0000000000329306

AUTHOR

Deotto L.

showing 2 related works from this author

Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial

2014

BACKGROUND: In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. First dose administration of fingolimod is associated with a transient, dose-dependent decrease in heart rate (HR) in the 6 hours after drug intake.The aim of the study is to to assess safety and tolerability of the first dose of fingolimod in a cohort of Italian patients with RRMS without alternative therapeutic options. METHODS: Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and had their vital signs monitored hourly. Extended on-site monitoring was provided when required. RESULTS: Of the 906 p…

OncologyMaleNeurologyfingolimod multiple sclerosis treatment first dose safetyadministration /&/ dosage/adverse effects/analogs /&/ derivatives/therapeutic useImmunosuppressive AgentSphingosineMultiple SclerosiAtrioventricular Blockadministration /&/ dosage/adverse effects/therapeutic useGeneral MedicineMiddle AgedTolerabilityPropylene GlycolFingolimoddrug therapyTolerabilityAnesthesiaCohortAdolescent Adult Atrioventricular Block; chemically induced/epidemiology Drug Therapy; Combination Female Humans Immunosuppressive Agents; administration /&/ dosage/adverse effects/therapeutic use Male Middle Aged Multiple Sclerosis; drug therapy Propylene Glycols; administration /&/ dosage/adverse effects/therapeutic use Sphingosine; administration /&/ dosage/adverse effects/analogs /&/ derivatives/therapeutic use Young AdultCombinationDrug Therapy CombinationSettore MED/26 - NeurologiaFemaleAtrioventricular block; Bradycardia; Fingolimod; Multiple sclerosis; Safety; Tolerability; Adolescent; Adult; Atrioventricular Block; Drug Therapy Combination; Female; Fingolimod Hydrochloride; Humans; Immunosuppressive Agents; Male; Middle Aged; Multiple Sclerosis; Propylene Glycols; Sphingosine; Young Adult; Neurology (clinical)SafetyAtrioventricular block Bradicardia Multiple sclerosis Fingolimod Safety TolerabilityImmunosuppressive AgentsResearch ArticleHumanmedicine.drugAdultmedicine.medical_specialtyMultiple SclerosisAdolescentClinical NeurologyYoung AdultFingolimod HydrochlorideInternal medicineBradycardiamedicineHumansNeurochemistryFingolimod Hydrochloridebusiness.industryMultiple sclerosisFingolimodmedicine.diseaseClinical trialPropylene GlycolsAtrioventricular block Bradycardia Multiple sclerosis Fingolimod Safety Tolerabilitychemically induced/epidemiologyNeurology (clinical)business
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MRI activity and neutralising antibody as predictors of response to interferon beta treatment in multiple sclerosis

2008

Objective: To prospectively validate MRI activity and neutralising anti-interferon antibody (NAb) during the first 6 months of interferon β treatment as response indicators in multiple sclerosis (MS). Methods: Patients with relapsing–remitting MS were followed during the first 2 years of treatment. Neurological assessments were performed every 3 months or when a relapse was suspected. MRI scans performed at baseline and at 3, 4, 5 and 6 months after the start of treatment were assessed centrally for disease activity: new T2 or gadolinium enhancing T1 lesions. NAb were assessed using the MxA protein assay; positivity was defined as two consecutive titres ⩾20 NU/ml. We evaluated the predictiv…

MaleNeutralising antibodyMULTICENTERPLACEBO-CONTROLLED TRIALGUIDELINESGastroenterologyDOUBLE-BLINDInterferon βMAGNETIC-RESONANCEProspective StudiesNeurologic ExaminationbiologyBrainIMPAIRMENTMiddle AgedPredictive valueMagnetic Resonance ImagingRecombinant ProteinsPsychiatry and Mental healthTreatment OutcomeSettore MED/26 - NeurologiaFemaleAntibodyInterferon beta-1bAdultmedicine.medical_specialtyDIAGNOSTIC-CRITERIAInjections SubcutaneousAntibodiesDrug Administration ScheduleDisease activityMultiple Sclerosis Relapsing-RemittingAdjuvants ImmunologicNeutralization TestsInternal medicinemedicineHumansInterferon betabusiness.industryMultiple sclerosisDISABILITYMSInterferon-betamedicine.diseaseConfidence intervalSurgerybiology.proteinSurgeryNeurology (clinical)businessFollow-Up Studies
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