Retrospective Analysis of the Treatment of Relapsing Remitting Multiple Sclerosis with Fingolimod at the Department of Neurology, Bon Secours Hosptial Tralee, Ireland

Background: Multiple sclerosis (MS) is a chronic, progressive immune mediated disease of the central nervous system. It is characterized by multifocal demyelination inflammation and axonal degeneration. The most common presentation of MS is a relapsing remitting course which is characterised by acute, disabling attacks followed by a period in which symptoms completely or in part abates.   Fingolimod (Gilenya®) is a once daily oral treatment that has been approved for the treatment of relapsing remitting MS in Ireland since July 2012. It is a functional sphingosine 1-phosphate receptor antagonist that acts to sequester potentially pathogenic T cells within the secondary lymphoid organs, thereby preventing their infiltration into the CNS and thus significantly reduces relapse rate and disability progression in patients. .  Upon initiation of the first dose of fingolimod, patients must undergo a 6 hour observation period as fingolimod treatment can result in an initial and transient decrease in heart rate

Objectives: Here we describe our experience with the first 30 patients who received fingolimod as a treatment for RRMS at the Neurology Department in Bon Secours Hospital in Tralee, Ireland.

Methods: Single-centre retrospective study evalu­ating baseline characteristics, heart rate at first dose and confirmed relapses since initiation in the first 30 patients for whom fingolimod was prescribed since approval.

Results: The mean patient age on initiation of fingolimod therapy was 42.4 ±9.3 years and the mean duration of disease was 8.2 ±3.7 years. As expected, the majority of the patient cohort was female.   Prior therapies included interferon beta-1a and 1b, glatiramer acetate, and natalizumab.  As of December 2014, the mean duration of ongoing fingolimod therapy was 22.6 ±8.5 months In these 30 patients we found that the mean heart rate decreased by 10% following first dose and the effect was maximal at 4 hours. One patient, with a baseline heart rate of 59 bpm, experienced a second-degree atrioventricular block and sustained bradycardia following initial dosing with fingolimod. This patient was successfully treated with an isoprenaline infusion, discharged and continued on treatment with no further cardiac events. Since initiation of fingolimod, 93% of the 30 patients have remained free from clinically confirmed relapses. However there have been 3 discontinuations to date, due to known fingolimod side effects of, raised liver enzymes, lymphopenia, and macular edema.

Conclusions: In summary, our experience in treating patients with RRMS with fingolimod has been generally consistent with results obtained previously in randomized, controlled clinical trials.