AUTHOR=Sun Yue , Yang Yanbo , Wang Zilan , Jiang Fan , Chen Zhouqing , Wang Zhong 

TITLE=Ozanimod for Treatment of Relapsing-Remitting Multiple Sclerosis in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 11 - 2020

YEAR=2020

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2020.589146

DOI=10.3389/fphar.2020.589146

ISSN=1663-9812

ABSTRACT=Ozanimod has been approved for use in the treatment of relapsing forms of multiple sclerosis by the US FDA. As a novel, orally available sphingosine 1-phosphate receptor modulator, ozanimod selectively binds to S1P1 and S1P5 receptor with high affinity, minimizing safety concerns caused by S1P3 receptor activation. We systematically searched PUBMED, EMBASE database, and Cochrane Library database to identify randomized controlled trials (RCTs) from inception to June 28, 2020. Trials were considered eligible if they (1) were randomized clinical trials (RCTs); (2) enrolled adult participants diagnosed with RRMS; (3) compared ozanimod with placebo or any other approved DMDs that evaluated in phase III or phase II clinical trials; (4) enrolled over 100 participants; (5)provided any available information for predefined primary or secondary outcomes.  2917 participants from 3 high-quality, multi-centered randomized clinical trials were pooled in our analysis. We found that using ozanimod was significantly associated with the reduction of the annualized relapse rate during the treatment period. Also, the decreased number of gadolinium-enhancing lesions at the end of the trial was relative to the treatment of ozanimod. Compared with patients in the control group, the number of new or enlarging T2 lesions over the treatment period decreased in patients treated with ozanimod . As to the safety endpoints, patients in the ozanimod group reported a lower rate of adverse events . Similar incidence of infection-related TEAEs was found across treatment groups. No case of macular oedema was noted as well as second-degree, type 2, or third-degree atrioventricular block. As for the subgroup analysis, compared with 0.5mg ozanimod, 1mg ozanimod is related with a significant reduction of the annualized relapse rate during the treatment period and a decreased number of new or enlarging T2 lesions over the treatment period. No significant difference in causing adverse events between 1mg and 0.5mg was found.