Risk of tuberculosis in patients treated with anti‐tumor necrosis factor therapy: a nationwide study in South Korea, a country with an intermediate tuberculosis burden

Jung, Seung Min; Ju, Ji Hyeon; Park, Mi-Sun; Kwok, Seung‐Ki; Park, Kyung-Su; Kim, Ho-Youn; Yim, Hyeon Woo; Park, Sung-Hwan

doi:10.1111/1756-185x.12530

Cited by 55 publications

(60 citation statements)

References 20 publications

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“…After adjusting for potential confounders, the 1-year risk of TB infection in RA patients on TNFi therapy was 7.19-fold higher than that of non-TNFi controls during 2008–2012. This finding was consistent with previous studies demonstrating that TNFi-treated RA patients had an increased risk of TB compared with non-TNFi controls [11, 13, 22, 23]. In contrast to previous studies, this study focused on the 1-year TB risk because the reactivation of LTBI occurred most commonly within one year after TNFi initiation [24, 25].…”

Section: Discussionsupporting

confidence: 89%

“…This finding was comparable to the result of a meta-analysis of randomized controlled trials and registry/cohort studies [10]. The risk of TB infection in ETN users has been demonstrated to be lower than that in patients taking monoclonal antibodies to TNF [13, 23, 27]. However, the NHIRD lacks information on disease activity, which was another potential confounder and might be related to disease duration and immunosuppressive agent use.…”

Section: Discussionsupporting

confidence: 75%

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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

et al. 2016

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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.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 75%

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

et al. 2016

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“…The annual incidence of notified active TB cases is approximately 78 per 100,000 in the general population in 2011, and the estimated prevalence of latent TB is 33% 8, 9 . Therefore, the risk of developing TB through LTBI reactivation or a new infection in patients undergoing TNF antagonist therapy in Korea is reportedly higher than it is in countries with a low TB burden 10, 11 . Studies investigating the incidence and characteristics of active TB in patients undergoing TNF antagonist therapy according to baseline LTBI are important in countries with a relatively high TB burden.…”

Section: Introductionmentioning

confidence: 99%

Active Tuberculosis Incidence and Characteristics in Patients Treated with Tumor Necrosis Factor Antagonists According to Latent Tuberculosis Infection

Lee

Kang

Leem

et al. 2017

Sci Rep

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This study aimed to determine the incidence and characteristics of active tuberculosis (TB) in patients treated with tumor necrosis factor (TNF) antagonists according to baseline latent tuberculosis infection (LTBI). Data were retrospectively obtained from 702 patients aged ≥20 years treated with TNF antagonists between November 2005 and June 2016 at Severance Hospital, a tertiary referral hospital in Seoul, South Korea. The interferon-gamma release assay (IGRA) with or without a tuberculin skin test (TST) was used to diagnose LTBI. Of the total of 702 patients, LTBI was diagnosed in 255 (36.3%) patients. 23.9% (168/702) had positive IGRA results, and 32.2% (165/512) had positive TST results. Five patients developed active TB after LTBI treatment, and 6 developed TB despite baseline negative LTBI results. After adjustment for age and sex, the standardized TB incidence ratio was 6.01 (95% CI 1.94–14.04) in the LTBI group and 5.14 (95% CI 1.88–11.18) in the baseline negative LTBI group. Clinicians should be aware of the risk of active TB in patients treated with TNF antagonists despite baseline negative LTBI screening results. Regular monitoring and serial tests should be considered during long-term TNF antagonist therapy, especially in intermediate to high TB burden country.

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“…In the initial report by Keane et al ., the case fatality ratio in patients with infliximab (IFX)‐induced TB was 17% . To date, all studies on this aspect of anti‐TNF‐α have come from countries where the prevalence of TB is either low or moderate . The limited data on this aspect from India are restricted to a solitary report from a rheumatologic perspective .…”

Section: Introductionmentioning

confidence: 99%

Infliximab‐induced tuberculosis in patients with UC: Experience from India—a country with high prevalence of tuberculosis

Puri

Desai

Sood

et al. 2017

J of Gastro and Hepatol

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Risk of tuberculosis in patients treated with anti‐tumor necrosis factor therapy: a nationwide study in South Korea, a country with an intermediate tuberculosis burden

Abstract: The difference in TB risk between TNF inhibitors was similar with countries of low TB burden. This study suggests that particular attention is required for patients treated with TNF monoclonal antibodies.

Cited by 55 publications

References 20 publications

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

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

Active Tuberculosis Incidence and Characteristics in Patients Treated with Tumor Necrosis Factor Antagonists According to Latent Tuberculosis Infection

Infliximab‐induced tuberculosis in patients with UC: Experience from India—a country with high prevalence of tuberculosis

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