中重度特应性皮炎患者对曲洛单抗长期治疗反应的稳定性

Andrew Blauvelt, Chih-ho Hong, Ketty Peris, Norito Katoh, Marie Tauber, Mahreen Ameen, Melinda Gooderham, C. Øland, Ann-Marie Tindberg, Le Gjerum, Kristian Reich
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引用次数: 0

摘要

简介:1,2特罗凯单抗是一种特异性中和白细胞介素-13的单克隆抗体,已被批准用于治疗中重度特应性皮炎。ECZTEND(NCT03587805)是一项正在进行的开放标签、为期 5 年的扩展试验,旨在研究曲洛单抗 300 毫克、每两周一次(Q2W)加可选局部皮质类固醇激素(TCS)的长期安全性和疗效。这项分析的目的是确定在 AD 临床试验中接受曲妥珠单抗治疗长达 4 年的患者中,出现以下情况的患者所占比例:1)病变范围和严重程度长期稳定改善,无波动或波动极小(即在≥80%的随访中出现应答);2)根据最近的治疗目标建议(EASI≤7,DLQI≤5或Itch NRS≤4),在AD体征和症状以及生活质量方面表现出稳定的长期综合应答(即曲妥珠单抗治疗长达4年,且在≥80%的随访中出现应答)。方法:这项事后分析纳入了347名患者,他们在设计相同的3期单药试验ECZTRA 1和2中连续接受了52周的曲妥珠单抗治疗,随后又在ECZTEND中接受了长达152周的治疗,截至2022年4月30日的数据截止日。在ECZTEND试验的第16-152周期间,在≥80%的就诊次数中达到目标终点,即为长期反应稳定,无波动或波动极小。分析的终点包括 EASI ≤7、EASI ≤2,以及综合长期治疗目标:EASI≤7和DLQI≤5或每周最严重瘙痒NRS≤4。结果:在ECZTEND治疗的第16-152周期间,70.2%(233/332)的曲妥珠单抗治疗患者观察到稳定的EASI≤7反应(就诊次数≥80%)。34.0%的患者(113/332)观察到稳定的EASI≤2反应,60.5%的患者(201/332)观察到长期最佳综合目标:EASI≤7和DLQI≤5或痒NRS≤4。结论在长达4年的持续曲妥珠单抗300毫克Q2W加可选TCS治疗中,有很高比例的临床试验患者保持了稳定的应答,疗效无波动或波动极小。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability of Long-Term Therapeutic Responses to Tralokinumab in Adults with Moderate-to-Severe Atopic Dermatitis
Introduction: To ensure minimal residual disease and to prevent relapses, recently published consensus reports have defined optimal long-term treatment targets for atopic dermatitis (AD).1,2 Tralokinumab, a monoclonal antibody specifically neutralizing interleukin-13, is approved for the treatment of moderate-to-severe AD. ECZTEND (NCT03587805) is an ongoing open-label, 5-year extension trial investigating the long-term safety and efficacy of tralokinumab 300 mg every other week (Q2W) plus optional topical corticosteroids (TCS). Objectives of this analysis were to determine the proportion of patients treated for up to 4 years with tralokinumab in AD clinical trials who: 1) exhibit stable improvement, with no or minimal fluctuations, in lesion extent and severity long-term (ie, response in ≥80% of attended visits), and 2) exhibit a stable long-term composite response (ie, up to 4 years of tralokinumab treatment and response in ≥80% of attended trial visits) in signs and symptoms of AD, and quality of life based on recent treat-to-target recommendations (EASI ≤7 and either DLQI ≤5 or Itch NRS ≤4). Methods: This post hoc analysis included 347 patients who were continuously treated with tralokinumab for 52 weeks in the identically designed phase 3 monotherapy trials ECZTRA 1&2 and subsequently for up to 152 weeks in ECZTEND as of the April 30, 2022 data cutoff. Stability of long-term response, with no or minimal fluctuations, was defined as meeting the target endpoints at ≥80% of attended visits between Weeks 16-152 in ECZTEND. Endpoints analyzed were EASI ≤7, EASI ≤2, and a composite long-term treatment target: EASI ≤7 and either DLQI ≤5 or worst weekly pruritus NRS ≤4. Results: A stable EASI ≤7 response (at ≥80% of attended visits) was observed in 70.2% (233/332) of tralokinumab-treated patients over Weeks 16-152 of ECZTEND. A stable EASI ≤2 response was observed in 34.0% (113/332) of patients, and a long-term optimal composite target, EASI ≤7 and either DLQI ≤5 or Itch NRS ≤4, was observed in 60.5% (201/332) of patients. Conclusions: High proportions of clinical trial patients maintained stable responses, with no or minimal fluctuations in efficacy, with continued tralokinumab 300 mg Q2W plus optional TCS for up to 4 years of treatment.
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