Inflammatory Rheumatic Diseases
Conditions
Keywords
anti-TNF, tuberculosis, QuantiFERON-TB Gold In-Tube, tuberculin skin test, rheumatoid arthritis, spondyloarthritis
Brief summary
The screening for latent tuberculosis infection (LTBI) prior to the onset of anti-tumor necrosis factor therapy, as well as a watchful monitoring during the treatment, is strongly recommended. Tuberculin skin test (TST), universally used for this purpose, lacks sensitivity and specificity. The novel screening tools, including QuantiFERON-TB Gold In-Tube (QFT-GIT), have shown a higher specificity compared to TST, but their feasibility in the setting of immunosuppression remains unclear. Aims of this study were to investigate the performance of QFT-GIT and its agreement with TST in patients awaiting anti-tumor necrosis factor (TNF) therapy, and to evaluate the usefulness of serial QFT-GIT during the treatment with biologics to assess whether dynamic changes in interferon (IFN)-gamma levels may be helpful in identifying reactivation of LTBI or cases of newly acquired tuberculosis.
Interventions
BIOLOGICALQuantiFERON-TB Gold In-Tube (QFT-GIT)
Patients were randomized to undergo, on the same day, TST and QFT-GIT by means of a randomization list to generate the order by which the 2 tests had to be executed. QFT-GIT was repeated after 3 and 6 months since TNF antagonist onset
Sponsors
University of Roma La Sapienza
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* clinical diagnosis of inflammatory rheumatic diseases * patients candidates to anti-TNF treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in IFN-gamma plasma levels following serial QFT-GIT testing during the treatment with anti-TNF agents | From date of randomization (before anti-TNF treatment) until the date of repeated QFT-GIT testing (after 12 weeks and again after 24 weeks) for a total assessment of 7 months. | QFT-GIT was performed at randomization (before commencement of anti-TNF treatment) and after 3 and 6 months since the beginning of biologicals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of QFT-GIT and its agreement with TST in patients under consideration for anti-TNF agents | From date of randomization (before anti-TNF treatment) until the date of acquisition of QFT-GIT and TST results, for a total of 1 month. | QFT-GIT and TST were performed at baseline, before the commencement of anti-TNF treatment. |
Outcome results
None listed