Loading...
 

Volume 31, Issue 1, March 2020




Sign in to download the Issue in PDF format.

Mediterr J Rheuamtol 2020;31(1):87-91
Development and Implementation of a Pilot Registry for Monitoring the Efficacy and Safety of Novel Therapies in Patients with Systemic Lupus Erythematosus
Authors Information
1. Rheumatology and Clinical Immunology, University of Crete Medical School and University Hospital of Heraklion, Heraklion, Greece
2. Rheumatology Clinic, General Hospital of Athens “Asklepeion Voula”, Athens, Greece
3. Rheumatology Clinic, 4th Department of Internal Medicine, National and Kapodistrian University of Athens, “Attikon” University Hospital, Athens,Greece
4. Rheumatology Clinic, “Sismanogleio” General Hospital, Athens, Greece
5. First Department of Propaedeutic Internal Medicine, National and Kapodistrian University of Athens, "Laiko" General Hospital, Athens, Greece
6. Department of Medicine, Solna, Rheumatology Unit, Karolinska University Hospital and Institutet, Stockholm, Sweden
7. 4th Department of Internal Medicine, Hippokration General Hospital, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
Abstract

The therapeutic armamentarium in Systemic Lupus Erythematosus (SLE) is expanding with the introduction of novel biologic and small-molecule agents. Complementary to randomized controlled trials, registry-based studies are advantageous due to the inclusion of a wider range of patients from daily practice and the potential for long-term monitoring of the efficacy and safety of therapies. Moreover, data from registries can be used to identify disease phenotypes that best respond to biologic agents, and to correlate clinical response with parameters such as co-administered therapies and comorbidities. In this project, we will use the configuration of the Hellenic Registry of Biologic Therapies for inflammatory arthritides in order to design a dedicated SLE module with variables pertaining to global and organ-specific disease activity, severity, flares, organ damage/outcome, comorbidities and adverse events. The second stage will involve the pilot implementation of this platform for the multicentric registration of SLE patients who are treated with belimumab. The significance lies in the development of a structured registry that enables the assessment of the disease burden and the long-term efficacy and safety of existing and future biological agents in SLE. Piloting the registry can serve as a basis for establishing nationwide collaborative efforts.

https://doi.org/10.31138/mjr.31.1.87

Article Submitted: 15 Jan 2020; Article Accepted: 2 Feb 2020; Published: 31 Mar 2020

This work is licensed under a Creative Commons Attribution 4.0 International License (CC-BY).

©Adamichou C, Flouri I, Fanouriakis A, Nikoloudaki M, Nikolopoulos D, Repa A, Boki K, Chatzidionysiou K, Garyfallos A, Boumpas D, Sidiropoulos P, Bertsias G.