Incidence of Infectious Adverse Events in Patients With Rheumatoid Arthritis and Spondyloarthritis on Biologic Drugs-Data From the Brazilian Registry for Biologics Monitoring

被引：14

作者：

Cecconi, Mariana ^{[1
]}

Ranza, Roberto ^{[1
]}

Titton, David C. ^{[2
]}

Moraes, Julio C. B. ^{[3
]}

Bertolo, Manoel ^{[4
]}

Bianchi, Washington ^{[5
]}

Brenol, Claiton ^{[6
]}

Carvalho, Hellen M. ^{[7
]}

de Castro, Glaucio R. W. ^{[8
]}

Costa, Izaias P. ^{[9
]}

Cunha, Maria F. L. ^{[10
]}

Duarte, Angela ^{[11
]}

Fernandes, Vander ^{[12
]}

Freire, Marlene ^{[13
]}

Louzada-Junior, Paulo ^{[14
]}

Macieira, Jose C. ^{[15
]}

Miranda, Jose R. S. ^{[16
]}

Pereira, Ivanio A. ^{[17
]}

Pinheiro, Geraldo R. C. ^{[18
]}

Stadler, Barbara ^{[19
]}

Toledo, Roberto A. ^{[20
]}

Valim, Valeria ^{[21
]}

Descalzo, Miguel A. ^{[22
]}

Pinto, Rogerio M. C. ^{[23
]}

Laurindo, Ieda ^{[24
]}

机构：

[1] Univ Fed Uberlandia, Campus Umuarama Uberlandia, BR-38411176 Uberlandia, MG, Brazil

[2] Univ Fed Parana, Curitiba, Parana, Brazil

[3] Univ Sao Paulo, Fac Med, Sao Paulo, Brazil

[4] Univ Estadual Campinas, Campinas, Brazil

[5] Santa Casa Misericordia Rio de Janeiro, Rio De Janeiro, Brazil

[6] Univ Fed Rio Grande do Sul, Hosp Clin Porto Alegre, Porto Alegre, RS, Brazil

[7] Hosp Base Dist Fed, Brasilia, DF, Brazil

[8] Hosp Celso Ramos Florianopolis, Florianopolis, SC, Brazil

[9] HUMAP EBSERH UFMS, Campo Grande, MS, Brazil

[10] Univ Fed Para, Belem, Para, Brazil

[11] Univ Fed Pernambuco, Recife, PE, Brazil

[12] Hosp Geral Univ Cuiaba, Cuiaba, MT, Brazil

[13] Univ Fed Triangulo Mineiro, Uberaba, Brazil

[14] USP Ribeirao Preto, Ribeirao Preto, Brazil

[15] Univ Fed Sergipe, Aracaju, SE, Brazil

[16] Artroctr Clin Med Taubate, Taubate, SP, Brazil

[17] Univ Fed Santa Catarina, Florianopolis, SC, Brazil

[18] Univ Estado Rio De Janeiro, Rio De Janeiro, Brazil

[19] Hosp Univ Evangel Curitiba, Curitiba, Parana, Brazil

[20] Fac Med Sao Jose do Rio Preto, Sao Jose Do Rio Preto, Brazil

[21] Univ Fed Espirito Santo, Vitoria, ES, Brazil

[22] Acad Espanola Dermatol & Venereol, Res Unit, Madrid, Spain

[23] Univ Fed Uberlandia, Fac Matemat, Uberlandia, MG, Brazil

[24] Univ Nove Julho, Fac Med, Sao Paulo, Brazil

来源：

JCR-JOURNAL OF CLINICAL RHEUMATOLOGY | 2020年 / 26卷 / 02期

关键词：

biological products; adverse drug events; rheumatoid arthritis; spondyloarthritis; registries; NECROSIS-FACTOR ANTAGONISTS; SERIOUS INFECTIONS; FACTOR INHIBITORS; BRITISH-SOCIETY; ANTI-TNF; RISK; BIOBADASER; THERAPY; DISEASES; OUTCOMES;

D O I：

10.1097/RHU.0000000000000935

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background The safety profile of biologic drugs might present substantial regional differences. Since 2009, the Brazilian Society of Rheumatology has maintained BIOBADABRASIL (Brazilian Registry for Biologic Drugs), a registry for monitoring of biologic therapies in rheumatic diseases. Objectives The aim of this study was to verify the incidence rate (IR) of serious infections in rheumatoid arthritis (RA) and spondyloarthritis (SpA) patients on biologic drugs. Methods BIOBADABRASIL prospectively included patients with rheumatic diseases who started the first biologic drug or a synthetic disease-modifying antirheumatic drug as a parallel control group. This study focuses on serious infectious adverse events (SIAEs) in RA and SpA patients on biologic drugs compared with controls, from January 2009 to June 2015. Time of exposure was set from initiation of the drug to the date of last administration or censorship. Serious infectious adverse events IR was calculated per 1000 patient/years with 95% confidence interval (CI). Results A total of 1698 patients (RA, 1121; SpA, 577) were included, 7119 patient/years. Serious infectious adverse events were more common among patients on tumor necrosis factor inhibitors (TNFi's) than controls (adjusted IR ratio, 2.96 [95% CI, 2.01-4.36]; p < 0.001). Subsequent TNFi was associated with a higher SIAEs incidence when compared with first TNFI (adjusted IR ratio, 1.55 [95% CI, 1.15-2.08]; p = 0.004). Serious infectious adverse events were associated with age and corticosteroids intake. Serious infectious adverse events were more frequent in the respiratory tract in all subgroups. Conclusions In BIOBADABRASIL, biologic drugs, especially the subsequent TNFi, were associated with a higher risk of serious infections compared with synthetic DMARDs. Corticosteroid intake and age represented risk factors for SIAEs. Constant monitoring is required to follow the safety profile of drugs in the clinical setting of rheumatic conditions in Brazil.

引用

页码：73 / 78

页数：6

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