Effects of Fingolimod on Cognitive Status in Patients with Multiple Sclerosis: Prospective, Controlled Trial (P3.071)
2016
Objective: To evaluate effect of fingolimod on cognitive function in multiple sclerisis (MS).
Background: Cognitive impairment occurs in 40-65[percnt] of patients with MS. Several clinical trials have shown beneficial effects of first line disease modifying therapies (DMTs) on cognitive measures in MS, but there has been no data regarding effects of fingolimod.
Methods: The present study had a multi-center, examiner-blinded, controlled, prospective design. Adult relapsing remitting MS (RRMS) patients who initiated fingolimod treatment enrolled in the study. To maintain treatment blinding, we used the two-physician principle: a treating neurologist was responsible for overall care of the patient; and an evaluating neurologist assessed patients at scheduled visits, but was not otherwise involved in patient care. Neurological evaluations and cognitive tests were performed at baseline and every six month for 2 years. Age, sex and education-matched healthy control people were also evaluated cognitively at the same scheduled visits. For cognitive evaluation The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery was used.
Results: A total of 96 patient (71 female) and 98 healthy control (74 female) included in the study. SDMT score improved at mounth 6 vs. baseline (39.25 vs. 42.45, p= 0.021. BVMTR score also improved at month 6 (24.35 vs. 26.2, p=0.017). CVLT2 improved from 48.3 to 50.95, p=0.012). 34 patients were found to be cognitively impaired at study entry on the basis of SDMT. At follow-up 22 patients were cognitively impaired (p=0.002). Number of cognitively impaired patients decreased from 36 to 27 on the basis of CVLT, and 33 to 19 on the basis of BVMTR at month 6. Patients were stable at month 12, month 18, and month 24.
Conclusions: The results of our study revealed a significant improvement in the cognitive function since sixth month of initiation of fingolimod in patients with RRMS.
Disclosure: Dr. Ozakbas has nothing to disclose. Dr. Piri Cinar has nothing to disclose. Dr. Kosehasanogullari has nothing to disclose. Dr. Yigit has nothing to disclose.
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