在中重度特应性皮炎患者中评估lebrikizumab治疗头、颈及面部受累的长期疗效。
完整摘要 · 中文译文
目的：头、颈、面部（HNF）特应性皮炎（AD）显著损害生活质量，但生物制剂在HNF区域的长期疗效数据仍有限。 方法：本项事后分析评估lebrikizumab在3期试验（ADvocate 1&2、ADjoin）及目标人群（ADmirable、ADapt）中对青少年（≥12岁，≥40 kg）和成人中重度AD的HNF疗效。结局指标包括HN EASI子评分和面部研究者总体评估（F-IGA）。 结果：Lebrikizumab 250 mg Q4W在第16周应答者中提供了持续至3年的持久疗效。在第152周，分别有94.8%、82.9%和85.3%的患者维持HN EASI 75、90和100应答。至第152周，88.8%（HN EASI 75）、80.0%（HN EASI 90）和74.0%（HN EASI 100）的患者观察到稳定应答（在≥80%的访视中维持应答）。此外，第16周应答者中，93.8%在第152周达到HN EASI绝对值≤1，69.2%达到HN EASI = 0。在ADmirable（有色皮肤）中，61%的Lebri治疗患者在第24周达到F-IGA 0。在ADapt（既往dupilumab暴露）中，55%在第24周达到F-IGA 0。 结论：Lebrikizumab在不同人群中提供了持久、稳定的长期HNF疗效，包括未接受过系统性治疗的患者及既往有生物制剂暴露的患者。
完整摘要 · 英文原文
OBJECTIVES: Head, neck, and face (HNF) atopic dermatitis (AD) substantially impairs quality of life, yet long-term biologic efficacy data in HNF areas remain limited. METHODS: This post hoc analysis evaluates HNF efficacy of lebrikizumab across phase 3 trials (ADvocate 1&2, ADjoin) and targeted populations (ADmirable, ADapt) in adolescents (≥12 years, ≥40 kg) and adults with moderate-to-severe AD. Outcomes included HN EASI sub-scores and Face Investigator's Global Assessment (F-IGA). RESULTS: Lebrikizumab 250 mg Q4W provided durable efficacy through 3 years among week 16 responders. At week 152, 94.8%, 82.9%, and 85.3% maintained HN EASI 75, 90, and 100 responses, respectively.Stable response (maintaining ≥80% of attended visits) through week 152 was observed in 88.8% (HN EASI 75), 80.0% (HN EASI 90), and 74.0% (HN EASI 100) of patients. Additionally, 93.8% achieved absolute HN EASI ≤1 and 69.2% achieved HN EASI = 0 at week 152 in week 16 responders. In ADmirable (skin of color), 61% of Lebri-treated patients achieved F-IGA 0 at week 24. In ADapt (prior dupilumab exposure), 55% achieved F-IGA 0 at week 24. CONCLUSIONS: Lebrikizumab provided durable, stable long-term HNF efficacy across diverse populations, including systemic-naive patients and those with prior biologic exposure.