Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis

BACKGROUND\ud Dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, inhibits\ud signaling of interleukin-4 and interleukin-13, type 2 cytokines that may be important\ud drivers of atopic or allergic diseases such as atopic dermatitis.\ud METHODS\ud In two randomized, placebo-controlled, phase 3 trials of identical design (SOLO 1\ud and SOLO 2), we enrolled adults with moderate-to-severe atopic dermatitis whose\ud disease was inadequately controlled by topical treatment. Patients were randomly\ud assigned in a 1:1:1 ratio to receive, for 16 weeks, subcutaneous dupilumab (300 mg)\ud or placebo weekly or the same dose of dupilumab every other week alternating\ud with placebo. The primary outcome was the proportion of patients who had both\ud a score of 0 or 1 (clear or almost clear) on the Investigator’s Global Assessment\ud and a reduction of 2 points or more in that score from baseline at week 16.\ud RESULTS\ud We enrolled 671 patients in SOLO 1 and 708 in SOLO 2. In SOLO 1, the primary\ud outcome occurred in 85 patients (38%) who received dupilumab every other week and\ud in 83 (37%) who received dupilumab weekly, as compared with 23 (10%) who received\ud placebo (P