Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome

Giancarlo Comi, Vittorio Martinelli, Mariaemma Rodegher, Lucia Moiola, Letizia Leocani, Ovidiu Bajenaru, Adriana Carra, Irina Elovaara, Franz Fazekas, Hans Peter Hartung, Jan Hillert, John King, Samuel Komoly, Catherine Lubetzki, Xavier Montalban, Kjell Morten Myhr, Paolo Preziosa, Mads Ravnborg, Peter Rieckmann, Maria A. RoccaDaniel Wynn, Carolyn Young, Massimo Filippi

Research output: Contribution to journalArticle

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Abstract

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%,

Original languageEnglish
Pages (from-to)1074-1083
Number of pages10
JournalMultiple Sclerosis Journal
Volume19
Issue number8
DOIs
Publication statusPublished - 2013

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Multiple Sclerosis
Brain
Therapeutics
Placebos
Atrophy
Glatiramer Acetate
Confidence Intervals

Keywords

  • brain atrophy
  • Clinically definite multiple sclerosis
  • clinically isolated syndrome (CIS)
  • EDSS
  • glatiramer acetate
  • MRI
  • relapse

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome. / Comi, Giancarlo; Martinelli, Vittorio; Rodegher, Mariaemma; Moiola, Lucia; Leocani, Letizia; Bajenaru, Ovidiu; Carra, Adriana; Elovaara, Irina; Fazekas, Franz; Hartung, Hans Peter; Hillert, Jan; King, John; Komoly, Samuel; Lubetzki, Catherine; Montalban, Xavier; Myhr, Kjell Morten; Preziosa, Paolo; Ravnborg, Mads; Rieckmann, Peter; Rocca, Maria A.; Wynn, Daniel; Young, Carolyn; Filippi, Massimo.

In: Multiple Sclerosis Journal, Vol. 19, No. 8, 2013, p. 1074-1083.

Research output: Contribution to journalArticle

Comi, G, Martinelli, V, Rodegher, M, Moiola, L, Leocani, L, Bajenaru, O, Carra, A, Elovaara, I, Fazekas, F, Hartung, HP, Hillert, J, King, J, Komoly, S, Lubetzki, C, Montalban, X, Myhr, KM, Preziosa, P, Ravnborg, M, Rieckmann, P, Rocca, MA, Wynn, D, Young, C & Filippi, M 2013, 'Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome', Multiple Sclerosis Journal, vol. 19, no. 8, pp. 1074-1083. https://doi.org/10.1177/1352458512469695
Comi, Giancarlo ; Martinelli, Vittorio ; Rodegher, Mariaemma ; Moiola, Lucia ; Leocani, Letizia ; Bajenaru, Ovidiu ; Carra, Adriana ; Elovaara, Irina ; Fazekas, Franz ; Hartung, Hans Peter ; Hillert, Jan ; King, John ; Komoly, Samuel ; Lubetzki, Catherine ; Montalban, Xavier ; Myhr, Kjell Morten ; Preziosa, Paolo ; Ravnborg, Mads ; Rieckmann, Peter ; Rocca, Maria A. ; Wynn, Daniel ; Young, Carolyn ; Filippi, Massimo. / Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome. In: Multiple Sclerosis Journal. 2013 ; Vol. 19, No. 8. pp. 1074-1083.
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AU - Martinelli, Vittorio

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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

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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%,

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