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度普利尤单抗与环孢素治疗成人中重度特应性皮炎:基于湿疹面积及严重程度指数的间接比较

Dupilumab Versus Cyclosporine for the Treatment of Moderate-to-Severe Atopic Dermatitis in Adults: Indirect Comparison Using the Eczema Area and Severity Index.

机构信息

Department of Dermatology and Allergology, UMC Utrecht, 3508 GA Utrecht, The Netherlands.

出版信息

Acta Derm Venereol. 2019 Sep 1;99(10):851-857. doi: 10.2340/00015555-3219.

Abstract

Dupilumab is approved for uncontrolled moderate-to-severe atopic dermatitis (AD); cyclosporine is approved for severe AD for ≤ 1 year. The efficacy/effectiveness of these treat-ments was compared indirectly. Regression models used pooled patient-level data to estimate response (Eczema Area and Severity Index (EASI) EASI-50/EASI-75 at weeks 12-16 and 24-30) to dupilumab 300 mg every 2 weeks (CHRONOS [NCT02260986]) or cyclosporine (University Medical Center). Models were adjusted for sex, baseline EASI, and thymus and activation-regulated chemokine level. A total of 106 patients received dupilumab (+ topical cortico-steroids; + TCS), and 57 received cyclosporine (+ TCS). Among University Medical Center patients, estimated EASI-50 responders were, dupilumab vs. cyclosporine, 91% vs. 77% (p = 0.038; weeks 12-16), and 96% vs. 67% (p < 0.0001; weeks 24-30); EASI-75 responders were 78% vs. 56% (p = 0.016; weeks 12-16) and 80% vs. 47% (p <0.001; weeks 24-30). Among CHRONOS patients, estimated EASI-50 responders were 90% vs. 74% (p <0.038; weeks 12-16) and 92% vs. 53% (p < 0.0001; weeks 24-30); EASI-75 responders were 75% vs. 52% (p = 0.016; weeks 12-16) and 74% vs. 40% (p <0.001; weeks 24-30), respectively. These results suggest a higher relative efficacy of dupilumab vs. cyclosporine.

摘要

度普利尤单抗获批用于治疗中重度特应性皮炎(AD);环孢素获批用于治疗 ≤ 1 年的重度 AD。本研究旨在间接比较这两种治疗方法的疗效。研究采用回归模型,基于患者水平数据评估度普利尤单抗 300mg 每 2 周(CHRONOS [NCT02260986])或环孢素(University Medical Center)治疗的应答情况(12-16 周和 24-30 周时的湿疹面积和严重程度指数[EASI]EASI-50/EASI-75)。模型调整了性别、基线 EASI 和胸腺激活调节趋化因子水平。共纳入 106 例接受度普利尤单抗(+局部皮质类固醇;+TCS)治疗的患者和 57 例接受环孢素(+TCS)治疗的患者。在 University Medical Center 患者中,度普利尤单抗治疗组和环孢素治疗组的估计 EASI-50 应答者分别为 91%和 77%(p=0.038;12-16 周)和 96%和 67%(p<0.0001;24-30 周);EASI-75 应答者分别为 78%和 56%(p=0.016;12-16 周)和 80%和 47%(p<0.001;24-30 周)。在 CHRONOS 患者中,度普利尤单抗治疗组和环孢素治疗组的估计 EASI-50 应答者分别为 90%和 74%(p<0.038;12-16 周)和 92%和 53%(p<0.0001;24-30 周);EASI-75 应答者分别为 75%和 52%(p=0.016;12-16 周)和 74%和 40%(p<0.001;24-30 周)。这些结果表明度普利尤单抗治疗 AD 的相对疗效优于环孢素。

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