Gender effects on intramuscular interferon beta-1a in relapsing-remitting multiple sclerosis: analysis of 1406 patients.
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.
Mellen Center for Treatment and Research (Neurological Institute), The Cleveland Clinic Foundation, Cleveland, OH 44195, USA. rudickr@ccf.org
R A
RA
Rudick
L
L
Kappos
R
R
Kinkel
M
M
Clanet
J T
JT
Phillips
R M
RM
Herndon
A W
AW
Sandrock
F E
FE
Munschauer
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D004185:Disability Evaluation; D018450:Disease Progression; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage* / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008279:Magnetic Resonance Imaging; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000188:drug therapy*; D016017:Odds Ratio; D016016:Proportional Hazards Models; D018570:Risk Assessment; D012307:Risk Factors; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D016899:Interferon-beta; D000068556:Interferon beta-1a