P0860 - Ustekinumab Monotherapy vs Ustekinumab Combined with Immunomodulators in Inflammatory Bowel Disease: A Propensity-Matched, Retrospective Cohort Study

Feyzullah Aksan, MD¹, Layla Barrera, DO², Thomas Ullman, MD^3
1Renaissance School of Medicine, Stony Brook University, Port Jefferson Station, NY; ²Stony Brook University Hospital, Port Jefferson Station, NY; ³Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY

Introduction: Patients with Inflammatory Bowel Disease (IBD) often receive treatment with anti-TNF, in combination with thiopurine or methotrexate immunomodulators (IMMs). When patients develop loss of response to anti-TNF therapy, they are often switched to different therapeutic classes while continuing IMMs if tolerated. Although there are established benefits of combining anti-TNF and IMMs, it remains uncertain whether similar benefits exist with concomitant use of ustekinumab (UST) and IMMs. This study aims to provide clarity on the effectiveness of combining UST with IMMs in IBD treatment.

Methods: We conducted a retrospective cohort study using TriNetX, a multi-institutional database, to compare effectiveness of UST vs UST+IMMs. Using ICD-10 codes, we identified patients, ≥18 years old, with Crohn’s disease (CD) or ulcerative colitis (UC) between January 2016 and January 2022. We excluded patients with colectomy or ileal resections. Two cohorts are created; patients who received UST+ IMM or UST alone after CD or UC event. We employed 1:1 propensity score match (PSM) based on demographics, age, gender, comorbidities, IBD subtype, and other IBD medications. We compared the 3 years all-cause mortality, colectomy, ileal resection, abscess formation, fistula formation, steroid use, severe and opportunistic infections, healthcare resource utilization (HRU, inpatient/outpatient visits). We used log-rank testing with calculations of hazard ratios (HR) and 95% Confidence Intervals (CI) to determine effect on outcomes with a significance level of α < 0.05

Results: Post-PSM, each cohort included 3,945 IBD patients. The UST+IMM cohort exhibited a significantly higher hazard of colectomy (HR: 1.4832, 95% CI: 1.174-1.875), fistula formation (HR: 1.327, 95% CI: 1.19-1.48), abscess formation (HR: 1.285, 95% CI: 1.063-1.554), and steroid use (HR: 1.257, 95% CI: 1.183-1.334) compared to the UST cohort. However, the hazards of all-cause mortality, ileum resection, healthcare resource utilization, and opportunistic infections were not statistically significant.

Discussion: Our retrospective study indicates higher HR of colectomy, fistula formation, abscess formation, and steroid use in patients receiving UST with IMMs compared to those receiving UST alone, highlighting potential concerns for concomitant use of UST and IMM in IBD treatment. Propensity matching likely limited selection biases related to medication use, but unknown confounders may be present. Future clinical studies are needed to confirm our findings.


Disclosures:


Feyzullah Aksan, MD¹, Layla Barrera, DO², Thomas Ullman, MD³. P0860 - Ustekinumab Monotherapy vs Ustekinumab Combined with Immunomodulators in Inflammatory Bowel Disease: A Propensity-Matched, Retrospective Cohort Study, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.