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Abstract

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.

Keywords

Composite outcome daclizumab clinical endpoints disease-activity-free magnetic resonance imaging no evidence of disease activity radiological endpoints relapsing-remitting multiple sclerosis treatment

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No evidence of disease activity in patients receiving daclizumab versus intramuscular interferon beta-1a for relapsing-remitting multiple sclerosis in the DECIDE study

Abstract

Background:

Objective:

Methods:

Results:

Conclusion:

Keywords

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References

Supplementary Material