Subcutaneous interferon ß-1a in the treatment of clinically isolated syndromes:3-year and 5-year results of the phase III dosing frequency-blind multicentre REFLEXION study
| Autor: | Delphine Issard, Nicola De Stefano, Mark S. Freedman, Marlieke de Vos, Giancarlo Comi, Liang Chen, Bernard M. J. Uitdehaag, Kurt Marhardt, Ludwig Kappos, Frederik Barkhof |
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| Přispěvatelé: | Comi, Giancarlo, De Stefano, Nicola, Freedman, Mark S., Barkhof, Frederik, Uitdehaag, Bernard M. J., De Vos, Marlieke, Marhardt, Kurt, Chen, Liang, Issard, Delphine, Kappos, Ludwig, Radiology and nuclear medicine, Amsterdam Neuroscience - Neuroinfection & -inflammation, Neurology |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Multiple Sclerosis Adolescent Injections Subcutaneous Surgery Arts and Humanities (miscellaneous) Neurology (clinical) Psychiatry and Mental Health Placebo Injections Subcutaneou Gastroenterology Drug Administration Schedule law.invention Follow-Up Studie 03 medical and health sciences Young Adult 0302 clinical medicine Randomized controlled trial Double-Blind Method law Internal medicine Early Medical Intervention Multiple Sclerosi medicine Humans 030212 general & internal medicine Adverse effect Neurologic Examination Expanded Disability Status Scale business.industry Multiple sclerosis Interferon beta-1a Middle Aged medicine.disease Clinical trial Psychiatry and Mental health Interferon β 1a Treatment Outcome Female business 030217 neurology & neurosurgery Follow-Up Studies medicine.drug Human |
| Zdroj: | Comi, G, Stefano, N D, Freedman, M S, Barkhof, F, Uitdehaag, B M J, de Vos, M, Marhardt, K, Chen, L, Issard, D & Kappos, L 2017, ' Subcutaneous interferon ß-1a in the treatment of clinically isolated syndromes : 3-year and 5-year results of the phase III dosing frequency-blind multicentre REFLEXION study ', Journal of Neurology, Neurosurgery and Psychiatry, vol. 88, no. 4, pp. 285–294 . https://doi.org/10.1136/jnnp-2016-314843 Journal of Neurology, Neurosurgery and Psychiatry, 88(4). BMJ Publishing Group |
| ISSN: | 0022-3050 |
| Popis: | Objective Early treatment following a first clinical demyelinating event (FCDE) delays further disease activity in patients with multiple sclerosis (MS). This study determined the effects of early versus delayed treatment (DT) with subcutaneous interferon (sc IFN) ß- 1a 44 μg in patients with an FCDE up to 60 months postrandomisation. Methods Patients who completed the 24-month double-blind REFLEX (REbif FLEXible dosing in early MS) study entered an extension (REFLEXION, REbif FLEXible dosing in early MS extensION): patients initially randomised to sc IFN ß-1a and not reaching clinically definite MS (clinically definite MS, CDMS (second attack or sustained Expanded Disability Status Scale (EDSS) score increase)) continued original treatment (three times weekly (tiw) or once weekly (qw)); placebo patients switched to tiw (DT); patients with CDMS switched to tiw. Clinical, MRI and adverse event data up to month 60 are reported. Results 402/517 (77.8%) REFLEX patients entered REFLEXION (DT, n=133; tiw, n=127; qw, n=142). At month 60, cumulative probability of CDMS was: DT 44.6%; qw 40.7% (nominal p=0.084 vs DT); tiw 39.2% (nominal p=0.032 vs DT). Cumulative probability of McDonald MS conversion (CDMS or new MRI activity) at month 60 was also reduced for tiw versus DT (nominal p |
| Databáze: | OpenAIRE |
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