TY - JOUR
T1 - Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome
AU - Comi, Giancarlo
AU - Martinelli, Vittorio
AU - Rodegher, Mariaemma
AU - Moiola, Lucia
AU - Leocani, Letizia
AU - Bajenaru, Ovidiu
AU - Carra, Adriana
AU - Elovaara, Irina
AU - Fazekas, Franz
AU - Hartung, Hans Peter
AU - Hillert, Jan
AU - King, John
AU - Komoly, Samuel
AU - Lubetzki, Catherine
AU - Montalban, Xavier
AU - Myhr, Kjell Morten
AU - Preziosa, Paolo
AU - Ravnborg, Mads
AU - Rieckmann, Peter
AU - Rocca, Maria A.
AU - Wynn, Daniel
AU - Young, Carolyn
AU - Filippi, Massimo
PY - 2013/7
Y1 - 2013/7
N2 - Background: The placebo-controlled phase of the PreCISe study showed that glatiramer acetate delayed onset of clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome and brain lesions on MRI. Objective: To compare the effects of early versus delayed glatiramer acetate treatment in the open-label phase of PreCISe. Methods: Patients with a clinically isolated syndrome suggestive of MS with unifocal manifestation and =2 T2-weighted brain lesions were randomized to receive glatiramer acetate 20 mg/d (early-treatment, n=198) or placebo (delayed-treatment, n=211) for 36 months or until conversion to CDMS, followed by open-label glatiramer acetate treatment for two years. Results: Early glatiramer acetate treatment reduced CDMS conversion risk by 41% (hazard ratio 0.59, 95% confidence interval 0.44-0.80; p=0.0005) versus delayed-treatment, and was associated with a 972-day delay (185%) in conversion to CDMS, less brain atrophy (-28%, p=0.0209), fewer new T2 lesions/year (-42%, <0.0001) and lower T2 lesion volume (-22%, p=0.0005) versus delayed treatment. Adverse events were consistent with the established safety profile of glatiramer acetate. Conclusions: Effects of early glatiramer acetate treatment on the rate of conversion to CDMS and on MRI measures of disease activity and lesion burden support initiating glatiramer acetate treatment soon after the first clinical symptoms suggestive of MS and continuing treatment to sustain benefits.
AB - Background: The placebo-controlled phase of the PreCISe study showed that glatiramer acetate delayed onset of clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome and brain lesions on MRI. Objective: To compare the effects of early versus delayed glatiramer acetate treatment in the open-label phase of PreCISe. Methods: Patients with a clinically isolated syndrome suggestive of MS with unifocal manifestation and =2 T2-weighted brain lesions were randomized to receive glatiramer acetate 20 mg/d (early-treatment, n=198) or placebo (delayed-treatment, n=211) for 36 months or until conversion to CDMS, followed by open-label glatiramer acetate treatment for two years. Results: Early glatiramer acetate treatment reduced CDMS conversion risk by 41% (hazard ratio 0.59, 95% confidence interval 0.44-0.80; p=0.0005) versus delayed-treatment, and was associated with a 972-day delay (185%) in conversion to CDMS, less brain atrophy (-28%, p=0.0209), fewer new T2 lesions/year (-42%, <0.0001) and lower T2 lesion volume (-22%, p=0.0005) versus delayed treatment. Adverse events were consistent with the established safety profile of glatiramer acetate. Conclusions: Effects of early glatiramer acetate treatment on the rate of conversion to CDMS and on MRI measures of disease activity and lesion burden support initiating glatiramer acetate treatment soon after the first clinical symptoms suggestive of MS and continuing treatment to sustain benefits.
KW - brain atrophy
KW - Clinically definite multiple sclerosis
KW - clinically isolated syndrome (CIS)
KW - EDSS
KW - glatiramer acetate
KW - MRI
KW - relapse
UR - http://www.scopus.com/inward/record.url?scp=84879752237&partnerID=8YFLogxK
U2 - 10.1177/1352458512469695
DO - 10.1177/1352458512469695
M3 - Article
AN - SCOPUS:84879752237
SN - 1352-4585
VL - 19
SP - 1074
EP - 1083
JO - Multiple Sclerosis Journal
JF - Multiple Sclerosis Journal
IS - 8
ER -