Эффективность и безопасность генно-инженерных биологических препаратов для лечения анкилозирующего спондилита: систематический обзор и метаанализ препаратов, зарегистрированных в РФ

Abstract

The aim of the study was to evaluate the comparative efficacy and safety of biologics registered and reimbursed in the Russian healthcare system for the treatment of adult patients with active ankylosing spondylitis. Material and methods . We performed a systematic literature review of randomized controlled trials in PubMed, Embase, and eLIBRARY.RU databases. 17 articles reporting results from 16 trials were selected for qualitative and quantitative analysis. The main efficacy criteria were ASAS 20/40 over 12-16 weeks of therapy, additional criteria were BASDAI 50, changes from baseline in BASDAI and BASFI indexes. Safety criteria were determined based on the incidence of adverse events; we also analysed the proportion of patients suffering from at least one serious adverse event. Biologics were ranked based on the SUCRA values. Results. Subgroup analysis showed no statistically significant differences between IL-17 and TNF-a inhibitors, but the IL-17 inhibitor class had a higher SUCRA values. For the combination of all analyzed efficacy outcomes, netakimab, infliximab, and ixekizumab hold the first three ranks. The safety profiles of biologics included in the review were comparable with each other. Conclusion . The results of this review are intended to help healthcare professionals make decisions about optimal therapy for adult patients with active ankylosing spondylitis.