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

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.

KEYWORDS:

• Glatiramer acetate
• multiple sclerosis
• safety
• tolerability

Acknowledgments

The authors would like to thank the patients and site personnel involved in these studies.

Declaration of interest

T Ziemssen has received personal compensation for participating on advisory boards, trial steering committees and data and safety monitoring committees, as well as for scientific talks and project support from: Almirall, Bayer HealthCare, Biogen Idec, Elan, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Synthon and Teva. The manuscript has been read and approved by all authors. Medical writing assistance was utilized in the preparation of this manuscript and was carried out by Justin Potuzak (Chameleon Communications International with funding from Teva Pharmaceutical Industries). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This study was funded by Teva Pharmaceutical Industries.