Background In Japan, the definition of the elderly was suggested as being over 75 years old by the Japan Geriatric Society. The effectiveness of biologics in elderly rheumatoid arthritis (RA) patients has been demonstrated in several clinical trials and cohort studies1. On the other hand, regarding safety, there are reports that the use of biologics in elderly RA patients is a significant risk for severe infections and that they do not increase the risk of serious infection 2,3. There is little evidence to support the association between age of RA patients and adverse events caused by biologics.
Objectives We aimed to examine whether the age of RA patients was associated with adverse events caused by biologics.
Methods RA patients using biologics were eligible. The participants were collected at Showa University Hospital, Showa University Northern Yokohama Hospital and Showa University Koto Toyosu Hospital from 2005 to 2016 in a retrospective cohort study.
RA patients of 75 years and above compared with RA patients under 75 years.
The primary outcome was the rate of discontinuation due to adverse events caused by biologics. Statistical analysis was Pearson's chi-square test. Multivariable analysis was performed by multi linear analysis. Covariates were sex, glucocorticoids dose, csDMARDs, interstitial pneumonia, diabetes mellitus and chronic kidney disease.
Results In total, 309 patients were enrolled. The mean age standard deviation was 57.1±15.6years, and 83.4% were women. 174 (56.3%) took glucocorticoid, and the mean glucocorticoid dose was 3.13±3.9mg.The patients over 75 years were 42 patients (13.6%), and those under 75 years were 267 patients (86.4%). The rate of discontinuation due to adverse events caused by biologics was 11/42 (26.2%) in the patients over 75 years and over, and 21/267 (7.9%) in the patients under the age of 75 (Relative Risk 1.24; 95% Confidential Interval (CI) 1.04 to 1.50; P 0.0003). Adverse events were bacterial pneumonia, pneumocystis pneumonia, exacerbation of interstitial pneumonia, urinary tract infection, herpes zoster, cytopenia, eruption, congestive heart failure. In the multivariable analysis adjusting for confounders, the rate of discontinuation in the group aged 75 years and older was significantly higher than that in the group under the age of 75 (regression coefficient 1.35; 95% CI 0.39–2.31; p=0.006).
Conclusions Our results demonstrated that the rate of discontinuation due to adverse events by biologics was high significantly in RA patients over 75 years and above.
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Widdifield J, et al. Serious infections in a population-based cohort of 86,039 serious with rheumatoid arthritis. Arthritis Care Res (Hoboken) 2013;65(3):353–61.
Disclosure of Interest None declared