ArticleTherapeutics and clinical risk management2018
A multicentric pharmacovigilance study: collection and analysis of adverse drug reactions in relapsing-remitting multiple sclerosis patients.
Article in Therapeutics and clinical risk management, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Ocular adverse events from pharmacological treatment in patients with multiple sclerosis-A systematic review of the literature.Systematic reviews · 2021Pooled it
- Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial.Drug safety · 2021Trial
- Real-World Data for Safety Studies: Challenges and Opportunities From the Italian Multiple Sclerosis and Related Disorders Register.Pharmacoepidemiology and drug safety · 2026Article
- Preliminary Results of the FASM Study, an On-Going Italian Active Pharmacovigilance Project.Pharmaceuticals (Basel, Switzerland) · 2020Article
- Salivary Biomarkers: Future Approaches for Early Diagnosis of Neurodegenerative Diseases.Brain sciences · 2020Review
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeWe performed a pharmacovigilance study of 10 drugs used in patients with relapsing-remitting multiple sclerosis (RR-MS). Our aim was to provide an overview of the safety of these drugs by the evaluation of reported expected and unexpected adverse reactions. PATIENTS AND
methodsWe collected and analyzed adverse drug reactions from RR-MS patients belonging to four hospitals in three Italian regions, for a period of 24 months.
resultsWe received a total of 411 adverse reactions, of which 84.18% were expected and only 15.82% were unexpected. We found no correlation between the number of reported adverse reactions and the route of administration (injectable/intravenous drugs N=224, oral drugs N=187). However, oral agents have caused a greater number of unexpected moderate-to-severe adverse reactions while, in injectable and infusion therapies, they have been evaluated as mild-moderate adverse reactions.
conclusionOur results underscore the importance of monitoring the safety profile of multiple sclerosis therapies, with particular attention to oral agents that have been introduced later in the clinical practice.
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