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First therapy choice in newly diagnosed Multiple Sclerosis patients: A multicenter Italian study.
Mult Scler Relat Disord. 2020 Jul; 42:102059.MS

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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).

CONCLUSION

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.

Authors+Show Affiliations

Neurological Clinic and Multiple Sclerosis Center of "AORN A.Cardarelli", Naples, Italy.Department of Neurosciences Reproductive Sciences and Odontostomatology Multiple Sclerosis Center, Federico II University, Naples, Italy.Multiple Sclerosis study center, ASST Valle Olona PO di Gallarate (VA), Italy.Multiple Sclerosis study center, ASST Valle Olona PO di Gallarate (VA), Italy.Multiple Sclerosis study center, ASST Valle Olona PO di Gallarate (VA), Italy.Centro SM Dipartimento di Neuroscienze, Ospedale Universitario Città della Salute e della Scienza di Torino, Italy.2nd Neurology Unit and CRRSM (Regional Referral Multiple Sclerosis Center), Careggi University Hospital University of Florence, Italy.The Multiple Sclerosis Center of the Veneto Region Department of Neurosciences, University of Padua, Padua, Italy.Clinical and Biological Sciences Department, Neurology Unit University of Torino San Luigi Gonzaga Hospital, Orbassano, Torino, Italy.Multiple Sclerosis Clinical and Research Unit Department of Systems Medicine, Tor Vergata University and Hospital, Rome, Italy.Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Italy.Centro Sclerosi Multipla ASST Papa Giovanni XXIII di Bergamo, Italy.Neuroimmunology and Neuromuscolar Diseases Unit, IRCCS Foundation Carlo Besta Neurological Institute, Milan, Italy.Department Neuroscience, University of Genova Rehabilitation Ophthalmology Genetics Maternal and Child Health Center of Excellence for Biomedical Research (CEBR); IRCCS Ospedale Policlinico San Martino, Genova, Italy.Multiple Sclerosis Centre Binaghi Hospital, ATS Sardegna-University of Cagliari.Multiple Sclerosis Centre Binaghi Hospital, ATS Sardegna-University of Cagliari.Neuroimmunology and Neuromuscolar Diseases Unit, IRCCS Foundation Carlo Besta Neurological Institute, Milan, Italy.Department of Clinical and Experimental Medicine, University of Sassari, Italy.Neurology Clinic, Department of Medical, Surgical, and Health Sciences, University of Trieste, Italy.University of Campania "Luigi Vanvitelli", Italy.Multiple Sclerosis Center, ASST Spedali Civili, PO di Montichiari (BS), Italy.Multiple Sclerosis Center, ASST Spedali Civili, PO di Montichiari (BS), Italy.Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy.Neurological Clinic Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, Italy.Department of Neurology and Psychiatry, Rome; Neurology and Stroke Unit Division, San Giovanni-Addolorata Hospital, Sapienza University, Rome, Italy.Department of Neurology, Ospedale Regina Montis Regalis-ASLCN1, Mondovì, Italy.Neurologia Universitaria OORR, Foggia, Italy.Institute of Neurology, University Magna Graecia of Catanzaro, Catanzaro, Italy.Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Italy.Department of Neurology, Valduce Hospital, Como.Multiple Sclerosis Clinical and Research Unit Department of Systems Medicine, Tor Vergata University and Hospital, Rome, Italy.Department of Neurosciences Reproductive Sciences and Odontostomatology Multiple Sclerosis Center, Federico II University, Naples, Italy.Centro Sclerosi Multipla ASST Papa Giovanni XXIII di Bergamo, Italy.Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Italy.Department of Neurology, Ospedale Regina Montis Regalis-ASLCN1, Mondovì, Italy.Department of Health Sciences Section of Biostatistics, University of Genova, Italy.Department of Health Sciences Section of Biostatistics, University of Genova, Italy; IRCCS Ospedale Policlinico San Martino, Genova, Italy.Department of Health Sciences Section of Biostatistics, University of Genova, Italy. Electronic address: alessio.signori@medicina.unige.it.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32208344

Citation

Maniscalco, Giorgia T., et al. "First Therapy Choice in Newly Diagnosed Multiple Sclerosis Patients: a Multicenter Italian Study." Multiple Sclerosis and Related Disorders, vol. 42, 2020, p. 102059.
Maniscalco GT, Saccà F, Lanzillo R, et al. First therapy choice in newly diagnosed Multiple Sclerosis patients: A multicenter Italian study. Mult Scler Relat Disord. 2020;42:102059.
Maniscalco, G. T., Saccà, F., Lanzillo, R., Annovazzi, P., Baroncini, D., Binello, E., Repice, A., Perini, P., Clerico, M., Mataluni, G., Bonavita, S., La Gioia, S., Gutierrez, L. P., Laroni, A., Frau, J., Cocco, E., Torri Clerici, V., Zarbo, I. R., Sartori, A., ... Signori, A. (2020). First therapy choice in newly diagnosed Multiple Sclerosis patients: A multicenter Italian study. Multiple Sclerosis and Related Disorders, 42, 102059. https://doi.org/10.1016/j.msard.2020.102059
Maniscalco GT, et al. First Therapy Choice in Newly Diagnosed Multiple Sclerosis Patients: a Multicenter Italian Study. Mult Scler Relat Disord. 2020;42:102059. PubMed PMID: 32208344.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - First therapy choice in newly diagnosed Multiple Sclerosis patients: A multicenter Italian study. AU - Maniscalco,Giorgia T, AU - Saccà,Francesco, AU - Lanzillo,Roberta, AU - Annovazzi,Pietro, AU - Baroncini,Damiano, AU - Binello,Eleonora, AU - Repice,Annamaria, AU - Perini,Paola, AU - Clerico,Marinella, AU - Mataluni,Giorgia, AU - Bonavita,Simona, AU - La Gioia,Sara, AU - Gutierrez,Lorena Pareja, AU - Laroni,Alice, AU - Frau,Jessica, AU - Cocco,Eleonora, AU - Torri Clerici,Valentina, AU - Zarbo,Ignazio Roberto, AU - Sartori,Arianna, AU - Signoriello,Elisabetta, AU - Rasia,Sarah, AU - Cordioli,Cinzia, AU - Stromillo,Maria Laura, AU - Cerqua,Raffaella, AU - Pontecorvo,Simona, AU - Di Sapio,Alessia, AU - Grasso,Roberta, AU - Barone,Stefania, AU - Lavorgna,Luigi, AU - Barrilà,Caterina, AU - Landi,Doriana, AU - Russo,Cinzia Valeria, AU - Frigeni,Barbara, AU - Ippolito,Domenico, AU - Turano,Gabriella, AU - Carmisciano,Luca, AU - Sormani,Maria Pia, AU - Signori,Alessio, Y1 - 2020/03/16/ PY - 2019/12/16/received PY - 2020/03/13/revised PY - 2020/03/15/accepted PY - 2020/3/26/pubmed PY - 2020/3/26/medline PY - 2020/3/26/entrez KW - Determinants first therapy KW - Immunomodulatory therapy KW - Multiple sclerosis KW - Naive KW - Relapsing-remitting SP - 102059 EP - 102059 JF - Multiple sclerosis and related disorders JO - Mult Scler Relat Disord VL - 42 N2 - BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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. SN - 2211-0356 UR - https://www.unboundmedicine.com/medline/citation/32208344/First_therapy_choice_in_newly_diagnosed_Multiple_Sclerosis_patients:_A_multicenter_Italian_study L2 - https://linkinghub.elsevier.com/retrieve/pii/S2211-0348(20)30135-8 DB - PRIME DP - Unbound Medicine ER -
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