ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2362

Incidence Of Adverse Events In Patients With Rheumatoid Arthritis and Spondyloarthritis Exposed To Anti-TNF Therapy. Data From The Brazilian Registry For Monitoring Of Biologic Therapies In Rheumatic Diseases (BiobadaBrasil)

Roberto Ranza1, David C Titton2, Valeria Vallim3, Ines Silveira4, Aline Ranzolin5, Andre Hayata6, Mirhelen M. Abreu7, Paulo Louzada-Jr8, Angela LBP Duarte5, Claiton Brenol9, Geraldo C Pinheiro10, Glaucio R Castro11, Hellen M Carvalho12, Isaias Costa13, Jose C Macieira14, Jose R Miranda15, Julio CM Bertacini16, Luis SG Barbosa17, Manoel B Bertolo18, Marcelo M. Pinheiro12, Maria F Sauma19, Marilia B Silva20, Marlene Freire21, Roberto A Toledo22 and Vander Fernandes23, 1Universidade Federal de Uberlandia, Uberlandia MG, Brazil, 2Hospital de Clínicas da UFPR, Curitiba PR, Brazil, 3Universidade Federal do Espirito Santo, Vitoria ES, Brazil, 4PUCRS, Porto Alegre RS, Brazil, 5Universidade Federal de Pernambuco, Recife PE, Brazil, 6CRO Osasco, Osasco SP, Brazil, 7Universidade Federal de São Carlos, São Carlos SP, Brazil, 8USP RP, Ribeirão Preto SP, Brazil, 9Universidade Federal do Rio Grande do Sul, Porto Alegre RS, Brazil, 10UERJ, Rio de Janeiro RJ, Brazil, 11Hospital Governador Celso Ramos, Florianopolis SC, Brazil, 12Brazilian Registry of Spondyloarthritis, São Paulo, Brazil, 13Universidade Federal MS, Campo Grande MS, Brazil, 14UFS Aracaju, Aracaju SE, Brazil, 15Artrocenter Clinica Medica, Taubate SP, Brazil, 16USP SP CDMAC, São Paulo SP, Brazil, 17Universidade Federal Mato Grosso, Cuiabá MT, Brazil, 18UNICAMP, Campinas SP, Brazil, 19UFPA, Belem PA, Brazil, 20Hospital Universitario Evangelico, Curitiba PR, Brazil, 21UFTM, Uberaba MG, Brazil, 22FUNFARP, São José do Rio Preto SP, Brazil, 23Universidade de Cuiabá, Cuiaba MT, Brazil

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: , , ,

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy III

Session Type: Abstract Submissions (ACR)

Background/Purpose: The safety profile of a-TNF biologic drugs might have substantial regional differences due to geographic and socio economic factors and to epidemiology of infectious diseases. Registries are the best way to monitor drugs safety in the real world. In 2009, the Brazilian Society of Rheumatology started BiobadaBrasil, as part of a Latin America project (BiobadaAmerica) developed with the methodological support of the Spanish Society of Rheumatology and of the Biobadaser Study Group.  Purpose:To report the incidence of adverse events (AE) in patients exposed to a-TNF drugs in Brazil

Methods: Since January 2009 a growing number of centers from almost all Brazilian states (32 at 12/31/2012 when data were downloaded) included patients with active rheumatic diseases who started a biologic drug or a synthetic DMARD as a parallel control group. A constant three level monitory of data quality has been performed (online, by phone and ïn situ”). The present study focuses on serious AE (SAE) and serious infectious AE (SIAE) (for SAE and SIAE definition: Protocolo 1.1 in https://biobadaser.ser.es/biobadamerica/Brasil/cgi-bin/upload/documentacion.aspx) in patients with Rheumatoid Arthritis (RA) and Spondyloarthritis (SpA = Ankylosing Spondylitis and Psoriatic Arthritis) exposed to a-TNFs. Time of exposure is considered from the beginning of therapy to the date of the last administration plus twice the half-life of the drug. Continuous variables were expressed as mean with standard deviation (SD). The AE incidence rate per 1000 patients per year of exposure and its 95% confidence level (95%CI) were calculated

Results: 1372 subjects with RA (877) and SpA (495) exposed to a-TNF drugs were included in BiobadaBrasil, 3202 patient/yrs, mean age at baseline of 47 (SD12) yrs, mean disease duration of 9 (SD8) yrs, 65% females. Controls were 486 (RA 452, SpA 34), 1210 patient/yrs, mean age 50 (SD12) yrs, mean disease duration 6 (SD7), 82% females. The incidence rates of AE for 1000 patient/yrs [95%CI] in the a-TNF vs the control group were: SAE 58 [50,67] vs 19 [13,29] (ratio 3.04 [1.97,4.69] p=0.000), SIAE 26 [21,32] vs 4 [2,10] (ratio 6.2 [2.51,15.29] p=0.000). The incidence rates for the three more prescribed a-TNFs were: for SAE = ADAlimumab 50 [39,65], ETAnercept 58 [44,77], IFliXimab 64 [52,80] (ADA vs IFX p=0.35) and for SIAE = ADA 17 [11,26], ETA 30 [20,44], IFX 31 [23,43] (ADA vs IFX p=0.07). The first a-TNF was associated with a lower incidence of SAE and SIAE when compared with the subsequent but with no statistical significance. No significant difference of AE incidence rates has been found between RA and SpA patients

Conclusion: In the BiobadaBrasil registry the incidence rate of SAE and SIAE in patients exposed to a-TNF drugs is similar to that reported by other registries. The comparison with the incidence rates of the internal control group showed a 3-fold risk for SAE and a 6-fold risk for SIAE

Acknowledgements: Biobadaser, Walber Vieira President of Brazilian Society of Rheumatology, Ieda MM Laurindo past Presidente of BSR. Other investigators of BiobadaBrasil (Adriana Kakehasi, Antonio Ximenes, Flavio Sztajnbok, Helena Pereira, Ivanio Pereira, Morton Scheinberg, Washington Bianchi, Willian Chahade)

Disclosure:

R. Ranza,
None;

D. C. Titton,
None;

V. Vallim,
None;

I. Silveira,
None;

A. Ranzolin,
None;

A. Hayata,
None;

M. M. Abreu,
None;

P. Louzada-Jr,
None;

A. L. Duarte,
None;

C. Brenol,
None;

G. C. Pinheiro,
None;

G. R. Castro,
None;

H. M. Carvalho,
None;

I. Costa,
None;

J. C. Macieira,
None;

J. R. Miranda,
None;

J. C. Bertacini,
None;

L. S. Barbosa,
None;

M. B. Bertolo,
None;

M. M. Pinheiro,
None;

M. F. Sauma,
None;

M. B. Silva,
None;

M. Freire,
None;

R. A. Toledo,
None;

V. Fernandes,
None.

« Back to 2013 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/incidence-of-adverse-events-in-patients-with-rheumatoid-arthritis-and-spondyloarthritis-exposed-to-anti-tnf-therapy-data-from-the-brazilian-registry-for-monitoring-of-biologic-therapies-in-rheumatic/