Multiple sclerosis (Houndmills, Basingstoke, England) · 2026
Clinical and radiological outcomes of directed treatment transitions from Gilenya® to generic fingolimod.
СтатьяНазвание и аннотация: Перевод в очереди
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Patel Mahi A, Punnen Tom G, Shan Kevin S, McCreary Morgan C, Wright Crystal M, Munoz Shanan B, Hardeman Paula, Burgess Katy W, Greenberg Benjamin M, Horton Lindsay A, Sguigna Peter V, Tardo Lauren M, Stüve Olaf, Okuda Darin T
Аннотация
BACKGROUND: Gilenya® (fingolimod), a sphingosine-1-receptor agonist, is an effective treatment for multiple sclerosis (MS). However, increased relapse activity has been observed after transitioning to generic fingolimod despite prior prolonged disease stability.
OBJECTIVE: To quantify the clinical and radiological impact of transitioning from Gilenya® to generic fingolimod in people with MS (PwMS).
METHODS: Retrospective data were evaluated from a single tertiary MS care center. Time to magnetic resonance imaging (MRI) activity and clinical relapse was assessed during Gilenya® and generic fingolimod treatment. Differences in absolute lymphocyte count (ALC) and side effects were also measured by treatment group.
RESULTS: The cohort included 88 PwMS (71 female; 76 White, mean age when starting Gilenya® was 39.6 years (standard deviation (SD) = 10.6 years), and mean age when starting generic fingolimod was 46.9 years (SD = 11.2 years)). A shorter time to MRI activity (p = 0.0026) and time to relapse (p = 0.0027) was observed during generic fingolimod treatment. The ALC increased by 8.81% after generic fingolimod treatment, relative to Gilenya® (95% CI = (2.00%, 16.08%), p = 0.01), with an intersubject variability of 1.97%. A 2.45-fold increase in side effects was observed with generic fingolimod relative to Gilenya® (95% CI = (1.38, 4.36), p = 0.002).
CONCLUSION: Measures of disease stability appear less optimal with generic fingolimod based on serological, clinical, and radiological measures.
OBJECTIVE: To quantify the clinical and radiological impact of transitioning from Gilenya® to generic fingolimod in people with MS (PwMS).
METHODS: Retrospective data were evaluated from a single tertiary MS care center. Time to magnetic resonance imaging (MRI) activity and clinical relapse was assessed during Gilenya® and generic fingolimod treatment. Differences in absolute lymphocyte count (ALC) and side effects were also measured by treatment group.
RESULTS: The cohort included 88 PwMS (71 female; 76 White, mean age when starting Gilenya® was 39.6 years (standard deviation (SD) = 10.6 years), and mean age when starting generic fingolimod was 46.9 years (SD = 11.2 years)). A shorter time to MRI activity (p = 0.0026) and time to relapse (p = 0.0027) was observed during generic fingolimod treatment. The ALC increased by 8.81% after generic fingolimod treatment, relative to Gilenya® (95% CI = (2.00%, 16.08%), p = 0.01), with an intersubject variability of 1.97%. A 2.45-fold increase in side effects was observed with generic fingolimod relative to Gilenya® (95% CI = (1.38, 4.36), p = 0.002).
CONCLUSION: Measures of disease stability appear less optimal with generic fingolimod based on serological, clinical, and radiological measures.