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Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised,
Gavin Giovannoni1, Ralf Gold2, Krzysztof Selmaj3
1Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
The Lancet. Neurology
|March 25, 2014
Summary
Extended treatment with daclizumab high-yield process (HYP) showed comparable safety and immunogenicity in multiple sclerosis patients. These findings support its continued evaluation for relapsing-remitting multiple sclerosis.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- The SELECT trial demonstrated reduced disease activity with daclizumab high-yield process (HYP) in multiple sclerosis (MS) patients over 52 weeks.
- The SELECTION extension study aimed to evaluate the long-term safety and immunogenicity of daclizumab HYP.
Purpose of the Study:
- To assess the safety and immunogenicity of extended daclizumab HYP treatment in patients with relapsing-remitting multiple sclerosis (RRMS).
- To evaluate continuous treatment versus washout and re-initiation of daclizumab HYP.
Main Methods:
- A 52-week, multicentre, randomised, double-blind extension trial involving 517 patients who completed the SELECT study.
- Patients were assigned to treatment initiation, continuous treatment, or washout and re-initiation groups.
- Primary endpoints included safety (adverse events) and immunogenicity (antidrug antibodies).
Main Results:
- Serious adverse events were infrequent across all groups (6-8%).
- One death due to autoimmune hepatitis occurred in the re-initiation group, with a possible link to daclizumab HYP.
- Neutralising antidrug antibodies were detected in a small percentage of patients (1-2%).
Conclusions:
- Extended daclizumab HYP treatment, including continuous therapy and re-initiation after a washout, did not increase adverse events or immunogenicity.
- The safety and immunogenicity profile supports further investigation of daclizumab HYP for RRMS management.
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