Mepolizumab Reduces Systemic Corticosteroid Utilization in Chronic Obstructive Pulmonary Disease With Type 2 Inflammation: Pooled Results From Phase III Randomised Trials (ID 819)
GSK
Abstract
Purpose: Guidelines recommend oral corticosteroids (OCS) for chronic obstructive pulmonary disease (COPD) exacerbations. OCS are associated with complications highlighting an unmet need for treatments to reduce OCS burden.
Methods: Pooled analysis of Phase III, randomized, placebo-controlled trials (METREX, METREO, MATINEE) in patients with COPD (≥1-year diagnosis), aged ≥40 years, receiving inhaled triple therapy, with history of exacerbations, GOLD grades 2–4 airflow limitation, no asthma diagnosis. METREX enrolled patients regardless of blood eosinophil count (BEC); METREO with BEC ≥150 cells/µL at screening (or ≥300 cells/µL in the previous year); MATINEE with BEC ≥300 cells/µL at screening (and ≥150 cells/µL in the previous year). Patients received mepolizumab 100 mg SC or placebo every 4 weeks for 52 (METREX/METREO) up to 104 (MATINEE) weeks. This reports the percentage of days receiving SCS and total SCS exposure for any cause. Patients were stratified by BEC ≥150 cells/µL at screening and/or ≥300 cells/µL in the previous year (or ‘BEC ≥150 cells/µL’), and BEC ≥300 cells/µL at screening. SCS doses were converted to prednisolone equivalent (mg/day) and stratified by low (<20 mg/day) or high (≥20 mg/day) dose.
Results: Of 2089 patients (1043 mepolizumab/1046 placebo), 1713 (857/856) had BEC ≥150cells/µL and 1144 (567/577) ≥300cells/µL; 57%(457/510) and 55%(289/342) received OCS, respectively. Mean (SD) percentage of days without OCS was 89.8% (20.9) vs 88.3% (21.7) in patients with BEC≥150cells/µL, and 90.8% (19.4) vs 88.9% (21.3) in those with BEC≥300cells/µL (mepolizumab vs placebo).In patients with BEC ≥150 cells/µL, mean (SD) percentage of days on OCS (mepolizumab vs placebo) were 5.7% (19.5) on low dose vs 5.7% (18.6) and 4.5% (7.2) on high dose vs 5.9% (11.2) . Mean (SD) total OCS exposure (mepolizumab vs placebo) was 434.64mg/year (990.90) vs 609.95mg/year (1392.30) in patients with BEC≥150 cells/µL (mean difference [95% CI]: 178.97 [62.09, 292.19]); and 354.28mg/year (761.53) vs 551.52mg/year in patients with BEC≥300 cells/µL (1118.74; mean difference [95% CI]: 193.58 mg/year [84.01, 306.80]).
Conclusions: Mepolizumab reduced total yearly exposure to OCS, in particular high-dose courses, in patients with COPD compared to placebo regardless of screening BEC150 or ≥300cells/µL.
Funding: GSK (117106/117113/208657).
Previously presented at ATS2026.
Funding: This study was funded by GSK
Conflicts of interest: Conflicts of interest
NAH reports advisory board honoraria from Sanofi, Pfizer, Genentech, AstraZeneca, GSK, Amgen, and Verona; lecture honoraria from Sanofi and Regeneron. His institution has received grants from GSK, AstraZeneca, Genentech, and Sanofi.
MK reports grants paid to her institution by National Institutes of Health, American Lung Association, AstraZeneca, and Sanofi; personal consulting fees from AstraZeneca, Sanofi, Chiesi, GSK, Regeneron, Kinaset, and Genentech; presentation fees from Chiesi, Sanofi, Regeneron, and GSK.
JW, EB, AB, SG, and JM are employed by GSK and hold financial equities in GSK.