Background: Real-world data on the effectiveness and safety of lebrikizumab for atopic dermatitis (AD) are limited. Objective: To evaluate the real-world effectiveness and safety of lebrikizumab on Japanese patients with AD. Methods: This two-center study included 126 Japanese patients with moderate-to-severe AD treated with lebrikizumab plus topical corticosteroids for 16 weeks. Eczema area and severity index (EASI), investigator's global assessment (IGA), peak-pruritus (PP)-numerical rating scale (NRS), sleep quality NRS, AD control tool (ADCT), dermatology life quality index (DLQI), patient-oriented eczema measure (POEM), immunoglobulin E (IgE), thymus and activation-regulated chemokine (TARC), lactate dehydrogenase (LDH), and total eosinophil count (TEC) were assessed during the treatment. Results: Lebrikizumab reduced all clinical indexes at week 4, which was maintained until week 16. The achievement rates of EASI 50, 75, 90, 100, and IGA 0/1 at week 16 were 83.1%, 57.1%, 27.3%, 11.7%, and 33.3%, respectively. The achievement rates of ≥4-point reduction in PP-NRS, sleep quality NRS, or DLQI, ADCT <7-point, and POEM ≤7-point at week 16 were 75.9%, 68.8%, 65.9%, 76.9%, and 80.4%, respectively. IgE, TARC, and LDH decreased while TEC increased during the treatment. No new safety concerns were observed. Conclusion: The 16-week treatment with lebrikizumab generated favorable effectiveness and safety in Japanese AD patients in real-world practice.
