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

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dc.contributor.authorCecconi M.
dc.contributor.authorRanza R.
dc.contributor.authorTitton D.C.
dc.contributor.authorMoraes J.C.B.
dc.contributor.authorBertolo M.
dc.contributor.authorBianchi W.
dc.contributor.authorBrenol C.
dc.contributor.authorCarvalho H.M.
dc.contributor.authorDe Castro G.R.W.
dc.contributor.authorCosta I.P.
dc.contributor.authorCunha M.F.L.
dc.contributor.authorDuarte A.
dc.contributor.authorFernandes V.
dc.contributor.authorFreire M.
dc.contributor.authorLouzada-Junior P.
dc.contributor.authorMacIeira J.C.
dc.contributor.authorMiranda J.R.S.
dc.contributor.authorPereira I.A.
dc.contributor.authorPinheiro G.R.C.
dc.contributor.authorStadler B.
dc.contributor.authorToledo R.A.
dc.contributor.authorValim V.
dc.contributor.authorDescalzo M.A.
dc.contributor.authorPinto R.M.C.
dc.contributor.authorLaurindo I.
dc.date.accessioned2024-03-12T23:48:46Z
dc.date.available2024-03-12T23:48:46Z
dc.date.issued2020
dc.description.abstract© 2020 Wolters Kluwer Health, Inc. All rights reserved.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.
dc.description.firstpage73
dc.description.issuenumber2
dc.description.lastpage78
dc.description.volume26
dc.identifier.doi10.1097/RHU.0000000000000935
dc.identifier.issn1536-7355
dc.identifier.urihttps://dspace.mackenzie.br/handle/10899/35024
dc.relation.ispartofJournal of Clinical Rheumatology
dc.rightsAcesso Aberto
dc.subject.otherlanguageadverse drug events
dc.subject.otherlanguagebiological products
dc.subject.otherlanguageregistries
dc.subject.otherlanguagerheumatoid arthritis
dc.subject.otherlanguagespondyloarthritis
dc.titleIncidence of Infectious Adverse Events in Patients with Rheumatoid Arthritis and Spondyloarthritis on Biologic Drugs-Data from the Brazilian Registry for Biologics Monitoring
dc.typeArtigo
local.scopus.citations10
local.scopus.eid2-s2.0-85064847860
local.scopus.subjectAntirheumatic Agents
local.scopus.subjectArthritis, Rheumatoid
local.scopus.subjectBiological Products
local.scopus.subjectBrazil
local.scopus.subjectHumans
local.scopus.subjectIncidence
local.scopus.subjectRegistries
local.scopus.subjectSpondylarthritis
local.scopus.subjectTumor Necrosis Factor-alpha
local.scopus.updated2024-05-01
local.scopus.urlhttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85064847860&origin=inward
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