Eichenfield Lawrence F, Armstrong April, Guttman-Yassky Emma, Lio Peter A, Chen Chi-Chang, Hines Dionne M, McGuiness Catherine B, Ganguli Sohini, Delevry Dimittri, Sierka Debra, Mallya Usha G
Departments of Dermatology and Pediatrics, University of California, San Diego School of Medicine, 3020 Children's Way, Mail Code 5092, San Diego, CA, 92123, USA.
Department of Dermatology, Keck School of Medicine at University of Southern California, Los Angeles, CA, USA.
Dermatol Ther (Heidelb). 2022 Jun;12(6):1337-1350. doi: 10.1007/s13555-022-00731-z. Epub 2022 May 11.
While the efficacy of dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) has been demonstrated in several clinical trials, patients in such trials may not necessarily reflect the real-world clinical practice setting. This study evaluated the real-world effectiveness of dupilumab in adults with moderate-to-severe AD based on physician global assessment, percent body surface area affected, and patient-reported itch.
From Modernizing Medicine's Electronic Medical Assistant dermatology-specific electronic medical records, adults (≥ 18 years) were identified with a diagnosis of AD and ≥ 1 dupilumab prescription (index event) between 1 April 2017 and 31 January 2019. Three cohorts were identified based on 3-month pre-index (1) Investigator Global Assessment (IGA) score ≥ 3, (2) an itch severity numerical rating scale (NRS) score ≥ 3, and (3) body surface area (BSA) affected ≥ 10%. Changes from pre-index on the outcome within each cohort were evaluated at 4 months post-index. Patients were also stratified for evaluation of outcomes by baseline demographic (sex, age) and prior AD treatments (topical therapy only or no treatment, any systemic therapy).
More than 70% of the 435 AD patients with baseline IGA score ≥ 3 improved to an IGA score of ≤ 2 at month 4 post-dupilumab initiation, including 42.8% who achieved IGA 0/1 (clear/minimal). Among 112 patients with a pre-index itch severity NRS ≥ 3, scores were reduced from mean (SD) 7.0 (2.4) pre-index to 2.8 (2.8) at month 4 (p < 0.0001); 70.5% of patients had a reduction ≥ 3 points. In the BSA cohort (n = 387), affected BSA was significantly reduced from a pre-index mean (SD) of 39.3% (26.1%) to 16.3% (21.2%) at month 4 (p < 0.0001). Significant improvements in IGA, itch NRS, and BSA were observed regardless of demographic (age and sex) or clinical characteristics such as treatment history (all p < 0.0001 compared with pre-index).
Consistent with outcomes observed in clinical trials, patients treated with dupilumab in real-world clinical settings achieved clinically meaningful improvements in severity and extent of AD and severity of itch comparable to those reported in clinical trials at a similar time point.
虽然在多项临床试验中已证明度普利尤单抗治疗中度至重度特应性皮炎（AD）成人患者的疗效，但此类试验中的患者不一定能反映真实世界的临床实践情况。本研究基于医生整体评估、体表面积受累百分比和患者报告的瘙痒情况，评估了度普利尤单抗在中度至重度AD成人患者中的真实世界有效性。
从Modernizing Medicine的电子医疗助手皮肤科特定电子病历中，识别出2017年4月1日至2019年1月31日期间诊断为AD且有≥1张度普利尤单抗处方（索引事件）的成人（≥18岁）。根据索引前3个月的情况确定了三个队列：（1）研究者整体评估（IGA）评分≥3，（2）瘙痒严重程度数字评定量表（NRS）评分≥3，（3）体表面积（BSA）受累≥10%。在索引后4个月评估每个队列中索引后结局相对于索引前的变化。患者还根据基线人口统计学特征（性别、年龄）和既往AD治疗情况（仅外用治疗或未治疗、任何全身治疗）进行分层以评估结局。
435例基线IGA评分≥3的AD患者中，超过70%在开始使用度普利尤单抗后第4个月时IGA评分改善至≤2，其中42.8%达到IGA 0/1（清除/轻微）。在112例索引前瘙痒严重程度NRS≥3的患者中，评分从索引前的平均（标准差）7.0（2.4）降至第4个月时的2.8（2.8）（p<0.0001）；70.5%的患者评分降低≥3分。在BSA队列（n = 387）中，受累BSA从索引前的平均（标准差）39.3%（26.1%）显著降至第4个月时的16.3%（21.2%）（p<0.0001）。无论人口统计学特征（年龄和性别）或临床特征（如治疗史）如何，IGA、瘙痒NRS和BSA均有显著改善（与索引前相比，所有p<0.0001）。
与临床试验中观察到的结局一致，在真实世界临床环境中接受度普利尤单抗治疗的患者在AD的严重程度和范围以及瘙痒严重程度方面取得了具有临床意义的改善，与临床试验在相似时间点报告的结果相当。
