title: 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.
authors.affiliation: a Center of Clinical Neuroscience , University Hospital , Dresden , Germany.
authors.forename: Tjalf
authors.initials: T
authors.lastname: Ziemssen
authors.affiliation: b Teva Pharmaceuticals , Netanya , Israel ​.
authors.forename: Natalia
authors.initials: N
authors.lastname: Ashtamker
authors.affiliation: b Teva Pharmaceuticals , Netanya , Israel ​.
authors.forename: Svetlana
authors.initials: S
authors.lastname: Rubinchick
authors.affiliation: c Teva Pharmaceuticals , Frazer , PA , USA.|d Heinrich-Heine Universität Düsseldorf , Düsseldorf , Germany ​.
authors.forename: Volker
authors.initials: V
authors.lastname: Knappertz
authors.affiliation: e Department of Neurology and INSPE , Vita-Salute San Raffaele University , Milan , Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects*; D000818:Animals; D016208:Databases, Factual; D000068717:Glatiramer Acetate / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D007267:Injections; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors
chemical_list: D000276:Adjuvants, Immunologic; D000068717:Glatiramer Acetate
keywords: Glatiramer acetate; multiple sclerosis; safety; tolerability