A post-hoc analysis from a Phase III clinical trial of AVONEX(R) (interferon beta-1a) and post-randomization eight-year follow up shows that six-month sustained progression of disability at two years, using the Expanded Disability Status Scale (EDSS), is a significant predictor of long-term disability, as measured by EDSS milestones of 4.0, 5.0, 6.0 and 7.0 at eight years, in patients with relapsing-remitting multiple sclerosis (RRMS).
The analysis suggests that patients taking AVONEX for two years were less likely to experience disability progression over time (eight years) when compared to placebo. These data were announced today at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference in Prague, Czech Republic.
The analysis involved 160 patients with RRMS who received at least two years of treatment (81 placebo, 79 interferon beta-1a), in the AVONEX Phase III trial and who were re-examined eight years post-randomization. 45 patients met the criteria for two-year disability progression sustained for six months (n=18 AVONEX, 27 placebo).
The analysis revealed:
Patients initially treated with AVONEX were less likely than patients initially receiving placebo to progress to EDSS scores of greater than or equal to 4.0 at eight years
Six month sustained EDSS progression during the pivotal two-year trial was a significant predictor of disability progression eight years later
Almost twice as many patients who had sustained progression in EDSS during the two-year trial progressed to an EDSS of greater than or equal to 4.0 than patients who did not progress (84% sustained, versus 44% unsustained)
Almost three times as many progressed to an EDSS of greater than or equal to 6.0 (67% sustained, versus 24% unsustained)
"This new analysis presents further evidence that patients who are treated for two years achieve long-term, clinically significant disability
benefits," said Dr. Richard Rudick, vice-chairman of Neurological Institute at the Cleveland Clinic Foundation. "For a person with RRMS, starting and staying with treatment slows disability progression, as measured by EDSS."
EDSS is a common disability outcome measure that is used in multiple sclerosis clinical trials. EDSS greater than or equal to 4.0 signifies
relatively severe disability, such as impacting physical coordination or the ability to walk without assistance.
AVONEX is the number one prescribed treatment for relapsing forms of multiple sclerosis (MS) worldwide, and is the only once-a-week MS therapy that is effective after the first attack. AVONEX is also proven to slow the progression of physical disability (as shown by 37% reduction over two years) and reduce the number of relapses. AVONEX has been proven effective in clinical trials for up to three years.
This study was funded by Biogen Idec.
Source: Biogen Idec. (15/10/07)