Germany-based Merck has reported the results of the complete 40-week IMPROVE (Investigating MRI Parameters with Rebif imprOVEd formulation) study.
Reportedly, the data showed a 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 (44mg three times a week) compared to placebo.
A post-hoc analysis showed that the positive effect can be detected as early as four 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 showed a 58% reduction in relapse rate versus placebo.
Additionally, 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).
Nicola De Stefano, professor of neurology, department of Neurological and Behavioural Sciences, University of Siena, and the principal investigator of the IMPROVE trial, said: “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.”
The IMPROVE study, a two-arm, randomized, double-blind, controlled, multicenter, international hase IIIb study, was to evaluate the efficacy, safety and tolerability of a reformulated version of Rebif in patients with relapsing-remitting MS and evidence of active disease.