Original article| Volume 42, 102059, July 2020

First therapy choice in newly diagnosed Multiple Sclerosis patients: A multicenter Italian study


      • Patient's age is the most important factor in DMTs choice
      • Choice of oral drugs vs self-injectables ones is driven by unfavorable prognostic factors
      • Natalizumab preferred in early stage of severe disease and in younger patients



      The approval of an increasing number of disease modifying drugs for the treatment of Multiple Sclerosis (MS) creates new challenges for patients and clinicians on the first treatment choice. The main aim of this study was to assess factors impacting first therapy choice in a large Italian MS cohort.


      Newly diagnosed relapsing-remitting (RR) MS patients (2010-2018) followed in 24 Italian MS centres were included in the study. We evaluated the association of baseline demographics, clinical and MRI characteristics to the first treatment choice by logistic regression models applied to pre-defined binary alternatives: dimethyl fumarate vs injectables (interferon and glatiramer acetate), teriflunomide vs injectables, fingolimod vs dimethyl fumarate and fingolimod vs natalizumab.


      We enrolled 3025 patients in the period between January 2010 and June 2018. Relapses in the previous year (OR = 2.75; p = 0.001), presence of spinal cord lesions (OR = 1.80; p = 0.002) and higher number (>9) of T2 lesions on the baseline brain MRI scan (OR = 1.65; p = 0.022) were the factors associated to dimethyl fumarate choice as first therapy vs an injectable drug. Older age (OR = 1.06; p < 0.001), male sex (OR = 2.29; p = 0.001) and higher EDSS (OR = 1.36; p < 0.001) were the factors associated with the choice of teriflunomide vs injectables. In more recent years, dimethyl fumarate (OR = 3.23; p < 0.001) and teriflunomide (OR = 2.53; p < 0.001) were chosen more frequently than injectables therapies. The main determinant for the choice of fingolimod as compared with dimethyl fumarate was a higher EDSS (OR = 1.56; p = 0.001), while there was a weak association with a longer disease duration (p = 0.068) and a longer time from onset to diagnosis (p = 0.085). Compared to fingolimod, natalizumab was preferred in patients with a younger age (OR = 0.95; p = 0.003) and higher EDSS (OR = 1.45; p = 0.007) and a shorter disease duration (OR = 0.52; p = 0.076).


      Many factors guided therapeutic decision for our Italian cohort of MS patients; they are mainly related to MS disease activity, baseline EDSS, disease duration and age.


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        • Thompson AJ
        • Banwell BL
        Barkhof F et al diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria.
        Lancet Neurol. 2018; 17: 162-173
        • Lublin FD
        • Reingold SC
        • Cohen JA
        • et al.
        Defining the clinical course of multiple sclerosis: the 2013 revisions.
        Neurology. 2014; 83: 278-286
        • Straus Farber R
        • Harel A
        • Lublin F
        Novel agents for relapsing forms of multiple sclerosis.
        Ann. Rev. Med. 2016; 67: 309-321
        • Banwell B
        • Giovannoni G
        • Hawkes C
        • Lublin FD
        Editors' welcome and a working definition for a multiple sclerosis cure.
        Mult. Scler. Relat. Disord. 2013; 2: 65-67
      1. EMA. Avonex: EPAR Product information. 29/11/2018.

      2. EMA. Aubagio: EPAR product information. 27/03/2019.

      3. EMA. Betaferon: EPAR product information 03/12/2018.

      4. AIFA Copaxone: AIFA 18/01/2019.

      5. AIFA Copemyl: AIFA08/10/2016.

      6. EMA. Extavia: EPAR product information26/07/2018.

      7. EMA. Gilenya: EPAR product information09/04/2019.

      8. EMA. Lemtrada: EPAR product information08/02/2018.

      9. EMA.Mavenclad: EPAR product information08/08/2018.

      10. EMA Ocrevus: EPAR product information26/06/2019.

      11. EMA Rebif: EPAR product information. 13/12/2018.

      12. EMA Tecfidera: EPAR product information18/01/2019.

      13. EMA Tysabri: EPAR product information. 10/08/2018.

        • Trojano M
        • Tintore M
        • Montalban X
        • Hillert J
        • Kalincik T
        • Iaffaldano P
        • Spelman T
        • Sormani M.P
        • Butzkueven H
        Treatment decisions in multiple sclerosis - insights from real-world observational studies.
        Nat. Rev. Neurol. 2017; 13 (Epub 2017 Jan 13): 105-118
      14. Sormani M. P, Laroni A.Approved drugs for multiple sclerosis: the challenge of choice Lancet Neurol. 2017 Apr;16(4):252–253.

        • Tintore M
        • À Rovira
        • Río J
        • et al.
        Defining high, medium and low impact prognostic factors for developing multiple sclerosis.
        Brain. 2015; 138: 1863-1874
        • Laroni A
        • Signori A
        • Maniscalco G
        • et al.
        Comorbidities affect treatment choice and persistence in RRMS: a multicenter study.
        Mult. Scler. 2016; 22: 850-851
        • McDonald W
        • Compston A
        • Edan G
        • et al.
        Recommended diagnostic criteria for multiple sclerosis: guidelines from the international panel on the diagnosis of multiple sclerosis.
        Ann. Neurol. 2001; 50: 121-127
        • Polman C.H
        • Reingold S.C
        • Banwell B
        • et al.
        Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria.
        Ann. Neurol. 2011; 69: 292-302
        • Saccà F
        • Lanzillo R
        • Signori A
        • et al.
        Determinants of therapy switch in multiple sclerosis treatment-naïve patients.
        A real-life study.Mult. Scler. 2018;
        • Setayeshgar S
        • Kingwell E
        • Zhu F
        • et al.
        Use of the new oral disease-modifying therapies for multiple sclerosis in British Columbia, Canada: the first five-years.
        Tremlett. H. Mult. Scler. Relat. Disord. 2018; 25: 57-60
        • Khatri B.
        • et al.
        Comparison of fingolimod with interferon beta-1a in relapsing-remitting multiple sclerosis: a randomized extension of the transforms study.
        Lancet Neurol. 2011; 10: 520-529
        • Spelman T.
        • et al.
        Comparative efficacy of switching to natalizumab in active multiple sclerosis.
        Ann. Clin. Transl. Neurol.. 2015; 2: 373-387
        • He A.
        • et al.
        Comparison of switch to fingolimod or interferon beta/glatiramer acetate in active multiple sclerosis.
        JAMA Neurol. 2015; 72: 405-413
        • Kalincik T.
        • et al.
        Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis.
        Ann. Neurol. 2015; 77: 425-435
        • Baroncini D
        • et al.
        Natalizumab versus fingolimod in patients with relapsing-remitting multiple sclerosis nonresponding to first-line injectable therapies.
        Mult. Scler. 2016; 22: 1315-1326
        • Barbin L.
        • et al.
        Comparative efficacy of fingolimod versus natalizumab: a French multicenter observational study.
        Neurology. 2016; 86: 771-778