Final ECZTEND Study Results Confirm Long-Term Safety and Efficacy of Tralokinumab for Moderate-to-Severe Atopic Dermatitis

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LEO Pharma announced final results of the phase 3 ECZTEND study (NCT03587805) at the Fall Clinical Dermatology Conference^.1 The data, presented in a poster,² reported efficacy and safety up to 5 years.

The ECZTEND study is an ongoing open-label extension trial designed to assess the long-term safety and efficacy of tralokinumab (Adbry; LEO Pharma) over a 5-year period. The study aims to provide insights into maintaining disease stability and preventing fluctuations in symptoms of atopic dermatitis (AD).

Recent consensus reports have outlined optimal long-term treatment targets for AD, emphasizing the importance of achieving minimal residual disease and preventing relapses, according to poster authors Blauvelt et al. The ECZTEND study seeks to evaluate whether tralokinumab can facilitate this transition from flare-driven treatment to stable disease control.

The study involved a cohort of adults who had previously participated in the parent trials of tralokinumab. Participants were enrolled in the ECZTEND study after completing 52 weeks of treatment in the ECZTRA trials. The primary endpoints included the proportion of patients achieving significant improvements in key clinical measures, such as the Eczema Area and Severity Index (EASI), Dermatology Life Quality Index (DLQI), and worst weekly pruritus numerical rating scale (NRS).

Researchers collected data at various time points, with a focus on the first 16 weeks and extending to 152 weeks.

The results of the study demonstrated that a substantial proportion of patients maintained stable therapeutic responses while receiving tralokinumab.

At the 16-152 week mark, 71.4% of patients achieved an EASI score of 7 or lower, indicating no to mild disease. Additionally, 61.2% of patients reported a DLQI score of 5 or lower, reflecting a significant improvement in quality of life. Furthermore, 48.5% of patients reported a worst weekly pruritus NRS of 4 or lower, indicating effective control of itch.

The data also indicated that patients experienced minimal fluctuations in their clinical outcomes over the treatment period.

"These data show that it is possible to transition from flare-driven treatment with topical therapies to stable disease control with long-term tralokinumab treatment in adult patients with moderate-to-severe AD," according to Blauvelt et al.

"With the release of the final results from the ECZTEND open-label extension study, we are pleased to present robust evidence further supporting the long-term safety and efficacy of tralokinumab-ldrm in the treatment of moderate-to-severe atopic dermatitis," said Brian Hilberdink, EVP and president of the North America region at LEO Pharma, in a news release.¹ "This important milestone underscores our unwavering commitment to transforming the lives of the millions of Americans affected by this chronic condition. With this new evidence and a single-dose autoinjector now available for adults in the US, we are excited to empower patients to help manage their symptoms for the long term."

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References

1. LEO Pharma presents final results of ECZTEND long-term Adbry trial (tralokinumab-ldrm) in patients with moderate-to-severe atopic dermatitis (AD) at Fall Clinical 2024. News release. LEO Pharma. October 25, 2024. Accessed October 25, 2024. https://www.biospace.com/press-releases/leo-pharma-presents-final-results-of-ecztend-long-term-adbry-trial-tralokinumab-ldrm-in-patients-with-moderate-to-severe-atopic-dermatitis-ad-at-fall-clinical-2024
2. Blauvelt A, Hong HCh, Peris K, et al. Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis. Poster presented at: 44th Annual Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, Nevada.