Monoclonal antibodies in severe asthma: is it worth it?

ABSTRACT

Background: To date, there is the strong need to compare the efficacy across the monoclonal antibodies (mAbs) approved to treat severe asthma.

Research design and method: A quantitative synthesis has been performed to compare the impact of omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and placebo on the risk of exacerbation and change in forced expiratory flow in 1 s (FEV₁) in severe asthmatic patients.

Results: All the investigated mAbs were more effective than placebo in reducing the risk of exacerbation and improving lung function. Dupilumab showed a general superiority compared to the other mAbs, as it significantly reduced the risk of exacerbation vs. omalizumab, and significantly improved FEV₁ when compared to omalizumab, mepolizumab, and benralizumab. The overall-marked placebo effect indicates that a better adherence to drug regimens in the context of RCTs may lead to noteworthy improvement in the clinical condition of severe asthmatic patients.

Conclusions: Further extensive meta-analyses are needed to identify the factors influencing the efficacy profile of mAbs in severe asthma. This may also permit to identify the profile of patients that are specifically responsive to either anti-IgE, anti-IL-4Rα, anti-IL-5, or anti-IL-5Rα mAbs.

KEYWORDS:

• Asthma exacerbation
• lung function
• meta-analysis
• monoclonal antibodies
• severe asthma

Author contributions

LC, MGM, and PR were involved in the conception and design, analysis and interpretation of the data; they drafted the paper and revised it critically for intellectual content; they approved the final version to be published; all authors agreed to be accountable for all aspects of the work.

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.

Reviewer disclosures

One peer reviewer has received funding for an investigator-led study of anti-IgE antibody Omalizumab, focusing on its effects on mechanisms of asthma and seeking to identify predictors of response, and also lectured in scientific symposia funded by Novartis, AstraZeneca and TEVA and has consulted (in ad boards) for Novartis, AstraZeneca, TEVA, and Sanofi. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.