No evidence of disease activity in patients receiving daclizumab versus intramuscular interferon beta-1a for relapsing-remitting multiple sclerosis in the DECIDE study
Language English Country England, Great Britain Media print-electronic
Document type Comparative Study, Journal Article, Randomized Controlled Trial
- Keywords
- Composite outcome, clinical endpoints, daclizumab, disease-activity-free, magnetic resonance imaging, no evidence of disease activity, radiological endpoints, relapsing-remitting multiple sclerosis, treatment,
- MeSH
- Adjuvants, Immunologic administration & dosage pharmacology MeSH
- Daclizumab MeSH
- Adult MeSH
- Outcome Assessment, Health Care methods MeSH
- Antibodies, Monoclonal, Humanized administration & dosage pharmacology MeSH
- Immunoglobulin G administration & dosage pharmacology MeSH
- Immunosuppressive Agents administration & dosage pharmacology MeSH
- Injections, Intramuscular MeSH
- Injections, Subcutaneous MeSH
- Interferon beta-1a administration & dosage pharmacology MeSH
- Middle Aged MeSH
- Humans MeSH
- Multiple Sclerosis, Relapsing-Remitting diagnostic imaging drug therapy physiopathology MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- Adjuvants, Immunologic MeSH
- Daclizumab MeSH
- Antibodies, Monoclonal, Humanized MeSH
- Immunoglobulin G MeSH
- Immunosuppressive Agents MeSH
- Interferon beta-1a MeSH
BACKGROUND: No evidence of disease activity (NEDA) is a composite endpoint being increasingly applied as an outcome measure in clinical trials as well as proposed for individual therapeutic decisions in multiple sclerosis (MS). OBJECTIVE: Assess the proportion of patients with relapsing-remitting MS achieving NEDA in the DECIDE study of daclizumab 150 mg subcutaneous versus intramuscular interferon beta-1a 30 µg for 96-144 weeks. METHODS: NEDA was defined as no relapses, no onset of 12-week confirmed disability progression (CDP), no new/newly enlarging T2 hyperintense lesions (NET2), and no gadolinium-enhancing (Gd+) lesions. Logistic regression models adjusted for baseline covariates compared treatment groups for baseline to week 96, weeks 0-24, and weeks 24-96. RESULTS: From baseline to week 96, more daclizumab versus intramuscular interferon beta-1a patients achieved NEDA (24.6% vs 14.2%; odds ratio (OR; 95% confidence interval): 2.059 (1.592-2.661); p < 0.0001). ORs for clinical NEDA (no relapses, no CDP) and magnetic resonance imaging (MRI) NEDA (no NET2, no Gd+ lesions) were 1.651 (1.357-2.007; p < 0.0001) and 2.051 (1.628-2.582; p < 0.0001), respectively. ORs in favor of daclizumab for weeks 24-96 were consistently higher than for weeks 0-24. CONCLUSION: More daclizumab versus intramuscular interferon beta-1a patients achieved NEDA early in DECIDE, with effects increasing over time.
Barts and The London School of Medicine and Dentistry Queen Mary University of London London UK
Department of Neurology 1st Faculty of Medicine Charles University Prague Prague Czech Republic
Judith Jaffe Multiple Sclerosis Center Weill Cornell Medical College New York NY USA
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