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A Randomized, Placebo-Controlled Trial of Natalizumab for Relapsing Multiple Sclerosis
Ist Teil von
The New England journal of medicine, 2006-03, Vol.354 (9), p.899-910
Ort / Verlag
Boston, MA: Massachusetts Medical Society
Erscheinungsjahr
2006
Quelle
MEDLINE
Beschreibungen/Notizen
This placebo-controlled, randomized trial of patients with relapsing multiple sclerosis demonstrated benefits of natalizumab (an α
4
integrin antagonist) in all the primary and secondary outcome measures. After two years, the probability of sustained progression of disability was 17 percent with natalizumab and 29 percent with placebo. Fatigue and allergic reaction were more common among patients receiving natalizumab.
This trial of patients with relapsing multiple sclerosis demonstrated benefits of natalizumab in all the primary and secondary outcome measures. In this trial, natalizumab in combination with interferon was more effective than interferon alone. Progressive multifocal leukoencephalopathy developed in two patients. In this systematic evaluation for PML in patients who received natalizumab in clinical trials, no additional cases were identified.
Relapsing multiple sclerosis is characterized by the intermittent development of inflammatory lesions in the brain and spinal cord, resulting in plaques of demyelination and axonal loss. Lymphocyte migration across the blood–brain barrier is thought to be an important early step in the formation of lesions.
1
The interaction of α
4
β
1
integrin, a protein on the surface of lymphocytes, with vascular-cell adhesion molecule 1 (VCAM-1), which is expressed on the surface of vascular endothelial cells in brain and spinal cord blood vessels, mediates the adhesion and migration of lymphocytes in areas of inflammation.
2
–
6
Furthermore, the interaction of α . . .