Results of an Open Prospective Trial of β-Interferon Bioanalogs

Objective. To study the safety and efficacy of bioanalog multiple sclerosis disease-modifying drugs (MS DMD) using an example population consisting of patients living in the Yaroslavl District (the Yaroslavl cohort) in a prospective, nonrandomized, open, long-term trial. Materials and methods. A total of 203 patients were recruited into the study and received bioanalog MS DMD for 30 months in compliance with the instructions for use. Efficacy was evaluated in terms of exacerbation frequency, dynamics of EDSS scores, and changes in the number of foci on T2-weighted images (T2-WI) on MRI scans. Safety was assessed by determining the proportions of patients experiencing adverse events during treatment. Reference points were values at baseline and 30 months. Results. A significant decrease in exacerbation frequency was seen with all bioanalogs as compared with baseline (by 0.30 with CinnoVex, 0.29 with Genfaxon, 0.13 with Ronbetal/interferon β-1b, and 0.36 with Infibeta). Use of all study analogs except Infibeta was associated with significant increases in EDSS scores (by +0.31 with Cinnovex, +0.38 with Genfaxon, +0.66 with Ronbeta/interferon β-1b, and +0.26 with Infibeta). MRI data showed increases in the numbers of foci in groups receiving CinnoVex (by 16.6%), Genfaxon (by 14.4%), and Ronbetal (by 10.6%), and a decrease in the number of foci on T2-WI in patients treated with Infibeta (by 14.5%). The most marked generalized reactions were seen on treatment with CinnoVex (influenza-like syndrome in 66% of cases); local reactions were most marked in the Genfaxon group, occurring in 82% of cases. Conclusions. Differences in the safety and efficacy profiles of individual bioanalogs of original MS DMD again draw attention to the need for detailed study of the effects of drugs in the framework of postmarketing trials, including maintaining drug company-independent registers of patients receiving the various MS DMD.

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