Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA.
Center for Neurology, Łódź, Poland and Collegium Medicum, Department of Neurology, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland.
Mult Scler. 2022 Oct;28(12):1944-1962. doi: 10.1177/13524585221102584. Epub 2022 Jun 28.
Ozanimod, an oral sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for treatment of relapsing forms of MS.
To characterize long-term safety and efficacy of ozanimod.
Patients with relapsing MS who completed a phase 1‒3 ozanimod trial were eligible for an open-label extension study (DAYBREAK) of ozanimod 0.92 mg/d. DAYBREAK began 16 October 2015; cutoff for this interim analysis was 2 February 2021.
This analysis included 2494 participants with mean 46.8 (SD 11.9; range 0.033‒62.7) months of ozanimod exposure in DAYBREAK. During DAYBREAK, 2143 patients (85.9%) had treatment-emergent adverse events (TEAEs; similar in nature to those in the parent trials), 298 (11.9%) had a serious TEAE, and 75 (3.0%) discontinued treatment due to TEAEs. Serious infections (2.8%), herpes zoster infections (1.7%), confirmed macular edema cases (0.2%), and cardiac TEAEs (2.8%) were infrequent. Adjusted annualized relapse rate was 0.103 (95% confidence interval, 0.086‒0.123). Over 48 months, 71% of patients remained relapse free. Adjusted mean numbers of new/enlarging T2 lesions/scan and gadolinium-enhancing lesions were low and similar across parent trial treatment subgroups.
This long-term extension of ozanimod trials confirmed a favorable safety/tolerability profile and sustained benefit on clinical and magnetic resonance imaging measures of disease activity.
奥扎尼莫德是一种鞘氨醇 1-磷酸受体 1 和 5 调节剂，已在多个国家获得批准用于治疗复发型多发性硬化症。
评估奥扎尼莫德的长期安全性和疗效。
完成奥扎尼莫德 1-3 期试验的复发型多发性硬化症患者有资格参加奥扎尼莫德 0.92mg/d 的开放标签扩展研究（DAYBREAK）。DAYBREAK 于 2015 年 10 月 16 日开始；本中期分析的截止日期为 2021 年 2 月 2 日。
本分析包括 2494 名参与者，在 DAYBREAK 中奥扎尼莫德暴露的平均时间为 46.8（SD 11.9；范围 0.033-62.7）个月。在 DAYBREAK 期间，2143 名患者（85.9%）出现治疗后出现的不良事件（TEAEs；与亲本试验中的 TEAEs 性质相似），298 名患者（11.9%）发生严重 TEAEs，75 名患者（3.0%）因 TEAEs 而停止治疗。严重感染（2.8%）、带状疱疹感染（1.7%）、确诊性黄斑水肿病例（0.2%）和心脏 TEAEs（2.8%）较为少见。调整后的年复发率为 0.103（95%置信区间，0.086-0.123）。在 48 个月期间，71%的患者保持无复发。调整后的新发/扩大 T2 病变/扫描和钆增强病变的平均数量较低，且在亲本试验治疗亚组中相似。
本奥扎尼莫德试验的长期扩展研究证实了其具有良好的安全性/耐受性，并且持续有益于疾病活动的临床和磁共振成像指标。
