Is Clinical Remission, an Ambitious Treatment Goal, Achievable in Patients with Moderate-to-Severe Asthma on Inhaled...

Background/Objectives: Clinical remission (CR) is an ambitious and attainable treatment goal for asthma; however, CR definitions vary. Evidence of CR in Japanese patients with moderate-to-severe asthma on inhaled therapies is lacking and was evaluated based on three guideline definitions: the United States Workgroup consensus statement, Japanese Guidelines for adult asthma (JGL), and Practical Guidelines for Asthma Management (PGAM). Methods: Post hoc analysis of Phase III studies including Japanese participants: Japanese subpopulation of CAPTAIN (NCT02924688) and a 52-week Japanese long-term safety study (NCT03184987). CAPTAIN randomized participants to once-daily fluticasone furoate/vilanterol (FF/VI) regimens ± umeclidinium (UMEC). The long-term safety study allocated participants to once-daily FF/UMEC/VI based on asthma control status. All three CR definitions assessed systemic corticosteroid use, severe exacerbations, and asthma control (Asthma Control Questionnaire-5 <1.5 [Workgroup] or ≤0.75 [JGL/PGAM]); Workgroup and JGL also assessed lung function (change from baseline in trough forced expiratory volume in 1 s of ≥0 [stabilized] or ≥100 mL [optimized]). Results: CR attainability varied on definition and thresholds used. At Week 24 in the CAPTAIN Japanese subpopulation, 34-59% and 18-45% of participants (Workgroup; stabilized and optimized), and 21-34% and 8-24% (JGL; stabilized and optimized) met CR criteria across treatment arms. At Week 52 in the long-term safety study, equivalent figures for CR achievement were 33-60%, 22-45%, 11-28%, and 11-23%. Conclusions: This analysis demonstrates that CR, using different definitions and criteria, is an attainable treatment goal with inhaled therapy in Japanese patients with moderate-to-severe asthma not yet eligible for biologics.