(3)2组有0.5%的患者出现钆(Gd)增强T1病变。NOVA研究是在对TOUCH处方项目进行分析之后启动的,旨在评估Tysabri Q6W IV给药方案的疗效。TOUCH处方项目分析显示,延长的给药间隔与PML概率的显著降低相关。来自TOUCH研究的最新数据分析表明,与批准的Q4W IV方案相比,平均Q6W给药方案与PML概率降低88%相关(危险比0...
5.2.TYSABRITOUCHPrescribingProgram TYSABRIisavailableonlythrougharestrictedprogramunderaREMScalledtheTOUCH® PrescribingProgrambecauseoftheriskofPML[seeWarningsandPrecautions(5.1)]. ReferenceID: ® Forprescribersandpatients,theTOUCHPrescribingProgramhastwocomponents:MS ®® TOUCH(forpatientswithmultiplesclerosis)...
TOUCHPrescribingProgram(TYSABRIOutreach; UnifiedCommitmenttoHealth) ♦ StatusupdateonMSriskmanagementplan ♦ Changestoriskmanagementplanwithaddition ofCDindication 3 TYSABRIRiskManagementGoals ♦ GoalsandactivitiesdevelopedincollaborationwithFDA ♦ Riskminimization ...
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