Evaluation of the Effect and Drug Side Effects of Fingolimod in the 3-Year Follow-up of Patients with Recurrent Form of Multiple Sclerosis (RRMS)

Fingolimod was the first oral drug in the treatment of multiple sclerosis in its recurrent form, which was approved in 2013 in Iran and has made patients better tolerant to treatment. The aim of the present study was to evaluate the efficacy and pharmacological side effects of Fingolimod in the follow-up of 3-year-old patients with multiple sclerosis.

The present study was a clinical trial. The study population included 28 patients with RRMS disease referred to the clinic of Imam Reza (AS) Hospital in Kermanshah. The patients took one oral capsule of Fingolimod daily for 36 months, and in the three-month period for 36 months after the onset of Fingolimod in terms of recurrence, progression of disability, and possible side effects of the drug were examined and they were followed up. After a period of 36 months, 28 patients were analyzed and 7 (2 due to medication, 1 due to immigration and 4 due to disability) were dropped out of the study. The EDSS questionnaire was completed for patients in each care period. Data were analyzed using Colomogram Smirnov, Kay Do and Variance analysis statistics.

The mean age was 23.67±7.31 and the mean duration of the disease was 6.89±3.47 years. The mean frequency of recurrence of MS before the intervention was 1.94±1.28 and in the first year after the intervention, it was 0.37±0.68, in the second year 0.5±0.63 and in the third year it was reduced 0.32±0.47. 88.9% patients had not progress in EDSS, 75% had no recurrence and 58.2% had no new lesions or an increase in the size of the lesions on MRI II. The frequency of GAD lesions was significantly reduced after the intervention (p=0.03). White blood cells had a decreasing trend in patients (p=0.0001) and two patients were discontinued due to leukopenia and increased liver enzymes, and no severe complication was reported in other patients.

Fingolimod was a suitable alternative for the treatment of RRMS. In addition to the high efficacy, relatively acceptable side effects of the study with a larger sample size are essential for a more informed assessment of the benefits and risks of this drug for recurrence.