Biotech Values

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BIIB/ABBV Daclizumab in RRMS ph3 DECIDE Detailed Results:

Primary Endpoint:
Patients on ZINBRYTA demonstrated a statistically significant 45 percent reduction in annualized relapse rate (ARR) compared to patients treated with AVONEX (p<0.0001).

Secondary Endpoints:
ZINBRYTA demonstrated superiority in reducing the number of new or newly enlarging T2-hyperintense lesions at week 96, with a 54 percent reduction relative to AVONEX (p<0.0001).
The risk of three-month confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), was reduced by 16 percent in patients treated with ZINBRYTA compared to those on AVONEX (p=0.16). This was not statistically significant.
Seventy-three percent of ZINBRYTA patients were relapse-free compared to 59 percent of AVONEX patients (nominal 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 percent in the ZINBRYTA group compared to the AVONEX group (nominal p=0.018).

DECIDE Safety Results
The safety profile of ZINBRYTA in the DECIDE study was generally consistent with the Phase 2 studies. The overall incidence of adverse events was comparable across the ZINBRYTA and AVONEX treatment groups.
In patients treated with ZINBRYTA compared to AVONEX, there was an increased incidence of serious infections (4 percent vs. 2 percent). The pattern and types of infections seen in the ZINBRYTA group were consistent with what has been previously observed in the MS population.
Also consistent with previous studies, patients in the ZINBRYTA group had a greater incidence of cutaneous adverse events (37 percent vs. 19 percent) and serious cutaneous reactions (2 percent vs. < 1 percent); and elevations of liver transaminases greater than five times the upper limit of normal (6 percent vs. 3 percent). There were four deaths in the AVONEX group and one death in the ZINBRYTA group, none of which was considered treatment related.

http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2377&M=NewsV2&PID=61997

From Medscape:

Where Will Daclizumab Fit?

Commenting for Medscape Medical News on where daclizumab may fit into current treatment, Jeff Cohen, MD, Cleveland Clinic, Ohio, said, "The safety is a concern and needs to be sorted out but it could be a useful addition. I like to have choices. I wouldn't think it would be used as initial therapy in most patients, however."

Jerry Wolinsky, MD, University of Texas Health Science Center at Houston, added: "If the drugs available in the US are listed in terms of effectiveness the list would probably be something like: natalizumab, fingolimod, DMF [dimethyl fumarate], ß-interferon/Copaxone. l think daclizumab would fit in somewhere in the fuzzy zone between fingolimod and DMF," he said.

"I don't like the skin reactions but they seem to turn up early and go away in time so maybe they are no worse than the GI [gastrointestinal] problems with DMF," he added.

Dr. Chitnis said she thought the efficacy of daclizumab looked good. "It seems to be a potent anti-inflammatory agent — a 45% relapse rate reduction vs ß-interferon is very impressive, although we do have to be careful about comparing between clinical trials of course. I think it will be reasonable to use it early on in RRMS."

Lily Jung Henson, MD, medical director of Swedish Neuroscience Neurology, Seattle, Washington, agreed. "Its efficacy data looks great across the board," she told Medscape Medical News. "I think we are learning from the other DMTs [disease-modifying therapies] that side effects are a necessary evil that we have to learn to monitor and deal with, which is a small price to pay for having more choices and great efficacy."

http://www.medscape.com/viewarticle/831753?src=rss