6533b824fe1ef96bd128154f

RESEARCH PRODUCT

A multicentRE observational analysiS of PErsistenCe to Treatment in the new multiple sclerosis era: the RESPECT study.

Massimiliano Calabrese 1Eleonora Cocco 2Roberta FantozziViviana NocitiAntonio GalloLaura BoffaAlice LaroniClaudio SolaroValentina Torri ClericiGiancarlo CogheSimona MalucchiMassimiliano Di FilippoValentina TomassiniMarcello MocciaPietro AnnovazziFederica PinardiCarla TortorellaPaola CavallaIlaria PesciLuca ProsperiniGiorgia Teresa ManiscalcoAlberto GajofattoClaudio GasperiniRoberta Lanzillo 2Fabio ButtariPaolo RagoneseMarta RadaelliMaria Chiara Buscarinu

subject

MaleInjectionTime FactorsPatient Dropoutdisease-modifying therapies; multiple sclerosis; outcome measurement; persistence to treatment; quality of lifeAdministration OralSelf AdministrationSex FactorKaplan-Meier EstimateRelapsing-Remittingmultiple sclerosisImmunologic Factor0302 clinical medicineQuality of lifeRetrospective StudieRisk FactorsMedicine030212 general & internal medicineDisease-modifying therapiedisease-modifying therapiesDisease-modifying therapies Multiple sclerosis Outcome measurement Persistence to treatment Quality of life Administration Oral Adult; Female Follow-Up Studies Humans Immunologic Factors Injections Kaplan-Meier EstimateMale Multiple Sclerosis Relapsing-Remitting Patient Dropouts Prognosis Proportional Hazards Models Retrospective Studies Risk Factors Self Administration Sex Factors Time FactorsHazard ratioPrognosisNeurologyTolerabilityAdministrationSettore MED/26 - NeurologiaFemaleoutcome measurementHumanOralAdultmedicine.medical_specialtyPatient DropoutsTime FactorPrognosiFollow-Up StudieInjections03 medical and health sciencesRoute of administrationMultiple Sclerosis Relapsing-RemittingSex FactorsInternal medicineHumansImmunologic FactorsMultiple sclerosiAdverse effectProportional Hazards ModelsRetrospective Studiesbusiness.industryProportional hazards modelRisk FactorRetrospective cohort studyDiscontinuationDisease-modifying therapies; Multiple sclerosis; Outcome measurement; Persistence to treatment; Quality of life; Administration Oral; Adult; Female; Follow-Up Studies; Humans; Immunologic Factors; Injections; Kaplan-Meier Estimate; Male; Multiple Sclerosis Relapsing-Remitting; Patient Dropouts; Prognosis; Proportional Hazards Models; Retrospective Studies; Risk Factors; Self Administration; Sex Factors; Time Factorsquality of lifeProportional Hazards Modelpersistence to treatmentNeurology (clinical)business030217 neurology & neurosurgeryFollow-Up Studies

description

In this independent, multicenter, retrospective study, we investigated the short-term persistence to treatment with first-line self-injectable or oral disease-modifying treatments (DMTs) in patients with relapsing–remitting multiple sclerosis. Data of patients regularly attending 21 Italian MS Centres who started a self-injectable or an oral DMT in 2015 were collected to: (1) estimate the proportion of patients discontinuing the treatment; (3) explore reasons for discontinuation; (3) identify baseline predictors of treatment discontinuation over a follow-up period of 12 months. We analyzed data of 1832 consecutive patients (1289 women, 543 men); 374 (20.4%) of them discontinued the prescribed DMT after a median time of 6 months (range 3 days to 11.5 months) due to poor tolerability (n = 163; 43.6%), disease activity (n = 95; 25.4%), adverse events (n = 64; 17.1%), convenience (i.e. availability of new drug formulations) and pregnancy planning (n = 21; 1.1%). Although the proportion of discontinuers was higher with self-injectable (n = 107; 22.9%) than with oral DMT (n = 215; 16.4%), the Cox regression model revealed no significant between-group difference (p = 0.12). Female sex [hazard ratio (HR) = 1.39, p = 0.01] and previous exposure to ≥ 3 DMTs (HR = 1.71, p = 0.009) were two independent risk factors for treatment discontinuation, regardless of prescribed DMTs. Our study confirms that persistence to treatment represents a clinical challenge, irrespective of the route of administration.

10.1007/s00415-018-8831-xhttps://pubmed.ncbi.nlm.nih.gov/29549468