A recent study showed dupilumab (Dupixent) was safe and effective for adolescent patients with moderate to severe atopic dermatitis (AD).
The randomized, double-blind phase 3 clinical trial included 251 adolescent participants with moderate to severe AD inadequately controlled by topical medications or whom topical therapy was contraindicated (mean age 14.5 years; 148 were male). For 16 weeks, participants were randomized to either 200 mg or 300 mg of dupilumab based on weight every 2 weeks (n=43, baseline weight less than 60 kg; n=39, baseline weight 60 kg or more, respectively), 300 mg dupilumab every 4 weeks (n=84), or placebo (n=85).
Primary co-endpoints included the proportion of patients with 75% or more improvement from baseline Eczema Area and Severity Index (EASI 75) and Investigator Global Assessment (IGA) 0 or 1 at week 16.
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Of 250 participants with data on concurrent allergic conditions, 53.6% had asthma, 60.8% had food allergies, and 65.6% had allergic rhinitis. A total of 240 participants completed the study.
Dupilumab showed significant treatment response compared with placebo at both 200 mg and 300 mg doses every 2 weeks and 300 mg every 4 weeks. “The proportion of patients with EASI-75 improvement from baseline increased (every 2 weeks, 41.5%; every 4 weeks, 38.1%; placebo, 8.2%) with differences vs placebo of 33.2% (95% CI, 21.1%-45.4%) for every 2 weeks and 29.9% (95% CI, 17.9%-41.8%) for every 4 weeks (P < .001),” the researchers said. In addition, the every-3-week regimen was found to be superior to the every-4-week regimen.
More participants treated with dupilumab developed conjunctivitis (9.8% every 2 week; 10.8% every 4 weeks; 4.7% in placebo), as well as injection site reactions (every 2 weeks, 8.5%; every 4 weeks, 6.0%; placebo, 3.5%) and nonherpetic skin infections (every 2 weeks, 9.8%; every 4 weeks, 9.6%; placebo, 18.8%).
“In this study, dupilumab significantly improved AD signs, symptoms, and quality of life in adolescents with moderate to severe AD, with an acceptable safety profile,” the researchers concluded. “Placebo-corrected efficacy and safety of dupilumab were similar in adolescents and adults.”
Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: A phase 3 randomized clinical trial [published online November 06, 2019]. JAMA Dermatol. doi:10.1001/jamadermatol.2019.3336