Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: A randomized, double-blinded, placebo-controlled phase 3 trial

Paller, Amy S.; Siegfried, Elaine C.; Thaci, Diamant; Wollenberg, Andreas; Cork, Michael J.; Arkwright, Peter D.; Gooderham, Melinda; Beck, Lisa A.; Boguniewicz, Mark; Sher, Lawrence; Weisman, Jamie; O'Malley, John T.; Patel, Naimish; Hardin, Megan; Graham, Neil M. H.; Ruddy, Marcella; Sun, Xian; Davis, John D.; Kamal, Mohamed A.; Khokhar, Faisal A.; Weinreich, David M.; Yancopoulos, George D.; Beazley, Bethany; Bansal, Ashish und Shumel, Brad (2020): Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: A randomized, double-blinded, placebo-controlled phase 3 trial. In: Journal of the American Academy of Dermatology, Bd. 83, Nr. 5: S. 1282-1293

Abstract

Background: Children with severe atopic dermatitis (AD) have limited treatment options. Objective: We report the efficacy and safety of dupilumab 1 topical corticosteroids (TCS) in children aged 6-11 years with severe AD inadequately controlled with topical therapies. Methods: In this double-blind, 16-week, phase 3 trial (NCT03345914), 367 patients were randomized 1:1:1 to 300 mg dupilumab every 4 weeks (300 mg q4w), a weight-based regimen of dupilumab every 2 weeks (100 mg q2w, baseline weight\ 30 kg;200 mg q2w, baseline weight >= 30 kg), or placebo;with concomitant medium-potency TCS. Results: Both the q4w and q2w dupilumab + TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QOL) versus placebo 1 TCS in all prespecified endpoints. For q4w, q2w, and placebo, 32.8%, 29.5%, and 11.4% of patients, respectively, achieved Investigator's Global Assessment scores of 0 or 1;69.7%, 67.2%, and 26.8% achieved >= 75% improvement in Eczema Area and Severity Index scores;and 50.8%, 58.3%, and 12.3% achieved >= 4-point reduction in worst itch score. Response to therapy was weight-dependent: optimal dupilumab doses for efficacy and safety were 300 mg q4w in children >= 30 kg and 200 mg q2w in children >= 30 kg. Conjunctivitis and injection-site reactions were more common with dupilumab + TCS than with placebo 1 TCS. Limitations: Short-term 16-week treatment period;severe AD only. Conclusion: Dupilumab + TCS is efficacious and well tolerated in children with severe AD, significantly improving signs, symptoms, and QOL.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 0190-9622
• Sprache: Englisch