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Dupixent shows efficacy in treating atopic dermatitis
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Adults with atopic dermatitis who were treated with Dupixent in two identical phase 3 trials experienced improvement in severity of disease and in symptoms including pruritus, anxiety and depression, according to study results recently published in The New England Journal of Medicine.
“These results support a growing body of evident for Dupixent as a potential new treatment option for patients with moderate-to-severe atopic dermatitis who are struggling to control their disease,” researcher Eric L. Simpson, MD, MCR, Oregon Health and Science University, stated in a press release form Sanofi and Regeneron Pharmaceuticals. “These … clinical trials are the first large pivotal studies where a systemic investigational therapy has demonstrated significant reduction in the signs and symptoms of atopic dermatitis, and showed improvement in studied quality of life measures.”
Simpson also presented the research at the European Academy of Dermatology and Venereology Congress in Vienna in conjunction with the publication of the study.
Simpson and colleagues enrolled 1,379 adults with moderate-to-severe atopic dermatitis whose disease was inadequately controlled by topical treatment in two phase 3 trials. There were 671 patients enrolled in the SOLO 1 trial and 708 patients enrolled in the SOLO 2 trial.
Patients were randomly assigned to subcutaneous 300 mg Dupixent (dupilumab; Regeneron Pharmaceuticals, Sanofi) or placebo weekly, or a same dosage of dupilumab every other week alternating with placebo for 16 weeks. An Investigator’s Global Assessment score of 0 or 1 (clear or almost clear), and a reduction of 2 points or more from baseline score were the primary outcomes. Dupilumab is an investigational human monoclonal antibody against interleukin-4 receptor alpha.
In the SOLO 1 study, 38% of patients who received dupilumab every other week and 37% of those who received dupilumab weekly achieved the primary outcome, compared with 10% of the placebo-treated cohort (P < .001 for both comparisons). In the SOLO 2 study, 36% of patients who received dupilumab every other week and 36% who received the drug weekly achieved the primary endpoint, compared with 8% of the placebo cohort (P < .001 for both comparisons).
Improvement from baseline of at least 75% on the Eczema Area and Severity Index was reported in both trials in significantly more patients in both dupilumab dosage cohorts compared with the placebo cohort (P < .001, all comparisons).
Reduction in patient-reported symptoms, including pruritus, anxiety and depression symptoms, and improvement in quality of life, secondary endpoints, were associated with dupilumab treatment.
Adverse events incidence was similar in the dupilumab-treatment cohorts and the placebo cohort in both studies. Exacerbations of atopic dermatitis, injection-site reactions and nasopharyngitis were the most common adverse events. – by Bruce Thiel
Disclosure: The study was supported by Sanofi and Regeneron Pharmaceuticals. Simpson reports personal fees and other support from Regeneron, both during the conduct of the study and outside the submitted work. Please see the full study for other researchers’ relevant financial disclosures.