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- Title
Gender effects on intramuscular interferon beta-1a in relapsing—remitting multiple sclerosis: analysis of 1406 patients.
- Authors
Rudick, R. A.; Kappos, L.; Kinkel, R.; Clanet, M.; Phillips, J. T.; Herndon, R. M.; Sandrock, A. W.; Munschauer, F. E.
- Abstract
Background: We aimed to evaluate effects of gender on efficacy and safety of intramuscular (IM) interferon beta (IFNβ)-1a in patients with relapsing—remitting MS (RRMS) or clinically isolated syndromes (CIS) characteristic of early MS.Methods: Pooled data from 1406 (1027 women; 379 men) patients enrolled in five clinical studies of IM IFNβ-1a were analyzed. One analysis examined data for all patients treated with IM IFNβ-1a from all studies. Separate analyses were conducted of pooled IM IFNβ-1a-treated groups from all studies and pooled IFNβ-1a-treated and placebo-treated patients from the placebo-controlled studies. Outcome measures included time to first relapse, annualized relapse rate, time to disability progression, number of gadolinium-enhanced lesions, adverse events, laboratory evaluations, and neutralizing antibodies.Results: All efficacy assessments indicated similar treatment effects of IM IFNβ-1a in men and women with no significant treatment-by-gender interactions. Women reported more headaches, urinary tract infections, and depression in the analysis; however, these were also common in women who received placebo. Men reported more frequent flu-like symptoms in the placebo-controlled studies only. There were no other differences in the safety profile of IM IFNβ-1a between men and women.Conclusions: We conclude that no significant gender-related differences were found in the efficacy and safety of IM IFNβ-1a in patients with RRMS or CIS.
- Subjects
ADVERSE health care events; DISEASE relapse; DISEASE progression; GADOLINIUM; MULTIPLE sclerosis; IMMUNOGLOBULINS
- Publication
Multiple Sclerosis Journal, 2011, Vol 17, Issue 3, p353
- ISSN
1352-4585
- Publication type
Article
- DOI
10.1177/1352458510384605