Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
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. In January 2009 started BiobadaAmerica, a common platform registry project open to all Latin American countries, focused on safety monitoring of bDMARDs. Purpose of this study is to present data on factors associated with serious infections (SI) in patients with RA exposed to bDMARDs in two Latin-American not mandatory registries.
Methods: Data from Argentinian Registry (BiobadaSar) and Brasilian Registry (BiobadaBrazil), both initiated in 2010, were downloaded on December 31, 2016, merged and analyzed. The same constant monitoring process guaranteed data quality. Patients with rheumatic diseases were included prospectively when started the first bDMARD. Time of exposure was set from start of the drug 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 were analyzed, for a total of 9300 p/y. Treatments were 3784, 64% aTNF (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab), 36% non-aTNF (Abatacept, Rituximab, Tocilizumab) including Tofacitinib. Females 85%, at baseline mean age 53 (SD 12.8)yrs , mean disease duration 10(8.5)yrs, mean follow-up 2.7 (2) yrs. The overall incidence rate of SI was 30.54 (CI 27.18-34.30), Comparing patients with (191) and without (2400) SI, age, sex, disease duration, use of concomitants DMARD, presence of diabetes mellitus or pulmonary chronic disease and a positive history of previous câncer did not differ statistically. Exposition to more than one bDMARD (p<0.01), corticosteroid use (p=<0.01), smoking (p=0.01) and presence of renal failure (p=0.03) were statistically associated with SI. Unexpectedly, basal DAS28 was higher in patients without SI (p=0.03).
Conclusion: Corticosteroid use, exposition to more than one biologic, smoking and renal failure are associated with serious infections in RA patients on bDMARDs.
To cite this abstract in AMA style:de la Vega M, Casado G, Citera G, Laurindo IMM, Christopoulos G, Descalzo MA, Ranza R. Corticosteroid Use, Biologic Therapy Switching, Smoking and Renal Failure Are Associated with Serious Infections in Rheumatoid Arthritis Patients Treated with Biologics: Data from Two Latin-American Registries [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/corticosteroid-use-biologic-therapy-switching-smoking-and-renal-failure-are-associated-with-serious-infections-in-rheumatoid-arthritis-patients-treated-with-biologics-data-from-two-latin-american-r/. Accessed November 15, 2019.
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