Efficacy, Safety, and Early Relapse After Cessation of Upadacitinib Versus Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis®: A Real-World Study in China.

Jiling Zhu, Hanwen Wu, Yahui Ye, Qiuyang Xu, Junyi Shao, Zicheng Bai, Yiwen Zhou, Zhenyan Li, Jingjing Liu, Zhiming Li
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Abstract

Background: The efficacy and safety of upadacitinib and dupilumab for atopic Dermatitis® (AD) in adolescent patients have been proven in clinical trials. However, few daily practice studies comparing agents have been conducted in this patient population. Objectives: This single-center retrospective cohort study aimed to investigate the efficacy, safety, and early relapse after cessation of upadacitinib and dupilumab for moderate-to-severe AD in Chinese adolescents. Methods: A retrospective study collected data on a cohort of 83 adolescent patients receiving upadacitinib or dupilumab from October 2021 to October 2023. This study comprised two main emphases. The first main emphasis involved the treatment phase, where the efficacy and safety of the two treatments were evaluated. Primary endpoints included the proportion of patients achieving an improvement of ≥50%, ≥75%, and ≥90% in Eczema Area and Severity Index (EASI) from baseline (EASI-50, EASI-75, EASI-90) and the proportion of patients achieving Validated Investigator Global Assessment (vIGA) 0/1 at week 4 and week 40. In the second main emphasis, AD recurrence after treatment discontinuation was assessed in the two treatment groups. The median time to relapse was calculated. Results: A total of 83 patients were enrolled. At week 4, the proportion of patients achieving the primary endpoints, including EASI-75 and EASI-90, was substantially higher with upadacitinib than with dupilumab (51.5% vs 14.0% [P < 0.001], 18.2% vs 2.0% [P < 0.05]). However, at week 40, higher proportion of patients on dupilumab were reaching EASI-50 and EASI-75 and vIGA 0/1. After the discontinuation of dupilumab or upadacitinib therapy, the Kaplan-Meier survival curve showed that the median time to relapse was 270 days in the dupilumab group and 18 days in the upadacitinib group. Conclusions: This study demonstrated that upadacitinib has superior short-term efficacy over dupilumab in adolescents with moderate-to-severe AD, whereas dupilumab trends toward better long-term remission over upadacitinib under the condition of treatment discontinuation in some patients.

中重度特应性皮炎青少年患者服用乌达帕替尼与杜匹单抗的疗效、安全性及停药后的早期复发情况:中国的一项真实世界研究
背景:临床试验证明,达帕替尼(upadacitinib)和杜匹单抗(dupilumab)对青少年特应性皮炎(AD)具有疗效和安全性。然而,在这一患者群体中开展的日常实践研究很少对药物进行比较。研究目的本项单中心回顾性队列研究旨在调查中国青少年使用奥达替尼和杜比鲁单抗治疗中重度特应性皮炎的疗效、安全性以及停药后的早期复发情况。研究方法回顾性研究收集了自2021年10月至2023年10月期间接受达达替尼或杜比鲁单抗治疗的83名青少年患者的队列数据。本研究包括两个重点。第一个重点是治疗阶段,评估两种疗法的疗效和安全性。主要终点包括湿疹面积和严重程度指数(EASI)较基线(EASI-50、EASI-75、EASI-90)改善≥50%、≥75%和≥90%的患者比例,以及在第4周和第40周达到经验证的研究者总体评估(vIGA)0/1的患者比例。第二个主要重点是评估两个治疗组患者停药后AD复发的情况。计算了复发的中位时间。结果共有 83 名患者入组。第4周时,达到主要终点(包括EASI-75和EASI-90)的患者比例,奥达替尼大大高于杜比鲁单抗(51.5% vs 14.0% [P < 0.001],18.2% vs 2.0% [P < 0.05])。然而,在第40周时,使用杜比鲁单抗的患者中达到EASI-50和EASI-75以及vIGA 0/1的比例更高。停用杜必鲁单抗或达达替尼治疗后,Kaplan-Meier生存曲线显示,杜必鲁单抗组的中位复发时间为270天,达达替尼组为18天。结论这项研究表明,在中重度AD青少年患者中,达达替尼的短期疗效优于杜比鲁单抗,而杜比鲁单抗在部分患者停止治疗的情况下,其长期缓解趋势优于达达替尼。
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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