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Evaluation of efficacy, safety and tolerability of fingolimod in patients with the relapsing form of multiple sclerosis – 12-month observation. A preliminary report
- II Klinika Neurologiczna, Instytut Psychiatrii i Neurologii w Warszawie
- Katedra i Klinika Neurologii Collegium Medicum, Uniwersytet Jagielloński w Krakowie
open access
Abstract
Oral fingolimod 0.5 mg daily was approved in the European Union in 2011 for the treatment of relapsing multiple sclerosis in the aggressive form and as a second line treatment in patients with high disease activity despite interferon beta therapy. The aim of this study was the evaluation of efficacy, safety and tolerance of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) during a 12-month observation period.
Material and methodsThe investigated group consisted of 11 patients aged between 23 and 63 years. All patients underwent immunomodulatory treatment (disease modifying drugs – DMD) or immunomodulatory treatment in combination with mitoxantrone (Mx) without a positive effect for 3–5 years. Patients received oral fingolimod 0.5 mg daily during 12 months. Disability was evaluated with Kurtzke Expanded Disability Status Scale (EDSS) scale. Safety and tolerability of fingolimod were evaluated by adverse events monitoring, laboratory tests, and ophthalmological and skin assessment.
ResultsBefore the initiation of fingolimod treatment all the patients progressed in disability and in MRI changes including five cases with gadolinium-enhancing lesions. During fingolimod treatment there was no new relapse in any patient and no patient stopped the treatment because of any adverse event. During the 12-month treatment, EDSS improvement was observed in seven patients, three patients were stable, and one patient progressed by 0.5 point in the EDSS.
ConclusionsIn our study patients fingolimod was effective, safe and well tolerated independently of disease activity and previous treatment.
Abstract
Oral fingolimod 0.5 mg daily was approved in the European Union in 2011 for the treatment of relapsing multiple sclerosis in the aggressive form and as a second line treatment in patients with high disease activity despite interferon beta therapy. The aim of this study was the evaluation of efficacy, safety and tolerance of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) during a 12-month observation period.
Material and methodsThe investigated group consisted of 11 patients aged between 23 and 63 years. All patients underwent immunomodulatory treatment (disease modifying drugs – DMD) or immunomodulatory treatment in combination with mitoxantrone (Mx) without a positive effect for 3–5 years. Patients received oral fingolimod 0.5 mg daily during 12 months. Disability was evaluated with Kurtzke Expanded Disability Status Scale (EDSS) scale. Safety and tolerability of fingolimod were evaluated by adverse events monitoring, laboratory tests, and ophthalmological and skin assessment.
ResultsBefore the initiation of fingolimod treatment all the patients progressed in disability and in MRI changes including five cases with gadolinium-enhancing lesions. During fingolimod treatment there was no new relapse in any patient and no patient stopped the treatment because of any adverse event. During the 12-month treatment, EDSS improvement was observed in seven patients, three patients were stable, and one patient progressed by 0.5 point in the EDSS.
ConclusionsIn our study patients fingolimod was effective, safe and well tolerated independently of disease activity and previous treatment.
Keywords
fingolimod, multiple sclerosis – relapsing-remitting form (RRMS)
Title
Evaluation of efficacy, safety and tolerability of fingolimod in patients with the relapsing form of multiple sclerosis – 12-month observation. A preliminary report
Journal
Neurologia i Neurochirurgia Polska
Issue
Pages
145-151
Page views
201
Article views/downloads
317
DOI
10.5114/ninp.2013.34719
Bibliographic record
Neurol Neurochir Pol 2013;47(2):145-151.
Keywords
fingolimod
multiple sclerosis – relapsing-remitting form (RRMS)
Authors
Zdzisław Maciejek
Hanna Wójcik-Drączkowska
Sławomir Wawrzyniak
Anna Niezgodzińska-Maciejek