The Italian Multiple Sclerosis Registry (Rism) is 10 years old, the database that contains the information and clinical history of almost 90 thousand people with MS and related pathologies. A tool that photographs real world data to help personalize therapies and better understand the evolution of the disease. A focus is dedicated to the projects and results obtained thanks to Rism on the second day of the congress of the Italian Multiple Sclerosis Foundation (Fism), in Rome from 28 to 30 May.
Eighty-six thousand people with multiple sclerosis, 600 with related pathologies (between Mogad and Nmod), 186 participating clinical centers (141 active), 5 thousand patients with pediatric-onset MS, 6,500 women with registered pregnancies, 3 thousand with primary progressive MS. The numbers (updated in January 2024) illustrate the wealth of information contained within the Italian Multiple Sclerosis and Related Pathologies Registry, a project promoted by the Italian Multiple Sclerosis Foundation together with the Aldo Moro University of Bari, which this year celebrates 10 years of activity. A precious observatory on the disease to better understand its evolution, delve into the efficacy and safety profiles of drugs in the long term and help clinicians in personalizing therapies, underline the experts at the Fism Congress.
The register – recalls a note – is one of the largest databases on MS at an international level, made possible thanks to the data collected by clinicians operating in Italy at the MS clinical centers and to a software (Rism-App) which allows you to have a detailed overview of the patient’s entire clinical history. The data in question – which now covers a period of 10 years for 30 thousand people – contains information relating to the evolution of the pathology, the presence of comorbidities, the type and effectiveness of treatment, safety in terms of adverse events and effects collaterals. It is this real world data that allows researchers to extrapolate valuable information on what happens during a chronic disease, especially in particular contexts excluded from clinical trials – such as advanced age, pregnancy and pediatric age – completing those collected during the registration studies. This information allows clinicians and researchers on the one hand to enhance the care of the person with MS, and on the other to imagine ever more concretely a new precision medicine, capable of giving each person the most suitable treatment, at the right time.
“The research developed in recent years thanks to the data contained in the Rism has made it possible to confirm the importance of early treatment in relation to disability trajectories, in addition to the benefits observed in the long term of highly effective treatments at the beginning of the therapeutic path – declares Mario Alberto Battaglia, president of Fism – Many other studies have been made possible by the data collected in the Rism database, especially regarding the observation of subgroups of subjects that require samples of acceptable size to be carried out advanced to understand whether patients over 50 can benefit like younger patients from disease-modifying treatments. The data from the registry made it possible to analyze the safety and efficacy profiles of the treatments, with a follow-up of up to 10 years , on a large population aged up to 69 years. The results highlighted how greater exposure to treatment reduces the risk of worsening of disability, even in this population.”
After 10 years of activity, to date there are 55 projects approved by the Rism Scientific Committee – 23 still ongoing and 32 completed – and there are over 30 scientific publications in international journals, the note reports. Rism is part of the European network of the most important disease registries ‘Big MS Data network’ (Bmsd network), coordinated since 2024 by Fism and recognized by the EMA European Medicines Agency as a high-quality initiative for the conduct of post authorization safety study (Post authorization safety study, or Pass study). At the moment Rism – together with other European and international registries – participates in 4 post-authorization studies on the safety of specific drugs for MS, to deepen knowledge on specific adverse events, some of which are serious but characterized by a very low incidence.
“The Italian Multiple Sclerosis and Related Pathologies Registry, given its dual nature as a useful tool for scientific research and for public health – highlights Battaglia – responds to the mission of the Multiple Sclerosis and Related Pathologies Agenda both for the mission line relating to ‘Research on Multiple Sclerosis’ and for that on ‘Taking charge, interdisciplinary and person-centred’. The project participates in national and international research initiatives, focusing on the collection and sharing of clinical data through the use of digital platforms , enhancing the network of reference clinical centers for MS, and contributes to pursuing the objective of utility also in the field of public health, for example contributing to the monitoring of essential levels of care and Pdta”.
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