MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS.

Este artículo está incluido en 3 Revisiones sistemáticas Revisiones sistemáticas (3 referencias)

Este artículo es parte de los siguientes hilos de publicación
  • AFFIRM [Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis study] (11 documentos)
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BACKGROUND:

In a 2-year, placebo-controlled trial (the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] study), involving 942 patients with relapsing multiple sclerosis (MS), natalizumab significantly reduced the relapse rate by 68% and progression of sustained disability by 42% vs placebo. We report the effect of natalizumab on MRI measures from the AFFIRM study.

METHODS:

The number and volume of gadolinium (Gd)-enhancing, new or enlarging T2-hyperintense, and new T1-hypointense lesions and brain parenchymal fraction were measured from annual scans obtained at baseline, 1 year, and 2 years.

RESULTS:

Compared with placebo, natalizumab produced a 92% decrease in Gd-enhancing lesions (means 2.4 vs 0.2; p < 0.001), an 83% decrease in new or enlarging T2-hyperintense lesions (means 11.0 vs 1.9; p < 0.001), and a 76% decrease in new T1-hypointense lesions (means 4.6 vs 1.1; p < 0.001) over 2 years. Median T2-hyperintense lesion volume increased by 8.8% in the placebo group and decreased by 9.4% in the natalizumab group (p < 0.001); median T1-hypointense lesion volume decreased by 1.5% in the placebo group and decreased by 23.5% in the natalizumab group (p < 0.001). Brain atrophy was greater in year 1 and less in year 2 in natalizumab-treated patients.

CONCLUSION:

Natalizumab has a sustained effect in preventing the formation of new lesions in patients with relapsing multiple sclerosis.
Epistemonikos ID: f7af7936e680d1fbac03a1f479d357cc117bb62a
First added on: Feb 15, 2012