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Randomised controlled trials in severe asthma: selection by phenotype or stereotype.
Thomas Brown1,2, Thomas Jones1,2, Kerry Gove3
1Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.
The European Respiratory Journal
|October 27, 2018
Summary
Most severe asthma patients, including those with eosinophilic asthma, are ineligible for clinical trials of biological therapies. Trial criteria exclude patients based on diagnosis rather than treatment biomarkers.
Area of Science:
- Pulmonology
- Clinical Trials
- Pharmacology
Background:
- Disparities exist between clinical trial populations and real-world patients.
- This gap is not well-established for phenotype-targeted biological therapies in severe asthma.
Purpose of the Study:
- To assess severe asthma patient eligibility for randomized controlled trials (RCTs) of biological therapies.
- To compare patient characteristics in a real-world cohort against trial inclusion criteria.
Main Methods:
- Detailed characterization data from 342 severe asthma patients (Wessex Severe Asthma Cohort) were compared with eligibility criteria of phase IIB and III RCTs.
- 37 RCTs evaluating 20 biological therapies published since 2000 were identified.
Main Results:
- A median of only 9.8% of severe asthma patients met eligibility criteria for phase III trials.
- Exclusion criteria included airflow obstruction, bronchodilator reversibility, and smoking history.
- Up to 78.9% of severe eosinophilic asthma patients were excluded from trials targeting IL-5/IL-5R therapies.
Conclusions:
- The majority of severe asthma patients are excluded from biological therapy trials.
- Trial eligibility criteria often reconfirm diagnoses rather than using predictive biomarkers.
- Current trial designs may limit the generalizability of findings for severe asthma treatments.
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