Characteristics of Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol or Other Triple Therapies in Japan: A Real-World Healthcare Claims Database Study (MITOS-AURA)

Introduction: In Japan, patients with chronic obstructive pulmonary disease (COPD) can be escalated to treatment with inhaled triple therapy. Two single-inhaler triple therapies combining an inhaled corticosteroid/long-acting muscarinic antagonist/long-acting beta 2-agonist (ICS/LAMA/LABA) are approved maintenance therapies for patients with COPD, and multiple-inhaler triple therapies (MITTs) are also available. There is limited evidence regarding real-life treatment patterns and characteristics of patients with COPD initiating triple therapies. Methods: This observational, retrospective cohort study identified patients with COPD in Japan from an administrative claims database (May 2018-December 2021). Demographics, clinical characteristics, and healthcare resource utilization (HCRU) were assessed in four cohorts initiating a triple therapy: budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) early adopters (initiated <= 12 months after market approval [September 1, 2019]), contemporary BGF users (initiated > 12 months after market approval), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) users, and any MITT users. Results: A total of 636 patients were BGF early adopters, 2558 were contemporary BGF users, 11,187 used FF/UMEC/VI, and 5931 used MITT. The percentage of patients with concomitant asthma in each cohort was 73.0%, BGF early adopter; 74.2%, contemporary BGF; 75.7%, FF/UMEC/VI; and 84.5%, MITT. During the 12-month baseline period, the frequency of patients with >= 1 moderate/severe exacerbation was 18.2%, BGF early adopter; 14.3%, contemporary BGF; 13.1%, FF/UMEC/VI; and 14.0%, MITT. ICS/LABA treatment during baseline was the most frequent pathway to triple therapy, ranging from 38.2% to 51.7% across cohorts. HCRU was relatively high across cohorts (range of hospital outpatient visits/patient during the 12-month baseline period, 11.0-14.1). Multimorbidity was observed in > 80% of patients in all cohorts; cardiovascular diseases were among the most common. Conclusion: Many patients initiating triple therapy for COPD had concomitant asthma and had previously received ICS/LABA maintenance therapy. Patients prescribed BGF in the initial post-launch period were more likely to have a previous exacerbation history versus other cohorts, indicating more severe disease. PLAIN LANGUAGE SUMMARY In Japan, single inhalers containing three medicines, known as single-inhaler triple therapies, are approved for people with chronic obstructive pulmonary disease (COPD). These inhalers include one medicine that reduces inflammation (a corticosteroid) and two medicines that expand the airways in the lung (bronchodilators). There are two approved single-inhaler triple therapies for long-term COPD treatment in Japan, consisting of active substances referred to as budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) or fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI). Although guidance is available to doctors on when to prescribe single-inhaler triple therapy, two important questions related to use in routine clinical practice remain: when are these medicines prescribed, and what types of patients receive them. To answer these questions, we assessed anonymized medical claims of people with COPD obtained from a large database in Japan. People with COPD who had used triple therapy were split into four groups: early BGF users (started treatment within 1-year of approval in Japan), contemporary BGF users (started treatment over 1-year after approval in Japan), FF/UMEC/VI users, and users of any multiple-inhaler triple therapy. Our findings showed that the majority of patients starting any triple therapy had diagnoses of both asthma and COPD, and multiple other medical conditions, including heart-related conditions. Healthcare use, including outpatient hospital clinic visits, was high across all groups before starting triple therapy. As early BGF users were more likely to have previous flare-ups (acute worsening of COPD symptoms) than the other groups, upon approval in Japan, doctors may have initially prescribed BGF to people with more severe COPD. [GRAPHICS] .