Dupixent®（dupilumab）为哮喘患者带来长达三年的肺功能持续改善

Regeneron and Sanofi announced results from a Phase 3 open-label extension trial of Dupixent® (dupilumab), finding that the previously observed safety and efficacy of Dupixent were maintained for up to three years in adults and adolescents with moderate to severe asthma.

Dupixent is the only biologic to demonstrate sustained improvements in lung function and asthma exacerbations in patients with widespread type 2 inflammation Michael Wexler said: "These data show that Dupixent slows the progressive decline in lung function in many patients with moderate to severe asthma who continue to improve lung function for up to three years. Additionally, patients treated with Dupixent maintained asthma control and reduced the incidence of severe asthma attacks that could lead to hospitalization. This reinforces the importance of Dupixent as a long-term treatment option to improve patients' ability to breathe and maintain asthma control, particularly in those with underlying markers of type 2 inflammation."

The analysis conducted at ERS included more than 2,200 patients who had previously participated in Dupixent's asthma trials, including three pivotal trials conducted between weeks 24 and 52. Patients entered the extension trial after completing active treatment or placebo in the initial trial and were treated for up to two years, providing a total of up to three years of treatment data. Safety analyzes included patients from all three pivotal asthma trials, while efficacy and biomarker analyzes included patients on oral corticosteroids (OCS) independent of the pivotal Phase 2b and Phase 3 QUEST trials. Additional long-term efficacy data in OCS-dependent patients will be presented at a future conference.

The results show:

Efficacy:

Lung function improvement: Patients continued to experience a 13-22% improvement in lung function at 96 weeks, as measured by the average change in mean expiratory volume in one second (FEV 1) compared with baseline in the initial asthma trial.

Asthma exacerbations: Patients maintained a low rate of severe asthma exacerbations (unadjusted severe exacerbation rate), averaging 0.31-0.35 events per year. In the year before starting the Dupixent trial, the annual rate of severe asthma exacerbations was 2.09 to 2.17 events.

Type 2 inflammation: Improvements in lung function and asthma exacerbations were greater among patients with elevated markers of type 2 inflammation at baseline. Among these long-term results, patients in the pivotal Phase 2b trial had reduced blood eosinophils (23-35%) and reduced blood IgE (82%) compared with baseline in the initial asthma trial.

Security:

The proportion of patients experiencing adverse events (AEs) in the open-label extension trial was similar to that previously seen in Dupixent's pivotal asthma trials. Over the 96-week treatment period, the overall AE rate was 76-88%, with the most common AEs being nasopharyngitis (18-26%) and injection site erythema (2-23%). Serious AEs were experienced by 9-13% of patients.

Dupixent is a fully human monoclonal antibody that inhibits signaling by the interleukin 4 (IL-4) and interleukin 13 (IL-13) proteins. Data from Dupixent clinical trials indicate that IL-4 and IL-13 are key drivers of type 2 inflammation and play a major role in asthma, chronic rhinosinusitis, nasal polyposis (CRSwNP) and atopic dermatitis. More than 170,000 patients have been treated with Dupixent across all approved indications globally.

https://news.yahoo.com/dupixent-dupilumab-long-term-data-045900394.html