381 Improved and cleared facial and hand dermatitis with lebrikizumab in patients with moderate-to-severe atopic dermatitis

Abstract

Abstract Lebrikizumab (LEB) is a novel, high affinity monoclonal antibody that selectively binds to interleukin (IL)-13. Lebrikizumab has been shown to provide robust improvements in signs and symptoms in adolescent and adult patients with moderate-to-severe AD across three phase 3 clinical trials (ADvocate1, ADvocate2 and ADhere). However, little is known about the efficacy of LEB in difficult to treat regions such as the face and hands. This study aims to report efficacy of LEB in improving facial and hand dermatitis. ADvocate1 and ADvocate2 assessed LEB 250 mg every 2 weeks (LEBQ2W) vs. placebo for 16 weeks in monotherapy. ADhere compared low-to-mid potency topical corticosteroids (TCS) in addition to LEB Q2W vs. TCS and placebo for 16 weeks. In all trials, clinicians assessed for the presence or absence of facial and hand dermatitis. If present at baseline, at Week 16, clinicians assessed the change from baseline on a scale of cleared, improved, no change or worsened. Patients with improved or cleared dermatitis are described. In ADvocate1 at baseline, facial dermatitis was identified in 71.4% (202/283) of LEBQ2W patients and 80.9% (114/141) of placebo. At Week 16, 61.9% (125/202; P < 0.001) of LEBQ2W were improved or cleared vs. 31.6% (36/114) of placebo. At baseline, hand dermatitis was identified in 72.1% (204/283) of LEBQ2W patients vs. 73.0% (103/141) of placebo. At Week 16, 67.2% (137/204; P < 0.001) of LEBQ2W were improved or cleared vs. 29.1% (30/103) of placebo. In ADvocate2 at baseline, facial dermatitis was identified in 73.7% (207/281) of LEBQ2W patients and 78.8% (115/146) of placebo. At Week 16, 57.5% (119/207; P < 0.001) of LEBQ2W were improved or cleared vs. 21.7% (25/115) of placebo. At baseline, hand dermatitis was identified in 73.3% (206/281) of LEBQ2W patients and 72.6% (106/146) of placebo. At Week 16, 61.7% (127/206; P < 0.001) of LEBQ2W were improved or cleared vs. 18.9% (20/106) of placebo. In ADhere at baseline, facial dermatitis was identified in 72.4% (105/145) of LEBQ2W patients and 59.1% (39/66) of placebo. At Week 16, 68.6% (72/105; P = 0.02) of LEBQ2W were improved or cleared vs. 46.2% (18/39) of placebo. At baseline, hand dermatitis was identified in 71.0% (103/145) of LEBQ2W patients and 66.7% (44/66) of placebo. At Week 16, 72.8% (75/103; P = 0.001) of LEBQ2W were improved or cleared vs. 43.2% (19/44) of placebo. Lebrikizumab treatment is efficacious in improving and clearing hand and face dermatitis in most patients at Week 16.