Dupilumab is the first investigational biologic to significantly improve lung function in COPD patients

Dupilumab (Dupixent; Sanofi) is the first and only investigational biologic to significantly improve lung function at 12 and 52 weeks and significantly reduce severe acute exacerbations compared with placebo in adults with chronic obstructive pulmonary disease (COPD), according to the authors. presented a positive Phase 3 best outcome at the 2023 American Thoracic Society (ATS) International Conference.

Inhaler technique counseling is essential to help patients with COPD get the most out of their therapy. Credit: peterschreiber.media – stock.adobe.com.

The results that were published in the New England Journal of Medicineshowed that dupilumab met the study\’s primary endpoint of the annual rate of acute moderate or severe COPD exacerbations. Specifically, the results showed that the treatment reduced exacerbations by 30% over 52 weeks.

\”I have seen patients with uncontrolled problems [COPD] struggle for too long with the debilitating symptoms of this progressive disease with limited and incremental improvements over current treatment options, said co-principal investigator Surya Bhatt, MD, MSPh, Birmingham Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama, in a recent press release.

COPD is a life-threatening respiratory disease that damages the lungs, leading to a decline in lung function that can lead to hospitalization or death. Estimates suggest that 300,000 people in the United States have uncontrolled COPD with evidence of type 2 inflammation.

Recurrent exacerbations, which include symptoms of dyspnea and persistent cough, are treated with systemic corticosteroids, and the disease is associated with a significant health and economic burden. Smoking can be a significant risk factor for COPD, and those who have quit are also at a higher risk. Investigators are currently conducting a COPD program evaluated in 2 clinical trials to evaluate dupilumab for patients with uncontrolled COPD who received standard of care (SoC).

BOREAS is the first of the tests; is a randomized, Phase 3, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of dupilumab in 939 adults who were smokers or ex-smokers with moderate to severe COPD and evidence (blood eosinophils of 300 cells/L) of type 2 inflammation. During the BOREAS study, 468 patients were randomized to the dupixent arm and 471 to the placebo arm.

For 52 weeks, patients received dupilumab or placebo every 2 weeks along with the maximal inhaled SoC triplet, which includes inhaled corticosteroids, long-acting beta agonists, and long-acting muscarinic antagonists.

Compared with placebo, dupilumab significantly reduced exacerbations at 52 weeks (30% reduction). Additionally, patients experienced improvement in lung function at 12 weeks from baseline, with improvement persisting at 52 weeks. Patients also experienced improvements in health-related quality of life at 4 weeks and a reduction in the severity of respiratory symptoms at 52 weeks.

Dupilumab has helped improve measures of health-related quality of life, which, from my years of experience as a physician, are as meaningful to patients as being able to breathe easier, Bhatt said in the news release.

The overall safety profile of dupilumab was consistent with previous findings; Seventy-seven percent of patients experienced adverse events (AEs), the most common including headache (8.1%), diarrhea (5.3%) and back pain (5.1%). Both dupilumab and placebo had similar adverse events leading to 1.7% and 1.5% death, respectively.

Dupilumab is a fully human monoclonal antibody that can inhibit the signaling pathways that drive type 2 inflammation. It is already approved in some countries for the treatment of atopic dermatitis and asthma, chronic rhinosinusitis with nasal polyposis, esophagitis eosinophilic and nodular prurigo.

This study demonstrated that dupilumab has the potential to influence the vicious cycle of exacerbations and lung function decline in uncontrolled COPD patients with type 2 inflammation and significantly improve respiratory symptoms, Bhatt said in the news release.

Reference

Sanofi. Press Release: Dupixent (dupilumab) Late Phase 3 COPD Results Presented at ATS and Simultaneously Published in the New England Journal of Medicine. Press release. May 21, 2023. Accessed May 23, 2023. https://www.sanofi.com/en/media-room/press-releases/2023/2023-05-21-18-17-12-2672904