Experimental MS Medication Yields Positive Results for Patients

Treatment with Zinbryta caused reductions in the risk of 24-week confirmed multiple sclerosis disability progression.

Results from the phase 3 DECIDE study presented at the European Committee for Treatment and Research in Multiple Sclerosis showed positive outcomes for relapsing-remitting multiple sclerosis (RRMS) patients treated with investigational Zinbryta compared with interferon beta-1a 30 mcg intramuscular (IM) injection.

In the new post-hoc analyses, Zinbryta was shown to increase the percentage of patients achieving no evidence of clinical and MRI disease activity, improve cognitive processing speed, and reduce 24-week confirmed disability progression across a broad range of subgroups at 2 years compared with interferon beta-1a IM.

“The new DECIDE data presented at ECTRIMS provide further insight into the potential of daclizumab HYP to reduce MS disease activity, including the efficacy it has demonstrated in reducing MS relapse rates, disability progression and brain lesion development,” said Ludwig Kappos, MD, chair, Department of Neurology and head, MS-Research Group, University Hospital, Basel, Switzerland, and lead investigator for DECIDE. “Over the 2 years of data we analyzed, nearly twice as many patients treated with daclizumab HYP had no evidence of MS disease activity compared to those taking an approved MS treatment.”

The data presented from the DECIDE study showed that more Zinbryta-treated patients exhibited no evidence of disease activity, showed improvement in cognitive processing speed, and prevention of clinically meaningful cognitive decline. Furthermore, Zinbryta treatment resulted in reductions in the risk of 24-week confirmed disability progression across a wide range of pre-specified patient subgroups based on baseline characteristics.

“These new analyses advance our understanding of Zinbryta and its ability to slow the progression of MS compared to a widely used, approved therapy,” said Gilmore O’Neill, MD, vice president of Multiple Sclerosis Research and Development at Biogen. “In addition, we are encouraged by the positive results of the analyses of Zinbryta on measures of cognitive function, which is also at risk as MS progresses.”

Safety and tolerability results were collected from a cohort of 2236 RRMS patients treated with Zinbryta, including some patients treated for more than 5 years. The results support the known benefit-risk profile of the drug as well as provide evidence that adverse events (AEs) did not appear to increase over time.

Over a 30-month period of time, the incidence of infection, cutaneous events, and hepatic events did not increase over time. The most common AEs associated with the investigational treatment were MS relapse, nasopharyngitis, upper respiratory infection, headache, and urinary tract infection.

However, a separate analysis of cutaneous AEs occurring in the DECIDE study showed that cutaneous AEs were more common with Zinbryta treatment versus treatment with interferon beta-1a.

Zinbryta is currently under regulatory review in the United States, Australia and the European Union.