Biogen Idec (NASDAQ: BIIB) today announced the findings from a randomized, multicenter, dose-blinded clinical trial that evaluated the effect of AVONEX® (interferon beta-1a) dose titration, or gradual dose escalation, on flu-like symptoms associated with the therapy. The data demonstrated that dose titration with AVONEX over three weeks at the initiation of treatment resulted in a 76 percent reduction in flu-like symptom severity between pre-injection and the four-six-hour post-injection time point versus no titration (p<0.001). The study also showed that titration over six weeks at the initiation of treatment led to a 50 percent reduction in flu-like symptom severity between the same pre- and post-injection time point versus no titration (p<0.001). These data were presented at the 2011 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting in Montreal.
"Some physicians have practiced titration in the past based on experience of improved tolerability at initiation of interferon treatment; however, there has been limited clinical evidence on the benefits of dose titration," said Elliot Frohman, M.D., Ph.D., Professor of Neurology and Neurotherapeutics and of Ophthalmology at UT Southwestern Medical Center in Dallas, and member of the AVONEX U.S. advisory board. "We now have robust data showing that people who initially received titrated doses of AVONEX experienced a reduction in severity and incidence of flu-like symptoms."
Flu-like symptoms (e.g., fever, chills, headache, muscle aches and pains, and fatigue) have been shown to occur with interferon treatment, and physicians currently may employ several different strategies to alleviate these symptoms. Biogen Idec conducted the AVONEX dose titration study to help characterize the impact of titration on severity and incidence of flu-like symptoms.
"AVONEX has been a leading prescribed treatment for multiple sclerosis for 15 years and continues to provide hope for patients suffering from this disease," said Aaron Deykin, M.D., Director of Late Stage Neurology Development at Biogen Idec. "Findings from the dose titration study add to the real-world efficacy and safety data we have acquired for AVONEX, and can potentially provide the medical community with additional knowledge they can use to augment their own clinical experience to guide their approach to the initiation of AVONEX treatment."