The Need for the Closer Monitoring of Novel Drugs in MS : A Siponimod Retrospective Cohort Study (Realhes Study)

Arantxa Sancho-López, Belén Ruiz-Antorán, Teresa Iglesias Hernangómez, Almudena Ramírez-García, Irene Gómez-Estévez, Judith Sanabria-Cabrera, Roser Llop Rius, Consuelo Pedrós, Diana Campodonico, Silvia Jiménez-Jorge, Amelia García Luque, Lucienne Costa Frossad França, Eva Montané Esteva, Ana Aldea-Perona, Nieves Téllez Lara, Montserrat Bosch Ferrer, Consuelo Rodriguez Jiménez, Elvira Bonilla-Toyos, Julia Sabín Muñoz, Cristina Avendaño SolaMaría Rosario Blasco Quilez

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background: Severe cases of lymphopenia have been reported during siponimod clinical trials, which may negatively impact its benefit/risk profile. Objective: We aimed to evaluate the incidence of lymphopenia following the initiation of siponimod treatment in clinical practice. The secondary objectives included the analysis of factors predisposing to and the clinical relevance of lymphopenia events. Methods: In this multicenter retrospective cohort study, information collected from the medical records of 129 patients with MS from 15 tertiary hospitals in Spain who initiated treatment with Siponimod were followed-up for at least 3 months, including at least one lymphocyte count evaluation per patient. Results: Of the 129 patients, 121 (93.6%) reported lymphopenia events, including 110 (85.3%) with grade ≤ 3 and 11 (8.5%) with grade 4 lymphopenia, higher than those reported in the pivotal clinical trial (73.3% and 3.3% for grade ≤ 3 and grade 4 lymphopenia, respectively). The study included an unexpectedly high proportion of male subjects (72.9%), which might have led to an underestimation of the actual magnitude of the risk. Conclusions: In this study, the incidence and severity of lymphopenia after starting siponimod treatment were higher than those reported in previous clinical trials. Therefore, our results reinforce the need for the closer monitoring of novel MS drugs in clinical practice, as well as larger and longer follow-up studies to properly characterize this risk.

Original languageEnglish
Article number6471
JournalJournal of Clinical Medicine
Volume12
Issue number20
DOIs
Publication statusPublished - 11 Oct 2023

Keywords

  • Lymphopenia
  • Multiple sclerosis
  • Pharmacovigilance
  • Real-world evidence
  • Siponimod
  • real-world evidence
  • multiple sclerosis
  • pharmacovigilance
  • lymphopenia
  • siponimod

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