0000000000560320

AUTHOR

A. Covezzoli

showing 3 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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Three years of experience : the Italian registry and safety data update

2011

At the end of 2006, a pharmacovigilance program on natalizumab was settled by the Italian Pharmaceutical Agency, and on January 2007, multiple sclerosis patients poorly responding to the immunomodulating therapies or with an aggressive clinical form of disease from onset initiated to be registered and to receive the medication. On February 2010, almost 3,000 cases have been treated with natalizumab. The drop-out rate is 10%. Almost 800 cases received cycles of natalizumab for more than 18 months. One case of PML was reported and other adverse events are similar to those described in phase III studies. The majority of cases remained stable, while in 25% of cases, an improvement of disability…

AdultMalemedicine.medical_specialtyPediatricsMultiple SclerosisDermatologyDiseaseAntibodies Monoclonal HumanizedNatalizumabPharmacovigilanceProduct Surveillance PostmarketingmedicineHumansRegistriesAdverse effectbusiness.industryNatalizumabMultiple sclerosisGeneral Medicinemedicine.diseasePsychiatry and Mental healthItalyPHARMACOVIGILANCEREGISTRYsurveillance program; pharmacovigilance; multiple sclerosis; natalizumabPhysical therapyFemaleSettore MED/26 - NeurologiaNeurology (clinical)NeurosurgerybusinessMultiple sclerosis NatalizumabSurveillance program Pharmacovigilancemedicine.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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