Long-term safety and tolerability of glatiramer acetate 20 mg/ml in the treatment of relapsing forms of multiple sclerosis

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Tjalf Ziemssen - , Department of Neurology (Author)
  • Natalia Ashtamker - , Teva Pharmaceutical Industries Ltd. (Author)
  • Svetlana Rubinchick - , Teva Pharmaceutical Industries Ltd. (Author)
  • Volker Knappertz - , Teva Pharmaceutical Industries Ltd., Heinrich Heine University Düsseldorf (Author)
  • Giancarlo Comi - , Vita-Salute San Raffaele University (Author)

Abstract

​Introduction: Glatiramer acetate (GA) is a first-line therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS). It has a well-characterized long-term safety profile and established efficacy, with over 2 million patient-years of exposure. Areas covered: To present long-term safety and tolerability findings for GA 20 mg/mL daily in the management of patients with multiple sclerosis (MS). A database analysis of all patients with MS who have ever been exposed to GA 20 mg/mL daily in clinical trials, including patients with up to 20 years of continuous treatment.Total exposure to GA in the clinical trials analyzed was 10,017 patient-years, and treatment duration ranged from 0 to 23.1 years (median 1.8 years). No unexpected adverse events (AEs) were recorded. The most common AEs were injection-site related (ISR), affecting 49% of patients receiving GA in clinical trials. Development of erythema at the injection site was the most common ISR, affecting 29.2% of study patients. Immediate post-injection reactions (IPIRs) were experienced by 24.0% of study patients; dyspnea was the most common IPIR, affecting 12.1% of patients. Expert opinion: The results of this analysis are consistent with long-term studies showing GA to be safe and generally well tolerated.

Details

Original languageEnglish
Pages (from-to)247-255
Number of pages9
JournalExpert opinion on drug safety
Volume16
Issue number2
Publication statusPublished - 1 Feb 2017
Peer-reviewedYes

External IDs

PubMed 27989217

Keywords

ASJC Scopus subject areas

Keywords

  • Glatiramer acetate, multiple sclerosis, safety, tolerability