post-registration studies

BCD-055 is a biosimilar of innovator infliximab (IFX). Here we present the 54-week results from phase 3 clinical study in patients with rheumatoid arthritis (RA). The aim of this study was to demonstrate the equivalent efficacy and safety of BCD-055 and IFX in patients with active rheumatoid arthritis. 426 adults with active RA were enrolled. Patients were randomized into 2 study arms in 2:1 ratio to receive BCD-055 or IFX innovator in dose of 3 mg/kg at week 0, 2, 6 and then every 8 weeks up to week 54. Primary efficacy endpoint was the rate of American College of Rheumatology (ACR) 20 response at week 14. The equivalence margin was set as 15%. Immunogenicity and safety were also assessed. Rate of ACR20 at week 14 in PP (Per-Protocol) population was 71.2% in BCD-055 group and 67.9% in IFX group. Difference in ACR20 rates between groups was 3.2% with 95% CI [- 7.0%; 13.5%] (р = 0.587). Throughout 54-week study period, both groups were characterized by similar rates of ACR20/50/70 respomore...

Interferon-based regimens for chronic hepatitis C (HCV) are quite common, just like interferon-free treatments, and are extensively used in Russia because interferon is widely available to most patients. In 2013 the original Russian drug cepeginterferon alpha-2b (cepegIFN alpha-2b marketed as Algeron by Biocad, Russia) was introduced into clinical practice. The aim of this study was to assess effectiveness and safety of cepegIFN alpha-2b as part of the combination therapy with ribavirin in patients with chronic HCV infection. The study was conducted over the period from 2014 to 2016 and recruited 37 patients with chronic genotype 1 HCV infection: 22 men and 15 women (mean age of 42.0 ±5.2 years). All of them received the following combination antiviral therapy (AT): 1.5 pg/kg cepegIFN alpha-2b once a week and 15 pg/kg ribavirin daily over the period of 48 weeks. Effectiveness of AT was assessed by the rate of sustained virological response (SVR), i. e. aviremia achieved 24 weeks after more...