Abstract Rationale Clinical remission is a recently recognized treatment goal in asthma management. In the phase 3 QUEST study (NCT02414854), dupilumab demonstrated significant efficacy in patients with type 2 asthma. This post hoc analysis evaluated whether achieving on-treatment clinical remission at QUEST Week 52 was associated with sustained clinical benefits through Week 48 of the open-label extension TRAVERSE (NCT02134028) study. Methods Patients with type 2 asthma (baseline blood eosinophil count ≥150 cells/μL or fractional exhaled nitric oxide ≥25 ppb) who completed QUEST and enrolled in TRAVERSE were included. In QUEST, patients received add-on dupilumab 200/300 mg or placebo q2w for 52 weeks. In TRAVERSE, those who received dupilumab in QUEST continued treatment (dupilumab-dupilumab), while those previously receiving placebo switched to dupilumab (placebo-dupilumab). Clinical remission was defined as achievement of 4 criteria at QUEST Week 52: 1) no severe exacerbations; 2) no oral corticosteroid use during the study period; 3) stable or improved pre-bronchodilator forced expiratory volume in 1 second (FEV₁; “stable” defined as ≤ 5% decline from QUEST baseline); and 4) 5-item Asthma Control Questionnaire (ACQ-5) score 1.5. Outcomes included the proportion of patients in remission, applying the same definition at TRAVERSE Week 48, annualized severe exacerbation rates, mean change in ACQ-5 score, and percent change in pre-bronchodilator FEV₁ from QUEST baseline, all stratified by QUEST Week 52 remission status. Results Patients in remission at QUEST Week 52 were more likely to remain in remission at TRAVERSE Week 48. In TRAVERSE, 76.9% (placebo-dupilumab) and 74.2% (dupilumab-dupilumab) of patients already in remission stayed in remission, compared with 44.8% (placebo-dupilumab) and 37.8% (dupilumab-dupilumab) of patients not in remission in QUEST who achieved remission at TRAVERSE Week 48 (Table). During TRAVERSE, annualized severe exacerbation rates were lower and ACQ-5 improvement was greater among patients who achieved remission in QUEST versus those who did not, although notable benefits were also seen in patients who didn’t achieve remission in QUEST (Table). Mean (SD) percent improvement in pre-bronchodilator FEV₁ from QUEST baseline to TRAVERSE Week 48 was greater in those who achieved remission at QUEST: 28.9% (26.7) (placebo-dupilumab) and 34.1% (40.1) (dupilumab-dupilumab) versus 24.2% (34.1) and 20.7% (33.4), respectively, in those who did not. Conclusion These findings support clinical remission as a durable and relevant treatment goal in type 2 asthma and reinforce the long-term benefits of achieving early disease control with dupilumab. This abstract is funded by: Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT02414854 and NCT02134028
Brusselle et al. (Fri,) studied this question.
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