Is Asthma Clinical Remission Achievable by Inhaled Therapy? A Post-Hoc Analysis of Single Inhaler Triple Therapy with FF/UMEC/VI in the CAPTAIN Trial

Introduction: The composite endpoint of clinical remission (CR) is a treatment goal for patients with asthma. It is currently unknown if CR is achievable in patients treated with inhaled therapy alone. This post-hoc analysis of the CAPTAIN Trial evaluated patients’ ability to achieve CR on FF/VI and FF/UMEC/VI. Methods: CAPTAIN, a phase IIIa RCT, investigated once-daily single-inhaler FF/UMEC/VI versus FF/VI in patients ≥18 years with uncontrolled moderate-to-severe asthma despite maintenance ICS/LABA. CR was defined as no systemic corticosteroid use, no severe exacerbations, ACQ-5 total score <1.5, and change from baseline in trough FEV₁ ≥100mL. CR was assessed at Weeks 24 and 52 for FF/UMEC/VI 100/62.5/25 or 200/62.5/25mcg versus FF/VI 100/25 or 200/25mcg. Odds/risk ratios (OR/RR; 95% CIs) were calculated for Week 24 data. Missing data/study withdrawals/lost-to-follow-up were considered non-responders. Results: At Week 24, 31%(127/406) and 36%(146/408) of patients receiving FF/UMEC/VI 100 or 200 achieved CR versus 19%(77/407) and 26%(104/406) receiving FF/VI 100 or 200; similar achievements were seen for patients with data at Week 52 (FF/UMEC/VI 100: 30%[27/91]; 200: 38%[35/91]; FF/VI 100: 21%[18/87]; 200: 24%[22/91]). Patients receiving FF/UMEC/VI 100 were more likely to achieve CR at Week 24 than those receiving FF/VI 100 (OR: 1.93[1.39, 2.68], p<0.001; RR: 1.65[1.29, 2.12], p<0.001), as was seen for FF/UMEC/VI 200 versus FF/VI 200 (OR: 1.62[1.19, 2.19], p=0.002; RR: 1.40[1.13, 1.72], p=0.002). All p-values are nominally statistically significant. Discussion: A greater proportion of patients with FF/UMEC/VI demonstrated CR than FF/VI. CR is a feasible treatment goal for patients with moderate-to-severe asthma receiving FF/UMEC/VI and FF/VI. Funding: GSK (205715; NCT02924688)