common AE are benign and tolerated, though long-term safety is lacking for most of them. A slightly increased risk of anaphylaxis to omalizumab and reslizumab required the inclusion of a black box warning, informing the patient, the need for post-injection observation period, and the provision of epinephrine autoinjectors for self-administration when needed. Hypersensitivity reactions, mainly urticaria and very rarely serum sickness have occurred.

KEYWORDS:

• Biological agents
• asthma
• atopic dermatitis
• urticaria
• nasal polyposis
• eosinophilic esophagitis
• omalizumab
• mepolizumab
• reslizumab
• benralizumab
• dupilumab

Article highlights

• Newly emerged biologic therapies have revolutionized the management of uncontrolled asthma and other allergic diseases.

• Several biologics have been available in the United States after being approved by the US Food & Drug Administration. So far, they include omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab.

• They are primarily additional in certain patients who are not adequately controlled on appropriate conventional management.

• Besides their proven efficacy, their reported adverse effects were acceptable – though mostly based on limited sample sizes and limited periods of observation.

• Anaphylaxis was a risk to omalizumab in 0.1–0.2% and to reslizumab in 0.1–1%, which required the inclusion of a black box warning.

• Their long-term safety remains to be seen. Hence, in addition to the already known AEs summarized in this review, it is prudent to watch for and report any newly observed ones.

• Data on agents that are still in clinical trials remains to be seen.

Declaration of interest

The authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

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

Additional information

Funding

This paper was not funded.