Paller Amy S, Blauvelt Andrew, Soong Weily, Chih-Ho Hong H, Schuttelaar Marie L A, Schneider Shannon K R, Simpson Eric L
Departments of Dermatology and Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Blauvelt Consulting, LLC, Annapolis, MD, USA.
Dermatol Ther (Heidelb). 2025 Jul 28. doi: 10.1007/s13555-025-01484-1.
Investigator's Global Assessment (IGA) of clear/almost clear (0/1) skin is a high standard to achieve after 16 weeks of treatment for patients with moderate-to-severe atopic dermatitis (AD) and does not capture clinically meaningful responses in other patient domains, such as improvement in itch and/or quality of life. To better evaluate the effect of tralokinumab in adolescents, we assessed the clinically meaningful impact of tralokinumab versus placebo in patients who did not meet IGA 0/1 at week 16 without rescue medication in ECZTRA 6.
These post hoc analyses included adolescents from the ECZTRA 6 (NCT03526861) phase 3 trial who did not achieve IGA 0/1 at week 16 without rescue medication (referred to as IGA >1). Clinically meaningful responses were defined as either ≥50% improvement from baseline in Eczema Area and Severity Index (EASI-50), ≥3-point improvement in Adolescent Worst Pruritus Numeric Rating Scale (itch NRS), or ≥6-point improvement in Children's Dermatology Life Quality Index (CDLQI) at week 16.
Among IGA >1 patients (n = 247), significantly greater percentages receiving tralokinumab (150 mg or 300 mg) versus placebo achieved EASI-50 (31.2% or 41.3% versus 10.0%), ≥3-point improvement in itch NRS (21.6% or 22.8% versus 8.0%), or ≥1 clinically meaningful measure (36.4% or 52.5% versus 21.1%) at week 16. The majority of IGA >1 patients who continued with open-label tralokinumab beyond week 16 achieved EASI-50 and ≥3-point improvement in itch NRS and about 40% met EASI-90 at week 52.
Clinically meaningful responses in both clinician-measured and patient-reported outcomes were observed in tralokinumab-treated (150 mg or 300 mg) adolescents who did not achieve IGA 0/1 at week 16 without rescue medication. Utilizing validated outcome measures of both efficacy and patient quality of life, alongside IGA scores, can enhance clinical decision-making regarding tralokinumab treatment responses in adolescents with moderate-to-severe AD.
ClinicalTrials.gov identifier, NCT03526861 (ECZTRA 6); study start date: 19 June 2018; primary completion date: 15 April 2020; study completion date: 16 March 2021. A Graphical Abstract is available for this article.
对于中度至重度特应性皮炎（AD）患者，在治疗16周后达到皮肤清晰/几乎清晰（0/1）的研究者整体评估（IGA）是一个很高的标准，并且该标准未涵盖其他患者领域中具有临床意义的反应，例如瘙痒和/或生活质量的改善。为了更好地评估曲罗芦单抗在青少年中的疗效，我们在ECZTRA 6试验中评估了曲罗芦单抗与安慰剂对16周时未使用救援药物且未达到IGA 0/1的患者的临床意义上的影响。
这些事后分析纳入了来自ECZTRA 6（NCT03526861）3期试验的青少年，他们在16周时未使用救援药物且未达到IGA 0/1（称为IGA>1）。具有临床意义的反应定义为在第16周时湿疹面积和严重程度指数（EASI-50）较基线改善≥50%、青少年最严重瘙痒数字评定量表（瘙痒NRS）改善≥3分或儿童皮肤病生活质量指数（CDLQI）改善≥6分。
在IGA>1的患者（n = 247）中，与安慰剂相比，接受曲罗芦单抗（150 mg或300 mg）的患者在第16周时达到EASI-50（分别为31.2%或41.3%对10.0%）、瘙痒NRS改善≥3分（分别为21.6%或22.8%对8.0%）或≥1项具有临床意义指标（分别为36.4%或52.5%对21.1%）的比例显著更高。在第16周后继续接受开放标签曲罗芦单抗治疗的大多数IGA>1患者达到了EASI-50且瘙痒NRS改善≥3分，约40%的患者在第52周时达到了EASI-90。
在第16周时未使用救援药物且未达到IGA 0/1的接受曲罗芦单抗治疗（150 mg或300 mg）的青少年中，观察到了临床医生测量和患者报告结局方面具有临床意义的反应。使用经过验证的疗效和患者生活质量指标，以及IGA评分，可以加强关于中度至重度AD青少年曲罗芦单抗治疗反应的临床决策。
ClinicalTrials.gov标识符，NCT03526861（ECZTRA 6）；研究开始日期：2018年6月19日；主要完成日期：2020年4月15日；研究完成日期：2021年3月16日。本文提供了图形摘要。
