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This study evaluated the efficacy of a new formulation of subcutaneous (sc) interferon (IFN)-β1a in relapsing-remitting multiple sclerosis (RRMS). Patients (n=180) were randomized (2 : 1) to IFN-β1a or placebo for 16 weeks; all patients then received IFN-β1a for 24 weeks. Monthly brain MRI was performed. At week 16, the mean number of combined unique active (CUA) lesions was lower with IFN-β1a than with placebo (p<0.001; 69% fewer lesions). The mean cumulative number of CUA lesions was already lower with IFN-β1a by week 4 (post hoc analysis; p=0.015). The new formulation of sc IFN-β1a has rapid beneficial effects on MRI outcomes in RRMS. [ABSTRACT FROM AUTHOR]