PMID- 18208875
OWN - NLM
STAT- MEDLINE
DCOM- 20081020
LR  - 20151119
IS  - 1352-4585 (Print)
IS  - 1352-4585 (Linking)
VI  - 14
IP  - 4
DP  - 2008 May
TI  - Long-term (up to 22 years), open-label, compassionate-use study of glatiramer 
      acetate in relapsing-remitting multiple sclerosis.
PG  - 494-9
LID - 10.1177/1352458507085029 [doi]
AB  - To evaluate the safety and efficacy of long-term glatiramer acetate (GA) therapy, 
      46 patients with relapsing-remitting multiple sclerosis (RRMS) were treated for 
      up to 22 years in an ongoing, open-label study. Kurtzke expanded disability 
      status scale (EDSS) was measured every six months, relapses were reported at 
      occurrence and patients self-reported adverse events (AEs). At GA initiation, 
      disease durations ranged from 0-20 years (median 6.0 years) and at data cut-off 
      (October 2004), GA therapy duration ranged from 1-22 years (median 12.0 years). 
      Mean EDSS score increased 0.9 +/- 1.9 from the pretreatment score (3.0 +/- 1.8; P 
      = 0.076). Only 10/28 (36%) patients with baseline EDSS <4.0 had a last observed 
      value >or= 4.0 and 8/34 (24%) with entry EDSS < 6.0 reached EDSS >or= 6.0. A 
      majority (57%) maintained improved or unchanged EDSS scores. Annualized relapse 
      rate decreased to 0.1 +/- 0.2 from 2.9 +/- 1.4 prestudy (P < 0.0001). Of the 18 
      remaining patients in October 2004 (average disease duration 23 years), 17% with 
      baseline EDSS scores < 4.0 reached EDSS >or= 4.0 and 28% with baseline scores < 
      6.0 reached EDSS >or= 6.0. Adverse events were similar to those reported in 
      short-term clinical trials. This study shows a low rate of relapses and EDSS 
      progression in RRMS patients on GA for up to 22 years.
FAU - Miller, Aaron
AU  - Miller A
AD  - Mount Sinai School of Medicine, New York, NY, USA. aaron.miller@mssm.edu
FAU - Spada, Vincent
AU  - Spada V
FAU - Beerkircher, Dorothy
AU  - Beerkircher D
FAU - Kreitman, Rivka Riven
AU  - Kreitman RR
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20080121
PL  - England
TA  - Mult Scler
JT  - Multiple sclerosis (Houndmills, Basingstoke, England)
JID - 9509185
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Peptides)
RN  - 5M691HL4BO (Glatiramer Acetate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Disability Evaluation
MH  - Disease Progression
MH  - Female
MH  - Glatiramer Acetate
MH  - Humans
MH  - Immunosuppressive Agents/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis, Relapsing-Remitting/*drug therapy
MH  - Peptides/*administration & dosage/adverse effects
MH  - Prospective Studies
MH  - Secondary Prevention
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2008/01/23 09:00
MHDA- 2008/10/22 09:00
CRDT- 2008/01/23 09:00
PHST- 2008/01/23 09:00 [pubmed]
PHST- 2008/10/22 09:00 [medline]
PHST- 2008/01/23 09:00 [entrez]
AID - 1352458507085029 [pii]
AID - 10.1177/1352458507085029 [doi]
PST - ppublish
SO  - Mult Scler. 2008 May;14(4):494-9. doi: 10.1177/1352458507085029. Epub 2008 Jan 
      21.