Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

Ilkka Rauma, Tiina Mustonen, Juha Matti Seppä, Maritta Ukkonen, Marianne Männikkö, Auli Verkkoniemi-Ahola, Marge Kartau, Jukka T. Saarinen, Liisa Luostarinen, Sakari Simula, Mervi Ryytty, Riitta Ahmasalo, Jussi O.T. Sipilä, Ilkka Pieninkeroinen, Tero Tapiola, Anne M. Remes, Hanna Kuusisto

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Abstract

Background: Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. Objectives: To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. Methods: In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. Results: Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1–3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. Conclusions: SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.

Original languageEnglish
JournalJournal of neurology
DOIs
Publication statusE-pub ahead of print - 13 Jul 2021
Publication typeA1 Journal article-refereed

Keywords

  • Alemtuzumab
  • Autoimmunity
  • Drug-related side effects and adverse reactions
  • Incidence
  • Multiple sclerosis
  • Safety

Publication forum classification

  • Publication forum level 1

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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