Atopic dermatitis drug under development effective in phase 3 trial

Sanofi and Regeneron’s drug Dupixent led to clearer skin in most patients in phase 3 trial involving 12- to 17-year-olds with moderate-to-severe atopic dermatitis, according to a press release from the company.

"Current treatment options for these adolescent patients, such as topical steroids, oral steroids, and non-steroidal immunosuppressants, can have significant side effects," Elias Zerhouni, MD, and president of Sanofi’s global research and development division, said in a press release.

“Treatment with Dupixent as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, and certain health-related quality of life measures. Dupixent is the first and only biologic to show positive results in this patient population,” the company stated.

Results from the 16-week trial involving 251 patients included:

18% of patients who received a fixed dose of Dupixent (dupilumab; Sanofi, Regneron) every 4 weeks (300 mg), and 24% of patients who received weight-based dosing of dupilumab every 2 weeks (200 mg or 300 mg), achieved clear or almost-clear skin vs. 2% of those who received placebo as measured by the Investigator’s Global Assessment score;
38% of patients who received dupilumab every 4 weeks and 41.5% of patients who received dupilumab every 2 weeks saw 75% or greater skin improvement vs. 8% of those who received placebo as measured by the Eczema Area and Severity Index;
45.5% improvement in patients who received dupilumab every 4 weeks, and 48% improvement in patients who received dupilumab every 2 weeks, in the average percent change from baseline in the pruritus numerical rating scale vs. 19% of those who took placebo;
65% improvement in the dupilumab every 4 weeks group and 66% improvement in patients who received dupilumab every 2 weeks in average percent change from baseline vs. 24% improvement of those who received placebo as measured by the Eczema Area and Severity Index; and
Dupilumab recipient groups had comparable rates of adverse events such as injection-site reactions and conjunctivitis, but there were no serious adverse events or events that caused patients to stop taking dupilumab.

Dupilumab blocks the IL-4/IL-13 pathway which, according to the press release, is the “central driver” for type 2 allergic inflammation. Other potential uses for the drug include asthma, atopic dermatitis, COPD, eosinophilic esophagitis, food allergy and nasal polyps, according to Regeneron.

The companies plan present this and other phase 3 trial data to regulatory authorities later this year, the release stated.

Disclosures: Zerhouni works for Sanofi.