Lebrikizumab Improves Atopic Dermatitis and ​Quality of Life in Patients With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab: ​ Results From the ADapt Trial

Abstract

ADapt (NCT05369403), an open-label, Phase 3b, 24-week study, evaluated the efficacy and safety of lebrikizumab (LEB) in patients with moderate-to-severe atopic dermatitis (AD) previously treated with dupilumab (DUPI). Patients must have discontinued DUPI due to inadequate response (non-response, partial response, or loss of response), intolerance or an adverse event (AE), or other reasons. Four or more weeks after discontinuing DUPI, patients received a 500-mg LEB loading dose at Baseline and at Week 2 followed by 250 mg every 2 weeks through Week 16 (Q2W). At Week 16, responders (IGA 0 or 1 with ≥2-point improvement (IGA0,1) or EASI75 [primary endpoint]) received LEB 250 mg once every 4 weeks (Q4W); other patients continued with 250 mg Q2W. Q2W and Q4W data were pooled and analyzed as-observed and with nonresponder/multiple imputation (NRI/MI). Among 86 enrolled patients, 56% discontinued DUPI due to inadequate response, 16% due to intolerance/AEs to DUPI, and 28% for other reasons. For all patients, at Weeks 16 and 24, respectively, proportions of patients achieving: 1) EASI75: 57.4% and 60.0%, as-observed; 50.7% and 52.8% NRI/MI; 2) IGA0,1: 38.7% and 38.2%, as-observed; 35.6% and 36.8%, NRI/MI; 3) Face-IGA 0: 42% and 49%, as-observed; 4) Pruritus NRS ≥4-point improvement 53.2% and 61.5% as-observed; 48.8% and 47.9% NRI/MI; and 5) DLQI ≥4-point improvement 83.0% and 83.0% as-observed. The safety profile was consistent with other LEB Phase 3 trials. Four patients who discontinued DUPI due to conjunctivitis did not report conjunctivitis with LEB. 3.5% of patients reported treatment-emergent conjunctivitis.  In DUPI-experienced patients, treatment of moderate-to-severe AD with LEB resulted in meaningful improvements in skin clearance, itch, and quality of life.