Comparative Efficacy of Beclomethasone/Formoterol/Glycopyrronium (BDP/FOR/GLY) Vs Budesonide/Glycopyrrolate/Formoterol (BUD/GLY/FOR): Indirect Comparison in Chinese Patients with Chronic Obstructive Pulmonary Disease

Speaker(s)

Orlovic M1, Tzelis D2, Mantopoulos T3, Punekar Y4, Spalding C5, Scott M5, Zhang R6, Xu F6, Madoni A7
1Chiesi Farmaceutici Spa, Parma, PR, Italy, 2IQVIA Ltd, Athens, A1, Greece, 3IQVIA Ltd, Athens, ATTICA, Greece, 4IQVIA, London, London, UK, 5FIECON Ltd, London, LON, UK, 6Chiesi Pharmaceutical Co., Ltd, Shanghai, Shanghai, China, 7Chiesi Farmaceutici Spa, PARMA, PR, Italy

Presentation Documents

OBJECTIVES: Although the comparative efficacy of single-inhaler triple therapies (SITT) in patients with chronic obstructive pulmonary disease (COPD) has been demonstrated, the comparative efficacy between SITTs in the Chinese COPD patient subgroup remains unclear. This study performed an indirect treatment comparison (ITC) of the efficacy of the extrafine SITT with beclomethasone/formoterol/glycopyrronium bromide (BDP/FOR/GLY) versus budesonide/glycopyrrolate/formoterol (BUD/GLY/FOR) for the Chinese COPD patient subgroup.

METHODS: The ITC was based on a systematic literature review that identified randomized control trials (RCT) for BDP/FOR/GLY and BUD/GLY/FOR in patients with COPD. Bucher ITCs were performed on studies reporting results for the COPD Chinese patient subgroup on moderate-to-severe exacerbations, pneumonia patients, pneumonia events, mortality, and change from baseline (CFB) in forced expiratory volume in 1 second (FEV1) over 24 weeks. Rate ratios (RR) and mean differences (MD) along with their 95% confidence intervals (CI) were calculated.

RESULTS: Following assessment of trial design, baseline characteristics, and outcome measures, ITC was considered feasible using two phase three RCTs: the BDP/FOR/GLY TRIVERSYTI (NCT03197818) study, and the BUD/GLY/FOR KRONOS (NCT02497001) study.

In the COPD Chinese patient subgroup, BDP/FOR/GLY demonstrated numerical, but not statistically significant improvements vs BUD/GLY/FOR in moderate-to-severe exacerbations (RR: 0.575 [0.247, 1.336]), and pneumonia (pneumonia patients RR: 0.753 [0.086, 6.599]; pneumonia events RR: 0.942 [0.112, 7.888]). ITC results demonstrated that BDP/FOR/GLY had higher incidence than BUD/GLY/FOR in mortality (RR: 1.977 [0.039, 99.651]) due to no deaths reported in the KRONOS study, which required continuity correction. BDP/FOR/GLY was also associated with a lower CFB in FEV1 vs BUD/GLY/FOR (MD: -5ml [-55.351, 45.351]), but CIs did not cross the clinically important difference of 100ml, suggesting non-inferiority of BDP/FOR/GLY.

CONCLUSIONS: Despite the inherent limitations of ITCs and uncertainty in results, this study demonstrated that BDP/FOR/GLY resulted in greater, but not statistically significant improvements in patient-centered COPD outcomes versus BUD/GLY/FOR.

Code

EE253

Topic

Study Approaches

Topic Subcategory

Meta-Analysis & Indirect Comparisons

Disease

No Additional Disease & Conditions/Specialized Treatment Areas, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)