Evaluating the clinicAl and MRI characteristics of Secondary Progressive multiplE sclerosis; a registRy-bAsed/multicentric cohort study (ASPERA).
SYNOPSIS AND RESULTS
Give a clear view of aims, phases and methods (max 3.000 characters) Introduction: Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system (CNS), with an unpredictable course [1, 2]. Relapsing-remitting (RRMS) and secondary progressive MS (SPMS) are commonly considered as part of a disease continuum each with ‘active’ and ‘not active’ clinical characteristics defined by the presence of relapses with or without magnetic resonance imaging (MRI) activity [3, 4]. According to the recent definition, both active an inactive SPMS have distinct pathophysiological mechanisms and clinical characteristics, but there is still no consensus regarding the frequency of these MS forms in real world setting [5, 6]. Furthermore, as the levels of disease activity and progression are likely to affect therapeutic decisions [7], detailed knowledge of the frequency and characteristics of both active and inactive SPMS is required to provide suitable treatment strategies. In this view, we will aim to evaluate frequency of active and inactive SPMS in a large cohort of Italian MS patients and to investigate whether these two groups differ in terms of clinical and MRI characteristics, disease progression, and treatment management. Objective: to evaluate the frequency and clinical and MRI characteristics of active and inactive SPMS in a real-world setting using a large sample of patients documented in the Italian MS Registry. Inclusion Criteria: age >18 years; diagnosis of SPMS in accordance with the Lublin criteria [1, 8]; availability of clinical (relapse and EDSS) and MRI data. Exclusion Criteria: diagnosis of primary progressive MS and neuromyelitis optica; lack of clinical (relapse and Expanded Disability Status Scale [EDSS] evaluations) and MRI data. Methods: In this cross-sectional multicenter study we will collect data about MS patients who have transitioned to the SP form in the period between 1st January 2016 to 31st December 2021 and who are followed by the MS centers contributing to the Italian MS Registry. We will define two groups, ‘active SPMS’ and ‘inactive SPMS’, based on both reported MRI data and relapse activity [1]. We will compare clinical, MRI and demographical data between active and inactive SPMS. Differences in terms of treatment choice after conversion to SPMS will be also evaluated in both active and inactive SPMS. Outcomes: (1) proportion of patients with active or inactive SPMS who have transitioned to the SP form in the period between 1st January 2016 to 31st December 2021; (2) differences in terms of demographical, clinical (age at MS onset and MS diagnosis, age at SPMS transition, symptoms at onset, expanded disability status scale [EDSS] at MS diagnosis and at SPMS transition) and MRI characteristics (number of brain and spine lesions at MS onset and SPMS transition), between active and inactive SPMS; (3) differences in terms of treatment choice after conversion to SPMS.
Fondazione Italiana Sclerosi Multipla – FISM – Ente del Terzo Settore/ETS e, in forma abbreviata, FISM ETS. Iscrizione al RUNTS Rep. N° 89695 - Fondazione con Riconoscimento di Personalità Giuridica - C.F. 95051730109
Evaluating the clinicAl and MRI characteristics of Secondary Progressive multiplE sclerosis; a registRy-bAsed/multicentric cohort study (ASPERA).
Give a clear view of aims, phases and methods (max 3.000 characters)
Introduction: Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system (CNS), with an unpredictable course [1, 2]. Relapsing-remitting (RRMS) and secondary progressive MS (SPMS) are commonly considered as part of a disease continuum each with ‘active’ and ‘not active’ clinical characteristics defined by the presence of relapses with or without magnetic resonance imaging (MRI) activity [3, 4]. According to the recent definition, both active an inactive SPMS have distinct pathophysiological mechanisms and clinical characteristics, but there is still no consensus regarding the frequency of these MS forms in real world setting [5, 6]. Furthermore, as the levels of disease activity and progression are likely to affect therapeutic decisions [7], detailed knowledge of the frequency and characteristics of both active and inactive SPMS is required to provide suitable treatment strategies.
In this view, we will aim to evaluate frequency of active and inactive SPMS in a large cohort of Italian MS patients and to investigate whether these two groups differ in terms of clinical and MRI characteristics, disease progression, and treatment management.
Objective: to evaluate the frequency and clinical and MRI characteristics of active and inactive SPMS in a real-world setting using a large sample of patients documented in the Italian MS Registry.
Inclusion Criteria: age >18 years; diagnosis of SPMS in accordance with the Lublin criteria [1, 8]; availability of clinical (relapse and EDSS) and MRI data. Exclusion Criteria: diagnosis of primary progressive MS and neuromyelitis optica; lack of clinical (relapse and Expanded Disability Status Scale [EDSS] evaluations) and MRI data.
Methods: In this cross-sectional multicenter study we will collect data about MS patients who have transitioned to the SP form in the period between 1st January 2016 to 31st December 2021 and who are followed by the MS centers contributing to the Italian MS Registry. We will define two groups, ‘active SPMS’ and ‘inactive SPMS’, based on both reported MRI data and relapse activity [1]. We will compare clinical, MRI and demographical data between active and inactive SPMS. Differences in terms of treatment choice after conversion to SPMS will be also evaluated in both active and inactive SPMS.
Outcomes: (1) proportion of patients with active or inactive SPMS who have transitioned to the SP form in the period between 1st January 2016 to 31st December 2021; (2) differences in terms of demographical, clinical (age at MS onset and MS diagnosis, age at SPMS transition, symptoms at onset, expanded disability status scale [EDSS] at MS diagnosis and at SPMS transition) and MRI characteristics (number of brain and spine lesions at MS onset and SPMS transition), between active and inactive SPMS; (3) differences in terms of treatment choice after conversion to SPMS.
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