The Food and Drug Administration (FDA) has approved Dupixent (dupilumab; Sanofi and Regeneron) as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).
The approval was based on data from two phase 3 randomized, double blind, placebo controlled trials (SINUS-24 and SINUS-52) that evaluated the safety and efficacy of Dupixent in patients with recurring severe CRSwNP despite previous treatment with surgery and/or systemic corticosteroids (N=724). More than half of these patients (59%) had comorbid asthma.
Results showed that compared with placebo, patients treated with Dupixent had a statistically significant reduction in nasal polyp size (33% and 27% reduction with Dupixent vs 7% and 4% increase with placebo in SINUS-24 and SINUS-52, respectively) and nasal congestion (57% and 51% improvement in nasal congestion/obstruction severity vs 19% and 15% improvement with placebo in SINUS-24 and SINUS-52, respectively).
In addition, treatment with Dupixent significantly improved loss of smell and resulted in a significant reduction of systemic corticosteroid use and need for sino-nasal surgery (hazard ratio 0.24; 95% CI: 0.17–0.35), when compared with placebo. In patients with comorbid asthma, improvements in pre-bronchodilator FEV1 were found to be similar to those observed in patients from the Dupixent asthma program.
The most common adverse reactions reported in the CRSwNP trials included injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
Dupixent, an interleukin-4 receptor alpha antagonist, is already approved as an add-on maintenance treatment in patients with moderate to severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma. It is also indicated to treat moderate to severe atopic dermatitis in adults who are not adequately controlled with topical prescription therapies or when they are not advisable.
Dupixent is supplied in single-dose prefilled syringes in 300mg/2mL and 200mg/1.14mL dosage strengths. Treatment is administered by subcutaneous injection.
For more information visit dupixent.com.