Effectiveness and safety of filgotinib in rheumatoid arthritis patients: data from the GISEA registry.

Autor:	Fornaro M; Department of Precision and Regenerative Medicine and Ionian Area, University of Bari, Italy., Caporali R; Department of Rheumatology and Medical Sciences, ASST G. Pini-CTO Milan, and Departmnent of Clinical Sciences and Community Health, University of Milan, Italy., Biggioggero M; Department of Rheumatology and Medical Sciences, ASST G. Pini-CTO Milan, Italy., Bugatti S; Dipartimento di Medicina Interna, IRCCS Policlinico S. Matteo, and Terapia Medica, Università di Pavia, Italy., De Stefano L; Dipartimento di Medicina Interna, IRCCS Policlinico S. Matteo, and Terapia Medica, Università di Pavia, Italy., Cauli A; Unità Operativa Complessa di Reumatologia, Dipartimento di Scienze Mediche e Sanità Pubblica, Azienda Ospedaliero-Universitaria e Università di Cagliari, Italy., Congia M; Unità Operativa Complessa di Reumatologia, Dipartimento di Scienze Mediche e Sanità Pubblica, Azienda Ospedaliero-Universitaria e Università di Cagliari, Italy., Conti F; Rheumatology Unit, Dipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari, Sapienza Università di Roma, Italy., Chimenti MS; Rheumatology, Allergology and Clinical Immunology, Department of Medicina Dei Sistemi, University of Rome Tor Vergata, Rome, Italy., Bazzani C; Unit of Rheumatology and Clinical Immunology, ASST Spedali Civili, Brescia, Italy., Perniola S; Clinical Immunology Division, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Atzeni F; Rheumatology Unit, Department of Experimental and Internal Medicine, University of Messina, Italy., Lapadula G; Gruppo Italiano di Studio sulla early Arthritis, GISEA, Bari, Italy., Ferraccioli G; Gruppo Italiano di Studio sulla early Arthritis, GISEA, Roma, Italy., Iannone F; Department of Precision and Regenerative Medicine and Ionian Area, University of Bari, Italy. florenzo.iannone@uniba.it.
Jazyk:	angličtina
Zdroj:	Clinical and experimental rheumatology [Clin Exp Rheumatol] 2024 May; Vol. 42 (5), pp. 1043-1050. Date of Electronic Publication: 2024 Apr 17.
DOI:	10.55563/clinexprheumatol/b40rv4
Abstrakt:	Objectives: The aim of this study was to evaluate the effectiveness and safety profile of filgotinib, a JAK1 preferential inhibitor, in rheumatoid arthritis (RA) patients included in Italian GISEA (Group for the Study of Early Arthritis) registry. Methods: Data from RA patients treated with filgotinib, recorded in the GISEA registry, were analysed. Disease activity scores and patient-reported outcomes (PROs) were assessed at baseline, as well as during 12-month follow-up. A difficult-to-treat (D2T) RA patient was defined according with EULAR criteria. Retention rate of filgotinib was estimated by the Kaplan-Meier method and factors influencing drug discontinuation were estimated by Cox regression models. Results: 246 RA patients (female 89%, 57.6±12.2 years old) started filgotinib, mostly as second (22%) or further (43.9%) b/tsDMARDs line of treatment. At 3 and 12 months, 18.8% and 27.5% of patients achieved Clinical Diseases Activity Index based remission and 30.1% and 37.7% obtained a visual analogue scale of pain ≤20 (all p<0.01 vs. baseline). Filgotinib survival rate was 84.5% at the 6-month and 75.8% at 12-month follow-up, and was comparable either in monotherapy or combination therapy, and irrespective of glucocorticoid intake. b/tsDMARD naive patients had the lowest hazard ratio (HR) of filgotinib discontinuation (HR 0.29, 95%CI 0.14-0.64), while D2T-RA the highest (HR 1.82, 95%CI 1.01-3.3). Eight patients (3.3%) discontinued filgotinib due to adverse events. Conclusions: In an Italian real-life setting, filgotinib is confirmed to be safe and with a good effectiveness profile both in monotherapy and without glucocorticoids.
Databáze:	MEDLINE
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