COMPARATIVE EFFICACY OF BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL FUMARATE VERSUS BECLOMETHASONE DIPROPIONATE/GLYCOPYRRONIUM/FORMOTEROL FUMARATE IN UNCONTROLLED ASTHMA: A MATCHING ADJUSTED INDIRECT COMPARISON (MAIC)
Author(s)
Lotte Westerink, PhD1, Krishnali Parsekar, MSc1, Barinder Singh, RPh2, Igor Artico, -3, Jacob Knagenhjelm, MSc3, Chris Edmonds, -4, Jonathan Marshall, -5, Arnaud Bourdin, MD, PhD6.
1Health Economics and Payer Evidence, BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, 2Pharmacoevidence Private Limited, Mohali, India, 3Global Market Access and Pricing, BioPharmaceuticals Medical, AstraZeneca, Barcelona, Spain, 4Global Price and Market Access, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA, 5Global Medical Respiratory, BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, 6Respiratory Disease, University of Montpellier, Montpellier, France.
1Health Economics and Payer Evidence, BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, 2Pharmacoevidence Private Limited, Mohali, India, 3Global Market Access and Pricing, BioPharmaceuticals Medical, AstraZeneca, Barcelona, Spain, 4Global Price and Market Access, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA, 5Global Medical Respiratory, BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, 6Respiratory Disease, University of Montpellier, Montpellier, France.
OBJECTIVES: The 2026 GINA report recommends adding a long-acting muscarinic antagonist for adults with uncontrolled asthma on medium-dose inhaled corticosteroid/long-acting β2-agonist therapy (MD-ICS/LABA). Although single-inhaler triple therapies (SITTs) improve outcomes versus ICS/LABA, direct comparative evidence between triple therapies is lacking. Differences in trial populations between KALOS/LOGOS (budesonide/glycopyrronium/formoterol fumarate dihydrate; BUD/GLY/FORM) and TRIMARAN (beclomethasone dipropionate/ glycopyrronium/formoterol fumarate dihydrate; BDP/GLY/FORM), including exacerbation history requirements and eligibility criteria, limit direct comparisons. This study estimated relative treatment efficacy using anchored population-adjusted indirect comparison (MAIC) methods.
METHODS: An anchored MAIC was conducted using individual patient-level data (IPD) from prespecified pooled KALOS/LOGOS trial data (BUD/GLY/FORM; FEV1, n=2259; exacerbations, n=2353), and aggregated data from TRIMARAN (n=1150) with MD-ICS/LABA as common comparator. In line with ISPOR, Cochrane, NICE TSD 18, and JCA guidance, analyses were adjusted for clinically relevant treatment effect modifiers (TEMs), determined by expert clinical input. KALOS/LOGOS IPD were reweighted to match TRIMARAN baseline characteristics including lung function (relevant FEV1); age, biomarkers and exacerbation history (relevant FEV1 TEMs), in addition to prior treatment and former smoking (relevant exacerbation rate TEMs). Covariate balance was confirmed post-weighting, and effective sample size (ESS) was used to gauge precision loss and population overlap.
RESULTS: After adjustment, ESS decreased to n=983 (FEV1) and n=614 (exacerbations). No statistically significant difference in lung function was observed between treatments following adjustment. Adjusted mean difference in trough FEV1 between BUD/GLY/FORM and BDP/GLY/FORM was 21.32 mL (95% CI; -37.96, 80.61). Similarly, no statistically significant difference in severe exacerbation rate was observed between treatments following adjustment, with an anchored MAIC estimated rate ratio of 0.99 (95% CI; 0.64, 1.52).
CONCLUSIONS: Anchored MAIC analysis showed no significant differences between BUD/GLY/FORM and BDP/GLY/FORM in improving lung function or reducing severe exacerbations. Consistent findings suggest comparable efficacy between treatments, providing comparative evidence to inform clinical and payer decision-making in the absence of head-to-head trials.
METHODS: An anchored MAIC was conducted using individual patient-level data (IPD) from prespecified pooled KALOS/LOGOS trial data (BUD/GLY/FORM; FEV1, n=2259; exacerbations, n=2353), and aggregated data from TRIMARAN (n=1150) with MD-ICS/LABA as common comparator. In line with ISPOR, Cochrane, NICE TSD 18, and JCA guidance, analyses were adjusted for clinically relevant treatment effect modifiers (TEMs), determined by expert clinical input. KALOS/LOGOS IPD were reweighted to match TRIMARAN baseline characteristics including lung function (relevant FEV1); age, biomarkers and exacerbation history (relevant FEV1 TEMs), in addition to prior treatment and former smoking (relevant exacerbation rate TEMs). Covariate balance was confirmed post-weighting, and effective sample size (ESS) was used to gauge precision loss and population overlap.
RESULTS: After adjustment, ESS decreased to n=983 (FEV1) and n=614 (exacerbations). No statistically significant difference in lung function was observed between treatments following adjustment. Adjusted mean difference in trough FEV1 between BUD/GLY/FORM and BDP/GLY/FORM was 21.32 mL (95% CI; -37.96, 80.61). Similarly, no statistically significant difference in severe exacerbation rate was observed between treatments following adjustment, with an anchored MAIC estimated rate ratio of 0.99 (95% CI; 0.64, 1.52).
CONCLUSIONS: Anchored MAIC analysis showed no significant differences between BUD/GLY/FORM and BDP/GLY/FORM in improving lung function or reducing severe exacerbations. Consistent findings suggest comparable efficacy between treatments, providing comparative evidence to inform clinical and payer decision-making in the absence of head-to-head trials.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO134
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy
Disease
Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)