Real-World Use of Fingolimod in Patients with Relapsing Remitting Multiple Sclerosis: A Retrospective Study Using the National Multiple Sclerosis Registry in Kuwait
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Fingolimod is an oral sphingosine-1-phosphate–receptor modulator, which has demonstrated efficacy in clinical trials and has recently been approved for multiple sclerosis (MS) treatment in Kuwait. Post-marketing studies are important to demonstrate real-life efficacy and safety.
The objective of this study was to examine the efficacy and safety of fingolimod treatment in a clinical setting.
Using the national Kuwait MS registry, relapsing remitting MS patients who had been prescribed fingolimod for ≥6 months were retrospectively identified. Three-monthly clinical evaluations and 6-monthly magnetic resonance imagings (MRIs) were performed. Patient status pre- and post-treatment was compared using chi-square and Student t-tests.
A total of 175 patients were included: 75.4 % female (n = 132); mean age 33.3 ± 9.2 years; mean disease duration 7.2 ± 5.2 years; mean fingolimod use 21.7 ± 9.1 months. Most had used previous disease-modifying therapy (78.9 %; n = 138), mainly interferons (66.9 %; n = 117). Twenty-three patients (11.4 %) discontinued/withdrew fingolimod; of whom eight had relapses. The proportion of relapse-free patients improved significantly (86.3 % vs. 32.6 %; p < 0.001), while the proportion of patients with MRI activity decreased (18.3.6 % vs. 77.7 %; p < 0.001). Mean expanded disability status scale (EDSS) score at the last visit improved when compared with pre-treatment (2.26 ± 1.49 vs. 2.60 ± 1.44; p = 0.03). Forty-three (24.6 %) patients experienced adverse events; headaches and lymphopenia were the most commonly reported adverse events.
Fingolimod treatment was associated with reduced relapse and MRI activity, and an improved EDSS score. Discontinuation/withdrawal rates and adverse events were low. Fingolimod presents a promising treatment for MS in Kuwait.
KeywordsMultiple Sclerosis Expand Disability Status Scale Natalizumab Glatiramer Acetate Fingolimod
We thank the medical and administrative staff of the Dasman Diabetes Institute for their comprehensive logistic support in helping to establish the national MS registry.
Conflict of interest
Drs. Al-Hashel, Ahmed, and Behbehani have no conflicts of interest to declare. Dr. Alroughani has received speaker fees from Biologix, Novartis, GSK, Bayer, and Merck Serono. He has received travel support to attend scientific meetings from Novartis, GSK, Bayer, and Merck Serono, and has been a paid speaker for Biologix, Novartis, GSK, and Bayer.
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
- 5.Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet. 1998;352(9139):1498–504.Google Scholar
- 6.Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group. Neurology. 1993;43(4):655–61.Google Scholar
- 12.Agashivala N, Wu N, Abouzaid S, et al. Comparison of compliance to fingolimod and other first-line disease modifying treatment among patients with multiple sclerosis. ACMP 2012 Education Conference, 3–5 October 2012, Cincinnati.Google Scholar
- 14.Devonshire V, Lapierre Y, Macdonell R, Ramo-Tello C, Patti F, Fontoura P, et al. The global adherence project (GAP): a multicenter observational study on adherence to disease-modifying therapies in patients with relapsing-remitting multiple sclerosis. Eur J Neurol. 2011;18(1):69–77.PubMedCrossRefGoogle Scholar
- 15.US Food and Drug Administration. In: Gilenya prescribing information; 2011. http://www.accessdata.fda.gov/drugsatfdadocs/label/2011/022527s002lbl.pdf.
- 16.Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, et al. Comparative effectiveness of fingolimod versus interferons or glatiramer acetate for relapse rates in multiple sclerosis: a retrospective US claims database analysis. Curr Med Res Opin. 2013;29(12):1647–56.PubMedCrossRefGoogle Scholar