ACR 2017 | Daily Highlights

Decreasing Trend of Serious Infections Incidence Rate Along Years in Rheumatoid Arthritis Patients Exposed to Biologics. Data from Two Latin America Registries

Abstract: 541
Authors: Roberto Ranza¹, Ieda Maria Magalhães Laurindo², Georges Christopoulos², Gimena Gomez³, Enrique R Soriano⁴, Miguel Angel Descalzo⁵ and Maria de la Vega⁶, ¹on behalf of the BiobadaBrasil study group, Sociedade Brasileira de Reumatologia, Uberlandia, Brazil, ²on behalf of the BiobadaBrasil study group, Sociedade Brasileira de Reumatologia, São Paulo, Brazil, ³on behalf of BiobadaSar study group, Sociedad Argentina de Reumatologia, Buenos Aires, Argentina, ⁴Argentina, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁵Research Unit, Fundacion piel sana AEDV, Madrid, Spain, Madrid, Spain, ⁶on behalf of BiobadaSar study group, Sociedad Argentina de Reumatologia, Buenos aires, Argentina

Background/Purpose
Infections are the most frequent and concerning serious adverse events related to rheumatoid arthritis (RA) treatment with biologic drugs (bDMARDs). Their safety profile might have substantial regional differences. Since January 2009, BiobadaAmerica, a common platform registry project open to all Latin America countries, was started with the goal of focusing on safety monitoring of bDMARDs. This study aims to to present data on the serious infections (SI) incidence rate trend along years in patients with RA exposed to bDMARDs in two no- compulsory Latin America registries.

Methods
Data from Brazil (BiobadaBrasil) and Argentina ( BiobadaSar) registries were downloaded on December 31, 2016 and merged. The same constant monitoring process granted data quality. Patients with rheumatic diseases were included prospectively when started on the first bDMARD. Time of exposure was set from starting of treatment to the date of last administration or censorship. SI incidence rate was calculated per 1000 patient/years with 95%CI.

Results
Data from 2591 RA patients on bDMARDs were analyzed, for a total of 9300 p/y. There were 3784 treatment courses, 64% with aTNF (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab), 36% non-aTNF (Abatacept, Rituximab, Tocilizumab) including Tofacitinib. Females 85%, mean age at baseline 53 yrs (SD 12.8) , mean disease duration 10 yrs (8.5), mean follow-up 2.7 yrs (2). The overall incidence rate of SI (2010 – 2016) was 30.54 (CI 27.18-34.30), The trend along the years is reported in the following table.

Remarkable, the trend was the same in both registries when data were analyzed separately and reflected the general tendency seen for all serious side effects.

Conclusion
A decreasing trend of serious infections incidence rate has been observed along the years in patients with RA exposed to bDMARDs, in accordance with published data from other registries

Disclosure
R. Ranza, None; I. M. M. Laurindo, None; G. Christopoulos, None; G. Gomez, None; E. R. Soriano, AbbVie, Janssen, Novartis, Pfizer Inc, UCB, 2,AbbVie, Janssen, Novartis, Pfizer Inc, UCB, 5,AbbVie, Bristol-Myers Squibb, Janssen, Novartis, Pfizer Inc, Roche, UCB, 8; M. A. Descalzo, None; M. de la Vega, None.