Tralokinumab预填充笔改善了特应性皮炎的体征和症状，并且在中度至重度特应性皮炎的成人和青少年中具有良好的耐受性：一项为期16周，开放标签，单组3期研究（INJECZTRA）。

IF 3.5 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-07-18 DOI:10.1007/s13555-025-01490-3

Jennifer Soung, Vivian Laquer, Matthew Zirwas, Peter van Iperen, John C Stinson, Katrine Lykke Albertsen, Linda Stein Gold

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引用次数: 0

摘要

tralokinumab预填充笔的开发是为了提高患者的便利性，并提供300mg tralokinumab（大多数患者的推荐剂量）一次注射。本研究评估了曲仑单抗预充笔式自动注射器在中重度特应性皮炎患者中的有效性、安全性和可用性。方法：这项为期16周、开放标签、单臂的3期研究纳入了年龄≥12岁、研究者总体评估（IGA）评分≥3、湿疹面积和严重程度指数(EASI)≥12的患者。患者通过预充笔每2周给药300 mg，共16周。主要终点为IGA 0/1和第16周EASI改善≥75%。安全性评估为从基线到第16周不良事件的数量。结果：在第16周，28.7%（39/136）的患者达到IGA 0/1(28.6%[30/105]的成人；29.0%[9/31]青少年和43.4%（59/136）的患者达到EASI-75(44.8%[47/105]成人；38.7%[12/31]青少年)。曲洛单抗预充笔耐受性良好，观察到的安全性与曲洛单抗预充注射器的安全性相当。结论：曲洛单抗作为预填充笔配制有效，耐受性良好，易于使用。曲洛单抗预填充笔可能提供更方便的曲洛单抗给药方法，每次剂量注射次数更少。试验注册：ClinicalTrials.gov识别码，NCT05194540。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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The Tralokinumab Pre-Filled Pen Improved Atopic Dermatitis Signs and Symptoms and Was Well Tolerated in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A 16-Week, Open-Label, Single-Arm Phase 3 Study (INJECZTRA).

Introduction: The tralokinumab pre-filled pen was developed to improve patient convenience and deliver 300 mg tralokinumab (the recommended dose for most patients) with one injection. This study evaluated the efficacy, safety, and usability of the tralokinumab pre-filled pen autoinjector in patients with moderate-to-severe atopic dermatitis.

Methods: This 16-week, open-label, single-arm phase 3 study enrolled patients ≥ 12 years with Investigator's Global Assessment (IGA) score ≥ 3 and Eczema Area and Severity Index (EASI) ≥ 12. Patients received tralokinumab 300 mg via self-administered pre-filled pen every 2 weeks for 16 weeks. The primary endpoints were IGA 0/1 and ≥ 75% improvement in EASI (EASI-75) at week 16. Safety was assessed as the number of adverse events from baseline to week 16.

Results: At week 16, 28.7% (39/136) of patients achieved IGA 0/1 (28.6% [30/105] adults; 29.0% [9/31] adolescents) and 43.4% (59/136) of patients achieved EASI-75 (44.8% [47/105] adults; 38.7% [12/31] adolescents). The tralokinumab pre-filled pen was well tolerated, and the observed safety profile was comparable to the safety profile with the tralokinumab pre-filled syringe.

Conclusions: Tralokinumab formulated as a pre-filled pen was effective, well tolerated, and easy to use. The tralokinumab pre-filled pen may offer a more convenient method of tralokinumab administration with fewer injections per dose.

Trial registration: ClinicalTrials.gov identifier, NCT05194540.

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.