Incidence rates of tuberculosis and inflammatory bowel disease in patients with ankylosing spondylitis treated with biologics in Korea

Objective: To describe the incidence rates of inflammatory bowel disease (IBD) and tuberculosis (TB) in Korean patients with ankylosing spondylitis receiving biologics.

Methods: Data from a Korean claims database between 2010 and 2021 was used to calculate crude incidence rates of TB and IBD using number of events and total patient-years (PYs).

Results: Overall, 43 643 and 43 396 patients were included in TB and IBD cohorts. Exposure adjusted incidence rates (EAIRs) of TB for non-exposure, tumor necrosis factor inhibitors (TNFis), and interleukin-17 inhibitors (IL-17is) were 0.14, 0.25, and 0.12 and of IBD were 0.18, 0.19, and 0.44 per 100 PYs, respectively. Incidence rates during biologic disease-modifying antirheumatic drugs (bDMARDs) non-exposure, adalimumab, etanercept, golimumab, infliximab, secukinumab and ixekizumab exposures for TB were 13.96, 27.79, 14.28, 21.19, 33.62, 12.74, and 0.00 and for IBD were 18.29, 19.98, 22.41, 18.85, 15.73, 44.99, and 0.00 per 10 000 PYs, respectively. Compared with bDMARDs non-exposure, adalimumab, golimumab, and infliximab exposures were associated with a significantly higher risk of TB. Etanercept and secukinumab exposure showed no significant increase in risk of TB. Compared with bDMARDs non-exposure, exposure to biologics did not show a significant difference in risk of IBD.

Conclusion: EAIRs of TB and IBD with use of IL-17is in patients with AS were within anticipated low range. IL-17is had numerically lower incidence of TB, and numerically higher incidence of IBD compared with TNFis. Notably, secukinumab showed no increased risk of TB compared with bDMARDs non-exposure. Neither TNFis nor IL-17is showed increased risk of IBD compared with bDMARDs non-exposure.