Assessing disease activity of rheumatoid arthritis patients and drug-utilization patterns of biologic disease-modifying antirheumatic drugs in the Tuscany region, Italy

Frontiers in Pharmacology

Pharmacology

Matteo Filippi¹  Michele Cristofano¹  Valentina Lorenzoni²  Giuseppe Turchetti²  Leopoldo Trieste²  Olga Paoletti³  Rosa Gini³  Claudia Bartolini³  Sabrina Giometto⁴  Silvia Tillati⁴  Ersilia Lucenteforte⁴  Giulia Valdiserra⁵  Marco Bonaso⁵  Irma Convertino⁵  Sara Ferraro⁵  Emiliano Cappello⁵  Corrado Blandizzi⁶  Marco Tuccori⁶  Marta Mosca⁷  Massimiliano Cazzato⁷ 

[1] Direzione Medica di Presidio, University Hospital of Pisa, Pisa, Italy;Institute of Management, Scuola Superiore Sant’Anna, Pisa, Italy;Tuscan Regional Healthcare Agency, Florence, Italy;Unit of Medical Statistics, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy;Unit of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy;Unit of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy;Unit of Adverse Drug Reactions Monitoring, University Hospital of Pisa, Pisa, Italy;Unit of Rheumatology, University Hospital of Pisa, Pisa, Italy;

关键词: DAS28;    initiation;    discontinuation;    biologic;    DMARD;    real-world;    drug-utilization;   

DOI  :  10.3389/fphar.2023.1244486

 received in 2023-06-22, accepted in 2023-09-04,  发布年份 2023

来源: Frontiers

【 摘 要 】

Introduction: The disease activity associated with the drug-utilization patterns of biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) is poorly investigated in real-world studies on rheumatoid arthritis (RA) patients. To investigate the relationship between biologic DMARD initiation/discontinuations in RA patients identified in the healthcare administrative databases of Tuscany and the Disease Activity Score 28 (DAS28) reported in the medical charts.Methods: This retrospective population-based study included RA’s first-ever biologic DMARD users of the Pisa University Hospital from 2014 to 2016. Patients were followed up until 31 December 2019. We evaluated the DAS28 recorded before (T0) and after (T1) the biologic DMARD initiation and before (TD0) and after (TD1) discontinuations. Patients were classified as “off-target” (DAS28 > 3.2) or “in-target” (DAS28 ≤ 3.2). We described the disease activity trends at initiation and discontinuation.Results: Ninety-five users were included (73 women, mean age 59.6). Among 70 patients (74%) with at least three DAS28 measures, 28 (40.0%) were off-target at T0 and 38 (54.3%) in-target at T1. Thirty-three (47%) patients had at least one discontinuation, among those with at least three DAS28 assessments. In the disease activity trend, disease stability or improvement was observed in 28 out of 37 (75.7%) patients at initiation and in 24 out of 37 (64.9%) at discontinuation.Discussion: Biologic DMARD discontinuations identified in the healthcare administrative databasese of Tuscany are frequently observed in situations of controlled RA disease. Further studies are warranted to confirm that these events can be used in studies using healthcare administrative databases as proxies of treatment effectiveness.

【 授权许可】

Unknown   
Copyright © 2023 Convertino, Cazzato, Tillati, Giometto, Gini, Valdiserra, Cappello, Ferraro, Bonaso, Bartolini, Paoletti, Lorenzoni, Trieste, Filippi, Turchetti, Cristofano, Blandizzi, Mosca, Lucenteforte and Tuccori.