Evaluation of efficacy, safety and tolerability of fingolimod in patients with the relapsing form of multiple sclerosis – 12-month observation. A preliminary report

Abstract Background and purpose 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 methods The 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. Results Before 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. Conclusions In our study patients fingolimod was effective, safe and well tolerated independently of disease activity and previous treatment.