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Dupilumab monotherapy improves moderate to severe atopic dermatitis
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Systemic dupilumab monotherapy significantly reduced moderate-to-severe atopic dermatitis symptoms in two phase 3 clinical trials, Regeneron Pharmaceuticals Inc. and Sanofi announced in a press release.
The SOLO1 and SOLO2 studies met their primary endpoints in improving measures of overall disease severity, skin clearing, itching, quality of life and mental health, according to the release.
"These are the first phase 3 studies of a systemic therapy to demonstrate a significant improvement in moderate-to-severe atopic dermatitis, a chronic, debilitating inflammatory disease that impacts over 1 million Americans," George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories, said in the release.
The SOLO1 and SOLO2 trials included 1,379 adult patients with moderate-to-severe atopic dermatitis whose symptoms were not adequately controlled with topical medications. The 5-point Investigator’s Global Assessment scale (IGA), Eczema Area and Severity Index (EASI) and other metrics were used to assess outcomes.
Patients were randomly assigned to dupilumab 300 mg subcutaneously once weekly or every 2 weeks, or placebo, for 16 weeks following an initial dupilumab loading dose of 600 mg or placebo.
Results showed that 37% of patients in SOLO1 and 36% of patients in SOLO2 who received dupilumab 300 mg weekly, and 38% of patients in SOLO1 and 36% of those in SOLO2 who received dupilumab 300 mg every 2 weeks, had clearing or near-clearing of skin lesions, the primary endpoint. Lesions cleared or nearly cleared in 10% of patients in SOLO1 and 8.5% of patients in SOLO2 who received placebo. The difference was significant (P < .0001).
EASI scores improved from baseline significantly more in patients who received weekly or biweekly doses of dupilumab than in those who received placebo (P < .0001).
Rates of adverse events in the dupilumab and placebo groups were similar.
Serious adverse events occurred in 1% to 3% of dupilumab patients and in 5% to 6% of the placebo group.
Injection site reactions occurred in 10% to 20% of patients in the dupilumab groups and 7% to 8% of those in the placebo groups. Conjunctivitis occurred in 7% to 12% of patients in the dupilumab groups and 2% of those in the placebo groups, according to the release.
More data from both trials will be presented at a future medical congress.
The phase 3 clinical program for dupilumab comprises five trials worldwide, the release said.