Development and Implementation of a Pilot Registry for Monitoring the Efficacy and Safety of Novel Therapies in Patients with Systemic Lupus Erythematosus

Mediterranean Journal of Rheumatology

Alexandros Garyfallos¹  Katerina Chatzidionysiou²  Dimitrios Boumpas³  Dionysios Nikolopoulos³  Antonios Fanouriakis⁴  Kyriaki Boki⁵  Irini Flouri⁶  Argyro Repa⁶  Christina Adamichou⁶  Myrto Nikoloudaki⁶  Prodromos Sidiropoulos⁶  George Bertsias⁶ 

[1] 4th Department of Internal Medicine, Hippokration General Hospital, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece;First Department of Propaedeutic Internal Medicine, National and Kapodistrian University of Athens, “Laiko” General Hospital, Athens, Greece,;Rheumatology Clinic, 4th Department of Internal Medicine, National and Kapodistrian University of Athens, “Attikon” University Hospital, Athens, Greece,;Rheumatology Clinic, General Hospital of Athens “Asklepeion Voula”, Athens, Greece,;Rheumatology Clinic, “Sismanogleio” General Hospital, Athens, Greece,;Rheumatology and Clinical Immunology, University of Crete Medical School and University Hospital of Heraklion, Heraklion, Greece,;

关键词: registry;    biological agents;    novel therapies;    belimumab;    rituximab;    systemic lupus erythematosus;   

DOI  :  10.31138/mjr.31.1.87

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown