Claudia Leiko Yonekura , Rene Donizeti Ribeiro Oliveira , David C. Titton , Roberto Ranza , Aline Ranzolin , André L. Hayata , Ângela Duarte , Inês G. Silveira , Hellen M. da S. de Carvalho , Júlio C. Bertacini de Moraes , Mirhelen Mendes de Abreu , Valéria Valim , Washington Bianchi , Claiton Viegas Brenol , Ivanio A. Pereira , Izaias Costa , José C. Macieira , José R.S. Miranda , Luiz S. Guedes-Barbosa , Manoel B. Bertolo , Paulo Louzada-Junior
{"title":"巴西使用TNF阻滞剂的类风湿关节炎患者的结核病发病率:来自巴西风湿病生物疗法登记处(Registro Brasileiro de monitora<s:1> o de Terapias Biológicas - BiobadaBrasil)的数据","authors":"Claudia Leiko Yonekura , Rene Donizeti Ribeiro Oliveira , David C. Titton , Roberto Ranza , Aline Ranzolin , André L. Hayata , Ângela Duarte , Inês G. Silveira , Hellen M. da S. de Carvalho , Júlio C. Bertacini de Moraes , Mirhelen Mendes de Abreu , Valéria Valim , Washington Bianchi , Claiton Viegas Brenol , Ivanio A. Pereira , Izaias Costa , José C. Macieira , José R.S. Miranda , Luiz S. Guedes-Barbosa , Manoel B. Bertolo , Paulo Louzada-Junior","doi":"10.1016/j.rbre.2017.05.005","DOIUrl":null,"url":null,"abstract":"<div><h3>Objectives</h3><p>To assess the incidence of tuberculosis and to screen for latent tuberculosis infection among Brazilians with rheumatoid arthritis using biologics in clinical practice.</p></div><div><h3>Patients and methods</h3><p>This cohort study used data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas – BiobadaBrasil), from 01/2009 to 05/2013, encompassing 1552 treatments, including 415 with only synthetic disease-modifying anti-rheumatic drugs, 942 synthetic DMARDs combined with anti-tumor necrosis factor (etanercept, infliximab, adalimumab) and 195 synthetic DMARDs combined with other biologics (abatacept, rituximab and tocilizumab). The occurrence of tuberculosis and the drug exposure time were assessed, and screening for tuberculosis was performed. Statistical analysis: Unpaired <em>t</em>-test and Fisher's two-tailed test; <em>p</em> <!--><<!--> <!-->0.05.</p></div><div><h3>Results</h3><p>The exposure times were 981 patient-years in the controls, 1744 patient-years in the anti-TNF group (adalimumab<!--> <!-->=<!--> <!-->676, infliximab<!--> <!-->=<!--> <!-->547 and etanercept<!--> <!-->=<!--> <!-->521 patient-years) and 336 patient-years in the other biologics group. The incidence rates of tuberculosis were 1.01/1000 patient-years in the controls and 2.87 patient-years among anti-TNF users (adalimumab<!--> <!-->=<!--> <!-->4.43/1000 patient-years; etanercept<!--> <!-->=<!--> <!-->1.92/1000 patient-years and infliximab<!--> <!-->=<!--> <!-->1.82/1000 patient-years). No cases of tuberculosis occurred in the other biologics group. The mean drug exposure time until the occurrence of tuberculosis was 27(11) months for the anti-TNF group.</p></div><div><h3>Conclusions</h3><p>The incidence of tuberculosis was higher among users of synthetic DMARDs and anti-TNF than among users of synthetic DMARDs and synthetic DMARDs and non-anti-TNF biologics and also occurred later, suggesting infection during treatment and no screening failure.</p></div>","PeriodicalId":101096,"journal":{"name":"Revista Brasileira de Reumatologia (English Edition)","volume":"57 ","pages":"Pages 477-483"},"PeriodicalIF":0.0000,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.rbre.2017.05.005","citationCount":"28","resultStr":"{\"title\":\"Incidence of tuberculosis among patients with rheumatoid arthritis using TNF blockers in Brazil: data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas – BiobadaBrasil)\",\"authors\":\"Claudia Leiko Yonekura , Rene Donizeti Ribeiro Oliveira , David C. Titton , Roberto Ranza , Aline Ranzolin , André L. Hayata , Ângela Duarte , Inês G. Silveira , Hellen M. da S. de Carvalho , Júlio C. Bertacini de Moraes , Mirhelen Mendes de Abreu , Valéria Valim , Washington Bianchi , Claiton Viegas Brenol , Ivanio A. Pereira , Izaias Costa , José C. Macieira , José R.S. Miranda , Luiz S. Guedes-Barbosa , Manoel B. Bertolo , Paulo Louzada-Junior\",\"doi\":\"10.1016/j.rbre.2017.05.005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objectives</h3><p>To assess the incidence of tuberculosis and to screen for latent tuberculosis infection among Brazilians with rheumatoid arthritis using biologics in clinical practice.</p></div><div><h3>Patients and methods</h3><p>This cohort study used data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas – BiobadaBrasil), from 01/2009 to 05/2013, encompassing 1552 treatments, including 415 with only synthetic disease-modifying anti-rheumatic drugs, 942 synthetic DMARDs combined with anti-tumor necrosis factor (etanercept, infliximab, adalimumab) and 195 synthetic DMARDs combined with other biologics (abatacept, rituximab and tocilizumab). The occurrence of tuberculosis and the drug exposure time were assessed, and screening for tuberculosis was performed. Statistical analysis: Unpaired <em>t</em>-test and Fisher's two-tailed test; <em>p</em> <!--><<!--> <!-->0.05.</p></div><div><h3>Results</h3><p>The exposure times were 981 patient-years in the controls, 1744 patient-years in the anti-TNF group (adalimumab<!--> <!-->=<!--> <!-->676, infliximab<!--> <!-->=<!--> <!-->547 and etanercept<!--> <!-->=<!--> <!-->521 patient-years) and 336 patient-years in the other biologics group. The incidence rates of tuberculosis were 1.01/1000 patient-years in the controls and 2.87 patient-years among anti-TNF users (adalimumab<!--> <!-->=<!--> <!-->4.43/1000 patient-years; etanercept<!--> <!-->=<!--> <!-->1.92/1000 patient-years and infliximab<!--> <!-->=<!--> <!-->1.82/1000 patient-years). No cases of tuberculosis occurred in the other biologics group. 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引用次数: 28
摘要
目的评估巴西类风湿关节炎患者的结核病发病率，并在临床应用生物制剂筛查潜伏性结核病感染。患者和方法该队列研究使用了2009年1月至2013年5月巴西风湿病生物疗法登记处(Registro Brasileiro de monitora o de Terapias Biológicas - BiobadaBrasil)的数据，包括1552种治疗方法，其中415种仅使用合成疾病改善抗风湿药，942种合成dmard联合抗肿瘤坏死因子(依那西普，英夫利昔单抗，阿达木单抗)和195种合成dmard联合其他生物制剂(阿巴接受普，利妥昔单抗和托珠单抗)。评估结核的发生情况和药物暴露时间，并进行结核筛查。统计分析:非配对t检验和Fisher双尾检验;p & lt;0.05.结果对照组暴露时间为981例患者-年，抗tnf组暴露时间为1744例患者-年(阿达木单抗= 676例，英夫利昔单抗= 547例，依那西普= 521例)，其他生物制剂组暴露时间为336例患者-年。结核病的发病率在对照组为1.01/1000患者-年，在抗肿瘤坏死因子使用者中为2.87患者-年(阿达木单抗= 4.43/1000患者-年;依那西普= 1.92/1000患者-年，英夫利昔单抗= 1.82/1000患者-年)。其他生物制剂组无结核病例发生。抗肿瘤坏死因子组的平均药物暴露时间为27(11)个月。结论使用合成DMARDs和抗肿瘤坏死因子制剂的患者结核的发病率高于使用合成DMARDs和合成DMARDs和非抗肿瘤坏死因子制剂的患者，且发生时间较晚，提示在治疗期间感染，未发现筛查失败。
Incidence of tuberculosis among patients with rheumatoid arthritis using TNF blockers in Brazil: data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas – BiobadaBrasil)
Objectives
To assess the incidence of tuberculosis and to screen for latent tuberculosis infection among Brazilians with rheumatoid arthritis using biologics in clinical practice.
Patients and methods
This cohort study used data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas – BiobadaBrasil), from 01/2009 to 05/2013, encompassing 1552 treatments, including 415 with only synthetic disease-modifying anti-rheumatic drugs, 942 synthetic DMARDs combined with anti-tumor necrosis factor (etanercept, infliximab, adalimumab) and 195 synthetic DMARDs combined with other biologics (abatacept, rituximab and tocilizumab). The occurrence of tuberculosis and the drug exposure time were assessed, and screening for tuberculosis was performed. Statistical analysis: Unpaired t-test and Fisher's two-tailed test; p < 0.05.
Results
The exposure times were 981 patient-years in the controls, 1744 patient-years in the anti-TNF group (adalimumab = 676, infliximab = 547 and etanercept = 521 patient-years) and 336 patient-years in the other biologics group. The incidence rates of tuberculosis were 1.01/1000 patient-years in the controls and 2.87 patient-years among anti-TNF users (adalimumab = 4.43/1000 patient-years; etanercept = 1.92/1000 patient-years and infliximab = 1.82/1000 patient-years). No cases of tuberculosis occurred in the other biologics group. The mean drug exposure time until the occurrence of tuberculosis was 27(11) months for the anti-TNF group.
Conclusions
The incidence of tuberculosis was higher among users of synthetic DMARDs and anti-TNF than among users of synthetic DMARDs and synthetic DMARDs and non-anti-TNF biologics and also occurred later, suggesting infection during treatment and no screening failure.
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