Influence of Safety Warnings on the Prescribing Attitude of JAK Inhibitors for Rheumatoid Arthritis in Italy.

Autor: Paroli M; Department of Clinical, Internist, Anesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, 00185 Rome, Italy., Becciolini A; Internal Medicine and Rheumatology Unit, University Hospital of Parma, 43126 Parma, Italy., Lo Gullo A; Rheumatology Unit, ARNAS Garibaldi, 95124 Catania, Italy., Parisi S; Rheumatology Department, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, 10126 Turin, Italy., Bravi E; Rheumatology Unit, Guglielmo da Saliceto Hospital, 29121 Piacenza, Italy., Andracco R; Rheumatology Unit, ASL1 Liguria, 18038 Bussana di Sanremo, Italy., Nucera V; Rheumatology Unit, ASL Novara, 28100 Novara, Italy., Ometto F; Rheumatology Unit, Azienda ULSS 6 Euganea, 35131 Padua, Italy., Lumetti F; Rheumatology Unit, Azienda USL of Modena and AOU Policlinico of Modena, 41100 Modena, Italy., Farina A; Internal Medicine Unit, Augusto Murri Hospital, 63900 Fermo, Italy., Del Medico P; Internal Medicine Unit, Civitanova Marche Hospital, 62012 Civitanova Marche, Italy., Colina M; Rheumatology Unit, Internal Medicine Division, Department of Medicine and Oncology, Santa Maria della Scaletta Hospital, 40026 Imola, Italy.; Rheumatology Unit, Alma Mater Studiorum-University of Bologna, 40126 Bologna, Italy., Ravagnani V; Rheumatology Unit, Santa Chiara Hospital APSS-Trento, 38122 Trento, Italy., Scolieri P; Rheumatology Unit, Nuovo Regina Margherita Hospital, 00154 Rome, Italy., Larosa M; Division of Rheumatology, Department of Medical Specialties, Azienda Sanitaria Locale 3 Genovese, 16132 Genoa, Italy., Priora M; Rheumatology Unit, ASL CN1, 12100 Cuneo, Italy., Visalli E; Rheumatology Unit, Policlinico San Marco Hospital, 95121 Catania, Italy., Addimanda O; Rheumatology Unit, AUSL of Bologna-Policlinico Sant'Orsola-AOU-IRCCS of Bologna, 40138 Bologna, Italy., Vitetta R; Rheumatology Unit, ASL VC Sant'Andrea Hospital, 13100 Vercelli, Italy., Volpe A; Rheumatology Unit, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Italy., Bezzi A; Internal Medicine and Rheumatology Unit, AUSL della Romagna-Rimini, 47924 Rimini, Italy., Girelli F; Rheumatology Unit, G.B. Morgagni-L. Pierantoni Hospital, 47121 Forlì, Italy., Molica Colella AB; Departmental Unit of Rheumatology, Azienda Ospedaliera Papardo, 98158 Messina, Italy., Caccavale R; Department of Clinical, Internist, Anesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, 00185 Rome, Italy., Di Donato E; Internal Medicine and Rheumatology Unit, University Hospital of Parma, 43126 Parma, Italy., Adorni G; Internal Medicine and Rheumatology Unit, University Hospital of Parma, 43126 Parma, Italy., Santilli D; Internal Medicine and Rheumatology Unit, University Hospital of Parma, 43126 Parma, Italy., Lucchini G; Internal Medicine and Rheumatology Unit, University Hospital of Parma, 43126 Parma, Italy., Arrigoni E; Rheumatology Unit, Guglielmo da Saliceto Hospital, 29121 Piacenza, Italy., Platè I; Rheumatology Unit, Guglielmo da Saliceto Hospital, 29121 Piacenza, Italy., Mansueto N; Rheumatology Unit, ASL1 Liguria, 18038 Bussana di Sanremo, Italy., Ianniello A; Rheumatology Unit, ASL Novara, 28100 Novara, Italy., Fusaro E; Rheumatology Department, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, 10126 Turin, Italy., Ditto MC; Rheumatology Department, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, 10126 Turin, Italy., Bruzzese V; Rheumatology Unit, Nuovo Regina Margherita Hospital, 00154 Rome, Italy., Camellino D; Division of Rheumatology, Department of Medical Specialties, Azienda Sanitaria Locale 3 Genovese, 16132 Genoa, Italy., Bianchi G; Division of Rheumatology, Department of Medical Specialties, Azienda Sanitaria Locale 3 Genovese, 16132 Genoa, Italy., Serale F; Rheumatology Unit, ASL CN1, 12100 Cuneo, Italy., Foti R; Rheumatology Unit, Policlinico San Marco Hospital, 95121 Catania, Italy., Amato G; Rheumatology Unit, Policlinico San Marco Hospital, 95121 Catania, Italy., De Lucia F; Rheumatology Unit, Policlinico San Marco Hospital, 95121 Catania, Italy., Dal Bosco Y; Rheumatology Unit, Policlinico San Marco Hospital, 95121 Catania, Italy., Foti R; Rheumatology Unit, Policlinico San Marco Hospital, 95121 Catania, Italy., Reta M; Rheumatology Unit, AUSL of Bologna-Policlinico Sant'Orsola-AOU-IRCCS of Bologna, 40138 Bologna, Italy., Fiorenza A; Rheumatology Unit, ASL VC Sant'Andrea Hospital, 13100 Vercelli, Italy., Rovera G; Rheumatology Unit, ASL VC Sant'Andrea Hospital, 13100 Vercelli, Italy., Marchetta A; Rheumatology Unit, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Italy., Focherini MC; Internal Medicine and Rheumatology Unit, AUSL della Romagna-Rimini, 47924 Rimini, Italy., Mascella F; Internal Medicine and Rheumatology Unit, AUSL della Romagna-Rimini, 47924 Rimini, Italy., Bernardi S; Rheumatology Unit, G.B. Morgagni-L. Pierantoni Hospital, 47121 Forlì, Italy., Sandri G; Rheumatology Unit, University of Modena and Reggio Emilia, 41125 Modena, Italy., Giuggioli D; Rheumatology Unit, University of Modena and Reggio Emilia, 41125 Modena, Italy., Salvarani C; Rheumatology Unit, University of Modena and Reggio Emilia, 41125 Modena, Italy., De Andres MI; Rheumatology Unit, ARNAS Garibaldi, 95124 Catania, Italy., Franchina V; Medical Oncology Unit, Azienda Ospedaliera Papardo, 98158 Messina, Italy., Molica Colella F; Medicine Unit, Milano-Bicocca University, 20126 Milan, Italy., Ferrero G; Unit of Diagnostic and Interventional Radiology, Santa Corona Hospital, 17027 Pietra Ligure, Italy., Raffeiner B; Department of Rheumatology, Bolzano Central Hospital, 39100 Bolzano, Italy., Ariani A; Internal Medicine and Rheumatology Unit, University Hospital of Parma, 43126 Parma, Italy.
Jazyk: angličtina
Zdroj: Journal of clinical medicine [J Clin Med] 2024 Jul 04; Vol. 13 (13). Date of Electronic Publication: 2024 Jul 04.
DOI: 10.3390/jcm13133929
Abstrakt: Background/Objectives: The Janus kinase inhibitors (JAKi) tofacitinib (TOFA), baricitinib (BARI), upadacitinib (UPA), and filgotinib (FILGO) are effective drugs for the treatment of rheumatoid arthritis. However, the US Food and Drug Administration (FDA) raised concerns about the safety of TOFA after its approval. This prompted the European Medicines Agency (EMA) to issue two safety warnings for limiting TOFA use, then extended a third warning to all JAKi in patients at high risk of developing serious adverse effects (SAE). These include thrombosis, major adverse cardiac events (MACE), and cancer. The purpose of this work was to analyze how the first two safety warnings from the EMA affected the prescribing of JAKi by rheumatologists in Italy. Methods: All patients with rheumatoid arthritis who had been prescribed JAKi for the first time in a 36-month period from 1 July 2019, to 30 June 2022 were considered. Data were obtained from the medical records of 29 Italian tertiary referral rheumatology centers. Patients were divided into three groups of 4 months each, depending on whether the JAKi prescription had occurred before the EMA's first safety alert (1 July-31 October 2019, Group 1), between the first and second alerts (1 November 2019-29 February 2020, Group 2), or between the second and third alerts (1 March 2021-30 June 2021, Group 3). The percentages and absolute changes in the patients prescribed the individual JAKi were analyzed. Differences among the three groups of patients regarding demographic and clinical characteristics were also assessed. Results: A total of 864 patients were prescribed a JAKi during the entire period considered. Of these, 343 were identified in Group 1, 233 in Group 2, and 288 in Group 3. An absolute reduction of 32% was observed in the number of patients prescribed a JAKi between Group 1 and Group 2 and 16% between Group 1 and Group 3. In contrast, there was a 19% increase in the prescription of a JAKi in patients between Group 2 and Group 3. In the first group, BARI was the most prescribed drug (227 prescriptions, 66.2% of the total), followed by TOFA (115, 33.5%) and UPA (1, 0.3%). In the second group, the most prescribed JAKi was BARI (147, 63.1%), followed by TOFA (65, 27.9%) and UPA (33, 11.5%). In the third group, BARI was still the most prescribed JAKi (104 prescriptions, 36.1%), followed by UPA (89, 30.9%), FILGO (89, 21.5%), and TOFA (33, 11.5%). The number of patients prescribed TOFA decreased significantly between Group 1 and Group 2 and between Group 2 and Group 3 ( p ˂ 0.01). The number of patients who were prescribed BARI decreased significantly between Group 1 and Group 2 and between Group 2 and Group 3 ( p ˂ 0.01). In contrast, the number of patients prescribed UPA increased between Group 2 and Group 3 ( p ˂ 0.01). Conclusions : These data suggest that the warnings issued for TOFA were followed by a reduction in total JAKi prescriptions. However, the more selective JAKi (UPA and FILGO) were perceived by prescribers as favorable in terms of the risk/benefit ratio, and their use gradually increased at the expense of the other molecules.
Databáze: MEDLINE
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