atus Scale (EDSS), was reduced by 16% in patients treated with daclizumab compared to those on interferon beta-1a(p=0.16).(p<0.0001). 73% of daclizumab-treated patients were relapse-free vs. 59% of interferon beta-1a treated pts (p<0.0001) at week 96. The risk of meaningful worsening in the physical impact of multiple sclerosis (MS) (> 7.5 point worsening in the Multiple Sclerosis Impact Scale [MSIS-29] physical score) was reduced by 24% in the daclizumab group compared to the interferon beta-1a group (nominal p=0.018). [12]
15/09/2014 08:50:23
Jun 14: Positive top-line results from the DECIDE study reported [11].
11/07/2014 17:19:28
Jun 14: Biogen Idec & AbbVie announce that, in a PII study, daclizumab significantly decreased annualised relapse rate by 45% vs. once-weekly Avonex (interferon beta-1a). Daclizumab also met one of two secondary endpoints [10].
18/06/2014 12:18:25
Mar 14: PIII SELECTION study published in The Lancet [9].
20/03/2014 10:10:34
NCT01797965 (EXTEND) is a long-term PIII extension study in 1,841 subjects with RRMS who have completed study NCT01064401 (DECIDE). All patients will receive open-label daclizumab monthly for up to 3 years. The study starts Feb 13 and finishes Dec 16 [8]
17/07/2013 18:35:51
Apr 13: Results from the daclizumab high-yield process (DAC HYP) SELECT study published early online in The Lancet (www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)62190-4/fulltext).
05/04/2013 09:33:03
Oct 12: Results from SELECTION, a 1 year extension study to the SELECT study reported at the European Committee for Treatment and Research in Multiple Sclerosis meeting. Daclizumab sustained efficacy in the 2nd year but serious autoimmune issues also emerged. Of 621 patients completing SELECT, 517 participated in SELECTION, with 92% remaining through the full year. Patients in SELECT originally taking placebo were re-randomized to either 150 or 300mg daclizumab monthly; those in the active drug arms were also re-randomized to receive either continuous treatment with the same dose, or to a 24-week washout period followed by resumption of the original dose for 24 weeks. The purpose was threefold: to confirm the drug´s efficacy in the original placebo group, to examine the durability of its effects with continuous treatment, and to see whether it would retain its efficacy when restarted after treatment interruption. Patients in the initial placebo group had a mean annualized relapse rate (ARR) of 0.434 in SELECT and an ARR of 0.179 (95% CI 1.23 to 0.261) in SELECTION (pooled data on both doses). Disability progression was also reduced (P=0.033). New or enlarging T2 MRI lesions declined by 74% and new gadolinium-enhancing T1 lesions decreased 86% after the switch. In patients continuously treated with daclizumab, ARR and the slowing of disability progression seen in SELECT was maintained. Rates of new/enlarging T2 lesions declined modestly but significantly (P=0.032). In the patients randomized to the 24-week daclizumab washout, gadolinium-enhancing lesion numbers rebounded to 3x the level seen at the end of SELECT; after 6 months daclizumab treatment mean lesion counts fell back to levels similar to those at the end of SELECT. CD56bright natural killer cell counts, a laboratory measure of daclizumab treatment, had risen roughly 10-fold from baseline during SELECT but levelled off in continuously treated patients. There were 13 serious infections, 6 skin events, 8 cases of liver enzyme |
