Final results from the Phase 3 ECZTEND study indicate that tralokinumab (Adbry; LEO Pharma) demonstrates sustained efficacy and safety in treating adults with moderate-to-severe atopic dermatitis (AD) over a 5-year period. The data, presented at the Fall Clinical Dermatology Conference, highlight the potential for long-term disease stability and reduced symptom fluctuations with tralokinumab treatment.
The ECZTEND study, an ongoing open-label extension trial (NCT03587805), evaluated the long-term safety and efficacy of tralokinumab. The study enrolled adults who had previously participated in the ECZTRA trials, assessing outcomes up to 5 years. Researchers focused on key clinical measures, including the Eczema Area and Severity Index (EASI), Dermatology Life Quality Index (DLQI), and worst weekly pruritus numerical rating scale (NRS).
Sustained Therapeutic Responses
The study results demonstrated that a substantial proportion of patients maintained stable therapeutic responses while receiving tralokinumab. Between weeks 16 and 152, 71.4% of patients achieved an EASI score of 7 or lower, signifying no to mild disease. Furthermore, 61.2% of patients reported a DLQI score of 5 or lower, indicating a notable improvement in their quality of life. Additionally, 48.5% of patients reported a worst weekly pruritus NRS of 4 or lower, reflecting effective itch control.
Minimal Clinical Fluctuations
The data also indicated that patients experienced minimal fluctuations in their clinical outcomes throughout the treatment period, suggesting consistent disease management with tralokinumab.
According to Blauvelt et al., "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."
LEO Pharma's Perspective
Brian Hilberdink, EVP and president of the North America region at LEO Pharma, stated, "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. 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."
