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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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Abstract

Background

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.

Objective

The objective of this study was to examine the efficacy and safety of fingolimod treatment in a clinical setting.

Methods

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.

Results

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.

Conclusion

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.

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Acknowledgments

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.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

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Authors and Affiliations

  1. Department of Neurology, Ibn Sina Hospital, P.O. Box 25427, 13115, Safat, Kuwait

    Jasem AL-Hashel & Samar F. Ahmed

  2. Faculty of Medicine, Kuwait University, P.O. Box 24923, 13110, Safat, Kuwait

    Jasem AL-Hashel

  3. Department of Neurology and Psychiatry, Minia University, P.O. Box 61519, Minia, 61111, Egypt

    Samar F. Ahmed

  4. Department of Ophthalmology, Al-Bahar Eye Center, Kuwait City, Kuwait

    Raed Behbehani

  5. Neurology Clinic, Dasman Diabetes Institute, P.O. Box 1180, 15462, Dasman, Kuwait

    Raed Behbehani & Raed Alroughani

  6. Division of Neurology, Department of Medicine, Amiri Hospital, Arabian Gulf Street, Sharq, Capital Governate, Kuwait

    Raed Alroughani

Authors
  1. Jasem AL-Hashel
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  2. Samar F. Ahmed
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  3. Raed Behbehani
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  4. Raed Alroughani
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Correspondence to Raed Alroughani.

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AL-Hashel, J., Ahmed, S.F., Behbehani, R. et al. Real-World Use of Fingolimod in Patients with Relapsing Remitting Multiple Sclerosis: A Retrospective Study Using the National Multiple Sclerosis Registry in Kuwait. CNS Drugs 28, 817–824 (2014). https://doi.org/10.1007/s40263-014-0185-z

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  • DOI: https://doi.org/10.1007/s40263-014-0185-z

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