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EFFICACY AND SAFETY OF INTERFERON BETA-1A FOR INTRAMUSCULAR INJECTIONS BIOSIMILAR IN PATIENTS WITH RELAPSING REMITTING MULTIPLE SCLEROSIS, 2017

назад к просмотру объектов

Описание

Authors: F. Khabirov1, L. Averianova1, N. Babicheva1, A.Dykhanov2, E. Granatov1, T. Khaybullin1, S. Shakirzianova1

Institutions: 1 Republican clinical neurological centre, Kazan, Russia; 2 LLC "SIA API", Mosсow, Russia.

Introduction. Interferons beta (IFN-beta) are still among the most frequently used agents for disease modifying therapy (DMT) of multiple sclerosis (MS). Many biosimilars of IFN-beta have appeared recently, but data about their efficacy and safety are controversial.

Aims. To evaluate the efficacy and safety of IFN-beta-1a for intramuscular injections (IM IFN-beta-1a) biosimilar in Russian patients with relapsing remitting MS (RR MS).

Patients and methods. 92 treatment naïve patients with newly diagnosed RR MS (McDonald 2010) were included in study. In all these patients treatment with IM IFN-beta-1a biosimilar (CinnoVex) was initiated (group 1, G1). The control group (n=59) was formed from historical cohort of patients, who were under our supervision and received the original IM IFN-beta-1a (Avonex) (group 2, G2). Efficacy and safety were evaluated after 1 year of treatment in both groups. The efficacy endpoints included annual relapse rate (ARR), the proportion of patients without disability progression (no stable increase in Expanded Disability Status Scale (EDSS)) and the proportion of patients without MRI activity (no gadolinium enhancing or new T2 lesions). The frequency and structure of adverse events were analyzed for safety assessment.

Main results. There were no statistically significant differences between groups in demographic characteristics, disease duration, pre-treatment relapse rate or MRI activity, median EDSS and previous DMT. In both groups significant reduction of ARR after 1 year of treatment were observed (G1: from 0,74 to 0,36, p<0,05); G2: from 0,81 to 0,39, p<0,05). The groups did not differ in ARR after 1 year treatment (p>0,05). No EDSS progression was observed in 91 and 88% of patients in G1 and G2 resp. 16% of patients were free from MRI activity in G1 and 14% — in G2 (p>0,05). The most frequent AE in both groups were flu like symptoms and local reactions (51 vs. 58%, and 4 vs. 3% resp.). No unsuspected treatment related AE were observed. The treatment was discontinued in 18% of patients in G1, and in 14% of patients in G2. AEs as the reason for treatment discontinuation were observed only in 3 and 2% resp. In 7 and 5% of patients in G1 and G2 resp. treatment was discontinued due to obvious lack of clinical efficacy.

Conclusion. The data obtained from the present study suggests the therapeutic and safety equivalence of IM IFN-beta-1-a biosimilar (CinnoVex, CinnaGen Co, Iran) and original IM IFN-beta1a (Avonex, Biogen, USA).