Abstract
Background
A 5-domain composite Core Outcome Measures set for Severe Asthma (COMSA) has been introduced for evaluation of treatment response.
Methods
The COMSA evaluation strategy was tested in a real-world study of 78 patients with severe asthma with blood eosinophilia taking mepolizumab. Exacerbations, oral corticosteroid (OCS) use, forced expiratory volume in 1 s, Asthma Quality of Life Questionnaire score and Asthma Control Questionnaire-5 results were determined before treatment and 4, 12, 24 and 36 months thereafter. Responses were quantified as the sum of changes in domains using both the relative CONFiRM (CompOsite iNdexes For Response in asthMa) scale, where exacerbations and OCS use are given most weight, and Modified Equal Weight Score (MEWS), where each domain gives equal weight. Both scales use identical cut-offs for degree of change within domains.
Results
After 1 year, the MEWS scoring system classified 13% as non-responders, 28% as sufficient-responders, 40% as substantial-responders and 19% as super-responders. Using CONFiRM, the corresponding group stratification was 22%, 22%, 33% and 23%, respectively. Group assignments remained unchanged at 24 and 36 months, for 66% of patients in COMSA-MEWS and 68% in COMFiRM. Baseline exhaled nitric oxide was highest among the super-responders, whereas other type 2 markers were similar across the groups.
Conclusion
In this first real-world application, the COMSA stratification assigned patients into distinct, graded responder groups that may be used in clinical research and management of severe asthma. Although patient-reported symptoms are given greater weight in COMSA-MEWS, the two algorithms performed similarly.