Abstract
Background
The IMPROVE study demonstrated that the fetal bovine serum (FBS)- and human serum
albumin (HSA)-free formulation of subcutaneous (sc) interferon (IFN) beta-1a had beneficial
effects on the numbers of combined unique active magnetic resonance imaging (MRI)
lesions in relapsing–remitting multiple sclerosis (RRMS). Here we report additional
MRI endpoints (including post hoc analyses), and clinical efficacy, safety, and immunogenicity
outcomes.
Methods
Patients with active RRMS were randomized (2:1) to IFN beta-1a, 44 mcg sc three times weekly (tiw) (n=120), or placebo (n=60), for 16 weeks (double-blind phase). All patients then received IFN beta-1a, 44 mcg sc tiw, for 24 weeks (rater-blind phase). Patients underwent MRI brain scans every 4 weeks.
Results
Compared with placebo, there was a 68% reduction in the mean cumulative number of
new gadolinium-enhancing lesions with IFN beta-1a as early as week 4 (p<0.001), and a 53% reduction in the mean cumulative number of new T2 lesions as early
as week 8 (p=0.025; post hoc analyses). During the 16-week double-blind phase, the relapse rate
was 0.14 (95% confidence interval [CI] 0.09–0.23) with IFN beta-1a and 0.33 (95% CI
0.22–0.52) with placebo (p=0.010). Safety outcomes were consistent with those expected with IFN-beta treatment.
Conclusions
The FBS/HSA-free formulation of sc IFN beta-1a has a beneficial impact on MRI and
efficacy outcomes as early as 4 weeks after treatment initiation in patients with RRMS and has a safety profile consistent
with previous trials of sc IFN beta-1a.
Keywords
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Article info
Publication history
Published online: September 01, 2011
Accepted:
August 8,
2011
Received in revised form:
August 5,
2011
Received:
June 7,
2011
Identification
Copyright
© 2011 Elsevier B.V. Published by Elsevier Inc. All rights reserved.
