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。