0000000000560318

AUTHOR

Nello Martini

showing 2 related works from this author

Natalizumab: a country-based surveillance program

2008

Natalizumab is a humanized monoclonal antibody with a selective adhesion-molecule inhibitor effect, and a demonstrated efficacy in decreasing the frequency of relapses and progression of disability in relapsing-remitting multiple sclerosis (RR MS). After the approval of FDA and EMEA in MS cases unresponsive to immunomodulating therapy or in severe MS patients also not previously treated with interferons, and considering the concern on the possible side effects, an accurate program of surveillance was organized in our country by a combined effort of AIFA, Cineca, Department of Pharmacology of University of Bologna, and a group of neurologists appointed by the National Society of Neurology (S…

AdultMalemedicine.medical_specialtyNeurologyDatabases FactualDrug-Related Side Effects and Adverse ReactionsNational Health ProgramsDrug ResistanceDermatologyDiseaseAntibodies Monoclonal HumanizedNatalizumabInternal medicineOutcome Assessment Health CareMultiple SclerosiPharmacovigilanceProduct Surveillance PostmarketingmedicineAdverse Drug Reaction Reporting SystemsHumansImmunologic FactorsMULTIPLE SCLEROSISNATALIZUMABClinical Trials as Topicbusiness.industryMultiple sclerosisAntibodies MonoclonalMean ageGeneral Medicinemedicine.diseasePsychiatry and Mental healthItalyREGISTRYPHARMACOVIGILANCEPhysical therapyFemaleSettore MED/26 - NeurologiaNeurology (clinical)NeurosurgerybusinessPreviously treatedFollow-Up Studiesmedicine.drug
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The pharmacovigilance program on natalizumab in Italy: 2 years of experience.

2009

At the end of 2006 a country-based surveillance program on natalizumab therapy in multiple sclerosis was settled in Italy by a collaborative effort of the Italian Drug Agency (AIFA) and a group of experts and neurologists appointed by the National Society of Neurology (SIN). After 2 years, 1,818 patients are registered in the database. The majority of cases (88.6%) failed the therapy with beta interferon or glatiramer acetate and had relapses or accumulated disability during immunomodulating treatment, while 11.4% of patients enrolled in the surveillance study were not previously treated with immunomodulating therapies and had a rapidly evolving clinical course. Almost 10% of the patients t…

AdultMalemedicine.medical_specialtyPediatricsNeurologyMultiple SclerosisPatient DropoutsDatabases FactualAlternative medicineDermatologyPharmacologyAntibodies Monoclonal HumanizedNatalizumabPharmacovigilanceProduct Surveillance PostmarketingMedicineHumansGlatiramer acetateMultiple sclerosis NatalizumabSurveillance programPharmacovigilancebusiness.industryMultiple sclerosisNatalizumabAntibodies MonoclonalDrug agencyGeneral Medicinemedicine.diseaseMagnetic Resonance ImagingPsychiatry and Mental healthItalyPHARMACOVIGILANCEREGISTRYSettore MED/26 - NeurologiaFemaleNeurology (clinical)Neurosurgerybusinessmedicine.drugFollow-Up StudiesNeurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
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