6533b85cfe1ef96bd12bca35

RESEARCH PRODUCT

Effects of immunomodulatory treatment with subcutaneous interferon beta-1a on cognitive decline in mildly disabled patients with relapsing-remitting multiple sclerosis

F. PattiS. Lo FermoR. VecchioD. MaimoneS. MessinaC. GasperiniV. OreficeV. MorraC. FlorioM. AmatoB. GorettiE. PortaccioV. ZipoliA. BertolottoP. BramantiE. SessaD. CentonzeS. CottoneG. SalemiM. FalciniP. GalloP. PeriniG. GigliG. GiulianiL. GrimaldiL. MurriA. LugaresiF. MonacoE. MontanariL. MottiS. NeriM. PacielloL. ProvincialiM. RagnoG. RosatiS. RuggieriM. TolaL. CaniattiP. TonaliA. BatocchiM. TrojanoE. Di Monte De Caro MfA. GhezziM. ZaffaroniP. ZoloM. ZorzonM. SignorinoE. ScarpiniL. DurelliA. CaroleiM. TodaroD. SpitaleriA. Tartaglione

subject

Maleinterferon beta-1aKaplan-Meier EstimateRelapsing-RemittingNeuropsychological TestsCohort StudiesDisability EvaluationMedicineMale; Adolescent; Young Adult; Middle Aged; Kaplan-Meier Estimate; Cognition Disorders; Survival Analysis; Female; Disability Evaluation; Dose-Response Relationship Drug; Humans; Multiple Sclerosis Relapsing-Remitting; Prospective Studies; Cohort Studies; Disease Progression; Interferon-beta; Injections Subcutaneous; Neuropsychological Tests; Adult; Immunologic Factors; Endpoint DeterminationProspective StudiesProspective cohort studyinterferon beta multiple sclerosis cognitive impairmentSubcutaneousCognitive disorderHazard ratioMiddle AgedSettore MED/26 - NEUROLOGIANeurologyDisease ProgressionSettore MED/26 - NeurologiaFemaleDrugmedicine.drugAdultmedicine.medical_specialtyMultiple SclerosisAdolescentEndpoint DeterminationInjections SubcutaneousLower riskInjectionsDose-Response RelationshipYoung AdultMultiple Sclerosis Relapsing-RemittingInternal medicineHumansImmunologic Factorscognitive functioncognitive impairmentExpanded Disability Status ScaleDose-Response Relationship Drugbusiness.industryInterferon beta-1aMcDonald criteriaOdds ratioInterferon-betamedicine.diseaseSurvival AnalysisSurgerydisabilityNeurology (clinical)businessCognition Disorderscognitive function; cognitive impairment; disability; disease progression; interferon beta-1a; multiple sclerosis

description

The objective of this study was to assess the effects of subcutaneous (sc) interferon beta-1a (IFNβ-1a) on cognition in mildly disabled patients with relapsing—remitting multiple sclerosis (RRMS). Patients aged 18—50 years with RRMS (McDonald criteria; Expanded Disability Status Scale score ≤4.0) were assigned IFNβ therapy at the physician’s discretion and underwent standardized magnetic resonance imaging, neurological examination and neuropsychological testing at the baseline and regular intervals for up to three years. This analysis included 459 patients who received sc IFNβ-1a (44 mcg: n = 236; 22 mcg: n = 223; three-year follow up was available for 318 patients). The hazard ratio for cognitive impairment over three years (44 mcg versus 22 mcg) was 0.68 (95% confidence interval [CI]: 0.480—0.972), suggesting a 32% lower risk with the higher dose treatment. At year 3, the proportion of patients who were cognitively impaired increased slightly from 23.5% at the baseline to 24.8% in the IFNβ-1a 22 mcg treatment group, but remained stable at 15.2% in the IFNβ-1a 44 mcg treatment group. The proportion of patients with cognitive impairment at year 3 was significantly higher in the 22 mcg group than in the 44 mcg group (P = 0.03), although a trend was also seen at the baseline (P = 0.058). Multivariate logistic regression (corrected for baseline cognitive deficits) indicated that treatment with the higher dose of IFNβ-1a was predictive of lower cognitive impairment at three years (odds ratio: 0.51, 95% CI: 0.26—0.99) compared with the lower dose of IFNβ-1a. These findings suggest that sc IFNβ-1a may have dose-dependent cognitive benefits in mildly disabled patients with RRMS, and may support early initiation of high-dose IFNβ-1a treatment.

http://hdl.handle.net/10807/7846