INDIANAPOLIS -- Daclizumab HYP (Zinbryta) may have an advantage over interferon-beta-1a (Avonex) in terms of patient-centered functional outcomes in multiple sclerosis (MS), researchers reported here.
In a post-hoc analysis from the DECIDE trial, patients randomized to the investigational agent had greater improvements in a composite of functional endpoints than those on the older agent, , of Carolinas Health Care, and colleagues reported at the Consortium of Multiple Sclerosis Centers meeting.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
- A post-hoc analysis of the DECIDE trial, which randomized 1,841 relapsing-remitting MS patients to either daclizumab HYP (Zinbryta) to interferon beta-1a (Avonex), found that those assigned to daclizumab HYP showed greater improvement in several measures of functional outcomes, including measures of walking, use of upper extremities, and cognition.
- Though these functional tests were not the primary outcome in the original study, these results further support the benefits of daclizumab HYP in relapsing-remitting patients.
The DECIDE trial previously found that daclizumab HYP cut relapse rates and disability progression to a greater extent than interferon beta 1a. Kaufman said the investigators also wanted to assess patient-centered functional outcomes because maintaining functional ability -- particularly ambulation and cognition -- is important to MS patients.
For the post-hoc analysis, Kaufman and colleagues looked at data from the 1,841-patient trial that randomized relapsing-remitting patients to either drug. They assessed outcomes on the Multiple Sclerosis Functional Composite (MSFC) test, which includes three standard MS ambulatory assessments -- the Timed 25-Foot Walk test (T25FW), the Nine-Hole Peg Test (9HP), and the Paced Auditory Serial Addition Test-3 (PASAT-3). They also assessed cognitive function using the Symbol Digit Modalities Test (SDMT).
They found that over the 96-week study period, the median z-score change from baseline in the MSFC was significantly greater in the daclizumab HYP group (0.091 versus 0.055 for interferon beta 1a, P=0.0007).
Differences were also significant for each of the individual tests within the composite:
- T25FW: P=0.006
- 9HP:P=0.0016
- PASAT-3: P=0.0411
The authors also reported significantly greater improvements in cognition as measured by the SDMT (P=0.0274).
"Over 2 to 3 years, daclizumab HYP showed greater improvement than interferon-beta 1a in patient-centered measures of functional disability," Kaufman said. "This supports earlier findings that daclizumab HYP demonstrated superior efficacy to interferon beta-1a across key clinical and radiographic MS outcome measures. It has the potential to be a new therapeutic option for relapsing-remitting MS."
The HYP at the end of the drug's name stands for high yield process, which is intended to distinguish the drug from an earlier formulation sold as Zenapax. Biogen and AbbVie recently filed the biologics license application (BLA) for daclizumab HYP.
Disclosures
The study was supported by Biogen.
Kaufman disclosed relevant relationships with Biogen, Bayer, EMD Serono, Novartis, and Teva.
Primary Source
Consortium of Multiple Sclerosis Centers
Source Reference: Kaufman M, et al "The effect of daclizumab high-yield process on patient-centered functional outcomes: Results from the DECIDE study" CMSC 2015; Abstract DX01.