Switch from fingolimod to ozanimod for safety or intolerance reasons

Introduction: Ozanimod is a new-generation sphingosine-1-phosphate (S1P) modulator, approved for the treatment of multiple sclerosis (MS), offering higher selectivity for S1P receptor 1 and 5 (SPR1-5), minimizing potential safety concerns related to S1P3 receptor activation, compared to fingolimod....

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Main Authors: Elisabetta Signoriello, Giuseppe Romano, Matteo Foschi, Aurora Zanghì, Emanuele D’Amico, Roberta Fantozzi, Diego Centonze, Giacomo Lus
Format: Article
Language:English
Published: SAGE Publishing 2025-07-01
Series:Therapeutic Advances in Neurological Disorders
Online Access:https://doi.org/10.1177/17562864251328191
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author Elisabetta Signoriello
Giuseppe Romano
Matteo Foschi
Aurora Zanghì
Emanuele D’Amico
Roberta Fantozzi
Diego Centonze
Giacomo Lus
author_facet Elisabetta Signoriello
Giuseppe Romano
Matteo Foschi
Aurora Zanghì
Emanuele D’Amico
Roberta Fantozzi
Diego Centonze
Giacomo Lus
author_sort Elisabetta Signoriello
collection DOAJ
description Introduction: Ozanimod is a new-generation sphingosine-1-phosphate (S1P) modulator, approved for the treatment of multiple sclerosis (MS), offering higher selectivity for S1P receptor 1 and 5 (SPR1-5), minimizing potential safety concerns related to S1P3 receptor activation, compared to fingolimod. Objectives: We aimed to compare the adherence and persistence on treatment in MS patients switched to ozanimod from fingolimod for safety reasons (mainly lymphopenia or liver enzymes increase). Methods: We retrospectively recruited patients treated with fingolimod who switched to ozanimod for safety reasons, with at least 12 months of follow-up. We collected demographic, clinical, biochemistry, and safety data during fingolimod and after switching to ozanimod to evaluate (1) lymphocytes and liver enzymes dynamics, (2) persistence on ozanimod over 6 months, (3) proportion of patients with no adverse events (NADE) on ozanimod and no evidence of disease activity (NEDA-3). Results: We recruited 60 relapsing–remitting MS patients (mean age of 42 ± 7.9 years) who were treated with fingolimod for an average of 5.7 years (61.6% female) and switched to ozanimod due to lymphopenia (70%) or hypertransaminasemia (21.6%). A total of 58/60 (96%) patients persisted on treatment with ozanimod for a mean of 1.50 ± 0.49 years; mean lymphocyte count increased from 0.39 to 0.56 ( p  = 0.025) in patients who switched due to lymphopenia; hypertransaminasemia decreased from 21.6% in fingolimod to 9.3% in ozanimod. NADE was recorded in 93% patients during ozanimod treatment and NEDA-3 in 88.3% of patients after 1 year. Overall, patients with complete control of disease (NEDA) in the absence of adverse events (NADE) were 83.7% (NEDA3/NADE). Discussion and conclusion: Our findings suggest that switching from fingolimod to ozanimod may mitigate lymphopenia or hypertransaminasemia and ameliorate effectiveness on disease activity.
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spelling doaj-art-ff20bc996bc744daa4361dd7d1e75ab42025-08-20T03:50:07ZengSAGE PublishingTherapeutic Advances in Neurological Disorders1756-28642025-07-011810.1177/17562864251328191Switch from fingolimod to ozanimod for safety or intolerance reasonsElisabetta SignorielloGiuseppe RomanoMatteo FoschiAurora ZanghìEmanuele D’AmicoRoberta FantozziDiego CentonzeGiacomo LusIntroduction: Ozanimod is a new-generation sphingosine-1-phosphate (S1P) modulator, approved for the treatment of multiple sclerosis (MS), offering higher selectivity for S1P receptor 1 and 5 (SPR1-5), minimizing potential safety concerns related to S1P3 receptor activation, compared to fingolimod. Objectives: We aimed to compare the adherence and persistence on treatment in MS patients switched to ozanimod from fingolimod for safety reasons (mainly lymphopenia or liver enzymes increase). Methods: We retrospectively recruited patients treated with fingolimod who switched to ozanimod for safety reasons, with at least 12 months of follow-up. We collected demographic, clinical, biochemistry, and safety data during fingolimod and after switching to ozanimod to evaluate (1) lymphocytes and liver enzymes dynamics, (2) persistence on ozanimod over 6 months, (3) proportion of patients with no adverse events (NADE) on ozanimod and no evidence of disease activity (NEDA-3). Results: We recruited 60 relapsing–remitting MS patients (mean age of 42 ± 7.9 years) who were treated with fingolimod for an average of 5.7 years (61.6% female) and switched to ozanimod due to lymphopenia (70%) or hypertransaminasemia (21.6%). A total of 58/60 (96%) patients persisted on treatment with ozanimod for a mean of 1.50 ± 0.49 years; mean lymphocyte count increased from 0.39 to 0.56 ( p  = 0.025) in patients who switched due to lymphopenia; hypertransaminasemia decreased from 21.6% in fingolimod to 9.3% in ozanimod. NADE was recorded in 93% patients during ozanimod treatment and NEDA-3 in 88.3% of patients after 1 year. Overall, patients with complete control of disease (NEDA) in the absence of adverse events (NADE) were 83.7% (NEDA3/NADE). Discussion and conclusion: Our findings suggest that switching from fingolimod to ozanimod may mitigate lymphopenia or hypertransaminasemia and ameliorate effectiveness on disease activity.https://doi.org/10.1177/17562864251328191
spellingShingle Elisabetta Signoriello
Giuseppe Romano
Matteo Foschi
Aurora Zanghì
Emanuele D’Amico
Roberta Fantozzi
Diego Centonze
Giacomo Lus
Switch from fingolimod to ozanimod for safety or intolerance reasons
Therapeutic Advances in Neurological Disorders
title Switch from fingolimod to ozanimod for safety or intolerance reasons
title_full Switch from fingolimod to ozanimod for safety or intolerance reasons
title_fullStr Switch from fingolimod to ozanimod for safety or intolerance reasons
title_full_unstemmed Switch from fingolimod to ozanimod for safety or intolerance reasons
title_short Switch from fingolimod to ozanimod for safety or intolerance reasons
title_sort switch from fingolimod to ozanimod for safety or intolerance reasons
url https://doi.org/10.1177/17562864251328191
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