One-Year Tuberculosis Risk in Rheumatoid Arthritis Patients Starting Their First Tumor Necrosis Factor Inhibitor Therapy from 2008 to 2012 in Taiwan: A Nationwide Population-Based Cohort Study

Abstract

ObjectiveTo investigate the risk of tuberculosis (TB) among rheumatoid arthritis (RA) patients within 1 year after initiation of tumor necrosis factor inhibitor (TNFi) therapy from 2008 to 2012.MethodsWe used the 2003–2013 Taiwanese National Health Insurance Research Database to identify RA patients who started any RA-related medical therapy from 2008 to 2012. Those who initiated etanercept or adalimumab therapy during 2008–2012 were selected as the TNFi group and those who never received biologic disease-modifying anti-rheumatic drug therapy were identified as the comparison group after excluding the patients who had a history of TB or human immunodeficiency virus infection/acquired immune deficiency syndrome. We used propensity score matching (1:6) for age, sex, and the year of the drug index date to re-select the TNFi group and the non-TNFi controls. After adjusting for potential confounders, hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated to examine the 1-year TB risk in the TNFi group compared with the non-TNFi controls. Subgroup analyses according to the year of treatment initiation and specific TNFi therapy were conducted to assess the trend of 1-year TB risk in TNFi users from 2008 to 2012.ResultsThis study identified 5,349 TNFi-treated RA patients and 32,064 matched non-TNFi-treated controls. The 1-year incidence rates of TB were 1,513 per 105 years among the TNFi group and 235 per 105 years among the non-TNFi controls (incidence rate ratio, 6.44; 95% CI, 4.69–8.33). After adjusting for age, gender, disease duration, comoridities, history of TB, and concomitant medications, TNFi users had an increased 1-year TB risk (HR, 7.19; 95% CI, 4.18–12.34) compared with the non-TNFi-treated controls. The 1-year TB risk in TNFi users increased from 2008 to 2011 and deceased in 2012 when the Food and Drug Administration in Taiwan announced the Risk Management Plan for patients scheduled to receive TNFi therapy.ConclusionThis study showed that the 1-year TB risk in RA patients starting TNFi therapy was significantly higher than that in non-TNFi controls in Taiwan from 2008 to 2012.

The risk of tuberculosis disease in rheumatoid arthritis patients on biologics and targeted therapy: A 15-year real world experience in Taiwan

“…A Higher dose of steroid use (prednisolone equivalent dose ≥ 5mg/ day) increased 5-fold risk of TB disease observed in this study. The result was in parallel to our previous population study and a Canadian cohort [27, 28]. Other factors associated with increased TB risk such as diabetes mellitus, chronic kidney disease, and the use of ciclosporin were reported in previous studies [20, 22, 23, 29].…”

Predictors of drug survival for biologic and targeted synthetic DMARDs in rheumatoid arthritis: Analysis from the TRA Clinical Electronic Registry

“…Taiwan is an endemic area of latent TB infection and in over 80% of latent TB cases, a prophylaxis strategy was applied [ 22 ]. We previously demonstrated that the 1-year TB risk in RA patients receiving TNF-α inhibitors was higher than that found among patients receiving non-TNF-α inhibitors in a nationwide population-based study between 2008 and 2012 [ 23 ]. An Italian study also demonstrated that RA patients with latent TB might discontinue anti-TNF therapy, because active TB occurred during and after anti-TB prophylactic therapy [ 24 ].…”

Safety of baricitinib in East Asian patients with moderate‐to‐severe active rheumatoid arthritis: An integrated analysis from clinical trials

“…Patients with RA from EA countries have a higher risk of developing TB, and the risk is further increased when using immunomodulatory drugs . The risk of developing TB infection is 2‐fold higher in Taiwanese patients and 9‐fold higher in Korean patients with RA, compared with the general population .…”