Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial,Journal of the American Academy of Dermatology

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Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial
Journal of the American Academy of Dermatology ( IF 12.8 ) Pub Date : 2022-07-19 , DOI: 10.1016/j.jaad.2022.07.019
Andrew Blauvelt ₁ , Richard G Langley ₂ , Jean-Philippe Lacour ₃ , Darryl Toth ₄ , Vivian Laquer ₅ , Stefan Beissert ₆ , Andreas Wollenberg ₇ , Pedro Herranz ₈ , Andrew E Pink ₉ , Ketty Peris ₁₀ , Stine Fangel ₁₁ , Le Gjerum ₁₁ , Joshua Corriveau ₁₂ , Hidehisa Saeki ₁₃ , Richard B Warren ₁₄ , Eric Simpson ₁₅ , Kristian Reich ₁₆

Affiliation

Oregon Medical Research Center, Portland, Oregon.
Division of Clinical Dermatology and Cutaneous Science, Dalhousie University, Halifax, Nova Scotia, Canada.
Department of Dermatology, University Hospital of Nice, Nice, France.
Probity Medical Research, Windsor, Ontario, Canada.
First OC Dermatology, Fountain Valley, California.
Department of Dermatology, TU Dresden, Dresden, Germany.
Department of Dermatology and Allergology, University Hospital, LMU Munich, Munich, Germany.
Department of Dermatology, Hospital Universitario La Paz, Madrid, Spain.
St. John's Institute of Dermatology, Guy's and St Thomas' Hospitals, London, United Kingdom.
Institute of Dermatology, Catholic University of the Sacred Heart, Rome, Italy.
LEO Pharma A/S, Ballerup, Denmark.
LEO Pharma Inc, Madison, New Jersey.
Department of Dermatology, Nippon Medical School, Tokyo, Japan.
Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, United Kingdom.
Department of Dermatology, Oregon Health & Science University, Portland, Oregon.
Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

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.

中文翻译：

tralokinumab 在成人中度至重度特应性皮炎患者中的长期 2 年安全性和有效性：ECZTEND 开放标签扩展试验的中期分析

背景

中度至重度特应性皮炎 (AD) 需要额外的长期治疗。一项正在进行的、开放标签、为期 5 年的扩展试验 ECZTEND (NCT03587805) 评估了 tralokinumab 加可选的外用皮质类固醇对来自先前 tralokinumab 父母试验 (PTs) 的中度至重度 AD 的参与者。

客观的

在事后中期分析中评估长达 2 年 tralokinumab 治疗的安全性和有效性。

方法

安全性分析包括参加 ECZTEND 的已完成 PT 的成人，无论 tralokinumab 暴露时间长短。疗效分析包括在 ECZTEND 中接受 tralokinumab 治疗≥1 年的成年参与者和接受 tralokinumab 2 年（从 PT 起 1 年，在 ECZTEND 中 1 年）的亚组分析。主要终点是具有附加疗效终点的不良事件数量。

结果

在安全性分析集中，tralokinumab 参与者的暴露调整率为 237.8 次不良事件/100 患者年暴露 ( N = 1174)。常见不良事件的暴露调整发生率与 PT 相当，但发生率较低。使用 2 年的 tralokinumab，AD 的范围和严重程度得到持续改善，82.5% 的参与者 ( N = 345) 出现湿疹面积和严重程度指数 (EASI-75)。