Yosipovitch Gil, de Bruin-Weller Marjolein, Armstrong April, Wu Jashin J, Herranz Pedro, Thaçi Diamant, Delevry Dimittri, Bagousse Gaëlle Bégo-Le, Zhang Raymond, Shumel Brad, Rossi Ana B, Chao Jingdong
Department of Dermatology and Itch Center, University of Miami Miller School of Medicine, Miami, FL, USA.
National Expertise Center of Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, The Netherlands.
Dermatol Ther (Heidelb). 2021 Dec;11(6):2147-2157. doi: 10.1007/s13555-021-00630-9. Epub 2021 Oct 29.
Atopic dermatitis (AD) can have a profound negative impact on the quality of life (QoL) of patients. We analyzed the long-term changes in AD symptoms, QoL, and patient assessment of treatment effect in adults with moderate-to-severe AD treated for 2 years with dupilumab.
LIBERTY AD OLE (NCT01949311) is a multicenter, open-label extension (OLE) study in adults with moderate-to-severe AD who previously participated in dupilumab clinical trials (parent studies). Patients received dupilumab 300 mg weekly. Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), EQ-5D-3L, and the Patient Global Assessment of Treatment Effect (PGATE) were assessed at weeks 48 and 100.
A total of 2677 patients were included in the OLE, and 1028 completed week 100. By weeks 48 and 100, 94.1% and 95.6% of patients achieved a ≥ 4-point change in POEM from the parent study baseline (PSBL), respectively, and 93.3% and 93.4% of patients had achieved a ≥ 4-point change in DLQI from PSBL, respectively. At week 100, 35.1% of patients had a POEM score ≤ 2 (AD clear/almost clear) compared with 0.1% at PSBL, and 49.9% had a DLQI score of 0 or 1 (no effect at all on patient's life) compared with 1.5% at PSBL. At week 100, 74.5-97.3% of patients reported no effect of AD on the individual EQ-5D-3L domains, and 93.8% rated the effect of dupilumab treatment as "excellent," "very good," or "good" according to PGATE.
In adults with moderate-to-severe AD, dupilumab treatment over 2 years resulted in sustained improvements in patient-reported symptoms and QoL and a favorable patient perception of treatment effect.
ClinicalTrials.gov Identifier: NCT01949311. Supplementary material 1 (MP4 552250 kb).
特应性皮炎(AD)会对患者的生活质量(QoL)产生深远的负面影响。我们分析了使用度普利尤单抗治疗2年的中度至重度AD成人患者的AD症状、生活质量和患者对治疗效果评估的长期变化。
LIBERTY AD OLE(NCT01949311)是一项针对中度至重度AD成人患者的多中心、开放标签扩展(OLE)研究,这些患者之前参与过度普利尤单抗的临床试验(母研究)。患者每周接受300mg度普利尤单抗治疗。在第48周和第100周评估患者导向性湿疹测量(POEM)、皮肤病生活质量指数(DLQI)、EQ-5D-3L和患者对治疗效果的整体评估(PGATE)。
共有2677名患者纳入OLE研究,其中1028名完成了第100周的研究。到第48周和第100周时,分别有94.1%和95.6%的患者自母研究基线(PSBL)起在POEM上实现了≥4分的变化,分别有93.3%和93.4%的患者自PSBL起在DLQI上实现了≥4分的变化。在第100周时,35.1%的患者POEM评分≤2(AD清除/几乎清除),而在PSBL时为0.1%;49.9%的患者DLQI评分为0或1(对患者生活完全无影响),而在PSBL时为1.5%。在第100周时,74.5%-97.3%的患者报告AD对EQ-5D-3L各个领域无影响,根据PGATE,93.8%的患者将度普利尤单抗治疗效果评为“优秀”“非常好”或“好”。
在中度至重度AD成人患者中,2年的度普利尤单抗治疗使患者报告的症状和生活质量持续改善,且患者对治疗效果的感知良好。
ClinicalTrials.gov标识符:NCT01949311。补充材料1(MP4 5522,50kb)。