ArticlePharmacological reports : PR2025
Lymphopenia associated with sphingosine 1-phosphate receptor modulators (S1PRMs) in multiple sclerosis: analysis of European pharmacovigilance data.
Article in Pharmacological reports : PR, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.
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The trial behind it
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
7 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- GPR3 in neuro-metabolic-immune-reproductive nexus - a potential therapeutic target for Multi-System diseases.Annals of medicine · 2026Pooled it
- Ocular disorders during treatment with GLP-1 receptor agonists: a systematic review and meta-analysis of observational studies.Frontiers in pharmacology · 2026Pooled it
- Clinical Impact of Fingolimod-Associated Lymphopenia in Multiple Sclerosis: A Real-World Cohort Study.Medicina (Kaunas, Lithuania) · 2026Observational
- Real-world experience of ozanimod in adults with multiple sclerosis.Neurodegenerative disease management · 2026Article
- Positioning siponimod and the post-treatment gap: the unmet needs of SPMS patients in Italian real-world practice.Therapeutic advances in neurological disorders · 2026Article
- Real-world comparison of lymphopenia profiles in S1P receptor modulators for multiple sclerosis: a multicenter retrospective study.Journal of neurology · 2025Article
- Case Report: Asymptomatic macular edema in ozanimod.Frontiers in ophthalmology · 2025Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe treatment landscape for Multiple Sclerosis (MS) has increased significantly over the past few decades, thanks to the introduction of disease-modifying therapies (DMTs). Fingolimod, siponimod, ozanimod, and ponesimod belong to the newer generation of oral DMTs categorized as sphingosine 1-phosphate receptor modulators (S1PRMs). Because of their mechanism of action, they may increase the risk of lymphopenia, which could influence the therapeutic management of people with MS. The aim of this study was to describe and compare the reporting frequency of lymphopenia related to four S1PRMs.
methodsIndividual case safety reports (ICSRs) were retrieved from the European spontaneous reporting system database (EudraVigilance) from January 1st, 2022, to December 31st, 2023. The reporting odds ratios (RORs) were computed to compare the reporting probability of lymphopenia between a S1PRM versus each other.
resultsWe retrieved 4017 ICSRs, of which 521 (13%) reported lymphopenia associated with fingolimod (53.3%), siponimod (38.4%), ozanimod (5.4%), and ponesimod (2.1%). The most common reporting source was the healthcare professional (94.2%), and more than half of the ICSRs (62.6%) reported serious lymphopenia. Fingolimod was associated with a lower reporting frequency of lymphopenia compared to siponimod. Both siponimod and fingolimod were associated with a higher reporting frequency of lymphopenia compared to ozanimod; siponimod also had a higher reporting probability in comparison with ponesimod.
conclusionsThe most relevant clinical implication of the disproportionality analysis is to increase the awareness of the risk of lymphopenia related to these drugs, thus supporting proactive monitoring and optimizing treatment strategies for people with MS. CLINICAL TRIAL NUMBER: Not applicable.
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