Are patients with rheumatoid arthritis still at an increased risk of tuberculosis and what is the role of biological treatments?

Arkema, Elizabeth V.; Jonsson, Jerker; Baecklund, Eva; Bruchfeld, Judith; Feltelius, Nils; Askling, Johan

doi:10.1136/annrheumdis-2013-204960

Cited by 94 publications

(84 citation statements)

References 24 publications

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“…The British and Swedish registers, however, have subsequently confirmed the concerns of an increased risk of TB with anti-TNF therapy and a differential risk between the initial anti-TNF drugs [39,40]. Forty cases in 39 patients were reported from the BSRBR over 34,025 PY of follow-up (crude IR: 118 (84, 160)/100,000 PY), of which 62% were extrapulmonary and 10 resulted in death [39].…”

Section: Risk Of Tuberculosis With Biologic Therapymentioning

confidence: 89%

“…This has changed the incidence and pattern of TB in more recent years. The recent Swedish study demonstrated the impact of such guidelines, with a fall in the rate of TB from 89/100,000 PY in 2002e2006 to 24.2/100,000 PY in 2007e2011 with a corresponding fall in the HR for TB from 7.9 (3.3, 18.9) to 2.4 (0.9, 6.1), respectively [40]. Thus, though the RR has decreased significantly, it remains elevated.…”

Section: Risk Of Tuberculosis With Biologic Therapymentioning

confidence: 95%

See 1 more Smart Citation

Risk of infection with biologic antirheumatic therapies in patients with rheumatoid arthritis

Lahiri¹,

Dixon²

2015

Best Practice & Research Clinical Rheumatology

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Section: Risk Of Tuberculosis With Biologic Therapymentioning

confidence: 89%

Section: Risk Of Tuberculosis With Biologic Therapymentioning

confidence: 95%

Risk of infection with biologic antirheumatic therapies in patients with rheumatoid arthritis

Lahiri¹,

Dixon²

2015

Best Practice & Research Clinical Rheumatology

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“…Rheumatoid arthritis (RA) is a well-established risk factor for TB [3–8]. In Taiwan, the risk of TB development was 2.28-fold higher in RA patients than in the general population [8].…”

Section: Introductionmentioning

confidence: 99%

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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“…Data from a prospective (2002-2011) population-based Swedish national cohort study [14] examined tuberculosis (TB) risks in the general population and in patients with rheumatoid arthritis both exposed and unexposed to biologics. As expected, although the risk of TB decreased among biologic exposed, the risk was still higher than the general population for biologic naïve patients with rheumatoid arthritis.…”

Section: Introductionmentioning

confidence: 99%

Infection, malignancy, switching, biosimilars, antibody formation, drug survival and withdrawal, and dose reduction

Ianculescu

Weisman²

2016

Current Opinion in Rheumatology

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TNFi agents have made their powerful impact on management of patients with rheumatoid arthritis, but questions remain: what is their true infection and malignancy risk in the evolving populations using these drugs today; are we able to maintain their benefit with a reduced schedule (and presumed less cost) and yet recapture their benefit if we guess wrong; are biosimilars just as good, or even better with less cost; are there data to inform us about how to achieve successful switching among different mechanism of action TNFi agents? Finally, are we going to face the specter of cost containment causing change from innovator to biosimilars over which we have no control?

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Are patients with rheumatoid arthritis still at an increased risk of tuberculosis and what is the role of biological treatments?

Abstract: In the past decade, the risk of TB has decreased among biological-exposed RA patients but remains higher than in biological-naïve RA patients. Most cases of TB in RA occur in biological-naïve RA patients, underscoring the elevated risk also in these patients.

Cited by 94 publications

References 24 publications

Risk of infection with biologic antirheumatic therapies in patients with rheumatoid arthritis

Risk of infection with biologic antirheumatic therapies in patients with rheumatoid arthritis

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

Infection, malignancy, switching, biosimilars, antibody formation, drug survival and withdrawal, and dose reduction

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