Silvio Danese, Remo Panaccione, Maria T Abreu, David T Rubin, Subrata Ghosh, Axel Dignass, Anita Afzali, Douglas C Wolf, Michael V Chiorean, Severine Vermeire, Anjali Jain, Lorna Charles, Garrett Lawlor, Mark T Osterman, Hsiuanlin Wu, James B Canavan, AnnKatrin Petersen, Jean-Frederic Colombel, Miguel Regueiro
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Efficacy, including endoscopic and histological endpoints, was assessed during the OLE for approximately 2 additional years through OLE Week 94, using observed case [OC] and nonresponder imputation [NRI] analyses. Adverse events were monitored from True North baseline through OLE data cutoff and expressed as exposure-adjusted incidence rates.</p><p><strong>Results: </strong>This analysis included 131 patients; 54% had achieved corticosteroid-free remission at True North Week 52. In OC analyses, clinical response, clinical remission, and corticosteroid-free remission were achieved by 91.4%, 69.1%, and 67.9% of patients, respectively, at OLE Week 94 [146 weeks of total treatment]. Similarly, endoscopic improvement, histological remission, and mucosal healing were achieved by 73.3%, 67.3%, and 56.3% of patients, respectively, at OLE Week 94. Efficacy rates were lower using NRI analyses, but maintenance of efficacy was demonstrated through OLE Week 94. No new safety signals emerged from this analysis. Serious infections, malignancy, cardiovascular events, and hepatic events occurred infrequently.</p><p><strong>Conclusions: </strong>Among patients who achieved clinical response after 1 year of ozanimod treatment during True North, a high percentage sustained clinical and mucosal efficacy over 2 additional years in the OLE. 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引用次数: 0
摘要
背景和目的:这项 "True North "开放标签扩展[OLE]研究的中期分析考察了中度至重度活动性溃疡性结肠炎患者连续接受奥扎莫德治疗约 3 年的疗效和安全性:方法: 对在 "真实北方 "三期研究中接受奥扎莫德治疗 52 周后,在 OLE 中继续接受治疗的临床应答者进行评估。在 OLE 期间,使用观察病例 [OC] 和非应答者归因 [NRI] 分析法,在 OLE 第 94 周之前的约 2 年时间内评估疗效,包括内镜和组织学终点。从 "真北 "基线到 OLE 数据截止期间对不良事件进行监测,并以暴露调整后的发病率表示:该分析包括 131 名患者;54% 的患者在 "真实北方 "第 52 周时获得了无皮质类固醇缓解。在 OC 分析中,91.4%、69.1% 和 67.9% 的患者在 OLE 第 94 周[共治疗 146 周]时获得了临床应答、临床缓解和无皮质类固醇缓解。同样,在OLE第94周时,分别有73.3%、67.3%和56.3%的患者实现了内镜改善、组织学缓解和粘膜愈合。使用 NRI 分析的有效率较低,但在 OLE 第 94 周时疗效得以维持。该分析未发现新的安全性信号。严重感染、恶性肿瘤、心血管事件和肝脏事件发生率较低:结论:在 "真北方 "期间接受奥扎莫德治疗 1 年后获得临床应答的患者中,有很高比例的患者在 OLE 治疗的另外 2 年中保持了临床和粘膜疗效。长期使用奥扎莫德未发现新的安全信号。
Efficacy and Safety of Approximately 3 Years of Continuous Ozanimod in Moderately to Severely Active Ulcerative Colitis: Interim Analysis of the True North Open-label Extension.
Backgrounds and aims: This interim analysis from the True North open-label extension [OLE] study examines efficacy and safety of approximately 3 years of continuous ozanimod treatment in patients with moderately to severely active ulcerative colitis.
Methods: Clinical responders after 52 weeks of ozanimod during the phase 3 True North study, who continued treatment in the OLE, were evaluated. Efficacy, including endoscopic and histological endpoints, was assessed during the OLE for approximately 2 additional years through OLE Week 94, using observed case [OC] and nonresponder imputation [NRI] analyses. Adverse events were monitored from True North baseline through OLE data cutoff and expressed as exposure-adjusted incidence rates.
Results: This analysis included 131 patients; 54% had achieved corticosteroid-free remission at True North Week 52. In OC analyses, clinical response, clinical remission, and corticosteroid-free remission were achieved by 91.4%, 69.1%, and 67.9% of patients, respectively, at OLE Week 94 [146 weeks of total treatment]. Similarly, endoscopic improvement, histological remission, and mucosal healing were achieved by 73.3%, 67.3%, and 56.3% of patients, respectively, at OLE Week 94. Efficacy rates were lower using NRI analyses, but maintenance of efficacy was demonstrated through OLE Week 94. No new safety signals emerged from this analysis. Serious infections, malignancy, cardiovascular events, and hepatic events occurred infrequently.
Conclusions: Among patients who achieved clinical response after 1 year of ozanimod treatment during True North, a high percentage sustained clinical and mucosal efficacy over 2 additional years in the OLE. No new safety signals were observed with long-term ozanimod use.
期刊介绍:
Journal of Crohns and Colitis is concerned with the dissemination of knowledge on clinical, basic science and innovative methods related to inflammatory bowel diseases. The journal publishes original articles, review papers, editorials, leading articles, viewpoints, case reports, innovative methods and letters to the editor.