Regeneron and Sanofi announced that the two Phase 3 studies, LIBERTY AD SOLO 1 and SOLO 2, evaluating dupilumab for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD), met their primary endpoints.
LIBERTY AD SOLO 1 and SOLO 2 are 2 randomized, placebo-controlled Phase 3 trials evaluating the safety and efficacy of dupilumab in patients with moderate-to-severe AD who were not adequately controlled with topical medications, or if topical treatment was not medically advisable. Patients received either dupilumab 300mg SC once a week, dupilumab 300mg SC every 2 weeks, or placebo for 16 weeks following an initial dupilumab loading dose of 600mg SC or placebo. The primary endpoint was the achievement ofclearing or near-clearing of skin lesions (IGA 0 or 1).
Results after 16 weeks of treatment showed that a greater percentage of patients treated with either dupilumab 300mg weekly or 300mg every 2 weeks achieved clearing or near-clearing of skin lesions (IGA 0 or 1) compared to placebo in both trials. For SOLO 1 and SOLO 2 respectively, 37% and 36% in the weekly group while 38% and 36% in the every 2 weeks group vs. 10% and 8.5% in the placebo group achieved clearing or near-clearing of skin lesions. In addition, for SOLO 1 and SOLO 2 respectively, the percent improvement in EASI from baseline was 72% and 69% in the weekly group, 72% and 67% in the every 2 weeks group, and 38% and 31% in the placebo group (P<0.0001). Both studies demonstrated that treatment with dupilumab as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, quality of life, and mental health. Detailed findings will be submitted for presentation at a future medical congress.
The FDA previously granted dupilumab Breakthrough Therapy designation in AD in November 2014.
Dupilumab is an investigational, fully human monoclonal antibody that inhibits the signaling of IL-4 and IL-13 cytokines.