QuantiFERON-TB Gold In-Tube assay for screening arthritis patients for latent tuberculosis infection before starting anti-tumor necrosis factor treatment

PLoS One. 2015 Mar 6;10(3):e0119260. doi: 10.1371/journal.pone.0119260. eCollection 2015.

Abstract

Background: Patients undergoing anti-tumor necrosis factor (TNF) treatment are at an increased risk of reactivating a latent tuberculosis infection (LTBI). This study evaluated the effectiveness of the QuantiFERON-TB Gold In-Tube (QFT) assay for diagnosing LTBI in arthritis patients undergoing anti-TNF treatment.

Methods: We enrolled 342 consecutive patients from August 2007 to October 2013: 176 (51.5%) patients with ankylosing spondylitis and 166 (48.5%) with rheumatoid arthritis. Screening tests included tuberculin skin test (TST) and QFT assay. Positive QFT results, regardless of TST results, were considered an indicator for LTBI treatment.

Results: Bacillus Calmette-Guérin scars were found in 236 (69.0%) patients. Of 342 patients, TST and QFT were positive in 122 (35.7%) and 103 (30.1%) patients, respectively, and discordant in 101 (29.5%) patients. During a median follow-up duration of 41.7 months, five patients (1.5%) developed TB in a median of 20.8 months after initiation of anti-TNF treatment (428/100,000 person-years). TB did not occur in 62 TST+/QFT+ patients who received LTBI treatment. Of 41 TST-/QFT+ patients who received LTBI treatment, one (2.4%) developed TB 20.5 months after starting anti-TNF treatment (705/100,000 person-years). Of 60 TST+/QFT- patients who did not receive LTBI treatment, two (3.3%) developed TB 20.8 and 22.0 months after starting anti-TNF treatment (871/100,000 person-years). Of 179 TST-/QFT- patients, two (1.1%) developed TB 7.2 and 22.7 months, respectively, after initiating anti-TNF treatment (341/100,000 person-years). TB incidence rate during the follow-up period did not differ among TST-/QFT+, TST+/QFT-, and TST-/QFT- patients (P = 0.661).

Conclusion: QFT might be used instead of TST for diagnosing LTBI in patients before starting anti-TNF therapy in countries, such as Korea, where the TB prevalence is intermediate and the BCG vaccination is mandatory at birth. In the absence of a true gold standard test for LTBI, however, there is still a risk of TB development during anti-TNF treatment.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab / pharmacology
  • Adalimumab / therapeutic use
  • Adult
  • Arthritis, Rheumatoid / complications*
  • Arthritis, Rheumatoid / drug therapy*
  • Female
  • Humans
  • Infliximab / pharmacology
  • Infliximab / therapeutic use
  • Latent Tuberculosis / complications
  • Latent Tuberculosis / diagnosis*
  • Male
  • Middle Aged
  • Spondylitis, Ankylosing / complications*
  • Spondylitis, Ankylosing / drug therapy*
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*

Substances

  • Tumor Necrosis Factor-alpha
  • Infliximab
  • Adalimumab

Grant support

This study was supported by a grant of the Korean Health technology R&D Project, Ministry for Health & Welfare, Republic of Korea (HI13C0871). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.