A great percentage of real-life patients with severe asthma who are treated with mepolizumab was found to be deemed ineligible for clinical trials of this biological, and to exhibit distinct characteristics from eligible patients, according to a study published in the Journal of Allergy and Clinical Immunology Practice.
In this retrospective cohort study, the data of 119 patients treated with mepolizumab for severe asthma were examined. Eligibility criteria for participation in mepolizumab clinical trials were extracted from 4 clinical trials. Doses of oral corticosteroids (OCS) at 6 months were obtained from electronic medical records, when applicable.
Of the 119 patients receiving mepolizumab, 98 patients (82.4%) were considered ineligible for trial inclusion, based on eligibility criteria, 51 patients (42.9%) met ≥1 exclusion criteria, and 47 patients (39.5%) did not meet all inclusion criteria and were therefore excluded from trial. Only 21 patients (17.6%) who received mepolizumab in the clinic fulfilled the eligibility criteria for 3 mepolizumab trials.
The patients who received mepolizumab in clinical care vs those enrolled in mepolizumab trials were older, more often men, and had a better lung function under lower of OCS maintenance dosage. Of the 66 patients treated with mepolizumab and dependent on OCS who were ineligible for mepolizumab clinical trials, 50% achieved reduction of their maintenance OCS dosage to ≤5 mg prednisone/day or equivalent.
Limitations of this study were the inclusion of patients who were treated in only 1 academic hospital as well as the lack of data on the frequency of asthma exacerbations.
The study investigators suggested that their findings indicate “that novel biological therapies may benefit a broader severe asthma population than initially described in randomized clinical trials.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Richards LB, van Bragt JJMH, Aarab R, et al. Treatment eligibility of real-life mepolizumab-treated severe asthma patients [published online April 25, 2020]. J Allergy Clin Immunol Pract. doi: 10.1016/j.jaip.2020.04.029