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Efficacy and Safety of Interferon Beta-1a (Avonex) Appears Unaffected by Gender of Patient: Presented at ECTRIMS
By Bruce Sylvester
THESSALONIKI, GREECE -- October 3, 2005 -- Treatment of multiple sclerosis with interferon beta-1a (Avonex) is equally efficacious in men and women, with similar safety profiles in both genders, researchers reported here on September 29th at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
"Some other studies had suggested that the treatment effect might be different, but we didn't find this result in this meta-analysis of the trials that we have done with the drug," said investigator and presenter Alfred Sandrock, MD, PhD, vice-president of medical research, Biogen Idec, Inc., Cambridge, Massachusetts, United States. "Moreover, the side-effect profile was also similar between men and women."
The investigators pooled data from 5 clinical studies of MS and compared the treatment response of male and female subjects to interferon beta-1a. They used 4 efficacy endpoints -- time to first relapse, annualised relapse rate, time to 1-point sustained Expanded Disability Status Scale progression, and gadolinium-enhancing lesions. They also pooled and analysed safety data.
The researchers included 1406 subjects in the analyses; 1027 female subjects and 379 male subjects.
For women, median time to first relapse was 495 days. For men it was 505 days. The annualised relapse rate was 0.68 for women and 0.65 for men.
The overall rate of flu-like symptoms was 69% for women and 74% for men. The investigators reported clinically notable increases in alanine aminotransferase related tests in 5% of women and 6% of men, and 3% of both females and males showed increases in aspartate aminotransferase tests.
Analyses using the 4 efficacy endpoints showed that the effect of interferon beta-1a was favorable and similarly so for women and men. The analyses also showed a similar safety profile for both genders.
"It appears that the benefit-risk ratio is very similar whether you are a man or a woman who takes this drug," Dr. Sandrock added.
The research was supported by Biogen Idec, Inc.
[Presentation title: A Study of the Effect of Gender on Interferon Beta-1a (Avonex(R) 30 Mcg) Treatment in Patients With Multiple Sclerosis. Poster 309]
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