多发性硬化是一种以中枢神经系统炎性脱髓鞘病变为主要特点的免疫介导性疾病，其病因尚不明确，可能与遗传、环境、病毒感染等多种因素相关^{[1]<\/span><\/sup>。髓鞘损伤会干扰大脑与身体其他部位之间的通信^{[3]<\/span><\/sup>，最终导致神经退行性损害，这一过程目前尚不可逆^{[15]<\/span><\/sup>。<\/p> \n}}}

复发型多发性硬化症包括临床孤立综合征、复发-缓解型疾病和活动性继发进展型疾病^{[16]<\/span><\/sup>。其中，复发-缓解型疾病是诊断时最常见的类型，80%-85%的患者初诊时被诊断为复发-缓解型疾病，其表现为明显的复发和缓解过程，每次发作后均基本恢复，不留或仅留下轻微后遗症^{[1]<\/span><\/sup>。约10%-15%的患者被诊断为进展型疾病^{[16]<\/span><\/sup>。<\/p> \n}}}

关于<\/span><\/strong>SUNBEAM<\/span><\/strong>和<\/span><\/strong>RADIANCE<\/span><\/strong>研究<\/span><\/strong> <\/p> \n

SUNBEAM研究和RADIANCE研究均为全球多中心、随机、双盲、阳性药物平行对照的III期临床研究，旨在评估奥扎莫德两种口服剂量（0.92mg和0.46mg，每日一次）与干扰素β-1a相比，治疗成人复发型多发性硬化患者的疗效和安全性。前者共纳入1346例患者，为期12个月；后者共纳入1320例患者，为期24个月。<\/p> \n

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

SUNBEAM<\/strong>（<\/strong>12<\/strong>个月）及<\/strong>RADIANCE<\/strong>（<\/strong>24<\/strong>个月）主要研究结果数据汇总<\/strong><\/span><\/p> <\/td> \n <\/tr> \n

研究终点<\/strong><\/span><\/p> <\/td> \n

时间<\/strong><\/span><\/p> <\/td> \n

奥扎莫德组<\/em><\/strong><\/span><\/p> <\/td> \n

干扰素β<\/strong><\/em>-1a<\/strong><\/em>组<\/strong><\/em><\/span><\/p> <\/td> \n

对比对照药物组的<\/strong>P<\/strong>值<\/strong><\/span><\/p> <\/td> \n <\/tr> \n

ARR <\/span><\/p> <\/td> \n

12<\/span>个月<\/span><\/p> <\/td> \n

0.18<\/span><\/p> <\/td> \n

0.35<\/span><\/p> <\/td> \n

P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n

24<\/span>个月<\/span><\/p> <\/td> \n

0.17<\/span><\/p> <\/td> \n

0.28<\/span><\/p> <\/td> \n

P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n

T1<\/span>加权<\/span>GdE<\/span>病灶平均数量<\/span><\/p> <\/td> \n

12<\/span>个月<\/span><\/p> <\/td> \n

0.16<\/span><\/p> <\/td> \n

0.43<\/span><\/p> <\/td> \n

P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n

24<\/span>个月<\/span><\/p> <\/td> \n

0.18<\/span><\/p> <\/td> \n

0.37<\/span><\/p> <\/td> \n

P=0.0006<\/span><\/p> <\/td> \n <\/tr> \n

新发<\/span>\/<\/span>扩大<\/span>T2<\/span>病灶平均数量<\/span><\/p> <\/td> \n

12<\/span>个月<\/span><\/p> <\/td> \n

1.47<\/span><\/p> <\/td> \n

2.84<\/span><\/p> <\/td> \n

P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n

24<\/span>个月<\/span><\/p> <\/td> \n

1.84<\/span><\/p> <\/td> \n

3.18<\/span><\/p> <\/td> \n

P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n

与基线相比，全脑容量平均百分比下降（<\/span>%<\/span>）<\/span><\/p> <\/td> \n

12<\/span>个月<\/span><\/p> <\/td> \n

-0.41<\/span><\/p> <\/td> \n

-0.61<\/span><\/p> <\/td> \n

P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n

24<\/span>个月<\/span><\/p> <\/td> \n

-0.71<\/span><\/p> <\/td> \n

-0.94<\/span><\/p> <\/td> \n

P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n

与基线相比，皮层灰质容量平均百分比下降（<\/span>%<\/span>）<\/span><\/p> <\/td> \n

12<\/span>个月<\/span><\/p> <\/td> \n

-0.16<\/span><\/p> <\/td> \n

-1.00<\/span><\/p> <\/td> \n

P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n

24<\/span>个月<\/span><\/p> <\/td> \n

-0.44<\/span><\/p> <\/td> \n

-1.11<\/span><\/p> <\/td> \n

P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n

与基线相比，丘脑容量平均百分比下降（<\/span>%<\/span>）<\/span><\/p> <\/td> \n

12<\/span>个月<\/span><\/p> <\/td> \n

-1.12<\/span><\/p> <\/td> \n

-1.72<\/span><\/p> <\/td> \n

P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n

24<\/span>个月<\/span><\/p> <\/td> \n

-1.40<\/span><\/p> <\/td> \n

-1.85<\/span><\/p> <\/td> \n

P=0.0004<\/span><\/p> <\/td> \n <\/tr> \n

SDMT<\/span>评分有临床意义改善的患者比例<\/span><\/p> <\/td> \n

12<\/span>个月<\/span><\/p> <\/td> \n

35.6 %<\/span><\/p> <\/td> \n

27.9 %<\/span><\/p> <\/td> \n

P=0.0302<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n
关于热珀西亚<\/span><\/strong>^{®<\/sup><\/span><\/strong>（盐酸奥扎莫德胶囊）<\/span><\/strong><\/p> \n}
热珀西亚<\/em>是一种口服鞘氨醇1-磷酸（S1P）受体调节剂，可高亲和力结合S1P受体1和5（S1P_{1<\/sub>和S1P_{5<\/sub>）^{[14]<\/span><\/sup>。热珀西亚<\/em>可适度抑制淋巴细胞迁出，减少外周血中淋巴细胞数量^{[14]<\/span><\/sup>。热珀西亚<\/em>对多发性硬化发挥治疗作用的机制尚不完全明确，可能与减少淋巴细胞向中枢神经系统的迁移相关^{[14]<\/span><\/sup>。<\/p> \n}}}}}
热珀西亚<\/em>是全球首个同时获批复发型多发性硬化和溃疡性结肠炎这两项适应症的S1P受体调节剂：美国食品药品监督管理局（FDA）分别于2020年3月和2021年5月批准热珀西亚<\/em>用于治疗成人复发型多发性硬化症和中度至重度活动性溃疡性结肠炎成人患者；欧盟委员会（EC）则分别于2020年5月和2021年11月批准热珀西亚<\/em>用于治疗由临床或影像学特征定义的活动性复发缓解型多发性硬化症成人患者和对常规疗法或生物制剂应答不足、失应答或不耐受的中度至重度活动性溃疡性结肠炎成人患者。<\/p> \n
此外，针对热珀西亚<\/em>治疗克罗恩病的临床研究也正在全球范围内开展中。<\/p> \n
注：热珀西亚溃疡性结肠炎和克罗恩病适应症尚未在中国获批<\/em><\/p> \n
关于百时美施贵宝中国<\/span><\/strong><\/p> \n
百时美施贵宝是一家以"研发并提供创新药物，帮助患者战胜严重疾病"为使命的全球性生物制药公司。在中国，公司在肝炎和免疫肿瘤等领域处于行业领先地位，并致力于在免疫肿瘤、血液学、免疫学等领域引入突破性创新产品，引领科学，改变患者生命。<\/p> \n
如需了解更多信息，请浏览百时美施贵宝中国官方网站www.bms.com.cn<\/a> 或关注百时美施贵宝中国官方微信<\/span>。<\/p> \n
新基与朱诺医疗是百时美施贵宝公司的全资子公司。在美国以外的部分市场，鉴于当地法律，新基和朱诺医疗分别被称之为新基-- 一家百时美施贵宝的公司和朱诺医疗 -- 一家百时美施贵宝的公司。<\/p> \n
^{[1] 《多发性硬化诊断和治疗中国专家共识（2018版）》，中国神经免疫学和神经病学杂志2018年11月第25卷第6期 Chin J Neuroimmunol & Neurol 2018，Vol.25，No.6，387:394<\/sup>
^{[2] National Multiple Sclerosis Society. Definition of MS.}}www.nationalmssociety.org\/What-is-MS\/Definition-of-MS<\/a>. Accessed on March 25, 2020<\/span>.<\/sup>
^{[3] National Multiple Sclerosis Society. What is Myelin?}www.nationalmssociety.org\/What-is-MS\/Definition-of-MS\/Myelin<\/a>. Accessed March 25, 2020<\/span>.<\/sup>
^{[4] National Multiple Sclerosis Society. MS Symptoms.}www.nationalmssociety.org\/Symptoms-Diagnosis\/MS-Symptoms<\/a>. Accessed March 25, 2020<\/span>.<\/sup>
^{[5] MS Atlas Report 2013.}http:\/\/www.msif.org\/wp-content\/uploads\/2014\/09\/Atlas-of-MS.pdf<\/a>. Accessed May 24, 2017<\/span>.<\/sup>
^{[6] Manca R, et al. J Neurol Sci. 2018;388:115-127.<\/sup>
^{[7] Sumowski JF, et al. Neurology. 2018;90:278-288<\/sup>
^{[8] Campbell J, et al. Postgrad Med J. 2017;93(1097):143-147.<\/sup>
^{[9] Deloire, et al. Multiple Sclerosis 2010;16:581–587.<\/sup>
^{[10] Sormani MP, et al. Mult Scler. 2017 Apr;23(5):656-664.<\/sup>
^{[11] Pitteri M, et al. Mult Scler. 2017;23(6):848-854.<\/sup>
^{[12] Comi, G, Kappos, L, Selmaj, KW, et at. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicenter, randomized, minimum 12-month, phase 3 trial. The Lancet: Neurology. DOI: 10.1016\/S1474-4422(19)30239-X.<\/sup>
^{[13] Cohen, JA, Comi, G, Selmaj, KW, et al. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicenter, randomized, 24-month, phase 3 trial. The Lancet: Neurology. DOI: 10.1016\/S1474-4422(19)30238-8.<\/sup>
^{[14] ZEPOSIA (ozanimod) capsules for oral use. Bristol Myers Squibb Pharmaceutical Corporation. Full prescribing information. 3\/2020.<\/sup>
^{[15] National Multiple Sclerosis Society. What Causes MS?}}}}}}}}}}www.nationalmssociety.org\/What-is-MS\/What-Causes-MS<\/a>. Accessed March 25, 2020<\/span>.<\/sup>
^{[16] National Multiple Sclerosis Society. Types of MS.}www.nationalmssociety.org\/What-is-MS\/Types-of-MS<\/a>. Accessed March 25, 2020<\/span>.<\/sup><\/p> \n
<\/p>"]; $("#dvExtra").html(content_array[0]);})();

SUNBEAM<\/strong>（<\/strong>12<\/strong>个月）及<\/strong>RADIANCE<\/strong>（<\/strong>24<\/strong>个月）主要研究结果数据汇总<\/strong><\/span><\/p> <\/td> \n <\/tr> \n
研究终点<\/strong><\/span><\/p> <\/td> \n	时间<\/strong><\/span><\/p> <\/td> \n	*奥扎莫德组<\/em><\/strong><\/span><\/p> <\/td> \n*	干扰素β<\/strong><\/em>-1a<\/strong><\/em>组<\/strong><\/em><\/span><\/p> <\/td> \n	对比对照药物组的<\/strong>P<\/strong>值<\/strong><\/span><\/p> <\/td> \n <\/tr> \n
ARR <\/span><\/p> <\/td> \n	12<\/span>个月<\/span><\/p> <\/td> \n	0.18<\/span><\/p> <\/td> \n	0.35<\/span><\/p> <\/td> \n	P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
24<\/span>个月<\/span><\/p> <\/td> \n	0.17<\/span><\/p> <\/td> \n	0.28<\/span><\/p> <\/td> \n	P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
T1<\/span>加权<\/span>GdE<\/span>病灶平均数量<\/span><\/p> <\/td> \n	12<\/span>个月<\/span><\/p> <\/td> \n	0.16<\/span><\/p> <\/td> \n	0.43<\/span><\/p> <\/td> \n	P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
24<\/span>个月<\/span><\/p> <\/td> \n	0.18<\/span><\/p> <\/td> \n	0.37<\/span><\/p> <\/td> \n	P=0.0006<\/span><\/p> <\/td> \n <\/tr> \n
新发<\/span>\/<\/span>扩大<\/span>T2<\/span>病灶平均数量<\/span><\/p> <\/td> \n	12<\/span>个月<\/span><\/p> <\/td> \n	1.47<\/span><\/p> <\/td> \n	2.84<\/span><\/p> <\/td> \n	P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
24<\/span>个月<\/span><\/p> <\/td> \n	1.84<\/span><\/p> <\/td> \n	3.18<\/span><\/p> <\/td> \n	P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
与基线相比，全脑容量平均百分比下降（<\/span>%<\/span>）<\/span><\/p> <\/td> \n	12<\/span>个月<\/span><\/p> <\/td> \n	-0.41<\/span><\/p> <\/td> \n	-0.61<\/span><\/p> <\/td> \n	P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
24<\/span>个月<\/span><\/p> <\/td> \n	-0.71<\/span><\/p> <\/td> \n	-0.94<\/span><\/p> <\/td> \n	P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
与基线相比，皮层灰质容量平均百分比下降（<\/span>%<\/span>）<\/span><\/p> <\/td> \n	12<\/span>个月<\/span><\/p> <\/td> \n	-0.16<\/span><\/p> <\/td> \n	-1.00<\/span><\/p> <\/td> \n	P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
24<\/span>个月<\/span><\/p> <\/td> \n	-0.44<\/span><\/p> <\/td> \n	-1.11<\/span><\/p> <\/td> \n	P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
与基线相比，丘脑容量平均百分比下降（<\/span>%<\/span>）<\/span><\/p> <\/td> \n	12<\/span>个月<\/span><\/p> <\/td> \n	-1.12<\/span><\/p> <\/td> \n	-1.72<\/span><\/p> <\/td> \n	P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
24<\/span>个月<\/span><\/p> <\/td> \n	-1.40<\/span><\/p> <\/td> \n	-1.85<\/span><\/p> <\/td> \n	P=0.0004<\/span><\/p> <\/td> \n <\/tr> \n
SDMT<\/span>评分有临床意义改善的患者比例<\/span><\/p> <\/td> \n	12<\/span>个月<\/span><\/p> <\/td> \n	35.6 %<\/span><\/p> <\/td> \n	27.9 %<\/span><\/p> <\/td> \n	P=0.0302<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n 关于热珀西亚<\/span><\/strong>^{®<\/sup><\/span><\/strong>（盐酸奥扎莫德胶囊）<\/span><\/strong><\/p> \n} 热珀西亚<\/em>是一种口服鞘氨醇1-磷酸（S1P）受体调节剂，可高亲和力结合S1P受体1和5（S1P_{1<\/sub>和S1P_{5<\/sub>）^{[14]<\/span><\/sup>。热珀西亚<\/em>可适度抑制淋巴细胞迁出，减少外周血中淋巴细胞数量^{[14]<\/span><\/sup>。热珀西亚<\/em>对多发性硬化发挥治疗作用的机制尚不完全明确，可能与减少淋巴细胞向中枢神经系统的迁移相关^{[14]<\/span><\/sup>。<\/p> \n}}}}} 热珀西亚<\/em>是全球首个同时获批复发型多发性硬化和溃疡性结肠炎这两项适应症的S1P受体调节剂：美国食品药品监督管理局（FDA）分别于2020年3月和2021年5月批准热珀西亚<\/em>用于治疗成人复发型多发性硬化症和中度至重度活动性溃疡性结肠炎成人患者；欧盟委员会（EC）则分别于2020年5月和2021年11月批准热珀西亚<\/em>用于治疗由临床或影像学特征定义的活动性复发缓解型多发性硬化症成人患者和对常规疗法或生物制剂应答不足、失应答或不耐受的中度至重度活动性溃疡性结肠炎成人患者。<\/p> \n 此外，针对热珀西亚<\/em>治疗克罗恩病的临床研究也正在全球范围内开展中。<\/p> \n *注：热珀西亚溃疡性结肠炎和克罗恩病适应症尚未在中国获批<\/em><\/p> \n* 关于百时美施贵宝中国<\/span><\/strong><\/p> \n 百时美施贵宝是一家以"研发并提供创新药物，帮助患者战胜严重疾病"为使命的全球性生物制药公司。在中国，公司在肝炎和免疫肿瘤等领域处于行业领先地位，并致力于在免疫肿瘤、血液学、免疫学等领域引入突破性创新产品，引领科学，改变患者生命。<\/p> \n 如需了解更多信息，请浏览百时美施贵宝中国官方网站www.bms.com.cn<\/a> 或关注百时美施贵宝中国官方微信<\/span>。<\/p> \n 新基与朱诺医疗是百时美施贵宝公司的全资子公司。在美国以外的部分市场，鉴于当地法律，新基和朱诺医疗分别被称之为新基-- 一家百时美施贵宝的公司和朱诺医疗 -- 一家百时美施贵宝的公司。<\/p> \n ^{[1] 《多发性硬化诊断和治疗中国专家共识（2018版）》，中国神经免疫学和神经病学杂志2018年11月第25卷第6期 Chin J Neuroimmunol & Neurol 2018，Vol.25，No.6，387:394<\/sup> ^{[2] National Multiple Sclerosis Society. Definition of MS.}}www.nationalmssociety.org\/What-is-MS\/Definition-of-MS<\/a>. Accessed on March 25, 2020<\/span>.<\/sup> ^{[3] National Multiple Sclerosis Society. What is Myelin?}www.nationalmssociety.org\/What-is-MS\/Definition-of-MS\/Myelin<\/a>. Accessed March 25, 2020<\/span>.<\/sup> ^{[4] National Multiple Sclerosis Society. MS Symptoms.}www.nationalmssociety.org\/Symptoms-Diagnosis\/MS-Symptoms<\/a>. Accessed March 25, 2020<\/span>.<\/sup> ^{[5] MS Atlas Report 2013.}http:\/\/www.msif.org\/wp-content\/uploads\/2014\/09\/Atlas-of-MS.pdf<\/a>. Accessed May 24, 2017<\/span>.<\/sup> ^{[6] Manca R, et al. J Neurol Sci. 2018;388:115-127.<\/sup> ^{[7] Sumowski JF, et al. Neurology. 2018;90:278-288<\/sup> ^{[8] Campbell J, et al. Postgrad Med J. 2017;93(1097):143-147.<\/sup> ^{[9] Deloire, et al. Multiple Sclerosis 2010;16:581–587.<\/sup> ^{[10] Sormani MP, et al. Mult Scler. 2017 Apr;23(5):656-664.<\/sup> ^{[11] Pitteri M, et al. Mult Scler. 2017;23(6):848-854.<\/sup> ^{[12] Comi, G, Kappos, L, Selmaj, KW, et at. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicenter, randomized, minimum 12-month, phase 3 trial. The Lancet: Neurology. DOI: 10.1016\/S1474-4422(19)30239-X.<\/sup> ^{[13] Cohen, JA, Comi, G, Selmaj, KW, et al. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicenter, randomized, 24-month, phase 3 trial. The Lancet: Neurology. DOI: 10.1016\/S1474-4422(19)30238-8.<\/sup> ^{[14] ZEPOSIA (ozanimod) capsules for oral use. Bristol Myers Squibb Pharmaceutical Corporation. Full prescribing information. 3\/2020.<\/sup> ^{[15] National Multiple Sclerosis Society. What Causes MS?}}}}}}}}}}www.nationalmssociety.org\/What-is-MS\/What-Causes-MS<\/a>. Accessed March 25, 2020<\/span>.<\/sup> ^{[16] National Multiple Sclerosis Society. Types of MS.}www.nationalmssociety.org\/What-is-MS\/Types-of-MS<\/a>. Accessed March 25, 2020<\/span>.<\/sup><\/p> \n <\/p>"]; $("#dvExtra").html(content_array[0]);})();