725 - The TCS/TCI-free rate remains high and stable while on lebrikizumab for treatment of moderate-to-severe atopic dermatitis over 1 year

Abstract Background The ADvocate1 and ADvocate2 phase 3 trials investigated lebrikizumab (LEB), a monoclonal antibody selectively targeting interleukin-13, for the treatment of patients with moderate-to-severe atopic dermatitis (AD). Topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI) are commonly used as concomitant treatment for AD. However, long term use can result in side effects. Thus, remaining free of TCS/TCI usage is important for evaluating the benefit of systemic AD therapies. Objectives To summarize and assess the proportion of patients without TCS or TCI usage over the course of the maintenance period based on pooled ADvocate1 and ADvocate2 studies. Methods This study consisted of pooled ADvocate1 and ADvocate2 data for patients responding to LEB at week 16 (induction period). Responders (N = 291) were re-randomized in a 2:2:1 ratio to receive 250 mg LEB every 2 weeks (Q2W; N = 113), 250 mg LEB every 4 weeks (Q4W; N = 118), or placebo every 2 weeks (LEB withdrawal/PBO; N = 60) for 36 weeks (maintenance period). Lack of TCS/TCI use was interpreted as an advantageous outcome of LEB treatment. Data are presented as observed data. Results Across the maintenance period, high proportions of patients in all groups (Q2W – 90.3%; Q4W – 88.1%; PBO – 86.7%) did not use TCS. Higher proportions (Q2W – 96.5%; Q4W – 98.3%; PBO – 95%) did not use TCI. Importantly, 88.5% of Q2W, 86.4% of Q4W, and 81.7% of PBO, did not use either TCS or TCI. This high TCS/TCI free rate remained stable over the course of the maintenance period. Conclusions Most patients with moderate-to-severe AD responding to LEB remained free of TCS, TCI, and TCS/TCI use throughout the first year of treatment.