Dupilumab Shows Promise as First Biologic Treatment for Adolescents with Moderate-to-Severe Atopic Dermatitis
Dupilumab (Dupixent) significantly improved disease severity in patients aged 12 to 17 years with moderate-to-severe atopic dermatitis.
Dupilumab (Dupixent) made headway as the first and only biologic treatment for moderate-to-severe atopic dermatitis in adolescents following the latest results from a phase 3 study, Sanofi Genzyme announced in a press release.
In the trial, treatment with dupilumab as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, and certain health-related quality of life measures in patients aged 12 to 17 years over a 16-week period. The drug met its primary and key secondary endpoints, making it the first biologic to show positive results in this patient population.
The trial enrolled 251 patients who were aged 12 to 17 years with moderate-to-severe atopic dermatitis whose disease could not be adequately controlled with topical medication or for whom topical treatment was medically inadvisable. The primary endpoint was the proportion of patients with an Investigator’s Global Assessment score of 0 or 1 at week 16.
The patients were randomized into 1 of 3 treatment groups: the first group was treated with dupilumab subcutaneous injection 200 mg or 300 mg every 2 weeks, the second group was treated with 300 mg dupilumab every 4 weeks with an initial dose of 600 mg, and the third group was treated with placebo every 2 weeks.
Ninety-two percent of patients in the trial had at least 1 concurrent allergic condition, such as allergic rhinitis, asthma, or food allergy.
According to the results:
- 24% of patients who received weight-based dosing of dupilumab every 2 weeks (200 mg or 300 mg) and 18% of patients who received a fixed dose of dupilumab every 4 weeks (300 mg) achieved the primary endpoint of clear or almost-clear skin, compared with 2% with placebo.
- 41.5% of patients who received dupilumab every 2 weeks and 38% of patients who received dupilumab every 4 weeks achieved 75% or greater skin improvement compared with 8% with placebo.
- There was a 66% improvement in the group that received dupilumab every 2 weeks and a 65% improvement in the group that received dupilumab every 4 weeks in average percent change from baseline Eczema Area and Severity Index score compared with a 24% improvement in the placebo group.
- There was a 48% improvement in the group that received dupilumab every 2 weeks and a 45.5% improvement in the group that received dupilumab every 4 weeks in average percent change baseline in the pruritus numerical rating scale compared with a 19% improvement in the placebo group.
“Moderate-to-severe atopic dermatitis can place a particularly significant burden on adolescents who have to deal with oozing skin lesions with unrelenting, intense itching during their formative years,” George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said in the press release. “Dupixent blocks the IL-4/IL-13 pathway which is emerging as a central driver of type 2 allergic inflammation.”
In 2016, the FDA granted breakthrough therapy designation for dupilumab for this indication. According the press release, data from the phase 3 trial will be submitted to regulatory authorities later this year.
Dupilumab is being jointly developed by Sanofi and Regeneron.
Dupixent® (dupilumab) showed positive Phase 3 results in adolescents with inadequately controlled moderate-to-severe atopic dermatitis [news release]. Sanofi Genzyme’s website. http://news.genzyme.com/press-release/dupixent-dupilumab-showed-positive-phase-3-results-adolescents-inadequately-controlled. Accessed May 16, 2018.