The new formulation of Rebif is said to offer substantial improvement in tolerability and reduction in antibody formation.
The primary objective of the study was to compare the antigenicity of new formulation Rebif to historical data. Historical data for the currently available formulation of Rebif is the ‘Evidence’ study.
The endpoint of the study is the proportion of neutralizing antibody positive patients at the last assessment. At 48 weeks, the data showed that 13.9% of patients treated with the new formulation of Rebif were neutralizing antibody positive.
In the Evidence study at 48 weeks, 24.4% of the patients were positive. Persistent neutralizing antibodies were detected in 2.5% of the patients treated with the new formulation of Rebif at 48 weeks. In the EVIDENCE study at 48 weeks, the rate of persistent neutralizing antibodies observed was 14.3%.
“If approved the new formulation of Rebif potentially represents an improvement in the treatment of patients with multiple sclerosis,” said Prof Per Soelberg Sorensen, from the Danish MS Research Center.
The new formulation of Rebif is currently under regulatory review by the European Medicines Agency, the FDA and other healthcare authorities.