Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial

医学 人口 内科学 临床终点 安慰剂 临床试验 物理疗法 病理 替代医学 环境卫生
作者
Gıancarlo Comı,Ludwig Kappos,Krzysztof Selmaj,Amit Bar‐Or,Douglas L. Arnold,Lawrence Steinman,Hans‐Peter Hartung,Xavier Montalbán,Eva Havrdová,Bruce Cree,James K. Sheffield,Neil Minton,Kartik Raghupathi,Ning Ding,Jeffrey A. Cohen
出处
期刊:Lancet Neurology [Elsevier BV]
卷期号:18 (11): 1009-1020 被引量:236
标识
DOI:10.1016/s1474-4422(19)30239-x
摘要

Ozanimod, a sphingosine 1-phosphate receptor modulator, selectively binds to receptor subtypes 1 and 5 with high affinity. The RADIANCE phase 2 study showed that ozanimod had better efficacy than placebo on MRI measures, with a favourable safety profile, in participants with relapsing multiple sclerosis. The SUNBEAM study aimed to assess the safety and efficacy of ozanimod versus intramuscular interferon beta-1a in participants with relapsing multiple sclerosis.SUNBEAM was a randomised, double-blind, double-dummy, active-controlled phase 3 trial done at 152 academic medical centres and clinical practices in 20 countries. We enrolled participants aged 18-55 years with relapsing multiple sclerosis, baseline expanded disability status scale (EDSS) score of 0·0-5·0, and either at least one relapse within the 12 months before screening or at least one relapse within 24 months plus at least one gadolinium-enhancing lesion within 12 months before screening. Participants were randomly assigned 1:1:1 by a blocked algorithm stratified by country and baseline EDSS score to at least 12 months treatment of either once-daily oral ozanimod 1·0 mg or 0·5 mg or weekly intramuscular interferon beta-1a 30 μg. Participants, investigators, and study staff were masked to treatment assignment. The primary endpoint was annualised relapse rate (ARR) during the treatment period and was assessed in the intention-to-treat population. Safety was assessed in all participants according to the highest dose of ozanimod received. This trial is registered at ClinicalTrials.gov, number NCT02294058 and EudraCT, number 2014-002320-27.Between Dec 18, 2014, and Nov 12, 2015, 1346 participants were enrolled and randomly assigned to ozanimod 1·0 mg (n=447), ozanimod 0·5 mg (n=451), or interferon beta-1a (n=448). 91 (6·8%) participants discontinued the study drug (29 in the ozanimod 1·0 mg group; 26 in the ozanimod 0·5 mg group; and 36 in the interferon beta-1a group). Adjusted ARRs were 0·35 (0·28-0·44) for interferon beta-1a, 0·18 (95% CI 0·14-0·24) for ozanimod 1·0 mg (rate ratio [RR] of 0·52 [0·41-0·66] vs interferon beta-1a; p<0·0001), and 0·24 (0·19-0·31) for ozanimod 0·5 mg (RR 0·69 [0·55-0·86] vs interferon beta-1a; p=0·0013). Few ozanimod-treated participants discontinued treatment because of adverse events (13 [2·9%] who received ozanimod 1·0 mg; seven [1·5%] who received ozanimod 0·5 mg; and 16 [3·6%] who received interferon beta-1a). No first-dose, clinically significant bradycardia or second-degree or third-degree atrioventricular block was reported. The incidence of serious adverse events was low and similar across treatment groups (13 [2·9%] participants who received ozanimod 1·0 mg; 16 [3·5%] who received ozanimod 0·5 mg; and 11 [2·5%] who received interferon beta-1a). No serious opportunistic infections occurred in ozanimod-treated participants.In participants with relapsing multiple sclerosis treated for at least 12 months, ozanimod was well tolerated and demonstrated a significantly lower relapse rate than interferon beta-1a. These findings provide support for ozanimod as an oral therapy for individuals with relapsing multiple sclerosis.Celgene International II.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
谓风完成签到,获得积分10
1秒前
恋雅颖月应助乐观的寻绿采纳,获得10
1秒前
Shrine完成签到,获得积分10
1秒前
英姑应助紫色奶萨采纳,获得10
3秒前
4秒前
5秒前
希望天下0贩的0应助Jay采纳,获得10
6秒前
6秒前
爆米花应助zewangguo采纳,获得10
7秒前
斯文败类应助loong采纳,获得10
8秒前
深情安青应助Xin采纳,获得10
9秒前
和花花发布了新的文献求助10
9秒前
摩卡完成签到,获得积分10
10秒前
11秒前
12秒前
端庄毛巾完成签到,获得积分10
12秒前
13秒前
13秒前
13秒前
张雯思发布了新的文献求助10
15秒前
ding应助Nugget采纳,获得10
15秒前
幸福大白发布了新的文献求助30
18秒前
wdy111举报ZZZ求助涉嫌违规
19秒前
zewangguo发布了新的文献求助10
19秒前
20秒前
高大的冰双完成签到,获得积分10
21秒前
23秒前
987完成签到 ,获得积分10
24秒前
loong完成签到,获得积分10
24秒前
紫色奶萨发布了新的文献求助10
25秒前
zewangguo完成签到,获得积分10
25秒前
26秒前
如意手链完成签到,获得积分10
27秒前
DongWei95发布了新的文献求助30
28秒前
锦诗完成签到,获得积分10
29秒前
isojso发布了新的文献求助10
30秒前
31秒前
科研通AI2S应助科研通管家采纳,获得10
35秒前
共享精神应助科研通管家采纳,获得10
35秒前
搜集达人应助科研通管家采纳,获得10
35秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989406
求助须知:如何正确求助?哪些是违规求助? 3531522
关于积分的说明 11254187
捐赠科研通 3270174
什么是DOI,文献DOI怎么找? 1804901
邀请新用户注册赠送积分活动 882105
科研通“疑难数据库(出版商)”最低求助积分说明 809174