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agate
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Joined: 17 May 2006
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Location: Oregon
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 Posted: Sat Apr 27, 2013 6:07 pm Post subject: Daclizumab HYP in RRMS |
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From Journal Watch Neurology, April 23, 2013:
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Summary and Comment
Daclizumab HYP in Relapsing–Remitting MS
Is this newer formulation safer than other daclizumab versions?
Daclizumab is a humanized monoclonal antibody that targets CD25, the high-affinity interleukin-2 receptor IL2R on lymphocytes. It is FDA approved for use in organ transplantation. These researchers conducted a multicenter, dose-ranging, manufacturer-funded, 1-year trial of high-yield process (HYP) daclizumab for relapsing–remitting multiple sclerosis (MS). Daclizumab HYP differs from other formulations of daclizumab in its glycosylation profile, which leads to less antibody-dependent cellular cytotoxicity activity. They randomized 621 patients in a 1:1:1 ratio to subcutaneous daclizumab 150 mg, subcutaneous daclizumab 300 mg, or placebo once per week for 52 weeks.
The primary endpoint was the annualized relapse rate at week 52. Secondary endpoints were the cumulative number of new gadolinium-enhancing lesions on brain magnetic resonance imaging (MRI) scans at weeks 8, 12, 16, 20, and 24; new or newly enlarging T2 hyperintense lesion count at week 52; the proportion of patients free of relapses during the study period; and quality of life.
Compared with the placebo group, both the daclizumab HYP 150-mg and 300-mg groups had significantly lower annualized relapse rates at week 52 (54% and 50% reduction, respectively), and they also had significantly fewer new MS lesions. Significantly more patients were relapse-free in the daclizumab HYP 150-mg (81%) and 300-mg (80%) groups than in the placebo group (64%). Serious adverse events (excluding MS relapse) occurred in 12 patients (6%) in the placebo group, 15 (7%) of those in the daclizumab 150-mg group, and 19 (9%) in the 300-mg group. One patient given daclizumab HYP 150 mg died because of local complication of a psoas abscess.
Comment:
Previous studies showed that standard daclizumab added to interferon reduced multiple sclerosis disease activity in patients previously refractory to interferon beta alone. The efficacy of daclizumab HYP appears to be similar to that of other newly approved drugs, and its safety profile appears to be acceptable, but longer-term studies are needed. Selection of therapy will need to be individualized to balance efficacy with tolerability and long-term risks.
— Samia J. Khoury, MD
Dr. Khoury is the Jack, Sadie, and David Breakstone Professor of Neurology, Harvard Medical School, and Codirector, Partners MS Center, Brigham and Women's Hospital, Boston; and Director, Abu Haidar Neuroscience Institute, American University of Beirut Medical Center, Beirut, Lebanon.
Citation(s):
Gold R et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): A randomised, double-blind, placebo-controlled trial. Lancet Apr 4; |
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