Fingolimod in Real Clinical Practice

Authors: V. Tichá 1;  L. Sobíšek 2;  E. Havrdová 1
Authors‘ workplace: Neurologická klinika a Centrum klinických neurověd, 1. LF UK a VFN v Praze 1;  Fakulta informatiky a statistiky, VŠE v Praze 2
Published in: Cesk Slov Neurol N 2017; 80/113(2): 213-219
Category: Short Communication
doi: 10.14735/amcsnn2017213


To assess retrospectively the clinical efficacy of fingolimod in one or two years of treatment in patients with active multiple sclerosis.

Patients and methods:
223 patients were treated with fingolimod for at least one year, 109 of whom were treated for two years. 126 patients were switched to fingolimod from interferon beta or glatiramer acetate, 3 patients were treatment-naive and 94 patients were switched from natalizumab.

In patients switched from IFN beta or GA, the relapse rate decreased by 72% in the first year and by 64% in the first 2 years, in patients switched from natalizumab the decrease was 25% in the first year and 31% during 2 years of treatment. 66% of patients in the overall group and in both subgroups remained relapse-free during the first year of treatment and 50.5% over the 2 years of fingolimod treatment. 80% of patients had stable or improved EDSS in the first year and also after 2 years of treatment. 94.6% of patients did not have a 6-months confirmed disability progression within one or 2-year observational period. No evidence of clinical activity of the disease was observed in 64.6% of patients in the first year and in 50% of patients after the first 2 years of treatment. 16.7% of patients with the washout period of 63 days or less after the last infusion of natalizumab relapsed, while the washout period longer than 63 days led to a relapse in 25% of patients.

Fingolimod is an effective escalation treatment in patients failing on DMDs or as the first line treatment in patients with high activity of MS. After termination of natalizumab treatment, fingolimod is an effective alternative for the majority of patients.

Key words:
multiple sclerosis – fingolimod – natalizumab – escalation

The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.

The Editorial Board declares that the manuscript met the ICMJE “uniform requirements” for biomedical papers.

Chinese summary - 摘要





223名患者用芬戈莫德治疗至少一年,其中109例接受治疗两年。 126名患者从干扰素β(IFN)或醋酸格拉默(GA)转为芬戈莫德,3名患者为无创性治疗,94名患者从那他珠单抗切换。


在从IFNβ或GA转换的患者中,第一年的复发率下降了72%,前2年的复发率下降了64%,从那他珠单抗转移的患者第一年下降了25%,2年内治疗下降了31%。整个组和两亚组66%的患者在治疗的第一年仍无复发,而在芬戈莫德治疗的2年中仍为50.5%。 80%的患者在第一年和治疗2年后均有稳定或改善的EDSS。 94.6%的患者在一年或两年观察期内没有6个月确诊的残疾进展。在第一年64.6%的患者和治疗前2年的50%患者中没有观察到该疾病的临床活动证据。最后一次输注natalizumab后,16.7%的清除期为63天或更少的患者复发,而超过63天的清除期导致25%的患者复发。




多发性硬化 - 芬戈莫德 - 那他珠单抗 - 升级


1. Com­munity register of medicinal products for human use: 18 Product information Gilenya. [acces­sed 2017 Feb 28]. Dostupné z URL:­munity-register/html/h677.htm.

2. SÚKL: Gilenya 0,5mg. [acces­sed 2017 Feb 28]. Dostupné z URL:

3. Cohen JA, Chun J. Mechanisms of fingolimod‘s ef­ficacy and adverse ef­fects in multiple sclerosis. Ann Neurol 2011;69(5):759– 77. doi: 10.1002/ ana.22426.

4. Hla T, Brinkmann V. Sphingosine 1-phosphate (S1P): Physiology and the ef­fects of S1P receptor modulation. Neurology 2011;76(Suppl 3):S3– 8. doi: 10.1212/ WNL.0b013e31820d5ec1.

5. Singer BA. Fingolimod for the treatment of relaps­ing multiple sclerosis. Expert Rev Neurother 2013;13(6): 589– 602. doi: 10.1586/ ern.13.52.

6. Tichá V. Fingolimod v léčbě roztroušené sklerózy. Farmakoterapie 2015;2(Suppl):3– 41.

7. Kappos L, Radue EW, O‘Con­nor P, et al. A placebo-control­led trial of oral fingolimod in relaps­ing multiple sclerosis. N Engl J Med 2010;362(5):387– 401. doi: 10.1056/ NEJMoa0909494.

8. Cohen JA, Barkhof F, Comi G, et al. Oral fingolimod or intramuscular interferon for relaps­ing multiple sclerosis. N Engl J Med 2010;362(5):402– 15. doi: 10.1056/ NEJMoa0907839.

9. Ziems­sen T, DiazLorente M, Fuchs A, et al. 24-month interim results of PANGAEA: a 5-year registry study evaluat­ing long-term safety, ef­ficacy and pharmacoeconomic data of German multiple sclerosis patients on fingolimod therapy. Neurology 2014;82(10):152.

10. Baldi E, Guareschi A, Vitetta F, et al. Previous treatment influences fingolimod ef­ficacy in relapsing-remitt­ing multiple sclerosis: results from an observational study. Curr Med Res Opin 2014;30(9):1849– 55. doi: 10.1185/ 03007995.2014.921144.

11. Cor­reia I, Batista S, Marques IB, et al. The ef­fectiveness of fingolimod in a Portuguese real-world population. Mult Scler Relat Disord 2016;6:41– 8. doi: 10.1016/ j.msard.2016.01.003.

12. Fonseca J. Fingolimod real world experience: ef­ficacy and safety in clinical practice. Neurosci J 2015; 2015:389360. doi: 10.1155/ 2015/ 389360.

13. Sempere AP, Martín-Medina P, Berenguer-Ruiz L, et al. Switch­ing from natalizumab to fingolimod: an observational study. Acta Neurol Scand 2013;128(2):e6– 10. doi: 10.1111/ ane.12082.

14. Hoepner R, Havla J, Eienbröker C, et al. Predictors for multiple sclerosis relapses after switch­ing from natalizumab to fingolimod. Mult Scler 2014;20(13):1714– 20. doi: 10.1177/ 1352458514533398.

15. Havla J, Tackenberg B, Hel­lwig K, et al. Fingolimod reduces recur­rence of disease activity after natalizumab withdrawal in multiple sclerosis. J Neurol 2013;260(5):1382– 7. doi: 10.1007/ s00415-012-6808-8.

16. Cohen M, Mail­lart E, Tourbah A, et al. Switch­ing from natalizumab to fingolimod in multiple sclerosis: a French prospective study. JAMA Neurol 2014;71(4):436– 41. doi: 10.1001/ jamaneurol.2013.6240.

17. Jokubaitis VG, Li V, Kalincik T, et al. Fingolimod after natalizumab and the risk of short-term relapse. Neurology 2014;82(14):1204– 11. doi: 10.1212/ WNL.0000000000000283.

18. de Seze J, Ongagna JC, Col­longues N, et al. Reduction of the washout time between natalizumab and fingolimod. Mult Scler 2013;19(9):1248. doi: 10.1177/ 1352458513490551.

19. Fragoso YD, Adoni T, Alves-Leon SV, et al. Alternatives for reduc­ing relapse rate when switch­ing from natalizumab to fingolimod in multiple sclerosis. Expert Rev Clin Pharmacol 2016:1– 6. doi: 10.1586/ 17512433.2016.1145053.

20. Kappos L, Radue EW, Comi G, et al. Switch­ing from natalizumab to fingolimod: a randomized, placebo--control­led study in RRMS. Neurology 2015;85(1):29– 39. doi: 10.1212/ WNL.0000000000001706.

Paediatric neurology Neurosurgery Neurology

Article was published in

Czech and Slovak Neurology and Neurosurgery

Issue 2

2017 Issue 2

Most read in this issue
Forgotten password

Don‘t have an account?  Create new account

Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.


Don‘t have an account?  Create new account