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Asthma biologics: Comparing trial designs, patient cohorts and study results
Ali Doroudchi1, Mohini Pathria2, Brian D Modena2
1Department of Pediatrics, University of California Los Angeles, Los Angeles, California.
Objective:
Five biologic therapies have FDA-approved indications for difficult-to-control asthma. The clinical trials that proved the efficacy and safety of these biologics were often similar in their inclusion criteria, study designs, and endpoints. Many of these trials have been reanalyzed post hoc to identify subsets of subjects considered to be enhanced responders. As a result, keeping up with the literature and deciding on the most appropriate biologic for our patients has become increasingly difficult. This review summarizes and compares trial designs, patient cohorts, and study results of the major trials involving these therapies.
Data Sources:
Included are basic science articles, online Food and Drug Administration (FDA) applications, and all the published reports of phase II and phase III clinical trials for FDA-approved asthma biologics.
Study Selections:
Included are the major phase II and phase III clinical trials of 5 asthma biologics.
Results:
Because of variations in inclusion criteria and natural variations in enrolled cohorts, the baseline clinical traits and severity of study populations in asthma biologic trials differed significantly, which is important because baseline annualized exacerbation rates and blood eosinophilia are both strong predictors of a biologic's success. Notwithstanding, the trial results, when considered together, can help guide care providers in choosing the most appropriate biologic for our patients.
Conclusion:
Understanding the details and differences in asthma biologic trial designs, patient cohorts, and in study results will help care providers make more informed decisions when choosing a biologic. We are hopeful this review will serve as a reference to care providers for this purpose.
Insights
Choosing the right biologic for severe asthma is complex. This review compares clinical trial data for five biologics, aiding physicians in selecting the most effective treatment based on patient characteristics.
Area of Science:
- Pulmonology and immunology
- Clinical pharmacology
Background:
- Five biologic therapies are FDA-approved for difficult-to-control asthma.
- Clinical trials for these biologics share similarities in design and endpoints.
- Post hoc analyses identify patient subsets with enhanced responses to specific biologics.
Purpose of the Study:
- To review and compare trial designs, patient cohorts, and results of major clinical trials for FDA-approved asthma biologics.
- To assist healthcare providers in selecting the most appropriate biologic therapy for patients with severe asthma.
Main Methods:
- Systematic review of phase II and III clinical trials for five asthma biologics.
- Inclusion of basic science articles and FDA applications.
- Analysis of trial inclusion criteria, study designs, patient cohorts, and endpoints.
Main Results:
- Significant variations exist in trial inclusion criteria and patient cohort characteristics.
- Baseline factors like exacerbation rates and blood eosinophilia predict biologic success.
- Trial results, when synthesized, can guide biologic selection.
Conclusions:
- Understanding differences in trial designs and patient populations is crucial for informed biologic selection.
- This review serves as a reference to aid clinicians in choosing optimal asthma biologic therapies.
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