Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial
Abstract
Background In the SELECT trial, disease activity was reduced in patients with multiple sderosis who received dadizumab high-yield process (HYP) for 52 weeks. The primary aim of the SELECTION extension study was to assess the safety and immunogenicity of extended treatment with dadizumab HYP.
This study is registered with ClinicalTrials.gov, number NCT00870740. Findings 517 (91%) of 567 patients who completed the SELECT trial entered SELECTION, of whom 170 were in the treatment initiation group, 173 in the continuous treatment group, and 174 in the washout and re-initiation group. 11 patients in the treatment initiation group (6%), 13 in the continuous treatment group (8%), and ten in the washout and re-initiation group (6%) had any serious adverse event other than relapse of multiple sderosis.
One patient in the washout and re-initiation group (300 mg dadizumab HYP) died because of autoimmtme hepatitis; a contributory role of dadizumab HYP could not be exduded. Seven patients tested positive for neutralising antidrug antibodies: one (1%) of 128 for whom data were available in the continuous treatment group (this patient also tested positive at SELECTION baseline), four (2%) in the treatment initiation group, and two (2%) of 129 in the washout and re-initiation group.
Interpretation Adverse events and immunogenidty were not increased in the second year of continuous treatment with dadizumab HYP or during treatment washout and re-initiation. These results support further assessment of dadizumab HYP for relapsing-remitting multiple sderosis.