Ständer Sonja, Pinter Andreas, Hougeir Firas G, Guyot Patricia, Xu Yingxin, Praestgaard Amy H, Freemantle Nick, Rossi Ana B, Bégo-Le-Bagousse Gaëlle, Wang Zhixiao, Noonan Kerry, Bastian Mike
Section Pruritus Medicine, Department of Dermatology and Center for Chronic Pruritus, University Hospital Münster, Münster, Germany.
Goethe-University Frankfurt Am Main, Frankfurt Am Main, Germany.
Dermatol Ther (Heidelb). 2025 Jul 11. doi: 10.1007/s13555-025-01479-y.
Dupilumab and lebrikizumab have demonstrated efficacy in atopic dermatitis (AD) clinical trials; however, no direct comparisons exist.
Efficacy outcome achievement (dupilumab and lebrikizumab with topical corticosteroids [TCS]) at 16 weeks and efficacy outcomes maintenance (dupilumab and lebrikizumab monotherapy without TCS) at 52 weeks were assessed using a placebo-adjusted Bucher indirect treatment comparison (ITC). Week 16 data were sourced from LIBERTY AD CHRONOS (dupilumab, n = 106; placebo, n = 315) and ADhere (lebrikizumab, n = 145; placebo, n = 66) trials. Week 52 data were sourced from SOLO-CONTINUE (dupilumab, n = 80; placebo, n = 39) and ADvocate 1 and 2 (lebrikizumab, n = 231; placebo, n = 60) trials, including patients who had achieved ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI)-75 or Investigator's Global Assessment (IGA) score 0/1 (clear/almost clear) at week 16. Results are presented as odds ratios (ORs) with 95% confidence intervals (CIs).
At week 16, patients receiving dupilumab every 2 weeks (q2w) + TCS had a significantly higher likelihood of achieving EASI-75 (OR 2.4; 95% CI 1.1-5.1) and a ≥ 4-point improvement in Peak Pruritus Numeric Rating Scale (PP-NRS; OR 2.7; 95% CI 1.2-6.0) versus those receiving lebrikizumab q2w + TCS. ORs for other endpoints (IGA-0/1 and ≥ 4-point improvement in Dermatology Life Quality Index) numerically favored dupilumab. At week 52, dupilumab q2w maintained a significantly higher OR for EASI-75 (OR 3.5; 95% CI 1.2-10.5) versus lebrikizumab every 4 weeks. ORs for EASI-90 (OR 3.3; 95% CI 1.0-11.3), IGA 0/1 (OR 3.3; 95% CI 0.7-15.1), and PP-NRS (OR 8.8; 95% CI 0.9-84.8) numerically favored dupilumab.
Placebo-adjusted Bucher ITC analyses showed that the likelihood of achieving efficacy outcomes at 16 weeks and maintaining efficacy outcomes at 52 weeks was higher for dupilumab versus lebrikizumab recipients.
度普利尤单抗和瑞必乐单抗在特应性皮炎（AD）临床试验中已证明具有疗效；然而，尚无直接比较。
使用安慰剂调整的布彻间接治疗比较（ITC）评估16周时的疗效结果达成情况（度普利尤单抗和瑞必乐单抗联合外用糖皮质激素 [TCS]）以及52周时的疗效结果维持情况（度普利尤单抗和瑞必乐单抗单药治疗，不使用TCS）。第16周的数据来自LIBERTY AD CHRONOS试验（度普利尤单抗，n = 106；安慰剂，n = 315）和ADhere试验（瑞必乐单抗，n = 145；安慰剂，n = 66）。第52周的数据来自SOLO - CONTINUE试验（度普利尤单抗，n = 80；安慰剂，n = 39）以及ADvocate 1和2试验（瑞必乐单抗，n = 231；安慰剂，n = 60），包括在第16周时湿疹面积和严重程度指数（EASI）改善≥75%或研究者整体评估（IGA）评分为0/1（清除/几乎清除）的患者。结果以比值比（OR）及95%置信区间（CI）表示。
在第16周时，每2周接受一次度普利尤单抗（q2w）+ TCS治疗的患者实现EASI - 75的可能性显著高于每2周接受一次瑞必乐单抗 + TCS治疗的患者（OR 2.4；95% CI 1.1 - 5.1），且在峰值瘙痒数字评定量表（PP - NRS）上改善≥4分的可能性也更高（OR 2.7；95% CI 1.2 - 6.0）。其他终点（IGA - 0/1以及皮肤病生活质量指数改善≥4分）的OR在数值上有利于度普利尤单抗。在第52周时，每2周一次的度普利尤单抗维持EASI - 75的OR显著高于每4周一次的瑞必乐单抗（OR 3.5；95% CI 1.2 - 10.5）。EASI - 90（OR 3.3；95% CI 1.0 - 11.3）、IGA 0/1（OR 3.3；95% CI 0.7 - 15.1）和PP - NRS（OR 8.8；95% CI 0.9 - 84.8）的OR在数值上有利于度普利尤单抗。
安慰剂调整的布彻ITC分析表明，与接受瑞必乐单抗的患者相比，接受度普利尤单抗的患者在16周时达成疗效结果以及在52周时维持疗效结果的可能性更高。
