Background: Patients with asthma often experience sleep disturbances, which can be associated with poor asthma control. This post hoc analysis used a composite criteria based on validated patient-reported outcomes to identify patients with HSD. Efficacy of dupilumab vs placebo in improving sleep quality and other clinical/patient-reported outcomes in patients with uncontrolled, moderate-to-severe asthma with elevated type 2 biomarkers, 5-item asthma control questionnaire (ACQ-5) scores ≥2.5, and high sleep disturbance (HSD), at baseline of phase 3 QUEST (NCT02414854) is reported.

Methods: Composite criteria included sleep-related items from the ACQ-5, Asthma Quality-of-Life Questionnaire (AQLQ), Rhino-conjunctivitis Quality-of-Life questionnaire (RQLQ), and 22-item Sino-Nasal Outcome Test (SNOT-22) and was based on patient response to at least one of these items: ACQ-5 (item #1 ≥“several times”), AQLQ (item #5 ≥“very limited”), AQLQ (items #24 or #29 ≥“a good bit of the time”), RQLQ (items #4, #5, or #6 ≥“moderately troubled”), SNOT-22 (items #13, #14, #15, or #16 ≥“moderate problems”). Patients meeting ≥1 criterion were identified as having HSD. Efficacy was assessed in patients treated with dupilumab (200/300 mg every 2 weeks combined) vs combined placebo for 52 weeks.

Results: In the ITT population, 497/775 (64%) of patients with type 2 asthma had HSD. HSD was more prevalent among patients with type 2 asthma with ACQ-5 ≥2.5 vs <2.5 at baseline (82% vs 41%; P<0.0001). In patients with type 2 asthma, HSD, and ACQ-5 ≥2.5 (n=362), dupilumab improved night-time symptom scores vs placebo by a least squares mean difference of 0.31 point, ACQ-5 scores by 0.57 point, and AQLQ by 0.50 point (all P<0.001). Dupilumab also reduced the annualized severe exacerbation rate by 66% vs placebo.

Conclusion: In patients with type 2 asthma, ACQ ≥2.5, and HSD, dupilumab significantly reduced night-time symptoms and exacerbations, and improved overall asthma control and health-related quality of life.