文摘
摘要目的:核磁共振结果报告在本周(W) 96(2年)LTS16004 (NCT03996291),一个正在进行的长期安全性(LTS)扩展2 b阶段试验的研究(NCT03889639)tolebrutinib, brain-penetrant布鲁顿的酪氨酸激酶抑制剂在参与者复发多发性硬化症。
背景:在双盲阶段2 b阶段试验(菲律宾),tolebrutinib在12周耐受剂量依赖性降低新钆增强T1和新/扩大t2损伤。
设计/方法:在一个LTS一部分,参与者继续接受他们菲律宾tolebrutinib剂量(5、15、30或60毫克/天),直到第三阶段剂量的选择。在非盲B部分,所有的参与者收到60毫克/天。核磁共振结果包括数量的新钆增强T1和新/扩大t2损伤,T2-lesion体积变化,慢慢进化病变(选取),顺rim病变(PRL)。
结果:124/125的参与者完成了部分和转换到B部分;114例(90.5%)仍在研究2022年2月18日(W96截止)。平均年龄±SD在菲律宾基线为37.7±9.6年(范围19-56);69%是女性。新钆增强病灶数保持在低位60/60-mg臂通过W96和减少在其他武器W48 W96 (W96意味着±SD: 0.85±2.5, 0.41±0.91, 0.90±2.16, 0.31±0.66, 5/60, 15/60, 30/60, 60/60-mg武器,分别)。新的60/60-mg /扩大T2-lesion数量保持在低位。60/60-mg T2-lesion体积变化保持在低位(W96 vs基线(平均数±标准差):+ 0.38±2.11厘米3)。中位数(差)W96选取体积是247.5(84 - 420),258(66 - 906),570(133.5 -1011)和244.5(87 - 939)毫米35/60——15/60——30/60,60/60-mg,分别。PRL数保持不变在18个参与者;2过1 PRL在基线但W96,和3有1 - 3额外PRL W96 vs基线(60/60-mg手臂没有)。
结论:新钆增强病灶数保持在低位tolebrutinib 60/60-mg和在低剂量减少武器通过W96 W48,当所有参与者转向60毫克。
披露:Reich博士收到NIH的研究支持。帝国已经收到博士研究的机构支持顶点药品。帝国已经收到博士研究的机构阿德尔森医疗研究基金会的支持。帝国已经收到博士研究的机构支持髓修复的基础。Reich博士的机构已经接到Sanofi-Genzyme研究支持。Reich博士的机构收到Abata疗法的研究支持。帝国已经收到博士研究的机构国家多发性硬化症协会的支持。Reich博士已经收到个人薪酬在500 - 4999美元的范围作为CME与PeerView教员。Reich博士已经收到个人薪酬在500 - 4999美元的范围作为CME与AcademicCME教员。Reich博士与Sanofi-Genzyme顾问关系non-compensated河畔相关利益或活动。 Dr. Reich has a non-compensated relationship as a Board of Directors with ACTRIMS that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with Abata Therapeutics that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with Roche that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with American Brain Foundation that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with University of Basel RC2NB that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with Multiple Sclerosis Society of Canada that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with Tuscan Doctorate in Neuroscience that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Editorial Board with Multiple Sclerosis Journal that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with Glaxo-Smith-Kline that is relevant to AAN interests or activities. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi Genzyme. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi Genzyme. The institution of Dr. Traboulsee has received research support from Roche. The institution of Dr. Traboulsee has received research support from Genzyme. Dr. Syed has received personal compensation for serving as an employee of Sanofi US. Dr. Xu has received personal compensation for serving as an employee of Sanofi. Timothy J. Turner has received personal compensation for serving as an employee of Sanofi. Timothy J. Turner has received stock or an ownership interest from Sanofi. Timothy J. Turner has received intellectual property interests from a discovery or technology relating to health care. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Celgene. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Frequency Therapeutics. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xfacto communications. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Arnold has stock in NeuroRx.
