Luca Cantarini1, Rosaria Talarico2, Elena Generali3, Giacomo Emmi4, Giuseppe Lopalco5, Luisa Costa6, Elena Silvestri4, Francesco Caso7, Rossella Franceschini8, Rolando Cimaz9, Florenzo Iannone5, Mauro Galeazzi1, Carlo Selmi3,10. 1. Department of Medical Sciences, Surgery and Neurosciences, Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, University of Siena, Siena, Italy. 2. Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Pisa, Pisa, Italy. 3. Division of Rheumatology and Clinical Immunology, Humanitas Research Hospital, Rozzano, Milan, Italy. 4. Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. 5. Interdisciplinary Department of Medicine, Rheumatology Unit, Policlinic Hospital, University of Bari, Bari, Italy. 6. Department of Clinical Medicine and Surgery, Rheumatology Unit, University Federico II, Naples, Italy. 7. Department of Clinical Medicine, Rheumatology Unit, DIMED, University of Padua, Padua, Italy. 8. Ophthalmology and Neurosurgery Department, University of Siena, Siena, Italy. 9. Department of Pediatrics, Rheumatology Unit, Anna Meyer Children's Hospital and University of Florence, Florence, Italy. 10. BIOMETRA Department, University of Milan, Milan, Italy.
Abstract
AIM: The primary aim of this study was to explore the safety profile of biologic treatments in Behçet's disease (BD), based on their mechanism of action; the secondary aim was to study any potential variation in terms of retention rate according to each single drug. METHOD: We studied a total of 85 treatment regimens with biologic agents from 64 patients. The total follow-up was calculated as 8640 patient-years (anti-tumor necrosis factor [TNF]-alpha 7.020, anti-interleukin [IL]-beta 1.368). Cumulative rates of drug retention were studied using the Kaplan-Meier plot and covariates in the regression model included the mechanism of action of the biologic agent, other concomitant therapies, disease duration, sex, age at start of drug therapy; for each confounding factor hazard ratios (HR) were calculated. RESULTS: The most frequently prescribed biologic treatments were anti-TNF-alpha agents (79%), while anti-IL1-beta was used in the remaining regimens. Concomitant disease-modifying antirheumatic drugs were prescribed in 36% of patients, mainly cyclosporine and methotrexate, while in 35/85 regimens low-dose glucocorticoids were associated. During the follow-up, in all but one regimen the safety profile was free of any adverse events or serious adverse events; we observed only one case of endocarditis, reported during the 10th month of etanercept. CONCLUSION: Data from a large multicenter cohort suggest that anti-TNF-alpha and anti-IL1-beta agents are characterized by an excellent safety profile in BD.
AIM: The primary aim of this study was to explore the safety profile of biologic treatments in Behçet's disease (BD), based on their mechanism of action; the secondary aim was to study any potential variation in terms of retention rate according to each single drug. METHOD: We studied a total of 85 treatment regimens with biologic agents from 64 patients. The total follow-up was calculated as 8640 patient-years (anti-tumornecrosis factor [TNF]-alpha 7.020, anti-interleukin [IL]-beta 1.368). Cumulative rates of drug retention were studied using the Kaplan-Meier plot and covariates in the regression model included the mechanism of action of the biologic agent, other concomitant therapies, disease duration, sex, age at start of drug therapy; for each confounding factor hazard ratios (HR) were calculated. RESULTS: The most frequently prescribed biologic treatments were anti-TNF-alpha agents (79%), while anti-IL1-beta was used in the remaining regimens. Concomitant disease-modifying antirheumatic drugs were prescribed in 36% of patients, mainly cyclosporine and methotrexate, while in 35/85 regimens low-dose glucocorticoids were associated. During the follow-up, in all but one regimen the safety profile was free of any adverse events or serious adverse events; we observed only one case of endocarditis, reported during the 10th month of etanercept. CONCLUSION: Data from a large multicenter cohort suggest that anti-TNF-alpha and anti-IL1-beta agents are characterized by an excellent safety profile in BD.
Authors: Jurgen Sota; Antonio Vitale; Antonella Insalaco; Paolo Sfriso; Giuseppe Lopalco; Giacomo Emmi; Marco Cattalini; Raffaele Manna; Rolando Cimaz; Roberta Priori; Rosaria Talarico; Ginevra de Marchi; Micol Frassi; Romina Gallizzi; Alessandra Soriano; Maria Alessio; Daniele Cammelli; Maria Cristina Maggio; Stefano Gentileschi; Renzo Marcolongo; Francesco La Torre; Claudia Fabiani; Serena Colafrancesco; Francesca Ricci; Paola Galozzi; Ombretta Viapiana; Elena Verrecchia; Manuela Pardeo; Lucia Cerrito; Elena Cavallaro; Alma Nunzia Olivieri; Giuseppe Paolazzi; Gianfranco Vitiello; Armin Maier; Elena Silvestri; Chiara Stagnaro; Guido Valesini; Marta Mosca; Salvatore de Vita; Angela Tincani; Giovanni Lapadula; Bruno Frediani; Fabrizio De Benedetti; Florenzo Iannone; Leonardo Punzi; Carlo Salvarani; Mauro Galeazzi; Rossella Angotti; Mario Messina; Gian Marco Tosi; Donato Rigante; Luca Cantarini Journal: Clin Rheumatol Date: 2018-05-17 Impact factor: 2.980
Authors: Claudia Fabiani; Antonio Vitale; Giacomo Emmi; Alice Bitossi; Giuseppe Lopalco; Jurgen Sota; Silvana Guerriero; Ida Orlando; Marco Capozzoli; Fiorella Fusco; Francesco Rana; Florenzo Iannone; Bruno Frediani; Mauro Galeazzi; Lorenzo Vannozzi; Gian Marco Tosi; Luca Cantarini Journal: Clin Rheumatol Date: 2018-04-03 Impact factor: 2.980
Authors: Antonio Vitale; Antonella Insalaco; Paolo Sfriso; Giuseppe Lopalco; Giacomo Emmi; Marco Cattalini; Raffaele Manna; Rolando Cimaz; Roberta Priori; Rosaria Talarico; Stefano Gentileschi; Ginevra de Marchi; Micol Frassi; Romina Gallizzi; Alessandra Soriano; Maria Alessio; Daniele Cammelli; Maria C Maggio; Renzo Marcolongo; Francesco La Torre; Claudia Fabiani; Serena Colafrancesco; Francesca Ricci; Paola Galozzi; Ombretta Viapiana; Elena Verrecchia; Manuela Pardeo; Lucia Cerrito; Elena Cavallaro; Alma N Olivieri; Giuseppe Paolazzi; Gianfranco Vitiello; Armin Maier; Elena Silvestri; Chiara Stagnaro; Guido Valesini; Marta Mosca; Salvatore de Vita; Angela Tincani; Giovanni Lapadula; Bruno Frediani; Fabrizio De Benedetti; Florenzo Iannone; Leonardo Punzi; Carlo Salvarani; Mauro Galeazzi; Donato Rigante; Luca Cantarini Journal: Front Pharmacol Date: 2016-10-24 Impact factor: 5.810