Real-world retrospective study of effectiveness and safety of FINgOlimod in relapsing remitting multiple sclerosis in the Middle East and North Africa (FINOMENA)

Affiliations


Abstract

Objectives: Evidence on the effectiveness and safety of fingolimod in real-world clinical practice in the Middle East and North African (MENA) region is limited. This study aimed to evaluate the effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) in real-world setting in the MENA region.

Patients and methods: RRMS patients who had been treated with fingolimod for at least 12 months were retrospectively identified from the databases of 34 centers across the MENA region. Study outcomes included the annualized relapse rate (ARR), relapse-free rate (RFR), time to first and second relapses, mean change in Expanded Disability Status Scale (EDSS), proportion of patients with Magnetic Resonance Imaging (MRI) activity and no evidence of disease activity (NEDA)-3, retention of patients on treatment, as well as all safety measures.

Results: A total of 806 patients were included: 66.34 % female; mean age 32.97 ± 9.62 years; mean disease duration 4.92 ± 4.66 years; mean fingolimod use 37.2 ± 16.7 months. Most patients had received previous disease-modifying therapy (79.65 %). Compared to the year preceding fingolimod initiation, RFR improved (33.00%-86.35%; p < 0.001), ARR decreased (0.84 ± 0.73 to 0.16 ± 0.45; p = 0.005), EDSS decreased (2.69 ± 1.74-2.01 ± 1.66; p < 0.001), and the proportion of patients with Gadolinium-enhancing T1 lesions decreased (57.84 % to 12.93 %; p < 0.001), after 12 months of fingolimod treatment. NEDA-3 was achieved in 41.3 % of patients. Median time to first and second relapses was not reached since 86.35 % and 98.39 % of patients had not experienced relapses for the first time and second time, respectively. Eight-hundred one (99.38 %) patients continued fingolimod treatment beyond 12 months. One-hundred thirty patients (16.13 %) experienced adverse events, mainly lymphopenia (5.46 %) and leukopenia (2.11 %), while 13 patients (1.61 %) experienced serious adverse events.

Conclusion: This study confirms the effectiveness and safety profile of fingolimod in real-world setting in the Middle East and North African (MENA) region.

Keywords: Effectiveness; Fingolimod; Multiple sclerosis; Real-world evidence; Safety.


Similar articles

Assessing 'No Evidence of Disease Activity' Status in Patients with Relapsing-Remitting Multiple Sclerosis Receiving Fingolimod in Routine Clinical Practice: A Retrospective Analysis of the Multiple Sclerosis Clinical and Magnetic Resonance Imaging Outcomes in the USA (MS-MRIUS) Study.

Weinstock-Guttman B, Medin J, Khan N, Korn JR, Lathi E, Silversteen J, Calkwood J, Silva D, Zivadinov R; MS-MRIUS Study Group.CNS Drugs. 2018 Jan;32(1):75-84. doi: 10.1007/s40263-017-0482-4.PMID: 29270772 Free PMC article.

The effectiveness of fingolimod in a Portuguese real-world population.

Correia I, Batista S, Marques IB, Sousa M, Ferreira R, Nunes C, Macário MC, Sousa L.Mult Scler Relat Disord. 2016 Mar;6:41-48. doi: 10.1016/j.msard.2016.01.003. Epub 2016 Jan 12.PMID: 27063621 Clinical Trial.

The real-world effectiveness and safety of fingolimod in relapsing-remitting multiple sclerosis patients: An observational study.

Izquierdo G, Damas F, Páramo MD, Ruiz-Peña JL, Navarro G.PLoS One. 2017 Apr 28;12(4):e0176174. doi: 10.1371/journal.pone.0176174. eCollection 2017.PMID: 28453541 Free PMC article.

Fingolimod for relapsing-remitting multiple sclerosis.

La Mantia L, Tramacere I, Firwana B, Pacchetti I, Palumbo R, Filippini G.Cochrane Database Syst Rev. 2016 Apr 19;4(4):CD009371. doi: 10.1002/14651858.CD009371.pub2.PMID: 27091121 Free PMC article. Review.

Teriflunomide for multiple sclerosis.

He D, Zhang C, Zhao X, Zhang Y, Dai Q, Li Y, Chu L.Cochrane Database Syst Rev. 2016 Mar 22;3:CD009882. doi: 10.1002/14651858.CD009882.pub3.PMID: 27003123 Review.


Cited by

Behavior of total alkaline phosphatase after radium-233 therapy in metastatic castration-resistant prostate cancer: a single-center, real-world retrospective study.

Lopes FPPL, Pedras MV, Ferreira ÁRS, Ledesma PM, Dias PRTP, Pedras FV.Radiol Bras. 2023 May-Jun;56(3):125-130. doi: 10.1590/0100-3984.2022.0080.PMID: 37564085 Free PMC article.


KMEL References