Volume 14, Issue 12 (February 2021)
Qom Univ Med Sci J 2021, 14(12): 61-69 |
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Dehghan H, Kheirollah Nezhad N, Kashipazha D, Sharifi M. Safety and Efficacy of Fingolimod Compared to Placebo in the Treatment of Relapsing Multiple Sclerosis: A Systematic Review and Meta-analysis Study. Qom Univ Med Sci J 2021; 14 (12) :61-69
URL: http://journal.muq.ac.ir/article-1-3082-en.html
URL: http://journal.muq.ac.ir/article-1-3082-en.html
1- Department of Health Technology Assessment, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
2- Department of Health Technology Assessment, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. ,nastaran.kheirollah@gmail.com
3- Department of Neurology, School of Medicine, Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
4- Department of Public Health, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
2- Department of Health Technology Assessment, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. ,
3- Department of Neurology, School of Medicine, Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
4- Department of Public Health, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Abstract: (1830 Views)
Background and Objectives: Multiple sclerosis (MS) is a disease that involves an individual's central nervous system and can affect many aspects of his/her life. This study was conducted to evaluate the safety and efficacy of fingolimod compared to placebo in the treatment of relapsing MS.
Methods: A detailed research was carried out on Medline, Web of Sciences, the Cochran Library, Embase, and Scopus databases within January-December 2020. The studies were evaluated regarding the effectiveness of the Expanded Disability Status Scale (EDSS) and the safety of complications. A random model with a 95% confidence interval was used for data analysis. To evaluate the heterogeneity of the studies I2 test was used in this research. The Cochrane risk of bias tool checklist was applied to assess the quality of the study methodology.
Results: The results indicated that in 3 and 1 studies fingolimod was used at a dose of 1.25 and 0.5 mg, respectively. Based on the findings, the use of fingolimod at a dose of 0.59 mg was effective in improving patients. The patients receiving fingolimod 1.25 mg were more likely to have lymphopenia than patients taking placebo.
Conclusion: Finally, the findings of this study showed that the use of fingolimod was effective on the EDSS index, compared to placebo. Doctors can use this drug to improve EDSS and the quality of life of patients.
Methods: A detailed research was carried out on Medline, Web of Sciences, the Cochran Library, Embase, and Scopus databases within January-December 2020. The studies were evaluated regarding the effectiveness of the Expanded Disability Status Scale (EDSS) and the safety of complications. A random model with a 95% confidence interval was used for data analysis. To evaluate the heterogeneity of the studies I2 test was used in this research. The Cochrane risk of bias tool checklist was applied to assess the quality of the study methodology.
Results: The results indicated that in 3 and 1 studies fingolimod was used at a dose of 1.25 and 0.5 mg, respectively. Based on the findings, the use of fingolimod at a dose of 0.59 mg was effective in improving patients. The patients receiving fingolimod 1.25 mg were more likely to have lymphopenia than patients taking placebo.
Conclusion: Finally, the findings of this study showed that the use of fingolimod was effective on the EDSS index, compared to placebo. Doctors can use this drug to improve EDSS and the quality of life of patients.
Type of Study: Review Article |
Subject:
بهداشت عمومی
Received: 2021/03/7 | Accepted: 2021/03/16 | Published: 2021/02/28
Received: 2021/03/7 | Accepted: 2021/03/16 | Published: 2021/02/28
References
1. 1. Swallow E, Patterson-Lomba O, Yin L, Mehta R, Pelletier C, Kao D, Sheffield JK, Stonehouse T, Signorovitch J. Comparative safety and efficacy of ozanimod versus fingolimod for relapsing multiple sclerosis. J Comp Eff Res. 2020 Mar;9(4):275-285. Link: https://www.futuremedicine.com/doi/10.2217/cer-2019-0169?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed [DOI:10.2217/cer-2019-0169]
2. Cohen JA, Comi G, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdová E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Huang V, Kappos L; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019 Nov;18(11):1021-1033. doi: 10.1016/S1474-4422(19)30238-8. Link: https://www.sciencedirect.com/science/article/pii/S1474442219302388?via%3Dihub [DOI:10.1016/S1474-4422(19)30238-8]
3. Comi G, Hartung HP, Bakshi R, Williams IM, Wiendl H. Benefit-Risk Profile of Sphingosine-1-Phosphate Receptor Modulators in Relapsing and Secondary Progressive Multiple Sclerosis. Drugs. 2017 Oct;77(16):1755-1768. doi: 10.1007/s40265-017-0814-1. Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5661009/ [DOI:10.1007/s40265-017-0814-1]
4. Fragoso YD, Alves-Leon SV, Becker J, Brooks JB, Correa EC, Damasceno A, Gama PD, Gama RA, Matta AP, Maciel EP, Winckler TC. Safety of switching from natalizumab straight into fingolimod in a group of JCV-positive patients with multiple sclerosis. Arq Neuropsiquiatr. 2016 Aug;74(8):650-2. Link: https://www.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2016000800650&lng=en&nrm=iso&tlng=en [DOI:10.1590/0004-282X20160090]
5. Thomas K, Proschmann U, Ziemssen T. Fingolimod hydrochloride for the treatment of relapsing remitting multiple sclerosis. Expert Opin Pharmacother. 2017 Oct;18(15):1649-1660. Link: https://www.tandfonline.com/doi/abs/10.1080/14656566.2017.1373093?journalCode=ieop20 [DOI:10.1080/14656566.2017.1373093]
6. Huwiler A, Zangemeister-Wittke U. The sphingosine 1-phosphate receptor modulator fingolimod as a therapeutic agent: Recent findings and new perspectives. Pharmacol Ther. 2018 May;185:34-49. Link: https://www.sciencedirect.com/science/article/abs/pii/S0163725817302851?via%3Dihub [DOI:10.1016/j.pharmthera.2017.11.001]
7. Groves A, Kihara Y, Chun J. Fingolimod: direct CNS effects of sphingosine 1-phosphate (S1P) receptor modulation and implications in multiple sclerosis therapy. J Neurol Sci. 2013 May 15;328(1-2):9-18. Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3640626/ [DOI:10.1016/j.jns.2013.02.011]
8. Yang T, Tian X, Chen CY, Ma LY, Zhou S, Li M, Wu Y, Zhou Y, Cui YM. The efficacy and safety of fingolimod in patients with relapsing multiple sclerosis: A meta-analysis. Br J Clin Pharmacol. 2020 Apr;86(4):637-645. Link: https://bpspubs.onlinelibrary.wiley.com/doi/pdfdirect/10.1111/bcp.14198 [DOI:10.1111/bcp.14198]
9. Chew WS, Wang W, Herr DR. To fingolimod and beyond: The rich pipeline of drug candidates that target S1P signaling. Pharmacol Res. 2016 Nov;113(Pt A):521-532. Link: https://www.sciencedirect.com/science/article/pii/S1043661816308775?via%3Dihub [DOI:10.1016/j.phrs.2016.09.025]
10. Amato MP, Fonderico M, Portaccio E, Pastò L, Razzolini L, Prestipino E, Bellinvia A, Tudisco L, Fratangelo R, Comi G, Patti F, De Luca G, Brescia Morra V, Cocco E, Pozzilli C, Sola P, Bergamaschi R, Salemi G, Inglese M, Millefiorini E, Galgani S, Zaffaroni M, Ghezzi A, Salvetti M, Lus G, Florio C, Totaro R, Granella F, Vianello M, Gatto M, Di Battista G, Aguglia U, Logullo FO, Simone M, Lucisano G, Iaffaldano P, Trojano M. Disease-modifying drugs can reduce disability progression in relapsing multiple sclerosis. Brain. 2020 Oct 1;143(10):3013-3024. Link: https://academic.oup.com/brain/article-abstract/143/10/3013/5906150?redirectedFrom=fulltext [DOI:10.1093/brain/awaa251]
11. Samjoo IA, Worthington E, Drudge C, Zhao M, Cameron C, Häring DA, Stoneman D, Klotz L, Adlard N. Comparison of ofatumumab and other disease-modifying therapies for relapsing multiple sclerosis: a network meta-analysis. J Comp Eff Res. 2020 Dec;9(18):1255-1274. Link: https://www.futuremedicine.com/doi/10.2217/cer-2020-0122?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed [DOI:10.2217/cer-2020-0122]
12. 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 Feb 4;362(5):387-401. Link: https://www.sciencedirect.com/science/article/pii/S1474442214700493?via%3Dihub [DOI:10.1056/NEJMoa0909494]
13. Calabresi PA, Radue EW, Goodin D, Jeffery D, Rammohan KW, Reder AT, Vollmer T, Agius MA, Kappos L, Stites T, Li B, Cappiello L, von Rosenstiel P, Lublin FD. 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 Jun;13(6):545-56. doi: 10.1016/S1474-4422(14)70049-3. Epub 2014 Mar 28. Erratum in: Lancet Neurol. 2013 Jun;13(6):536. Link: https://www.sciencedirect.com/science/article/pii/S1474442214700493?via%3Dihub [DOI:10.1016/S1474-4422(14)70049-3]
14. Saida T, Kikuchi S, Itoyama Y, Hao Q, Kurosawa T, Nagato K, Tang D, Zhang-Auberson L, Kira J. A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Mult Scler. 2012 Sep;18(9):1269-77. Link: https://journals.sagepub.com/doi/10.1177/1352458511435984 [DOI:10.1177/1352458511435984]
15. Lublin F, Miller DH, Freedman MS, Cree BAC, Wolinsky JS, Weiner H, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, Merschhemke M, Li B, Putzki N, Liu FC, Häring DA, Kappos L; INFORMS study investigators. Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Mar 12;387(10023):1075-1084. Link: https://www.sciencedirect.com/science/article/pii/S0140673615013148?via%3Dihub [DOI:10.1016/S0140-6736(15)01314-8]
16. Hughes R, Dalakas MC, Merkies I, Latov N, Léger JM, Nobile-Orazio E, Sobue G, Genge A, Cornblath D, Merschhemke M, Ervin CM, Agoropoulou C, Hartung HP; FORCIDP Trial Investigators. Oral fingolimod for chronic inflammatory demyelinating polyradiculoneuropathy (FORCIDP Trial): a double-blind, multicentre, randomised controlled trial. Lancet Neurol. 2018 Aug;17(8):689-698. doi: 10.1016/S1474-4422(18)30202-3. Link: https://www.sciencedirect.com/science/article/pii/S1474442218302023?via%3Dihub
17. Cree BAC, Cutter G, Wolinsky JS, Freedman MS, Comi G, Giovannoni G, Hartung HP, Arnold D, Kuhle J, Block V, Munschauer FE, Sedel F, Lublin FD; SPI2 investigative teams. Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2020 Dec;19(12):988-997. doi: 10.1016/S1474-4422(20)30347-1. Link: https://www.tandfonline.com/doi/abs/10.1517/17425255.2016.1136288?journalCode=iemt20
18. Zajicek J, Ball S, Wright D, Vickery J, Nunn A, Miller D, Cano MG, McManus D, Mallik S, Hobart J; CUPID investigator group. Effect of dronabinol on progression in progressive multiple sclerosis (CUPID): a randomised, placebo-controlled trial. Lancet Neurol. 2013 Sep;12(9):857-865. Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3744749/ [DOI:10.1016/S1474-4422(13)70159-5]
19. Tourbah A, Lebrun-Frenay C, Edan G, Clanet M, Papeix C, Vukusic S, De Sèze J, Debouverie M, Gout O, Clavelou P, Defer G, Laplaud DA, Moreau T, Labauge P, Brochet B, Sedel F, Pelletier J; MS-SPI study group. MD1003 (high-dose biotin) for the treatment of progressive multiple sclerosis: A randomised, double-blind, placebo-controlled study. Mult Scler. 2016 Nov;22(13):1719-1731. Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5098693/ [DOI:10.1177/1352458516667568]
20. Mankinen P, Lundström T, Soini E, Sumelahti ML, Ruutiainen J, Niskala U, Järvinen E. Cost Assessment Modelling of Treatments for Highly Active Relapsing Multiple Sclerosis. Adv Ther. 2020 Feb;37(2):800-818. Link: https://link.springer.com/article/10.1007/s12325-019-01186-z [DOI:10.1007/s12325-019-01186-z]
21. Lucchetta RC, Oliveira ML, Bonetti AF, Fernandez-Llimos F, Wiens A. Outcome measures for disease-modifying therapies in relapsing multiple sclerosis randomized clinical trials: a scoping review protocol. JBI Evid Synth. 2020 Aug;18(8):1781-1787. Link: https://journals.lww.com/jbisrir/Fulltext/2020/08000/Outcome_measures_for_disease_modifying_therapies.12.aspx
22. Oliveira ML, Lucchetta RC, Bonetti AF, Fernandez-Llimós F, Becker J, Gonçalves MVM, Tauil CB, Pontarolo R, Wiens A. Efficacy outcomes reported in trials of multiple sclerosis: A systematic scoping review. Mult Scler Relat Disord. 2020 Oct;45:102435. Link: https://www.sciencedirect.com/science/article/abs/pii/S2211034820305101?via%3Dihub [DOI:10.1016/j.msard.2020.102435]
23. Pinheiro B, Guerreiro R, Costa J, Miguel LS. Cost-effectiveness of cladribine tablets versus fingolimod in patients with highly active relapsing multiple sclerosis in Portugal. J Med Econ. 2020 May;23(5):484-491. Link: https://www.tandfonline.com/doi/full/10.1080/13696998.2020.1717499 [DOI:10.1080/13696998.2020.1717499]
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