PMID- 27989217
OWN - NLM
STAT- MEDLINE
DCOM- 20170310
LR  - 20220408
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 16
IP  - 2
DP  - 2017 Feb
TI  - Long-term safety and tolerability of glatiramer acetate 20 mg/ml in the treatment 
      of relapsing forms of multiple sclerosis.
PG  - 247-255
LID - 10.1080/14740338.2017.1274728 [doi]
AB  - ​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.
FAU - Ziemssen, Tjalf
AU  - Ziemssen T
AD  - a Center of Clinical Neuroscience , University Hospital , Dresden , Germany.
FAU - Ashtamker, Natalia
AU  - Ashtamker N
AD  - b Teva Pharmaceuticals , Netanya , Israel ​.
FAU - Rubinchick, Svetlana
AU  - Rubinchick S
AD  - b Teva Pharmaceuticals , Netanya , Israel ​.
FAU - Knappertz, Volker
AU  - Knappertz V
AD  - c Teva Pharmaceuticals , Frazer , PA , USA.
AD  - d Heinrich-Heine Universitat Dusseldorf , Dusseldorf , Germany ​.
FAU - Comi, Giancarlo
AU  - Comi G
AD  - e Department of Neurology and INSPE , Vita-Salute San Raffaele University , Milan 
      , Italy.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Adjuvants, Immunologic)
RN  - 5M691HL4BO (Glatiramer Acetate)
SB  - IM
MH  - Adjuvants, Immunologic/administration & dosage/*adverse effects
MH  - Animals
MH  - Databases, Factual
MH  - Glatiramer Acetate/administration & dosage/*adverse effects
MH  - Humans
MH  - Injections
MH  - Multiple Sclerosis, Relapsing-Remitting/*drug therapy/physiopathology
MH  - Time Factors
OTO - NOTNLM
OT  - Glatiramer acetate
OT  - multiple sclerosis
OT  - safety
OT  - tolerability
EDAT- 2016/12/19 06:00
MHDA- 2017/03/11 06:00
CRDT- 2016/12/20 06:00
PHST- 2016/12/19 06:00 [pubmed]
PHST- 2017/03/11 06:00 [medline]
PHST- 2016/12/20 06:00 [entrez]
AID - 10.1080/14740338.2017.1274728 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2017 Feb;16(2):247-255. doi: 10.1080/14740338.2017.1274728.