The systemic therapy dupilumab met primary endpoints in two phase 3 studies on adults with inadequately controlled moderate-to-severe atopic dermatitis, according a recent release by Regeneron Pharmaceuticals and Sanofi.
In the identically designed SOLO 1 and SOLO 2 trials, monotherapy with investigational dupilumab significantly improved disease severity, skin clearing, itching, quality of life and mental health.
"These data provide strong evidence that the IL-4 and IL-13 signaling pathway is a fundamental driver of inflammation in atopic dermatitis. Dupilumab is the first in a new class of immunotherapies – in these 16 week trials, dupilumab blocked the aberrant activation of this pathway, resulting in significant efficacy without evidence of immune-suppressing side effects," George D. Yancopoulos, M.D., Ph.D., chief scientific officer of Regeneron and president of Regeneron Laboratories, says in the release.
Researchers studied 1,379 subjects with moderate-to-severe disease who were inadequately controlled with topical medications or were not good candidates for topical treatment. They assessed subjects using the Investigator's Global Assessment (IGA) scale, ranging from 0 (clear) to 4 (severe). Study participants had IGA scores of 3 or 4 at baseline. They also assessed subjects with the Eczema Area and Severity Index (EASI).
Subjects were randomized to receive dupilumab 300 mg subcutaneously once per week; dupilumab 300 mg subcutaneously every two weeks; or placebo for 16 weeks following an initial dupilumab loading dose of 600 mg subcutaneously, or placebo.
In SOLO 1, 37% of patients who received 300 mg of dupilumab weekly and 38% who received the 300 mg of the investigational drug every two weeks achieved IGA 0 or 1, compared with 10% in the placebo group. In SOLO 2, 36% of those receiving the weekly and every-two-week regimens achieved IGA 0 or 1 compared to 8.5% of controls.
EASI measures improved 72% from baseline in both the once-weekly and every-other-week treatment groups in SOLO 1, compared to 38% for placebo. In SOLO 2 EASI improved 69% in the weekly dose group and 67% among those who received dupilumab every two weeks, compared to 31% in placebo.
A secondary endpoint for the United States studies was the percentage of patients who achieved EASI-75. In SOLO 1, 52.5% in the weekly dupilumab treatment group and 51% in the every two weeks treatment group achieved EASI-75, compared to 15% of those in the placebo group. In SOLO 2, researchers reported 48% of patients in the weekly group and 44% in the every two weeks treatment group achieved EASI-75, compared to 12% in the placebo group.