Real World Assessment of Once-a-Month Dosing of Lebrikizumab in Commercial Claims

Abstract

Introduction and Objectives: Lebrikizumab received U.S. Food and Drug Administration approval on September 13, 2024, for adults and adolescents (≥12 years, ≥40 kg) with moderate-to-severe atopic dermatitis (AD). The recommended dosing regimen consists of a 500-mg loading dose (two 250-mg injections) at Week 0 and Week 2, followed by 250 mg every 2 weeks (Q2W) until Week 16 or adequate clinical response. The approved maintenance dose is lebrikizumab 250 mg every 4 weeks (Q4W). Due to prescribing information (PI) flexibility and clinician discretion, real-world evidence describing the proportion of patients who transition to lebrikizumab Q4W dosing is warranted.

Methods: We assessed the proportion of patients treated with lebrikizumab who transitioned from Q2W to Q4W dosing using the IQVIA Longitudinal Access and Adjudication Data (LAAD) database. Patients who initiated lebrikizumab between September 13, 2024, and August 31, 2025 were identified; only final paid claims were included. The index date was defined as the date of the first paid lebrikizumab prescription. Patients were required to be ≥12 years old and to have pharmacy activity for ≥6 months following the index date. Data from weeks 16, 20, and 24 were assessed. If a patient receives five lebrikizumab prescriptions (28-day supply), the first, consistent opportunity to move to Q4W dosing per the label is at Week 16. However, the first opportunity to identify an Q4W dosing interval in the data would be between fills five and six, Week 16 and 20.

Results: Overall, 2,948 patients were included had pharmacy activity for ≥6 months and were ≥12 years old. The mean age of the study population was 44.1 years (SD 18.9). The majority (78.6%) of patients utilizing lebrikizumab were 18–64 years. Among patients who initiated lebrikizumab, Q2W dosing, and had ≥5 lebrikizumab claims (n = 1,717) over 6 months, 72.7% had transitioned from Q2W to Q4W dosing by Week 16, 83.3% by Week 20, and 88.1% by Week 24. Of the 83.3% of patients that transitioned from Q2W to Q4W dosing by Week 20, the average time (mean) to dosing transition (Q2W to Q4W) was 13.3 weeks.

Conclusion: By Week 20, 83.3% of patients receiving lebrikizumab transitioned to Q4W maintenance dosing, a proxy for adequate clinical response. This analysis was restricted to patients with consistent lebrikizumab fills and is subject to the inherent limitations of claims administrative data. Additional research will further elucidate broader lebrikizumab treatment patterns.

Funding sources: this study was funded by Eli Lilly and Company.