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

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.

[Epileptic seizures as a manifestation of brain tumors: clinical and electroencephalographic correlations]. / Napady padaczkowe w przebiegu guzów mózgu--korelacje kliniczno-elektroencefalograficzne.

Epilepsy may be the earliest and the sole clinical manifestation of brain tumours. Different studies present epileptic seizures as the first symptom of a brain tumours in adults in approximately 30-40% of cases and in children from 1-10%. In order to evaluate the incidence of epileptic seizures in children versus adults with brain tumors, we investigated the group of 113 children and 578 adults who were hospitalized at the Departments of Neurology and Developmental Neurology between 1990-1999. Clinical presentation, imaging findings, EEG and pathology reports were collected by chart review and entered into computerized database. Of 113 children, epileptic seizures as a first symptom occurred in 14 children and in 211 adults. Histopathological origin and localization of tumours changed according to the age of patients. In all children's seizures were caused by supratentorial tumours originated from neuroepithelial tissue and mainly astrocytomas. In adult patients seizures were observed also mainly in supratentorial tumours (5 cases infratentorial) which were of metasthatic origin (60%) others were glioblastomas multiforme and sporadically meningiomas. The types of seizures in both groups differ significantly. Children had mainly secondary generalized seizures, while adults simple and complex partial seizures. Electroencephalographical findings showed paroxysmal activity always associated with supratentorial brain tumours with seizures; however, we found also abnormal EEG patterns in patients with infratentorial tumours without seizures. Partial and secondary generalized seizures, especially when they are intractable, should be subjected to further investigation for exclusion of brain tumour not only in adults but also in children. Normal EEG argues against the likehood of supratentorial lesions.