Pooled analysis reveals health-related quality of life improvements with dupilumab in COPD
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Key takeaways:
- Researchers measured health-related quality of life changes via the St. George’s Respiratory Questionnaire (SGRQ).
- Patients receiving dupilumab vs. placebo had more improvement in baseline SGRQ total score.
BOSTON — Receiving dupilumab for 52 weeks led to health-related quality of life improvement in adults with COPD and type 2 inflammation, according to a pooled analysis of BOREAS and NOTUS presented at the CHEST Annual Meeting.
As Healio previously reported, outcomes from the multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 NOTUS study confirmed findings from the multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 BOREAS study.
Both studies assessed current/former smokers with moderate to severe COPD and type 2 inflammation (blood eosinophil count ≥ 300 cells/μL) primarily receiving background and stable triple therapy to see if 300 mg dupilumab every 2 weeks decreased the annual exacerbation rate over 52 weeks.
Pooling data from the BOREAS and NOTUS studies, Surya P. Bhatt, MD, professor in the division of pulmonary, allergy and critical care medicine at The University of Alabama at Birmingham, and colleagues evaluated 1,660 adults with moderate to severe COPD and type 2 inflammation who were current or former smokers to find out the impact of dupilumab on health-related quality of life via four St. George’s Respiratory Questionnaire (SGRQ) scores in a larger population.
Researchers previously presented the impact of dupilumab on exacerbations and lung function vs. placebo in the pooled analysis, as well as the drug’s safety profile at this year’s European Respiratory Society International Congress.
At randomization, 830 patients received dupilumab and 830 patients received placebo.
At baseline, both groups had similar mean scores for each of the assessed SGRQ scores: total score (dupilumab, 50.3 vs. placebo, 49.5), symptoms domain score (59.3 vs. 58.6), activity domain score (66.3 vs. 65.8) and impact domain score (38.2 vs. 37.3).
Compared with patients receiving placebo, patients receiving dupilumab had more improvement in baseline SGRQ total score at the 52-week mark (least-squares mean difference, –3.366 points; 95% CI, –4.953 to –1.778; nominal P < .0001).
Researchers noted that this pattern held true when assessing changes in baseline SGRQ symptoms domain scores, with larger improvements with dupilumab vs. placebo at week 52 (least-squares mean difference, –3.502 points; 95% CI, –5.487 to –1.518; nominal P = .0006).
The dupilumab group also had improvements to a greater degree in the SGRQ activity domain score vs. the placebo group (least-squares mean difference, –3.997 points; 95% CI, –5.916 to –2.079; nominal P < .0001), as well as in the SGRQ impact domain score (least-squares mean difference, –2.87 points; 95% CI, –4.608 to –1.132; nominal P = .0012), according to the abstract.
Notably, the FDA recently granted approval to dupilumab for treating adults with poorly controlled COPD with type 2 inflammation.
“Patients with frequent exacerbations have a high symptom burden between exacerbation events and often have a poor quality of life,” Bhatt told Healio. “This is despite optimal inhaled controller therapy.
“We now have an additional drug to target these patients with, especially those with high type 2 inflammation,” Bhatt continued. “In addition to decreasing exacerbations, the added effects on lung function, daily symptoms and quality of life are certainly impactful and much needed.”
For more information:
Surya P. Bhatt, MD, can be reached at sbhatt@uabmc.edu.