PARIS — For adolescents with moderate to severe atopic dermatitis, dupilumab significantly improves the signs and symptoms of the disease, including itch, new data from a phase 3 study show.
And the drug, administered without topical steroids, was well tolerated in the study population, said Eric Simpson, MD, from Oregon Health and Sciences University in Portland.
"Currently, there are really limited treatment options for adolescents that have a nice safety and efficacy ratio over the long term," he said during a late-breaking abstract session here at the 27th European Academy of Dermatology and Venereology Congress.
Atopic dermatitis is common among adolescents. Prevalence in the United States is 8.6%, in many European countries is 5% to 10%, and in the United Kingdom is 10% to 15%, he reported.
Findings from the SOLO 1 and SOLO 2 trials showed that the reduction in the severity of atopic dermatitis in adults was significantly greater with the monoclonal antibody than with placebo, as reported by Medscape Medical News.
In their multisite, randomized, placebo-controlled, double-blind, parallel-group study, Simpson and his colleagues randomized 251 patients to one of three groups. Eighty-two participants received dupilumab injections — 200 mg or 300 mg, depending on weight — every 2 weeks, 84 received dupilumab injections every 4 weeks, and 85 received placebo.
Participants were 12 to 17 years of age (average, 14 years) and the average disease duration was 12 years, so "these patients had the disease basically their whole lives," Simpson said.
More than 40% of the cohort had previously been exposed to some kind of systemic therapy, most commonly systemic steroids.
Topical or systemic therapies for atopic dermatitis were only allowed as rescue treatments.
By week 16, more patients in the dupilumab groups than in the placebo group had achieved the two primary end points: an Investigator Global Assessment (IGA) score of 0 or 1, and an improvement of at least 75% in the Eczema Area and Severity Index score (EASI-75).
For both end points, treatment responses were higher in the 2-week and 4-week dosing groups than in the placebo group. For EASI-75, the differences between the dupilumab groups and the placebo group were significant.
|Table. Percent of Patients Who Achieved the Primary End Points|
|End Point||2-Week Dupilumab Group, %||4-Week Dupilumab Group, %||Placebo Group, %|
|IGA 0 or 1||24.4||17.9||2.4|
Rescue medications were used less often in the dupilumab groups than in the placebo group, and less often in the 2-week group than in the 4-week group.
The reduction in itch, which was statistically significant, was about 45%. In the SOLO trials of adults, the reduction was 36% to 41%, Simpson pointed out.
None of the adverse events related to treatment were serious or severe, and no patients in the dupilumab groups discontinued treatment. Rates of conjunctivitis, something seen in the adult trials, and injection-site reactions were higher in the dupilumab groups, but rates of atopic dermatitis flares and nonherpetic skin infections were higher in the placebo group.
"The results suggest very promising data in adolescents, as they were for the adults," said Dedee Murrell, MD, from St. George Hospital at the University of New South Wales in Australia.
When she asked Simpson if the data showed which areas of the body improved first, he explained that the team would be looking at that in a future analysis of the data.
This research was sponsored by Sanofi/Regeneron. Simpson has been an investigator and consultant for Sanofi/Regeneron. Murrell was an investigator for dupilumab in 2013, but was not associated with this study, and has been an advisory board member for Sanofi.
27th European Academy of Dermatology and Venereology (EADV) Congress: Abstract D3T01.1L. Presented September 15, 2018.
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Cite this: Dupilumab Effective in Teens With Moderate to Severe Eczema - Medscape - Sep 19, 2018.