Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsingâremitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study)
| Autor: | 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, Chisari, Clara Grazia, Marfia, Girolama Alessandra, Morra, Vincenzo Brescia, Capra, Ruggero, Bianchi, Valentina, Ghezzi, Angelo, Roscio, Marco, Sangalli, Francesca, Pietrolongo, Erika, Francia, Ada, Danni, Maura Chiara, Nocentini, Ugo, Bramanti, Placido, Tedeschi, Gioacchino, Maimone, Davide, Grimaldi, Luigi Maria Edoardo, Scarpini, Elio Angelo, Uccelli, Antonio, Rottoli, Mariarosa, Ruggieri, Stefano, Trojano, Maria, Bergamaschi, Roberto, Buttmann, Mathias, Rieckmann, Peter, Safavi, Ali |
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| Přispěvatelé: | Comi, Giancarlo, Patti, Francesco, Rocca, Maria Assunta, Mattioli, Flavia Caterina, Amato, Maria Pia, Gallo, Paolo, Centonze, Diego, Pozzilli, Carlo, Saccã , Francesco, Bergh, Florian Then, Bartezaghi, Marta, Turrini, Renato, Filippi, Massimo, Chisari, Clara Grazia, Marfia, Girolama Alessandra, Morra, Vincenzo Brescia, Capra, Ruggero, Bianchi, Valentina, Ghezzi, Angelo, Roscio, Marco, Sangalli, Francesca, Pietrolongo, Erika, Francia, Ada, Danni, Maura Chiara, Nocentini, Ugo, Bramanti, Placido, Tedeschi, Gioacchino, Maimone, Davide, Grimaldi, Luigi Maria Edoardo, Scarpini, Elio Angelo, Uccelli, Antonio, Rottoli, Mariarosa, Ruggieri, Stefano, Trojano, Maria, Bergamaschi, Roberto, Buttmann, Mathia, Rieckmann, Peter, Safavi, Ali, Sacca, Francesco, on beahlf of the Golden Study, Group, Saccà, Francesco |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Male Brain atrophy Pilot Projects Relapsing-Remitting Neuropsychological Tests law.invention Efficacy Brief repeatable battery test Disability Evaluation Electrocardiography Executive Function 0302 clinical medicine Randomized controlled trial law Delis–Kaplan executive function test Longitudinal Studies Original Communication Depression Statistics Cognitive impairment Fingolimod Interferon beta-1b Neurology Neurology (clinical) Middle Aged Magnetic Resonance Imaging Adolescent Adult Female Fingolimod Hydrochloride Humans Immunologic Factors Statistics Nonparametric Treatment Outcome Young Adult Cognition Disorders Multiple Sclerosis Relapsing-Remitting Tolerability Settore MED/26 - Neurologia DelisâKaplan executive function test medicine.drug medicine.medical_specialty Multiple Sclerosis Settore MED/26 03 medical and health sciences Internal medicine medicine Nonparametric Delisâ Kaplan executive function test Expanded Disability Status Scale business.industry Multiple sclerosis medicine.disease 030104 developmental biology Physical therapy business 030217 neurology & neurosurgery Delis–Kaplan Executive Function System |
| Zdroj: | Journal of Neurology |
| Popis: | Cognitive impairment (CI) affects 40â65% of multiple sclerosis (MS) patients. This study attempted evaluating the effects of fingolimod and interferon beta-1b (IFN β-1b) on CI progression, magnetic resonance imaging (MRI) and clinical outcomes in relapsingâremitting MS (RRMS) patients over 18Âmonths. The GOLDEN study was a pilot study including RRMS patients with CI randomised (2:1) to fingolimod (0.5Âmg daily)/IFN β-1b (250µg every other day). CI was assessed via Raoâs Brief Repeatable Battery and DelisâKaplan 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 β-1b, 41.18%; pÂâ¤Â0.0001). Patients randomised to fingolimod had more severe clinical and MRI disease characteristics at baseline compared with IFN β-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 β-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 β-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 benefitârisk profile of fingolimod reported in previous studies. |
| Databáze: | OpenAIRE |
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