Real-world data on siponimod-related lymphopenia among people with secondary progressive multiple sclerosis

Author:

Gilmartin Christopher GS12ORCID,Hoyle Natasha3,Garjani Afagh12ORCID,Dixon Terri2,Jos Helena4,Paling David3,Brownlee Wallace56,Tench Christopher17,Evangelou Nikos12ORCID

Affiliation:

1. Mental Health and Clinical Neurosciences Academic Unit, School of Medicine, University of Nottingham, Nottingham, UK

2. Clinical Neurology, Nottingham University Hospitals NHS Trust, Nottingham, UK

3. Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK

4. University College London Medical School, London, UK

5. Department of Neuroinflammation, UCL Queen Square Institute of Neurology, University College London, London, UK

6. National Institute for Health and Care Research (NIHR) University College London Hospitals Biomedical Research Centre, London, UK

7. NIHR Nottingham Biomedical Research Centre, Nottingham, UK

Abstract

Background: Siponimod-related lymphopenia in real-world clinical practice has implications for dose adjustment and infection risk. Objective: To characterise siponimod-related lymphopenia in people with secondary progressive multiple sclerosis (pwSPMS). Methods: This is a retrospective cohort of 188 pwSPMS. The development of grade 4 lymphopenia was interrogated with Kaplan–Meier survival analysis and binary logistic regression. Results: Lymphopenia develops soon after commencing siponimod. In total, 15 (8.5%) of 176 experienced grade 4 lymphopenia at 1 month after initiation. There were no clinically significant associations between patient characteristics and development of grade 4 lymphopenia. Conclusion: Grade 4 lymphopenia can occur soon after siponimod initiation and cannot be predicted.

Publisher

SAGE Publications

Reference12 articles.

1. European Medicines Agency (EMA). Mayzent, https://www.ema.europa.eu/en/medicines/human/EPAR/mayzent (2019, accessed 11 September 2023).

2. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study

3. An update on the use of sphingosine 1-phosphate receptor modulators for the treatment of relapsing multiple sclerosis

4. Jones. NDA 209884 Mayzent (siponimod). Center for Drug Evaluation and Research, 2017, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209884Orig1s000MedR.pdf

5. Inmunosenescencia: el rol de la edad en la esclerosis múltiple

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