Biologic National Registry (BINAR) protocol: Design and Rationale of the Tunisian clinical multicentric study of efficacy and safety of biologics in Rheumatoid arthritis and Spondyloarthritis

Abstract

INTRODUCTION: The advent of biological therapies has greatly improved the treatment and management of rheumatoid arthritis (RA) and spondyloarthritis (SpA). However, evaluating the efficacy and long-term safety of these therapies is a necessity. So far in Tunisia, no large prospective multicentric trial reflecting national data has been published. Thus, the objective of the study was to collect data on sociodemographic characteristics of Tunisian patients with RA and SpA receiving biologics and to evaluate the clinical efficacy and safety of this therapy. METHODS: BINAR is a prospective, observational registry with a 2-year follow-up period. A total of 600 consecutive patients treated with biologic for RA or SpA form different regions of Tunisia, are included until the end of the recruitment period, set at one year. Patients are officially included in BINAR only if they are aged 18 years and older. All patients monitored for RA according to ACR-EULAR criteria or SpA according to ASAS Criteria starting biological treatment at the time of inclusion or within two years before the inclusion date are eligible to be enrolled. All patients provided written informed consent. The primary end point is the safety and tolerability assessment of biologics and the incidence of adverse events over 2 years. The secondary end points are the assessment of RA and SpA activity at baseline and at two years of follow-up. RESULTS: One hundred rheumatologists are involved in this study. Ten departments participated in the registry. Demographic profile, activity and disability of RA and SpA will be evaluated. Efficacy and safety of biologic and the incidence of adverse events will be determined at the end of the 2-year follow-up period for every patient. CONCLUSION: BINAR is an essential source of clinical efficacy and safety information for biologic agents. It will be a large register for Tunisian patients. This study would add and provide valuable data for the long-term outcome of patients with RA and SpA treated with biologics.