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
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
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.
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.
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.
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
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.
This was a combined study from Brazilian and Argentinian registries that included patients from the initiation of biological DMARD therapy. Though not specifically defined, it can be assumed that serious infections comprised those requiring intravenous antibiotics and/or hospitalization.
2591 patients over a total of 9300 patient years were analyzed. 64 % were on TNF inhibitor therapy and 36 % on non-anti-TNF, including tofacitinib.
Incidence rates in 2010 were 26.57 (confidence interval 14.71-47.98) and over decreased to 7.27 in 2016 (CI 4.79-11.05), which conforms to the trend from other analyses. The inclusion of mortality data would have been o great interest.
The authors do not provide any reasons for the decline, though improved surveillance, extension of use to less severely affected cases earlier in the course of disease and tapering of the medications may have contributed. Given the relatively high incidence rate of > 7 in 2016, caution and early intervention are still crucial for patient safety under targeted DMARDs.
Prof. Dr. Paul Hasler