J Clin Neurol.  2022 Nov;18(6):663-670. 10.3988/jcn.2022.18.6.663.

Safety and Temporal Pattern of the Lymphocyte Count During Fingolimod Therapy in Patients With Multiple Sclerosis: Real-World Korean Experience

Affiliations
  • 1Department of Neurology, College of Medicine, Kosin University, Busan, Korea
  • 2Department of Neurology, Research Institute and Hospital of National Cancer Center, Goyang, Korea
  • 3Department of Neurology, Seoul National University Hospital, Seoul, Korea
  • 4Department of Neurology, Yonsei University College of Medicine, Seoul, Korea
  • 5Department of Neurology, Neuroscience Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 6Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
  • 7Department of Neurology, Dongguk University Ilsan Hospital, Goyang¸ Korea
  • 8Department of Neurology, Chonnam National University Medical School and Hospital, Gwangju, Korea
  • 9Department of Neurology, Jeju National University School of Medicine, Jeju, Korea
  • 10Department of Neurology, Konkuk University Medical Center, Seoul, Korea
  • 11Department of Neurology, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea
  • 12Department of Neurology, Chungnam National University Hospital, Daejeon, Korea

Abstract

Background and Purpose
Fingolimod (FTY) inhibits lymphocyte egress from lymphoid organs to cause lymphopenia, but the clinical implications of FTY-induced lymphopenia are not fully understood. We aimed to determine the frequency and severity of lymphopenia during FTY treatment among Korean patients with multiple sclerosis (MS), and its association with infections.
Methods
We retrospectively reviewed the medical records of patients with MS treated using FTY from 12 referral centers in South Korea between March 2013 and June 2021. Patients were classified according to their nadir absolute lymphocyte count (ALC) during treatment: grade 1, 800–999/μL; grade 2, 500–799/μL; grade 3, 200–499/μL; and grade 4, <200/μL.
Results
FTY treatment was administered to 69 patients with a median duration of 18 months (range=1–169 months), with 11 patients being treated for ≥7 years. During FTY treatment, mean ALCs were reduced after the first month (653.0±268.9/μL, mean±standard deviation) (p<0.0001) and remained low during treatment lasting up to 84 months. During follow-up, 41 (59.4%) and 7 (10.1%) patients developed grade-3 and grade-4 lymphopenia, respectively. No significant difference was found in age at FTY initiation, sex, baseline ALC, body mass index, or prior disease-modifying treatment between patients with and without grade-4 lymphopenia. Infections were observed in 11 (15.9%) patients, and the frequencies of patients with and without grade-4 lymphopenia were similar.
Conclusions
FTY treatment induced grade-4 lymphopenia in 10% of South Korean patients with MS, but did not appear to be associated with an increased infection risk.

Keyword

multiple sclerosis; fingolimod; lymphopenia
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