Abstract Importance Data on advanced therapy (AT) in patients with HIV and inflammatory bowel disease (HIV-IBD) are limited. Objective We evaluated the safety and outcomes of AT in this population using real-world data. Design, Setting, and Participants We conducted a retrospective cohort study in the TriNetX database (2015–2020). Adult patients with HIV-IBD on anti-retroviral therapy were identified using ICD-10 codes. Propensity score matching (PSM) adjusted for baseline clinical and demographic differences. Intervention(s) or Exposure(s) AT exposure identified via prescription codes of biologics or small molecules. Main Outcomes and Measures Primary outcomes were serious infections, opportunistic infections, and incident cancers; secondary outcomes included IBD-related surgery and all-cause mortality. Results Among 3422 patients with HIV-IBD, 173 (5.05%) received AT. The most commonly used agents were infliximab (41.6%), adalimumab (36.4%), and ustekinumab (11.6%). Mean follow-up was 4.86 years (9861 patient-years). In the unmatched cohort, rates of serious infections (34.1% vs 36.9%, OR 0.86, P = .14) and opportunistic infections (26.6% vs 26.9%, OR 0.99, P = .94) were similar between patients receiving AT and those not receiving AT. After PSM (163 matched pairs), no significant differences were observed in serious infections (34.3% vs 35.6%, OR 0.85, P = .26), opportunistic infections (24.5% vs 28.2%, OR 0.83, P = .45), malignancy rate, IBD-related surgery, or mortality. Kaplan–Meier analyses showed no statistically significant differences in the cumulative incidence of infections or mortality between groups. Conclusions and Relevance In this large multicenter cohort, AT use in HIV-IBD was rare but not associated with higher risks of infection, cancer, surgery, or death. These findings support the safety of AT in this population.
Kaur et al. (2026) studied this question.