Phase III ADhere trial of RG 3637 shows improvement in atopic dermatitis at 16 weeks.
At 16 weeks, 70 percent of patients with moderate-to-severe atopic dermatitis (AD) receiving RG 3637 (lebrikizumab) combined with standard-of-care topical corticosteroids (TCS) achieved at least 75 percent improvement in overall disease severity (EASI-75) in the phase III ADhere trial, Eli Lilly has announced at the 4th Annual Revolutionizing Atopic Dermatitis (RAD) Conference.
Lebrikizumab, an investigational IL-13 inhibitor, also showed improvements in itch, sleep interference, and quality of life when combined with TCS, compared to placebo plus TCS.
Among patients taking lebrikizumab plus TCS, 41 percent achieved clear or almost clear skin (IGA) at 16 weeks compared to 22 percent of patients taking placebo plus TCS. At 16 weeks, 70 percent of patients taking lebrikizumab plus TCS achieved an EASI-75 response compared to 42 percent taking placebo plus TCS. Differences between patients receiving lebrikizumab in combination with TCS and placebo with TCS were observed as early as four weeks for EASI-75.
Patients treated with lebrikizumab plus TCS also achieved statistically significant improvements across key secondary endpoints including skin clearance and itching, interference of itch on sleep, and quality of life measures, compared to placebo with TCS. Clinically meaningful differences were observed as early as four weeks for itch, interference of itch on sleep, and quality of life measures. Safety results were consistent with prior lebrikizumab studies in AD.