Fingolimod real life experience in non-naive multiple sclerosis patients

Yıl 2024, Cilt: 10 Sayı: 5, 430 - 438, 04.09.2024

Furkan Sarıdaş , Emine Rabia Koç , Güven Özkaya , Ömer Faruk Turan

https://doi.org/10.18621/eurj.1422897

Öz

Objectives: Fingolimod is approved in Turkey or the treatment of cases of multiple sclerosis (MS) which cannot be controlled with first-line treatments. There is limited information about its efficacy and safety in clinical practice in Turkey. The aim of this study was to evaluate the efficacy and safety of fingolimod treatment in patients with relapsing-remitting multiple sclerosis who were prescribed fingolimod by the Multiple Sclerosis specialists of Bursa Uludağ University Department of Neurology.

Methods: This is a single-center observational study evaluating 142 patients using fingolimod who were followed up for at least 12 months in our center between April 2015 and October 2022. Efficacy results were evaluated in terms of mean number of attacks, annualized relapse rate, relapse-free patient rate, disease progression, clinical and radiological disease activity, and no evidence of disease activity (NEDA-3). The safety outcomes are the rates of treatment-related severe adverse events and patients' continuation rates.

Results: Over 12 months of treatment with fingolimod, the average number of attacks decreased by 94.6%, the annual relapse rate decreased by 87%, and most patients did not relapse (83.1%). Alongside this, in 76.4% of cases, there was no disability progression and in 83.3% of cases, magnetic resonance imaging (MRI) activation was not observed. Excluding replacement due to ineffectiveness, 89.4% of patients continued fingolimod therapy. Cardiac events, treatment-related infections and a decreased lymphocyte count were observed as side effects.

Conclusion: In our center, switching from first-line treatments to fingolimod was effective in reducing disease activity in patients with multiple sclerosis.

Anahtar Kelimeler

Fingolimod, real world, observational study, relapsing-remitting multiple sclerosis

Kaynakça

• 1. Compston A, Coles A. Multiple sclerosis. Lancet. 2008;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
• 2. 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.
• 3. Cohen JA, Barkhof F, Comi G, et al; TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):402-15. doi: 10.1056/NEJMoa0907839.
• 4. Kappos L, Radue EW, O'Connor P, Polman C, Hohlfeld R, Calabresi P, Selmaj K, Agoropoulou C, Leyk M, Zhang-Auberson L, Burtin P; FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362(5):387-401. doi: 10.1056/NEJMoa0909494.
• 5. Calabresi PA, Radue EW, Goodin D, et al. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(6):545-56. doi: 10.1016/S1474-4422(14)70049-3.
• 6. Mazibrada G, Sharples C, Perfect I. Real-world experience of fingolimod in patients with multiple sclerosis (MS Fine): An observational study in the UK. Mult Scler J Exp Transl Clin. 2018;4(4):2055217318801638. doi: 10.1177/2055217318801638.
• 7. Walczak A, Kurkowska-Jastrzebska I, Zakrzewska-Pniewska B, et al. Real-world effectiveness of fingolimod in Polish group of patients with relapsing-remitting multiple sclerosis. Clin Neurol Neurosurg. 2019;184:105453. doi: 10.1016/j.clineuro.2019.105453.
• 8. Ziemssen T, Lang M, Tackenberg B, et al; PANGAEA study group. Real-world persistence and benefit-risk profile of fingolimod over 36 months in Germany. Neurol Neuroimmunol Neuroinflamm. 2019;6(3):e548. doi: 10.1212/NXI.0000000000000548.
• 9. Ziemssen T, Schulze-Topphoff U. The Change of Fingolimod Patient Profiles over Time: A Descriptive Analysis of Two Non-Interventional Studies PANGAEA and PANGAEA 2.0. J Pers Med. 2021;11(6):561. doi: 10.3390/jpm11060561.
• 10. Barrero F, Mallada-Frechin J, Martínez-Ginés ML, et al; in representation of the MS NEXT study investigators. Spanish real-world experience with fingolimod in relapsing-remitting multiple sclerosis patients: MS NEXT study. PLoS One. 2020;15(4):e0230846. doi: 10.1371/journal.pone.0230846.
• 11. Comi G, Pozzilli C, Morra VB, et al. Effectiveness of fingolimod in real-world relapsing-remitting multiple sclerosis Italian patients: the GENIUS study. Neurol Sci. 2020;41(10):2843-2851. doi: 10.1007/s10072-020-04380-y.
• 12. Biernacki T, Sandi D, Füvesi J, et al; on the behalf of the study investigators. The safety and efficacy of fingolimod: Real-world data from a long-term, non-interventional study on the treatment of RRMS patients spanning up to 5 years from Hungary. PLoS One. 2022;17(4):e0267346. doi: 10.1371/journal.pone.0267346.
• 13. Tichá V, Počíková Z, Vytlačil J, Štěpánová R. Real-world effectiveness and safety of fingolimod in patients with multiple sclerosis in the Czech Republic: results from core and extension parts of the GOLEMS study up to 48 months. BMC Neurol. 2022;22(1):143. doi: 10.1186/s12883-022-02656-8.
• 14. Ozakbas S, Piri Cinar B, Yigit P, Baba C, Sagici O; Multiple Sclerosis Research Group. Five-year real-world data on fingolimod treatment's effects on cognitive function. Mult Scler Relat Disord. 2021;54:103089. doi: 10.1016/j.msard.2021.103089.
• 15. Boz C, Ozakbas S, Terzi M, et al. The comparative effectiveness of fingolimod, natalizumab, and ocrelizumab in relapsing-remitting multiple sclerosis. Neurol Sci. 2023;44(6):2121-2129. doi: 10.1007/s10072-023-06608-z.
• 16. Terzi M, Helvacı EM, Şen S, et al. Clinical and Demographic Characteristics and Two-Year Efficacy and Safety Data of 508 Multiple Sclerosis Patients with Fingolimod Treatment. Noro Psikiyatr Ars. 2023;60(1):23-27. doi: 10.29399/npa.28081.
• 17. McGinley MP, Goldschmidt CH, Rae-Grant AD. Diagnosis and Treatment of Multiple Sclerosis: A Review. JAMA. 2021;325(8):765-779. doi: 10.1001/jama.2020.26858.
• 18. Calic Z, Cappelen-Smith C, Hodgkinson SJ, McDougall A, Cuganesan R, Brew BJ. Treatment of progressive multifocal leukoencephalopathy-immune reconstitution inflammatory syndrome with intravenous immunoglobulin in a patient with multiple sclerosis treated with fingolimod after discontinuation of natalizumab. J Clin Neurosci. 2015;22(3):598-600. doi: 10.1016/j.jocn.2014.08.016.