This paper studies the effectiveness and safety of dupilumab (a medication) in young children with moderate-to-severe atopic dermatitis that wasn't well controlled with topical treatments. The study combined dupilumab with low-strength steroid creams and compared it to a placebo treatment.
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Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial
Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial
Amy S Paller, Eric L Simpson, Elaine C Siegfried, Michael J Cork, Andreas Wollenberg, Peter D Arkwright, Weily Soong, Mercedes E Gonzalez, Lynda C Schneider, Robert Sidbury, Benjamin Lockshin, Steven Meltzer, Zhixiao Wang, Leda P Mannent, Nikhil Amin, Yiping Sun, Elizabeth Laws, Bolanle Akinlade, Myles Dillon, Matthew P Kosloski, Mohamed A Kamal, Ariane Dubost-Brama, Naimish Patel, David M Weinreich, George D Yancopoulos, John T O'Malley, Ashish Bansal, participating investigators
DOI: 10.1016/S0140-6736(22)01539-2
Controlled Clinical Trial
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162 participants
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2022
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55 citations
Key insights related to Dupixent from this study:
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What is this paper about?
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How did the authors study this?
The researchers conducted a 16-week clinical trial at 31 medical centers in Europe and North America. They randomly assigned patients to receive either dupilumab injections or placebo injections every 4 weeks, with both groups also using a mild steroid cream. They measured success by looking at how clear the skin became and how much the eczema improved.
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What populations did the authors study?
The study included children aged 6 months to under 6 years who had moderate-to-severe atopic dermatitis that hadn't responded well enough to topical steroids. A total of 162 children participated, with 83 receiving dupilumab and 79 receiving placebo.
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What did the authors find?
After 16 weeks, 28% of children taking dupilumab achieved clear or almost clear skin, compared to only 4% in the placebo group. Additionally, 53% of children on dupilumab had at least a 75% improvement in their eczema symptoms, compared to 11% in the placebo group. Side effects were similar between groups, though more children on dupilumab experienced eye inflammation.
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What conclusions can we draw?
The authors concluded that dupilumab significantly improved atopic dermatitis in young children compared to placebo. They found it to be well-tolerated with an acceptable safety profile, similar to what has been seen in older children and adults.
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