Evaluating the efficacy and side effects fingolimod in 3 -year follow-up of patients in RRMS

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Abstract:

Fingolimod is the first DMT drug to treat MS that oral form was available. This study was done with aim to study the effectiveness and long-term side effects of bio similar fingolimod oral forms in 3-year follow-up of patients with RRMS.     Methods: This study was a clinical trial (before and after) on 28 patients with RRMS referring to Clinic of Imam Reza Hospital in Kermanshah. Patients received daily, oral administration of a Fingolimod capsule for at least 36 months. Patients were followed up relapse ,progression disability and Probable complications of drug,every  3-month period  for  36 months after start of fingolimod. EDSS questionnaire for patients in each treatment period was completed.   Results: Information of 28 patients were analyzed and 7 patients(2 drug complications, 1 patient has migrated  and 4 patients had progression disability) were excluded. The mean age was 33.67±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 1.9 ± 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% patiens had not progress in  EDSS score. 58.2% of patients did not have new or enlarge T2 lesions. During the 3 years follow-up, the number of lymphocytes and white blood cells in patients was decreasing (P = .0001). The level of liver enzymes ALT and AST was significantly different during the study period (P = 0.0001). Frequency of T2 lesions did not differ before with  after medication intervention fingolimod. However, the frequency of GAD lesions was significantly decreased after intervention (p = 0.003). Conclusion: Fingolimod is a good alternative for treatment of RRMS. In addition of  high efficacy and low side effects playing relatively acceptable. Study with larger sample size for evaluation more informed benefits and the dangers of this drug are essential for the relapse of the disease.

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volume 25  issue 2

pages  0- 0

publication date 2020-04

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