Real-world Effectiveness and Safety of Lebrikizumab in Atopic Dermatitis: A TREATgermany Analysis.

Atopic dermatitis (AD) is driven by type 2 inflammation, with interleukin-13 (IL-13) as one of the central operators. Lebrikizumab is a monoclonal antibody that inhibits IL-13 signalling. Adult patients with moderate-to-severe AD who received lebrikizumab in the TREATgermany registry until 12/2024 were selected, and patient characteristics as well as effectiveness and safety outcomes after 1, 3 and 6 months were evaluated. A total of 108 patients were initiated on lebrikizumab, with 80 having follow-up data available for this analysis ("registry cohort"). Forty-one patients were switched to lebrikizumab without a "washout period" from another advanced systemic therapy ("switchers"). The mean Eczema Area and Severity Index (EASI) decreased from 14.8 at baseline to 5.6 and 3.0 at month 3 and month 6 and was comparable between switchers and nonswitchers. Clinically meaningful improvements were also seen across all patient reported outcomes (PROs) equally in both groups, e.g. a decrease of the mean peak pruritus numeric rating scale (PP-NRS) from 6.6 to 3.8 and 3.4 and the Dermatology Life Quality Index (DLQI) from 11.9 to 4.9 and 4.8. Overall, adverse events (AEs) were reported for 26.6% of patients within the first 3. The most frequently reported AE was conjunctivitis or other ocular complications, reported in 13 patients (20.3%). 32 patients (40%) had an initial EASI≥16 and were comparable to patients in lebrikizumab phase 3 studies. In this "trial-like" cohort, EASI-75 and EASI-90 response rates were 60% and 26.7% at month 3 and 70% and 50% at month 6. Lebrikizumab shows effectiveness in routine care well comparable to observations made in randomized controlled trials.