12-17 岁特应性皮炎 (AD) 患者接受特罗凯单抗治疗 52 周后病情得到进展和持续控制

Andreas Wollenberg, M. Cork, Chih-ho Hong, A. Kurbasic, Emilia Vacko, Amy S. Paller
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摘要

简介ECZTRA 6试验显示,曲妥珠单抗300mg对中重度AD青少年患者具有渐进和持续的疗效,且耐受性良好,52周的长期安全性令人放心:评估ECZTRA 6中接受曲妥珠单抗300mg治疗的青少年患者在整个52周治疗期间的EASI反应和PROs:患者被随机分配至曲妥珠单抗 300 毫克 Q2W(n=97)或安慰剂(n=94)治疗 16 周。第16周时,开始接受曲妥珠单抗治疗并达到主要终点(IGA 0/1和/或EASI-75)而未获救治的患者被重新随机分配至曲妥珠单抗300毫克Q2/4W单药治疗,疗程延长36周;其他患者则转为开放标签曲妥珠单抗300毫克Q2W加可选局部皮质类固醇激素治疗。通过汇总最初随机接受曲妥珠单抗 300 毫克 Q2W 治疗的所有患者的第 16-52 周数据,进行了事后分析。结果显示与安慰剂相比,更多接受曲妥珠单抗治疗的患者在第16周时达到了主要终点;第52周时病情出现了逐渐改善。此外,从基线到第16周,更多的曲妥珠单抗与安慰剂治疗患者的瘙痒NRS评分得到改善,并在第52周之前得到进一步改善。瘙痒NRS评分≥4分、POEM评分≥4分和CDLQI评分≥6分的患者比例与基线相比也有逐渐改善。 安全性与第16周后的长期治疗一致。结论在第16周时,曲洛单抗300毫克Q2W可改善AD青少年患者的EASI和PROs,并在第52周时出现渐进和持续的改善。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Progressive and Sustained Disease Control in Patients with Atopic Dermatitis (AD) Aged 12–17 Years Treated with Tralokinumab for 52 Weeks
Introduction: The ECZTRA 6 trial showed that tralokinumab 300mg provided progressive and sustained efficacy in adolescent patients with moderate-to-severe AD, and was well tolerated with a reassuring long-term safety profile over 52 weeks. Objective: To evaluate EASI response and PROs in adolescents from ECZTRA 6 treated with tralokinumab 300mg for the full 52-week treatment period. Methods: Patients were randomized to tralokinumab 300mg Q2W (n=97) or placebo (n=94) for 16 weeks. At Week 16, patients initiated on tralokinumab and achieving primary endpoints (IGA 0/1 and/or EASI-75) without rescue were re-randomized to tralokinumab 300mg Q2/4W monotherapy for 36 additional weeks; other patients were switched to open-label tralokinumab 300mg Q2W plus optional topical corticosteroids. Post-hoc analyses were conducted by pooling Week 16–52 data for all patients initially randomized to tralokinumab 300mg Q2W.  Results: Greater proportions of tralokinumab- vs placebo-treated patients achieved primary endpoints at Week 16; progressive improvement was seen through Week 52. In addition, pruritus NRS score was improved for a greater proportion of tralokinumab- vs placebo-treated patients from baseline to Week 16, with further improvement up to Week 52. Progressive improvements over time were also observed for proportions of patients with reductions of pruritus NRS ≥4, POEM ≥4, and CDLQI ≥6, from baseline.  The safety profile was consistent with prolonged treatment following Week 16.  Conclusions: At Week 16, tralokinumab 300mg Q2W improved EASI and PROs in adolescents with AD, with progressive and sustained improvement seen up to Week 52.
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