52041 Safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis: integrated analysis from 10 clinical trials
Recommended Citation
Stein-Gold L, Thaci D, Katoh N, Shi V, Irvine A, Buziqui Piruzeli ML, Montmayeur S, Gallo G, de Bruin-Weller M. 52041 Safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis: integrated analysis from 10 clinical trials. J Am Acad Dermatol 2024; 91(3):AB307.
Document Type
Conference Proceeding
Publication Date
9-1-2024
Publication Title
J Am Acad Dermatol
Abstract
Background: We provide updated lebrikizumab long-term safety in adults and adolescents with moderate-to-severe atopic dermatitis. Methods: Integrated data from 10 phase 2/3 clinical trials, including Japan (ADhere-J) and vaccine (ADopt-VA) studies with 4 months of additional data from our previous report[1] were summarized in 2 datasets: All-placebo-controlled Week 0-16 ([All-PC], lebrikizumab 250mg every 2 weeks [Q2W] vs placebo) and All-LEB (patients who received any dose of lebrikizumab any time during the studies). Adjusted percentages and exposure-adjusted incidence rates (IR)/100 patient-years are provided for All-PC; crude rates for All LEB. Results: This analysis provides an additional 475 patients (N=2195) and 634 (total=2271) patient-years (All-LEB) from our previous report[1]. In All-PC, the frequency of treatment emergent adverse events (TEAEs) was similar between treatment groups; most were nonserious and mild/moderate in severity. The most frequently reported TEAEs in All-PC were atopic dermatitis in placebo (14.6%) and conjunctivitis in Q2W (6.3%). Frequencies of conjunctivitis cluster were 2.7% (placebo IR=9.7), 10.0% (Q2W IR=37.0), and 12.9% (All-LEB IR=13.9); most events were mild/moderate. Frequencies of injection site reactions were 1.9% (placebo IR=6.9), 3.0% (Q2W IR=10.2), and 3.6% (All-LEB IR=3.6). Frequencies of adverse events leading to treatment discontinuation were 1.7% (placebo IR=5.9), 2.2% (Q2W IR=7.6), and 3.8% (All-LEB IR=3.7). Frequencies of SAEs were low (placebo 1.8%, IR=6.5; Q2W 1.1%, IR=3.8; All-LEB 3.3%, IR=3.3). Conclusion: This updated integrated safety analysis is consistent with previously reported data from the lebrikizumab clinical trial program. IRs of most TEAEs did not increase with longer duration of exposure to lebrikizumab in adolescents and adults with AD.
Volume
91
Issue
3
First Page
AB307
