早期临床反应与ixekizumab治疗放射性轴性脊柱关节炎的长期疗效有关

IF 5.1 2区 医学 Q1 RHEUMATOLOGY
Sofia Ramiro, Cédric Lukas, Louis Bessette, Pendleton Wickersham, Tommaso Panni, Rebecca Bolce, Soyi Liu-Leage, Boris Janos, Michael J Nissen, James Cheng-­Chung Wei
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To investigate the association between treatment response at week 12 and/or week 24 and attainment of the ASDAS<2.1 treat-to-target recommendation at week 52 in bDMARD-naïve patients with radiographic (r-)axSpA treated with ixekizumab (IXE). Methods This post hoc analysis included patients randomly assigned to IXE 80 mg every 4 weeks from COAST-V ([NCT02696785][1]), a phase 3 trial in bDMARD-naïve patients with r-axSpA. The proportion of patients who achieved ASDAS<2.1 at week 52 was measured among those who attained or not clinically important improvement (CII, ∆ASDAS≥1.1) response, and among those with ID, LDA and high or very high disease activity at week 12 and/or week 24. Non-response was assumed for missing data. Results Amongst 81 patients, 47 (58.0%) achieved ASDAS CII at week 12, with 70.2% (n=33) achieving ASDAS<2.1 at week 52. At week 24, 52 (64.2%) patients achieved ASDAS CII, with 71.2% (n=37) achieving ASDAS<2.1 at week 52. Of the 24 patients who did not achieve ASDAS CII at either week 12 or week 24, 5 (20.8%) achieved ASDAS<2.1 at week 52. Conclusion This analysis reinforces the current recommendation that continuing treatment in those achieving ASDAS CII at week 12 and/or week 24 increases the likelihood of obtaining ID/LDA at week 52. Trial registration number [NCT02696785][1]. Data are available on reasonable request. Lilly provides access to all individual participant data collected during the trial, after anonymisation, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org. 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引用次数: 0

摘要

背景 国际脊柱关节炎学会-欧洲风湿病学协会联盟关于轴性脊柱关节炎(axSpA)治疗的评估建议包括在至少治疗 12 周后对患者进行生物改变病情抗风湿药(bDMARD)治疗反应评估。轴性关节炎(axSpA)目前的靶向治疗策略是达到非活动性疾病(ID;轴性脊柱关节炎疾病活动度评分(ASDAS)<1.3)或至少达到低疾病活动度(LDA;1.3≤ASDAS<2.1)。目的 研究接受ixekizumab (IXE)治疗的bDMARD无效放射学(r-)axSpA患者第12周和/或第24周的治疗反应与第52周达到ASDAS<2.1治疗目标推荐值之间的关系。方法 这项事后分析纳入了COAST-V([NCT02696785][1])中随机分配到IXE 80 mg、每4周一次的患者,COAST-V是一项针对bDMARD无效的r-axSpA患者的3期试验。第52周达到ASDAS<2.1的患者比例是在第12周和/或第24周达到或未达到临床重要改善(CII,∆ASDAS≥1.1)反应的患者中,以及在第12周和/或第24周有ID、LDA和高度或极高度疾病活动的患者中进行测量的。缺失数据假定为无应答。结果 81例患者中,47例(58.0%)在第12周达到ASDAS CII,70.2%(33例)在第52周达到ASDAS<2.1。在第 24 周,52 名患者(64.2%)达到了 ASDAS CII,其中 71.2%(37 人)在第 52 周达到了 ASDAS<2.1 的水平。在第 12 周或第 24 周均未达到 ASDAS CII 的 24 名患者中,有 5 人(20.8%)在第 52 周达到了 ASDAS<2.1 的水平。结论 该分析加强了目前的建议,即在第12周和/或第24周达到ASDAS CII的患者继续治疗可增加在第52周获得ID/LDA的可能性。试验注册号[NCT02696785][1]。如有合理要求,可提供数据。除了药代动力学或遗传学数据外,礼来公司提供试验期间收集的所有匿名参与者个人数据。在所研究的适应症在美国和欧盟获得批准后 6 个月或主要出版物被接受后(以较晚者为准),可申请获取数据。数据提供后,目前没有规定数据申请的截止日期。在收到签署的数据共享协议后,经为此目的确定的独立审查委员会批准后,即可提供数据。数据和文件(包括研究方案、统计分析计划、临床研究报告、空白或带注释的病例报告表)将在安全的数据共享环境中提供。有关提交申请的详细信息,请参阅 www.vivli.org 上提供的说明。[1]:/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02696785&atom=%2Frmdopen%2F10%2F3%2Fe004429.atom
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Early clinical response associates with long-term outcomes with ixekizumab in radiographic axial spondyloarthritis
Background The Assessment of SpondyloArthritis international Society-European Alliance of Associations for Rheumatology recommendations for axial spondyloarthritis (axSpA) management include patient assessment for biological disease-modifying antirheumatic drug (bDMARD) treatment response after at least 12 weeks of treatment. The current treat-to-target strategy for axSpA is to achieve inactive disease (ID; Axial Spondyloarthritis Disease Activity Score (ASDAS) <1.3) or at least low disease activity (LDA; 1.3≤ASDAS<2.1). To investigate the association between treatment response at week 12 and/or week 24 and attainment of the ASDAS<2.1 treat-to-target recommendation at week 52 in bDMARD-naïve patients with radiographic (r-)axSpA treated with ixekizumab (IXE). Methods This post hoc analysis included patients randomly assigned to IXE 80 mg every 4 weeks from COAST-V ([NCT02696785][1]), a phase 3 trial in bDMARD-naïve patients with r-axSpA. The proportion of patients who achieved ASDAS<2.1 at week 52 was measured among those who attained or not clinically important improvement (CII, ∆ASDAS≥1.1) response, and among those with ID, LDA and high or very high disease activity at week 12 and/or week 24. Non-response was assumed for missing data. Results Amongst 81 patients, 47 (58.0%) achieved ASDAS CII at week 12, with 70.2% (n=33) achieving ASDAS<2.1 at week 52. At week 24, 52 (64.2%) patients achieved ASDAS CII, with 71.2% (n=37) achieving ASDAS<2.1 at week 52. Of the 24 patients who did not achieve ASDAS CII at either week 12 or week 24, 5 (20.8%) achieved ASDAS<2.1 at week 52. Conclusion This analysis reinforces the current recommendation that continuing treatment in those achieving ASDAS CII at week 12 and/or week 24 increases the likelihood of obtaining ID/LDA at week 52. Trial registration number [NCT02696785][1]. Data are available on reasonable request. Lilly provides access to all individual participant data collected during the trial, after anonymisation, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02696785&atom=%2Frmdopen%2F10%2F3%2Fe004429.atom
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来源期刊
RMD Open
RMD Open RHEUMATOLOGY-
CiteScore
7.30
自引率
6.50%
发文量
205
审稿时长
14 weeks
期刊介绍: RMD Open publishes high quality peer-reviewed original research covering the full spectrum of musculoskeletal disorders, rheumatism and connective tissue diseases, including osteoporosis, spine and rehabilitation. Clinical and epidemiological research, basic and translational medicine, interesting clinical cases, and smaller studies that add to the literature are all considered.
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