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

Authors

  • 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

DOI:

https://doi.org/10.62438/tunismed.v103i4.5557

Keywords:

Biologic, Safety, Efficacy, Rheumatoid Arthritis, Spondyloarthritis, Registry, 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).

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Published

2025-03-30

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Vol. 103 No. 4 (2025): Tunis Med Apr 2025

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