Background: The data are limited on the real-world effectiveness of an anti-interleukin (IL)-13 monoclonal antibody lebrikizumab for atopic dermatitis (AD). Objective: To evaluate the 24-week real-world effectiveness of lebrikizumab in Japanese patients with AD, stratified by the presence or absence of prior systemic therapy. Methods: We conducted a multicenter, prospective study of 134 Japanese AD patients treated with lebrikizumab. We evaluated clinical outcomes throughout a 24-week period in patients with or without prior systemic therapy. Results: Among lebrikizumab-treated patients, eczema area and severity index (EASI) and scores of patient-reported outcomes (peak pruritus numerical rating scale, sleep quality numerical rating scale, AD control tool, dermatology life quality index, and patient-oriented eczema measure) rapidly decreased until week 12, and these improvements persisted until week 24. At week 24, the achievement rates of EASI 75, EASI 90, and investigator's global assessment 0/1 in systemic therapy-naïve patients were 75.6%, 58.5%, and 43.5%, respectively, which were higher than those in systemic therapy-experienced patients, 55.5%, 22.2%, and 26.9%, respectively. There were no serious treatment-emergent adverse events until week 24. Conclusion: Lebrikizumab treatment provided favorable effectiveness and tolerability for AD in real-world practice, with slightly higher effectiveness in systemic therapy-naïve patients compared to therapy-experienced patients.
