Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis

Abstract

Among patients with relapsing-remitting multiple sclerosis, daclizumab HYP showed efficacy superior to that of interferon beta-1a with regard to the annualized relapse rate and lesions, as assessed by means of MRI, but was not associated with a significantly lower risk of disability progression confirmed at 12 weeks. The rates of infection, rash, and abnormalities on liver-function testing were higher with daclizumab HYP than with interferon beta-1a. (Funded by Biogen and AbbVie Biotherapeutics; DECIDE ClinicalTrials.gov number, NCT01064401.).

Daclizumab: another option for highly active relapsing‐remitting MS

“…In the overall population, daclizumab treatment resulted in a statistically significant delay in disability progression. 6 However, when examining the subgroups of participants with highly active disease and rapidly evolving disease, there was no statistically significant reduction in disability progression. This will continue to be investigated with the extended arm of this trial.…”

“…In a cohort of 1841 subjects 59% had not received any previous treatment. 6 In these clinical trials, daclizumab reduced relapse rate and delayed accumulation of disability, and was more effective than placebo and interferon. 5,6 In the DECIDE trial, there was a 45% reduction in relapse rate compared with interferon.…”

“…6 In these clinical trials, daclizumab reduced relapse rate and delayed accumulation of disability, and was more effective than placebo and interferon. 5,6 In the DECIDE trial, there was a 45% reduction in relapse rate compared with interferon. In the overall population, daclizumab treatment resulted in a statistically significant delay in disability progression.…”

Pharmacodynamic effects of daclizumab in the intrathecal compartment

“…Application of the “No evidence of disease activity” (NEDA)1 outcome to Phase III clinical trials2 or longitudinal multiple sclerosis (MS) cohorts3 demonstrated remarkably prevalent (e.g., 78% in 2‐year trial of daclizumab or >90% in 7‐year natural history cohort) residual MS disease activity on current disease‐modifying therapies (DMTs). The mechanism(s) for this residual activity are currently unknown.…”

Immune Response to Seasonal Influenza Vaccine in Patients with Relapsing-Remitting Multiple Sclerosis Receiving Long-term Daclizumab Beta

“…[1][2][3] (Daclizumab beta, formerly daclizumab high-yield process, approved as Zinbryta [Biogen, Cambridge, MA, USA], has a different form and structure than an earlier form of daclizumab.) Daclizumab beta is a humanized monoclonal antibody that binds to the interleukin (IL)-2 receptor α subunit (CD25) and modulates IL-2 signaling.…”