Long-term safety and tolerability of glatiramer acetate 20 mg/ml in the treatment of relapsing forms of multiple sclerosis
| Autor: | Giancarlo Comi, Volker Knappertz, Natalia Ashtamker, Tjalf Ziemssen, Svetlana Rubinchick |
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| Přispěvatelé: | Ziemssen, Tjalf, Ashtamker, Natalia, Rubinchick, Svetlana, Knappertz, Volker, Comi, Giancarlo |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
safety
medicine.medical_specialty Injection Time Factors Erythema Databases Factual Time Factor Pharmacology Injections 03 medical and health sciences 0302 clinical medicine Glatiramer acetate Multiple Sclerosis Relapsing-Remitting Adjuvants Immunologic Internal medicine Injection site Medicine Animals Humans Pharmacology (medical) 030212 general & internal medicine tolerability Adverse effect business.industry Animal Multiple sclerosis General Medicine Glatiramer Acetate medicine.disease Clinical trial Tolerability multiple sclerosi Long term safety medicine.symptom business 030217 neurology & neurosurgery medicine.drug Human |
| Popis: | âIntroduction: 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 20Â 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 20Â mg/mL daily in clinical trials, including patients with up to 20Â 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 23.1Â years (median 1.8Â 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. |
| Databáze: | OpenAIRE |
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