Induction of a non-encephalitogenic type 2 T helper-cell autoimmune response in multiple sclerosis after administration of an altered peptide ligand in a placebo-controlled, randomized phase II trial. The Altered Peptide Ligand in Relapsing MS Study Group.
In this 'double-blind', randomized, placebo-controlled phase II trial, we compared an altered peptide ligand of myelin basic protein with placebo, evaluating their safety and influence on magnetic resonance imaging in relapsing-remitting multiple sclerosis. A safety board suspended the trial because of hypersensitivity reactions in 9% of the patients. There were no increases in either clinical relapses or in new enhancing lesions in any patient, even those with hypersensitivity reactions. Secondary analysis of those patients completing the study showed that the volume and number of enhancing lesions were reduced at a dose of 5 mg. There was also a regulatory type 2 T helper-cell response to altered peptide ligand that cross-reacted with the native peptide.
Kappos
L
L
Department of Neurology, University Hospitals, Petersgraben 4, CH-4031, Basel, Switzerland.
Comi
G
G
Panitch
H
H
Oger
J
J
Antel
J
J
Conlon
P
P
Steinman
L
L
D004305:Dose-Response Relationship, Drug; D004342:Drug Hypersensitivity / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008024:Ligands; D008279:Magnetic Resonance Imaging; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000276:immunology* / Q000473:pathology; D004676:Myelin Basic Protein / Q000378:metabolism / Q000627:therapeutic use*; D010446:Peptide Fragments / Q000378:metabolism / Q000627:therapeutic use*; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D018418:Th2 Cells / Q000276:immunology*
D008024:Ligands; D004676:Myelin Basic Protein; D010446:Peptide Fragments; D010455:Peptides; C104448:myelin basic protein 83-99; C415588:NBI 5788