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Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced results of the complete 40-week IMPROVE (Investigating MRI Parameters with Rebif imprOVEd formulation) study. These data show a significant 69% reduction in the number of combined unique brain MRI lesions in patients with relapsing-remitting multiple sclerosis (RRMS) at 16 weeks after initiation of treatment with Rebif (44 micrograms three times a week) compared to placebo (3.0 versus 0.9 in the placebo and Rebif groups respectively, p< 0.001), (primary endpoint).
A post-hoc analysis showed that this positive effect can be detected as early as 4 weeks after treatment initiation. The decreased number of brain lesions was sustained over the 40-week trial period in patients treated with Rebif. The 16-
week results also show a 58% reduction in relapse rate versus placebo (p = 0.0104).
“The IMPROVE study confirms the consistency of the safety profile of Rebif, while showing further evidence of the early onset of action of Rebif on MRI outcomes in patients suffering from multiple sclerosis”, said Dr Nicola De Stefano, Professor of
Neurology, Department of Neurological and Behavioural Sciences, University of Siena, Italy, and the Principal Investigator of the IMPROVE trial.
The 40-week analysis shows that patients originally randomized to placebo and switched to Rebif at week 16 had a statistically significant decrease in combined unique active (CUA) lesions (mean number of CUA lesions/patient/scan decreased from 2.31 while on placebo (up to week 16) to 0.65 while on Rebif (weeks 17-40), p <0.001) (secondary endpoint). The safety profile of Rebif reported in this study is consistent with the known safety profile of Rebif. No unexpected safety concerns were identified in this study.