Dupilumab Improves Health-Related Quality of Life in Patients with Chronic Obstructive Pulmonary Disease and Type 2 Inflammation: Pooled Boreas and Notus Results

Purpose: Impaired quality of life contributes significantly to morbidity in chronic obstructive pulmonary disease (COPD). St. George’s Respiratory Questionnaire (SGRQ) is a patient-reported outcome measure of health-related quality of life (HRQoL) in respiratory disease.

Methods: BOREAS (NCT03930732) and NOTUS (NCT04456673) were phase 3, randomized trials of efficacy and safety of subcutaneous add-on dupilumab 300 mg or placebo q2w in patients with COPD and type 2 inflammation (screening blood eosinophils≥300 cells/µL), with moderate-to-severe airflow limitation, on triple therapy. Data from the primary analysis population of both trials was pooled. Endpoints were change from baseline in SGRQ total score (range 0 – 100, lower scores indicate a better quality of life) and individual domain scores (symptoms, impacts, activity) at Week 52.

Results: Participants were randomized to placebo (n=830) or dupilumab (n=830). The mean baseline (standard deviation [SD]) SGRQ total score was 50.3 (17.2) for dupilumab and 49.5 (17.2) for placebo. Mean symptoms domain scores were 59.3 (20.2) vs 58.6 (20.9), mean activity scores 66.3 (19.1) vs 65.8 (18.9) and mean impact domain scores 38.2 (19.9) vs 37.3 (19.6) for dupilumab and placebo respectively. At Week 52, the least-squares mean difference vs placebo, -3.366 [95% CI, -4.953 to -1.778]; nominal P<0.0001). Similar improvements were observed for individual SGRQ domain mean scores at Week 52; mean symptoms domain score least-squares mean difference vs placebo for the change from baseline to week 52 (-3.502 [95% CI, -5.487 to -1.518]; nominal P=0.0006); mean activity domain score least-squares mean difference vs placebo for the change from baseline to week 52 -3.997 [95% CI, -5.916 to -2.079]; nominal P=<.0001; and mean impact domain score-squares mean difference vs placebo for the change from baseline to week 52 -2.870 [95% CI, -4.608 to -1.132]; nominal P=0.0012).

Conclusions: In pooled analysis of 2 phase 3 clinical trials of patients with COPD and type 2 inflammation, dupilumab improved HRQoL as measured by the SGRQ in the total score and all domains as compared to placebo. Impairment in HRQoL is a significant contributor to morbidity in COPD. These data demonstrate that dupilumab improves HRQoL, as measured by the SGRQ, in patients with COPD and type 2 inflammation.

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Artikel online veröffentlicht:
18. März 2025