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RESEARCH PRODUCT

The Italian Multiple Sclerosis Database Network (MSDN): The risk of worsening according to IFNβ exposure in multiple sclerosis

M TrojanoP RussoA FuianiD PaolicelliE Di MonteEnrico Gavino Giuseppe GranieriG RosatiG SavettieriG ComiP Livrea Msdn Study Group

subject

AdultMaleTime Factorscomputer.software_genreCentral nervous system diseaseCohort Studies03 medical and health sciencesDisability Evaluation0302 clinical medicineAdjuvants ImmunologicmedicineHumansImmunologic Factors030212 general & internal medicineRisk factorMULTIPLE SCLEROSISDemographyProportional Hazards ModelsRISKAnalysis of VarianceDatabasebusiness.industryProportional hazards modelMultiple sclerosisInterferon-betaIFNP; Long term effectiveness; Multiple sclerosis; Observational studies;Middle Agedmedicine.diseaseTreatment OutcomeNeurologyDatabases as TopicItalyPropensity score matchingDisease ProgressionRegression AnalysisObservational studyFemaleNeurology (clinical)Analysis of variancebusinesscomputer030217 neurology & neurosurgeryCohort study

description

We evaluated the risk of worsening according to the length of exposure to interferon beta (IFNβ)ina large cohort of 2090 multiple sclerosis patients collected by the Italian MS Database Network. Overall 44-140 patient-visits with a follow-up of 22-143 patient-years were evaluated. Forty-one per cent of patients were exposed to IFNβ for up to 2 years, 39% for 2- 4 years and 20% for more than 4 years. A Cox regression model was used to analyse two clinical outcomes: disability progression and worsening of relapse rate. The technique of propensity score was applied to reduce bias in the comparison of non-randomized groups. The risks of disability progression (HR=0.23; 95% CI: 0.17 - 0.30) and worsening of relapse rate (HR=0.19; 95% CI: 0.14 - 0.27) were reduced by about 4- 5- fold in patients exposed to IFNβ for more than four years, compared with patients exposed for up to two years. The propensity score technique confirmed the findings. The proportion of days covered by IFNβ treatment was lower ( P<0.0001) in patients exposed to IFNβ for up to two years than in other groups. A clinical stabilization over two years of IFNβ exposure may predict a subsequent good clinical response to treatment.

10.1177/1352458506070620http://hdl.handle.net/11392/494650