Safety and Efficacy of Cladribine in Patients Discontinuing Fingolimod Due to Elevated Transaminase Levels: The FinClad Study

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dc.authorid0000-0002-7994-6223
dc.authorid0000-0001-8509-6563
dc.authorid0000-0002-9747-5285
dc.authorid0000-0002-0438-4502
dc.authorid0000-0002-6469-5185
dc.authorid0000-0003-4418-7906
dc.authorid0000-0003-0469-0064
dc.contributor.authorSonmez, Meryem Tuba
dc.contributor.authorYetkin, Mehmet Fatih
dc.contributor.authorMehdiyev, Duygu Arslan
dc.contributor.authorKoseoglu, Mesrure
dc.contributor.authorMungan, Semra
dc.contributor.authorKale, Nilufer
dc.contributor.authorTerzi, Murat
dc.date.accessioned2026-02-03T12:02:40Z
dc.date.available2026-02-03T12:02:40Z
dc.date.issued2025
dc.departmentÇanakkale Onsekiz Mart Üniversitesi
dc.description.abstractBackground: Elevated liver enzymes pose a significant challenge for patients with multiple sclerosis (pwMS) undergoing treatment with fingolimod. Cladribine has demonstrated comparable efficacy with a more favorable safety profile in terms of hepatotoxicity risk. However, there is still limited data regarding the transition from fingolimod to cladribine for patients with elevated transaminase levels. Objective: The objective of this study is to evaluate the safety and short-term efficacy of cladribine in pwMS who are discontinuing fingolimod due to elevated liver enzyme levels. Methods: This retrospective, multicenter study included 45 pwMS who transitioned from fingolimod to cladribine because their AST/ALT levels were greater than three times the upper limit of normal. Clinical data, liver function tests, and disease activity parameters were collected at predefined time points. Disease activity was assessed based on relapse rates and radiological findings, which included new or enlarging T2 lesions and gadolinium-enhancing lesions. Results: Both AST and ALT levels normalized and remained within the normal range after transition to cladribine (p < 0.001) with no reports of liver-related adverse events. During three months of follow-up, 86.7 % of patients maintained effective disease control, five patients had relapses, and one showed signs of radiological activity. A longer washout period was significantly associated with the presence of disease activity (p = 0.011). Conclusion: Cladribine emerges as a safe and effective option for pwMS discontinuing fingolimod due to hepatotoxicity concerns. To optimize treatment outcomes, implementing shorter washout periods alongside close monitoring is essential to prevent disease reactivation.
dc.identifier.doi10.1016/j.msard.2025.106578
dc.identifier.issn2211-0348
dc.identifier.issn2211-0356
dc.identifier.pmid40570400
dc.identifier.scopus2-s2.0-105008772516
dc.identifier.scopusqualityQ2
dc.identifier.urihttps://doi.org/10.1016/j.msard.2025.106578
dc.identifier.urihttps://hdl.handle.net/20.500.12428/34813
dc.identifier.volume101
dc.identifier.wosWOS:001524055200001
dc.identifier.wosqualityQ2
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.language.isoen
dc.publisherElsevier Sci Ltd
dc.relation.ispartofMultiple Sclerosis and Related Disorders
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/closedAccess
dc.snmzKA_WOS_20260130
dc.subjectRelapsing-remitting multiple sclerosis (RRMS)
dc.subjectFingolimod
dc.subjectCladribine
dc.subjectDisease-modifying therapies (DMTs)
dc.subjectLiver function tests (LFTs)
dc.subjectTransaminases
dc.subjectHepatotoxicity
dc.subjectExpanded disability status scale (EDSS)
dc.subjectTreatment transition
dc.subjectWashout period
dc.titleSafety and Efficacy of Cladribine in Patients Discontinuing Fingolimod Due to Elevated Transaminase Levels: The FinClad Study
dc.typeArticle

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