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CNS Drugs. 2024 Nov;38(11):931-941. doi: 10.1007/s40263-024-01116-w. Epub 2024 Oct 5.
Ozanimod (Zeposia), an orally administered sphingosine 1-phosphate (S1P) receptor modulator (S1PRM) that is selective for the S1P and S1P receptor subtypes, is approved in the USA for relapsing forms of multiple sclerosis (RMS). In pivotal phase III clinical trials in patients with RMS, ozanimod significantly reduced annualised relapse rates and the number of new or enlarging T2 lesions and gadolinium-enhancing lesions, and was associated with reduced brain volume loss, compared with interferon (IFN)-β1a. However, there were no significant differences in 3- and 6-month disability progression between the groups. Ozanimod was generally well tolerated, with the most common adverse reactions including upper respiratory tract infection and hepatic transaminase elevation. Efficacy and tolerability were sustained over more than 6 years with continued treatment. S1PRM-related adverse events seen with ozanimod are generally manageable with screening and/or monitoring. Notably, ozanimod does not require first-dose cardiac monitoring in the USA. In conclusion, ozanimod is a valuable once-daily oral disease-modifying therapy that extends the available treatment options for patients with RMS.
奥扎尼莫德(Zeposia),一种口服鞘氨醇 1-磷酸(S1P)受体调节剂(S1PRM),对 S1P 和 S1P 受体亚型具有选择性,已获美国批准用于治疗多发性硬化症(MS)的复发型。在奥扎尼莫德治疗 MS 的关键性 III 期临床试验中,与干扰素(IFN)-β1a 相比,奥扎尼莫德显著降低了年复发率和新发病灶或扩大 T2 病灶及钆增强病灶的数量,并与脑容量减少减少相关。然而,两组间 3 个月和 6 个月残疾进展无显著差异。奥扎尼莫德总体耐受性良好,最常见的不良反应包括上呼吸道感染和肝转氨酶升高。继续治疗超过 6 年,疗效和耐受性得以维持。奥扎尼莫德相关的 S1PRM 不良反应通常可通过筛查和/或监测进行管理。值得注意的是,奥扎尼莫德在美国不需要首剂量心脏监测。总之,奥扎尼莫德是一种有价值的每日一次口服疾病修正治疗药物,为 RMS 患者提供了更多的治疗选择。