Simpson Eric L, Wollenberg Andreas, Soong Weily, Steffensen Louise Abildgaard, Kurbasic Azra, Schneider Shannon, Zoidis John, Silverberg Jonathan I
Department of Dermatology, Oregon Health and Science University, Portland, Oregon.
Klinikum der Universität München, Klinik und Poliklinik für Dermatologie und Allergologie, Munich, Germany; Department of Dermatology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
Ann Allergy Asthma Immunol. 2022 Nov;129(5):592-604.e5. doi: 10.1016/j.anai.2022.07.007. Epub 2022 Jul 14.
Tralokinumab, as monotherapy or in combination with topical corticosteroids (TCS), has exhibited marked efficacy through 52 weeks in phase 3 trials of adults with moderate-to-severe atopic dermatitis and additional efficacy in a long-term extension trial. Early changes in patient-reported symptoms have not been communicated.
To evaluate early changes in patient-reported outcomes (PROs) across the ECZTRA 1, 2, and 3 tralokinumab trials.
Monotherapy data (ECZTRA 1 + 2) was pooled; ECZTRA 3 evaluated tralokinumab plus optional TCS. The PROs were assessed through the trials.
A total of 1596 and 380 patients were randomized in ECZTRA 1 and 2 and ECZTRA 3, respectively. Baseline demographics and clinical characteristics were similar between groups. Early separation from placebo was observed in percentage improvement in worst average daily pruritus numerical rating score (NRS) (week 1, ECZTRA 1 + 2; week 2, ECZTRA 3) and from day 2 in ECZTRA 1 and 2 daily data. More tralokinumab-treated patients achieved clinically meaningful improvements (≥ 4 points) in NRS by week 2 (ECZTRA 1 + 2) or week 3 (ECZTRA 3) vs placebo. Improvements in eczema-related sleep NRS were seen within 2 weeks (week 1, ECZTRA 1 + 2; week 2, ECZTRA 3), supported by similar improvements in other sleep measures. Meaningful changes in Dermatology Life Quality Index were observed from week 2 (ECZTRA 1 + 2). Results were supported by numerical differences from placebo in Patient-Oriented Eczema Measure total score (week 2, both data sets).
Tralokinumab with or without TCS exhibited early and clinically meaningful improvements vs placebo in several PROs, which may be beneficial to patients because atopic dermatitis symptom relief is a key treatment concern for patients.
在中度至重度特应性皮炎成人患者的3期试验中，曲罗芦单抗作为单一疗法或与外用糖皮质激素（TCS）联合使用，在52周内均显示出显著疗效，并且在一项长期扩展试验中具有额外疗效。患者报告症状的早期变化尚未公布。
评估曲罗芦单抗在ECZTRA 1、2和3试验中患者报告结局（PROs）的早期变化。
汇总单一疗法数据（ECZTRA 1 + 2）；ECZTRA 3评估曲罗芦单抗加可选的TCS。在试验中评估PROs。
分别有1596例和380例患者在ECZTRA 1和2以及ECZTRA 3中随机分组。各组间基线人口统计学和临床特征相似。在最差平均每日瘙痒数字评定量表（NRS）改善百分比方面（第1周，ECZTRA 1 + 2；第2周，ECZTRA 3）以及在ECZTRA 1和2的每日数据中从第2天开始观察到与安慰剂的早期分离。与安慰剂相比，到第2周（ECZTRA 1 + 2）或第3周（ECZTRA 3）时，更多接受曲罗芦单抗治疗的患者在NRS上实现了具有临床意义的改善（≥4分）。在2周内（第1周，ECZTRA 1 + 2；第2周，ECZTRA 3）观察到湿疹相关睡眠NRS的改善，其他睡眠指标也有类似改善。从第2周（ECZTRA 1 + 2）开始观察到皮肤病生活质量指数有意义的变化。以患者为导向的湿疹测量总分与安慰剂的数值差异支持了该结果（第2周，两个数据集）。
无论是否使用TCS，曲罗芦单抗与安慰剂相比，在多个PROs方面均表现出早期且具有临床意义的改善，这可能对患者有益，因为缓解特应性皮炎症状是患者治疗的关键关注点。
