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. 2025 Jul 9:18:17562864251328191.
doi: 10.1177/17562864251328191. eCollection 2025.

Switch from fingolimod to ozanimod for safety or intolerance reasons

Elisabetta Signoriello  1 , Giuseppe Romano  2 , Matteo Foschi  3   4 , Aurora Zanghì  5 , Emanuele D'Amico  5 , Roberta Fantozzi  6 , Diego Centonze  6   7 , Giacomo Lus  2
Affiliations

Switch from fingolimod to ozanimod for safety or intolerance reasons

Elisabetta Signoriello et al. Ther Adv Neurol Disord. .

Abstract

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.

Keywords: fingolimod; multiple sclerosis; ozanimod; relapsing–remitting MS.

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Figures

Figure 1.
Figure 1.
Mean lymphocytes count before and after switching in patients who had lymphopenia.
Figure 2.
Figure 2.
Mean AST, ALT, and GGT levels before and after switching in patients who had hypertransaminasemia. ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma glutamyl transferase.
Figure 3.
Figure 3.
Percentage of patients with NEDA-3 and NADE on ozanimod. NADE, no adverse events; NEDA-3, no evidence of disease activity.
See this image and copyright information in PMC

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