Abstract
Background: Additional long-term treatments are needed for moderate-to-severe atopic dermatitis (AD). An ongoing, open-label, 5-year extension trial, ECZTEND (NCT03587805), assesses tralokinumab plus optional topical corticosteroids in participants from previous tralokinumab parent trials (PTs) with moderate-to-severe AD. Objective: To evaluate the safety and efficacy of up to 2 years tralokinumab treatment in a post hoc interim analysis. Methods: Safety analyses included adults from completed PTs enrolled in ECZTEND, regardless of tralokinumab exposure duration. Efficacy analyses included adult participants treated with tralokinumab in ECZTEND for ≥1 year and subgroup analyses of those on tralokinumab for 2 years (1 year from PT, 1 year in ECZTEND). Primary end point was the number of adverse events with additional efficacy end points. Results: Participants on tralokinumab had an exposure-adjusted rate of 237.8 adverse events/100 patient-years’ exposure (N = 1174) in the safety analysis set. Exposure-adjusted incidence rates of common adverse events were comparable to PTs, although at lower rates. With 2 years of tralokinumab, improvements in extent and severity of AD were sustained, with Eczema Area and Severity Index (EASI-75) in 82.5% of participants (N = 345). Limitations: Possible selection bias; no placebo arm; some participants experienced treatment gaps between PTs and ECZTEND. Conclusion: Over 2 years, tralokinumab was well tolerated and maintained long-term control of AD signs and symptoms.
Original language | English (US) |
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Pages (from-to) | 815-824 |
Number of pages | 10 |
Journal | Journal of the American Academy of Dermatology |
Volume | 87 |
Issue number | 4 |
DOIs | |
State | Published - Oct 2022 |
Keywords
- IL-13
- atopic dermatitis
- biologic therapy
- efficacy
- long-term
- monoclonal antibody
- open label
- safety
- tralokinumab
ASJC Scopus subject areas
- Dermatology