Does the patient require a Quantiferon Gold (Interferon-Gamma Release Assay) test prior to initiating treatment with Humira (Adalimumab)?

From the Guidelines

I strongly recommend obtaining a QuantiFERON-TB Gold test before starting Humira (adalimumab) therapy to screen for latent tuberculosis infection, as TNF inhibitors like Humira can reactivate dormant TB, potentially leading to serious complications. This blood test is preferred over the tuberculin skin test (TST) due to its better performance in diagnosing latent TB and lower interference from treatments such as glucocorticoids, DMARDs, or immunosuppressants 1. The test requires drawing blood into specialized collection tubes and sending them to a laboratory for analysis. Results are typically available within a few days.

Key Considerations

• If the test is positive, the patient will need TB treatment before starting Humira, usually with isoniazid for 9 months or a shorter rifampin-based regimen 1.
• Even with a negative test, patients should be monitored for TB symptoms throughout Humira therapy.
• This screening is essential because Humira suppresses the immune system by blocking tumor necrosis factor (TNF), which plays a crucial role in containing TB infection.
• Without proper screening and treatment of latent TB, the risk of developing active TB disease increases substantially during anti-TNF therapy.

Additional Recommendations

• A chest X-ray may also be considered as part of the TB screening procedure, especially to rule out active TB or in cases of high suspicion for latent TB in high-endemic countries 1.
• The choice between different IGRA tests, such as QuantiFERON and EliSPOT, does not significantly impact the screening outcome, as concordance between them is good 1.

From the FDA Drug Label

Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating HUMIRA and periodically during therapy. Treatment of latent tuberculosis infection prior to therapy with TNF blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy Prior to initiating HUMIRA, assess if treatment for latent tuberculosis is needed; and consider an induration of ≥ 5 mm a positive tuberculin skin test result, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG)

The patient needs a Quantiferon Gold test before starting Humira to assess for latent tuberculosis infection, as treatment with Humira may increase the risk of reactivating tuberculosis. This is a necessary precaution to take before initiating therapy with Humira 2.

From the Research

Quantiferon Gold Test for Latent Tuberculosis Infection

• The QuantiFERON-TB Gold In-Tube (QFT-TB) assay is a diagnostic test used to detect latent tuberculosis (TB) infection 3.
• It is more specific than the tuberculosis skin test (TST) in diagnosing latent TB infection 3.
• The QFT-TB test is useful in screening patients for latent TB infection before starting anti-tumor necrosis factor (TNF) treatment, such as Humira 4.

Performance of QuantiFERON-TB Gold In-Tube Assay

• The QFT-TB test was positive in 30.8% of patients with suspected TB infection, and 66.9% of persons with origin from a TB endemic country 3.
• The test was more frequently positive in those with TST > or = 15 mm (47.5%) compared to TST 11-14 mm (21.3%) and TST 6-10 mm (10.5%) 3.
• Origin from a TB endemic country, recent stay in a TB endemic country, duration of TB exposure, and previous TB disease were all independently associated with a positive QFT-TB test 3.

Use of QuantiFERON-TB Gold In-Tube Assay in Clinical Practice

• The QFT-TB test may be used instead of TST for diagnosing latent TB infection in patients before starting anti-TNF therapy 4.
• However, there is still a risk of TB development during anti-TNF treatment, even with a negative QFT-TB test result 4.
• The test should not be used to monitor the effect of preventive therapy, as most patients remained QFT-TB positive after therapy 3.

Comparison with Other Tests

• The QuantiFERON-TB Gold Plus (QFT-Plus) test has similar diagnostic performance to the QFT-GIT test 5.
• The agreement between QFT-Plus and QFT-GIT was high, with a pooled Cohen's kappa statistic of 0.83 5.
• The impact of immunosuppressive therapy on QFT-G-IT and TST for screening of latent TB in patients with inflammatory bowel disease scheduled for anti-TNF therapy was found to be minimal 6.