#New england journal of medicine trial#

Numerical improvements were observed as early as 2 weeks, with the benefit versus placebo sustained through 52 weeks (Dupixent: 153 mL, placebo: 70 mL p<0.001).ĩ.7-point improvement in health-related quality of life (QoL patient-reported outcome on a scale from 0-100) from baseline at 52 weeks versus a 6.4-point improvement (p=0.002), with numerical improvements observed as early as 4 weeks.Ģ.7-point reduction in respiratory symptom severity (patient-reported outcome on a scale from 0-40) from baseline at 52 weeks versus a 1.6-point reduction (p=0.001). As presented and published, patients receiving Dupixent (n=468) compared to placebo (n=471) added to maximal standard-of-care inhaled triple therapy experienced a:ģ0% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p<0.001), the primary endpoint.ġ60 mL improvement in lung function from baseline at 12 weeks versus 77 mL (p<0.001).

The results presented at ATS and published in NEJM are from the BOREAS trial, which met the primary and all key secondary endpoints. alone, approximately 300,000 people live with uncontrolled COPD with evidence of type 2 inflammation.

Smoking and exposure to noxious particles are key risk factors for COPD, but even individuals who quit smoking can still develop or continue having the disease. COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to hospitalization or even death. Symptoms include persistent cough and breathlessness that may not only impair the ability to perform routine daily activities, but can also lead to anxiety, depression and sleep disturbances. Dupilumab also helped improve health-related quality of life measures, which, from my years of experience as a physician, are just as meaningful for patients as being able to breathe easier.”ĬOPD is a life-threatening respiratory disease that damages the lungs and causes progressive lung function decline.

#New england journal of medicine trial#

“This trial showed that dupilumab has the potential to impact the vicious cycle of exacerbations and lung function decline in patients with uncontrolled COPD with type 2 inflammation, and significantly improve respiratory symptoms. “I've seen patients with uncontrolled chronic obstructive pulmonary disease struggle for far too long with the debilitating symptoms of this progressive disease – with limited, incremental improvement on current treatment options,” said Surya Bhatt, M.D., MSPH, Associate Professor at the University of Alabama at Birmingham Division of Pulmonary, Allergy, and Critical Care Medicine, and a co-principal investigator of the trial. These results will also be presented in the “Breaking News: Clinical Trial Results in Pulmonary Medicine” session on May 22. Discussion on the Edge: Reports of Recently Published Pulmonary Research” and simultaneously published in the New England Journal of Medicine ( NEJM). The Dupixent Phase 3 results were presented in the 2023 American Thoracic Society (ATS) International Conference session “New England Journal of Medicine and JAMA. (NASDAQ: REGN) and Sanofi today presented positive Phase 3 results evaluating the investigational use of Dupixent ® (dupilumab) compared to placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation. and PARIS, (GLOBE NEWSWIRE) - Regeneron Pharmaceuticals, Inc. Dupixent is the first and only investigational biologic for COPD that has demonstrated a significant reduction in moderate or severe acute exacerbations by 30% compared to placeboĭupixent is the first and only investigational biologic for COPD that has significantly improved lung function at 12 and 52 weeks, with numerical improvements seen as early as 2 weeksĭupixent significantly improved quality of life, with numerical improvements as early as 4 weeks after initiating treatment, and respiratory symptomsĬOPD is the third leading cause of death worldwide, with no new treatment approaches approved in more than a decade trial enrolled patients with moderate-to-severe disease and evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells/µL)