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Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsing-remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study).
Comi, Giancarlo; Patti, Francesco; Rocca, Maria Assunta; Mattioli, Flavia Caterina; Amato, Maria Pia; Gallo, Paolo; Centonze, Diego; Pozzilli, Carlo; Saccà, Francesco; Bergh, Florian Then; Bartezaghi, Marta; Turrini, Renato; Filippi, Massimo.
Afiliación
  • Comi G; Department of Neurology, Institute of Experimental Neurology, San Raffaele Hospital, Milan, Italy. comi.giancarlo@hsr.it.
  • Patti F; "GF Ingrassia", Section of Neurosciences, Department of Medical, Surgery Science and Advanced Technology, MS Center, University Hospital, Catania, Italy.
  • Rocca MA; Department of Neurology, Institute of Experimental Neurology, San Raffaele Hospital, Milan, Italy.
  • Mattioli FC; Neuroimaging Research Unit, Division of Neuroscience, Institute of Experimental Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
  • Amato MP; Neuropsychology Unit, Spedali Civili of Brescia, Brescia, Italy.
  • Gallo P; Department NEUROFARBA, University of Florence, Florence, Italy.
  • Centonze D; Department of Neurosciences, Multiple Sclerosis Centre, Veneto Region (CeSMuV), University Hospital of Padova, Padua, Italy.
  • Pozzilli C; Multiple Sclerosis Research Unit, Department of Systems Medicine, Tor Vergata University, Rome, Italy.
  • Saccà F; Unit of Neurology and Neurorehabilitation, IRCCS Istituto Neurologico Mediterraneo (INM) Neuromed, Pozzilli, Italy.
  • Bergh FT; Department of Neurology and Psychiatry, Multiple Sclerosis Centre, S. Andrea Hospital, Sapienza University, Rome, Italy.
  • Bartezaghi M; Department of Neurosciences, Odontostomatological and Reproductive Sciences, University Federico II, Naples, Italy.
  • Turrini R; Department of Neurology, University of Leipzig, Leipzig, Germany.
  • Filippi M; Novartis Farma, Origgio, Varese, Italy.
J Neurol ; 264(12): 2436-2449, 2017 Dec.
Article en En | MEDLINE | ID: mdl-29063244
ABSTRACT
Cognitive impairment (CI) affects 40-65% of multiple sclerosis (MS) patients. This study attempted evaluating the effects of fingolimod and interferon beta-1b (IFN ß-1b) on CI progression, magnetic resonance imaging (MRI) and clinical outcomes in relapsing-remitting MS (RRMS) patients over 18 months. The GOLDEN study was a pilot study including RRMS patients with CI randomised (21) to fingolimod (0.5 mg daily)/IFN ß-1b (250 µg every other day). CI was assessed via Rao's Brief Repeatable Battery and Delis-Kaplan Executive Function System test. MRI parameters, Expanded Disability Status Scale scores and relapses were measured. Overall, 157 patients were randomised, of whom 30 discontinued the study (fingolimod, 8.49%; IFN ß-1b, 41.18%; p ≤ 0.0001). Patients randomised to fingolimod had more severe clinical and MRI disease characteristics at baseline compared with IFN ß-1b. At Month (M) 18, both treatment groups showed improvements in all cognitive parameters. At M18, relapse rate, total number and volume of T2/T1 gadolinium-enhancing lesions were higher with IFN ß-1b, as well as the percentage brain volume change during the study. Safety and tolerability of both treatments were similar to previous studies. Both treatments showed improvements in cognitive parameters. Fingolimod demonstrated significantly better effects on MRI parameters and relapse rate. Imbalance in baseline characteristics and the drop-out pattern may have favoured IFN ß-1b. A longer duration trial may be needed to observe the complete expression of differential effects on CI scales reflecting the between-groups differences on MRI. Although limited in size, the GOLDEN study confirms the favourable benefit-risk profile of fingolimod reported in previous studies.
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Imagen por Resonancia Magnética / Trastornos del Conocimiento / Esclerosis Múltiple Recurrente-Remitente / Clorhidrato de Fingolimod / Interferon beta-1b / Factores Inmunológicos Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies Idioma: En Revista: J Neurol Año: 2017 Tipo del documento: Article

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Imagen por Resonancia Magnética / Trastornos del Conocimiento / Esclerosis Múltiple Recurrente-Remitente / Clorhidrato de Fingolimod / Interferon beta-1b / Factores Inmunológicos Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies Idioma: En Revista: J Neurol Año: 2017 Tipo del documento: Article