Sa1266 Interferon-γ Release Assay Versus Tuberculin Skin Test in Patients With Moderate-to-Severely Active Ulcerative Colitis: Results From the PURSUIT UC Program

Abstract

Objective: To report results of an interferonΥ release assay (IGRA) vs standard tuberculin skin test (TST) as a screening tool for latent TB infection in patients with UC in PURSUIT. Methods: Patients with moderately to severely active UC were screened for latent TB using the standard TST and the IGRA to assess eligibility for entry into the induction studies of golimumab (PURSUIT-SC [C0524T17]and PURSUIT-IV [C0524T1]Any patient with a newly identified positive finding for TB on a diagnostic test in whom there was no evidence of active TB was permitted to enter provided appropriate treatment for latent TB was initiated before or at the time of the first dose of study agent. TST was performed according to the Mantoux method, using 5 tuberculin units (TU) of purified protein derivative (PPD) standard or 2 TU of PPD RT-23. The TST was deemed positive for latent TB infection according to the local country guidelines for defining an immunosuppressed host or, in the absence of local guidelines, according to the presence of induration >5mm. The IGRA used to screen for latent TB was the QuantiFERON-TB Gold In-Tube test. Overall IGRA and TST results were assessed. The impact of prior BCG vaccination and concomitant medication (ie corticosteroids and/or immunomodulators ) on outcome was assessed. Results: 1283 patients had both IGRA and TST screening prior to GLM treatment. Among these patients, 8.7% had at least one test yielding positive findings for latent TB, including 6.2% with positive results