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

In this 'double-blind', randomized, placebo-controlled phase II trial, we c ompared an altered peptide ligand of myelin basic protein with placebo, eva luating their safety and influence on magnetic resonance imaging in relapsi ng-remitting multiple sclerosis. A safety board suspended the trial because of hypersensitivity reactions in 9% of the patients. There were no increas es in either clinical relapses or in new enhancing lesions in any patient, even those with hypersensitivity reactions. Secondary analysis of those pat ients completing the study showed that the volume and number of enhancing l esions 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.