Abstract
The objective of this study is to determine the risk of tuberculosis (TB) disease in biologics users among rheumatoid arthritis (RA) patients in Taiwan from 2000 to 2015. This retrospective cohort study enrolled adult RA patients initiated on first biologics at Taichung Veterans General Hospital. TB risks were determined as hazard ratio (HR) with 95% confidence interval (CI) using cox regression. A total of 951 patients were recruited; etanercept (n = 443), adalimumab (n = 332), abatacept (n = 74), golimumab (n = 60), tocilizumab (n = 31) and tofacitinib (n = 11). Twenty-four TB cases were identified; 13 in etanercept and 11 in adalimumab group with the TB incidence rate of 889.3/ 100,000 and 1055.6/ 100,000 patient-years respectively. There was no significant difference in TB risk between adalimumab and etanercept users with an incidence rate ratio of 1.27 (p = 0.556 by Poisson model). Significant 2-year TB risk factors included elderly patient >65 year-old (HR: 2.72, 95% CI: 1.06–6.99, p = 0.037), history of TB (HR: 6.24, 95% CI: 1.77–22.00, p = 0.004) and daily glucocorticoid use ≥5mg (HR:5.01, 95% CI: 1.46–17.21, p = 0.010). Sulfasalazine treatment appeared to be protective (HR: 0.32, 95% CI: 0.11–0.97, p = 0.043). Risk management plan (RMP) for TB before initiation of biologics commenced in 2012. The 2-year TB risks after RMP was compared with that before 2012 (HR:0.67, 95% CI: 0.30–1.49, p = 0.323). Elderly RA patients with a history of previous TB infection and concomitant moderate dose glucocorticoid were at higher risk of TB disease. Concurrent sulfasalazine treatment appeared to be a protective factor against TB disease.
Highlights
Tuberculosis (TB) remains one of the top 10 leading cause of death worldwide
With the introduction of biological disease modifying anti-rheumatic drugs and targeted disease modifying anti-rheumatic drugs that act against the host defense immunities, the risk of TB disease is further increased among bDMARDs and tDMARDs users in rheumatoid arthritis (RA) patients
The use of concomitant sulfasalazine appeared to be a protective factor against TB disease among bDMARDs and tDMARDs users (HR: 0.32, 95% confidence interval (CI): 0.11–0.97, p = 0.043)
Summary
Tuberculosis (TB) remains one of the top 10 leading cause of death worldwide. It was estimated to have 10.4 million new cases worldwide in 2015 [1]. Incidence of TB was reported as 45.6 cases per 100,000 populations with 10,534 new cases in 2015 [2]. As shown in a Spanish study, rheumatoid arthritis (RA) patient has 4-fold increased risk of TB disease as compared to general population [3]. The risk of TB disease varied in different bDMARDs and tDMARDs. In tumor necrosis factor-α inhibitor (TNFi), TB risk was reported to be higher in monoclonal antibody TNFi than in soluble receptor for TNF-α [7,8,9,10]. For non-TNFi bDMARDs such as tocilizumab (interleukin-6 inhibitor) and abatacept (T-cell costimulator blocker) the TB risk was reported to be relatively low [11, 12]. For tofacitinib (janus kinase inhibitor) the TB rate varied according to different regional backgrounds of TB endemicity [13]
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