Tuesday, 11 June 2013

Daclizumab in RRMS

Daclizumab SELECTION results. Slide presentation from the ENS. #MSBlog #MSResearch

Giovannoni et al  Efficacy and safety of daclizumab high-yield process (DAC HYP) treatment in relapsing-remitting multiple sclerosis: results from the SELECTION extension study. Multiple Sclerosis III: Other

Objective: Results from the SELECT trial, a 1-year study of the efficacy and safety of daclizumab high-yield process (DAC HYP) in RRMSers, have been reported. SELECTION was a 52-week extension study to evaluate the safety and efficacy of extended treatment with DAC HYP and assess the impact of a 24-week treatment interruption. 

Methods: 517 MSers were randomised in SELECTION. MSers who received placebo in SELECT (n=170) were randomised to subcutaneous 150mg or 300mg DAC HYP every 4 weeks. MSers who received 150mg or 300mg DAC HYP in SELECT were randomized to continue their current dose or to a 24-week treatment interruption before resuming their original dose. Because efficacy data between dose groups were similar, data were pooled for reporting. 

Results: 455 (91%) MSers completed the 52-week study period. In MSers randomized to continue DAC HYP for 2 years, the reductions in annualized relapse rate (ARR) achieved in Year 1 (ARR: 0.148; 95% CI, 0.096-0.229) were maintained in Year 2 (ARR: 0.165; 95% CI, 0.105-0.259). There were fewer new/newly enlarging T2 lesions in Year 2 of DAC HYP compared with Year 1 (1.2 vs. 1.9; P=0.032) and 89% of MSers were free of 3-month confirmed disability progression after 2 years of DAC HYP. In MSers initiating treatment with DAC HYP in SELECTION, the ARR was reduced by 59% (0.179 vs. 0.434; P<0.001) and the proportion of MSers with confirmed disability progression was reduced by 50% (5% vs. 11%; P=0.033) compared with the previous year when these MSers received placebo in the SELECT trial. In MSers randomized to treatment interruption, there was no evidence of disease rebound; the mean number of gadolinium-enhancing lesions at the end of the washout (1.1) remained below pretreatment baseline levels (1.6). There was one death (autoimmune hepatitis) in the 300-mg treatment-interruption group. During the second year of continuous DAC HYP therapy, the number of serious infections (DAC HYP 150mg n=2; 300mg n=2), serious cutaneous events (DAC HYP 150mg n=0; 300mg n=3), and transaminase elevations >5xULN (DAC HYP 150mg n=0; 300mg n=2) remained low, particularly in the 150mg group. 

Conclusion: The safety and efficacy of DAC HYP observed in SELECT was sustained through the second year of treatment and prior efficacy results were confirmed in new patients starting DAC HYP in SELECTION. MS disease activity did not appear to rebound after DAC HYP washout.

"I think Daclizumab is the dark horse. It is impact on progression is surprisingly good; better than what you would expect for its effect on relapse rate." 

CoI: multiple

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