ERS: Dupixent data reinforce clinically meaningful benefit from pooled analysis of two COPD phase 3 studies
September 10, 2024 – Clinical Trials, Drug Delivery, Pharmaceutical – COPD, Sanofi, clinical trials, lung function
- Pooled results from the BOREAS and NOTUS studies show meaningful clinical benefit with 31% reduction in exacerbations along with lung function improvement
- Data from these two phase 3 studies supported Dupixent as the first-ever biologic approved for certain patients with uncontrolled COPD in the EU.
10 September 2024 — Paris, France — A pooled analysis from the BOREAS and NOTUS phase 3 studies showed that Dupixent reduced exacerbations and improved lung function compared to placebo in adults with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation (i.e., raised blood eosinophils). The results were presented today, in collaboration with Regeneron, for the first time at the 2024 European Respiratory Society (ERS) International Congress.
The European Medicines Agency was the first regulatory authority in the world to approve Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Dupixent has also been approved by ANVISA (the Brazilian health regulatory agency) and the Russian Ministry of Health for certain adults with uncontrolled
COPD associated with type 2 inflammation. Regulatory submissions are under review with other authorities around the world, including in the US, China, and Japan.
Surya Bhatt, M.D., MSPH, Professor at the University of Alabama at Birmingham, US, Division of Pulmonary, Allergy, and Critical Care Medicine, and a co-principal investigator of the study “For far too long, I have watched patients with uncontrolled COPD struggle with a relentless cycle of exacerbations that diminish lung function, with no new treatment approaches to help alleviate this downward spiral. The pooled analysis of the pivotal BOREAS and NOTUS phase 3 studies provide more comprehensive examination of the unprecedented efficacy and safety data, which reinforce the benefit of dupilumab for patients on maximal inhaled therapy and limited additional options.”
As presented, this pooled analysis reinforces previous positive results from the BOREAS and NOTUS phase 3 studies. All patients were on background maximal standard-of-care inhaled therapy (with nearly all on triple therapy). Dupixent patients (n=938) achieved the following compared to placebo (n=936):
- 31% reduction in the annualized rate of moderate or severe COPD exacerbations over
52 weeks (nominal p<0.0001). - Improvement in lung function (pre-bronchodilator FEV1) from baseline by 147 mL
compared to 64 mL at 12 weeks (nominal p<0.0001). These improvements were
observed as early as two weeks and sustained at 52 weeks (nominal p<0.0001).
Safety results in this pooled analysis were generally consistent with the known safety profile of Dupixent in its approved indications. Overall rates of adverse events (AEs) were 72% for Dupixent and 71% for placebo. AEs more commonly observed with Dupixent than placebo included nasopharyngitis (7.8% Dupixent, 7.4% placebo) and headache (7.8% Dupixent, 6.6% placebo). AEs leading to deaths were 2% for Dupixent and 1.6% for placebo. The potential use of Dupixent and its safety and efficacy in COPD have not been fully evaluated by any regulatory authorities outside of the EU, Brazil, and Russia.
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