Daclizumab in RRMS aiming for Disease free status

Havrdova E, Giovannoni G, Stefoski D, Forster S, Umans K, Mehta L, Greenberg S, Elkins J. Disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with daclizumab high-yield process in the SELECT study. Mult Scler. 2013 Sep 10. [Epub ahead of print]

BACKGROUND:Daclizumab high-yield process (DAC HYP) is a humanized anti-CD25 monoclonal antibody that inhibits high-affinity interleukin-2 receptor signaling.
OBJECTIVE:The objective of this paper is to assess the proportion of DAC HYP- versus placebo-treated patients who were free from disease activity.
METHODS: SELECT was a randomized, double-blind, multicenter study of DAC HYP 150 mg or 300 mg, or placebo, administered subcutaneously every four weeks for 52 weeks. In this post-hoc analysis of the SELECT trial, ‘disease-activity free’ was defined as completion through week 52 without relapses or confirmed three-month disability progression (clinical), with no new/newly enlarging T2-hyperintense lesions and no new gadolinium-enhancing lesions at the week 52 scan (radiological). Primary analyses were based on logistic regression controlling for baseline characteristics.
RESULTS: More DAC HYP-treated (39%, n = 156) versus placebo-treated patients (11%, n = 22) were disease-activity free (odds ratio (95% confidence interval), 6.18 (3.71-10.32); p < 0.0001). Furthermore, 77% and 48% of DAC HYP-treated patients were free from clinical or radiological disease activity, respectively, compared with 60% and 18% of placebo-treated patients.
At one year, DAC HYP resulted in a meaningful increase in the proportion of relapsing-remitting MS patients who were disease-activity free versus placebo.

Here are some more results from the daclizumab study, that profG has talked about previously. Isn’t interesting that news of SELECT were published in 2011..So remember the issue about embargo and the ingelfinger rule. But this is a good example how investors get to know things first.  

CoI: Multiple ProfG is author of this paper

10 Apr 2013
20 Mar 2013
“Why is daclizumab so interesting? It has a greater impact on disability progression than you would expect from it impact on relapses. 
14 Aug 2011
Press release WESTON, Mass. & ABBOTT PARK, Ill., Aug 09, 2011 (BUSINESS WIRE) · Biogen Idec (NASDAQ: BIIB) and Abbott (NYSE: ABT) announced positive top-line results from SELECT, a global, registrational Phase …
23 Oct 2012
Late Breaking News II. Saturday, October 13, 2012, 09:15 – 09:30. Primary results of the SELECTION trial of daclizumab HYP in relapsing multiple sclerosis. G. Giovannoni, R. Gold, K. Selmaj, E. Havrdova, X. Montalban, E.-W.

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1 comment

  • Prof G,

    When you say no evidence of disease activity, what does this mean? Does it mean the disease has stopped of is the disease still doing damage but this can't be seen with current technology / clinical examination?

    If NEDA is the aim, 61% of patients of Daclizumab didn't achieve this. What would you suggest for this patients i.e. more Daclizumab or switch treatment?

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