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

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Published Mar 30, 2025
https://doi.org/10.62438/tunismed.v103i4.5557
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Vol. 103 No. 4 (2025): Tunis Med Apr 2025

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Haifa Hachfi
Rheumatology department, Tahar Sfar Hospital, Mahdia, Tunisia
Mouna Braham
Rheumatology department, Tahar Sfar Hospital, Mahdia, Tunisia
Najla El Amri
Rheumatology department, Farhat Hached Hospital, Sousse, Tunisia
Kawther Ben Abdelghani
Rheumatology department,Mongi Slim hospital, Faculty of Medicine of Tunis, University Tunis El Manar, Tunisia
Soumaya Boussaid
Rheumatology department, La Rabta hospital, Faculty of Medicine of Tunis, University Tunis El Manar, Tunisia
Rim Dhahri
Rheumatology department, National Military hospital, Faculty of Medicine of Tunis, University Tunis El Manar, Tunisia
Saoussen Miladi
Rheumatology department, Mongi Slim hospital, Faculty of Medicine of Tunis, University Tunis El Manar, Tunisia
Hela Fourati
Rheumatology department, Hedi Chaker Hospital, Sfax, Tunisia
Mahbouba Jeguirim
Rheumatology department, Fattouma Bourguiba Hospital, Monastir, Tunisia
Kaouther Maatallah
Rheumatology department, Orthopedics Kassab Institute, Faculty of Medicine of Tunis, University Tunis El Manar, Tunisia
Rawdha Tekaya
Rheumatology department, Charles Nicolle hospital, University Tunis El Manar, Faculty of Medicine of Tunis,Tunisia
Rabie Razgallah
DACIMA Consulting, Tunis, Tunisia
Leila Abdelmoula
Internal Medicine department, Habib Thameur hospital, Faculty of Medicine of Tunis,University Tunis El Manar, Tunisia
Sofiene Baklouti
Rheumatology department, Hedi Chaker Hospital, Sfax, Tunisia
Naceur Bargaoui
Rheumatology department, Fattouma Bourguiba Hospital, Monastir, Tunisia
Elyes Bouajina
Rheumatology department, Farhat Hached Hospital, Sousse, Tunisia
Mohamed ElEuch
Rheumatology department, La Rabta hospital, Faculty of Medicine of Tunis,University Tunis El Manar,Tunisia
Imen Gharsallah
Rheumatology department, National Military hospital, Faculty of Medicine of Tunis, University Tunis El Manar, Tunisia
Wafa Hamdi
Rheumatology department, Orthopedics Kassab Institute, Faculty of Medicine of Tunis, University Tunis El Manar, Tunisia
Samir Kochbati
Internal Medicine department, Habib Thameur Hospital , Faculty of Medicine of Tunis, University Tunis El Manar,Tunisia
Ahmed Laatar
Rheumatology department, Mongi Slim hospital, Faculty of Medicine of Tunis,University Tunis El Manar,Tunisia
Mohamed Younès
Rheumatology department, Tahar Sfar Hospital, Mahdia, Tunisia

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  ..(abstract truncated at 250 words).

Keywords:

Biologic, Safety, Efficacy, Rheumatoid Arthritis, Spondyloarthritis, Registry, Tunisia

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