Treatment with dupilumab improved quality of life in patients with moderate-to-severe chronic obstructive pulmonary disease and type 2 inflammation: Phase 3 BOREAS trial

Abstract

Prérequis/Contexte

Chronic obstructive pulmonary disease (COPD) significantly impacts a patient's quality of life across physical, emotional, and social aspects. Dupilumab, a human monoclonal antibody, blocks interleukin 4/13 signaling, key and central driver of type 2 inflammation. In BOREAS, dupilumab reduced exacerbation events and improved lung function in patients with COPD and type 2 inflammation. Safety was consistent with the known dupilumab safety profile.

Objectifs

Here, we evaluated the effect of dupilumab on patients’ quality of life in BOREAS.

Méthodes

In phase 3 BOREAS (NCT03930732), patients with COPD, moderate-to-severe airflow limitation, and type 2 inflammation (screening blood eosinophils ≥ 300 cells/μL), on triple therapy, received add-on dupilumab 300 mg every 2 weeks or placebo for 52 weeks. St. George's Respiratory Questionnaire (SGRQ) total and domain scores (activity, symptoms, and impact) were assessed at baseline and Week 52.

Résultats/Discussions

At baseline, mean (standard deviation [SD]) SGRQ total scores were 48.4 (17.0) (dupilumab: n = 468) and 48.4 (17.8) points (placebo: n = 471). For SGRQ domains, baseline scores were 65.1 (19.2) and 64.1 (19.4) (activity), 56.1 (21.0) and 56.6 (21.5) (symptoms), and 36.4 (19.5) and 36.8 (20.2) (impact) for dupilumab and placebo, respectively. At Week 52, dupilumab vs. placebo reduced SGRQ scores as follows: total 38.5 (19.0) vs. 42.1 (18.5), activity 54.3 (23.2) vs. 58.9 (22.0), symptoms 43.5 (24.5) vs. 47.3 (24.4), and impact 27.8 (19.5) vs. 30.6 (19.6). Change from baseline to Week 52 in SGRQ total score was significantly greater with dupilumab vs. placebo (least squares mean difference vs. placebo − 3.4 [95% CI: −5.4, −1.3]; P = 0.0017) and nominally significant across all domains, including activity (−4.6 [−7.2, −2.0]; P = 0.0005), symptoms (−3.4 [−6.0, −0.7]; P = 0.0121), and impact (−2.6 [−4.8, −0.3]; P = 0.0242).

Conclusion

In patients with moderate-to-severe COPD and type 2 inflammation, dupilumab significantly improved quality of life over the 52-week treatment period as measured by SGRQ total and domain scores.