Efficacy of biologic and small molecule agents as second-line therapy after exposure to TNF inhibitors in patients with ulcerative colitis: A propensity-matched cohort study

Background: There is limited real-world data on comparative effectiveness of different biologic or small molecule agents as second-line therapies in patients with ulcerative colitis (UC) with prior exposure to a tumor necrosis factor inhibitor (TNFi).
Methods: The authors conducted a retrospective cohort study using TriNetX, a multi-institutional database to assess the efficacy of tofacitinib, vedolizumab and ustekinumab in patients with UC with prior exposure to a TNFi. Failure of medical therapy was defined as a composite outcome of intravenous steroids or colectomy within 2 years. One-to-one propensity score matching was performed for demographics, disease extent, mean hemoglobin, C-reactive protein, albumin and calprotectin, prior inflammatory bowel disease (IBD) medications and steroid use between cohorts.
Results: Among 2141 patients with UC and prior exposure to TNFi, 348 (16.2%), 716 (33.4%) and 1077 (50.3%) were switched to tofacitinib, ustekinumab and vedolizumab, respectively. After propensity-score matching, there was no difference in the composite outcome (adjusted odds ratio [aOR] = 0.77, 95% confidence interval [CI]: 0.55–1.07) but higher risk of colectomy (aOR = 2.69, 95% CI: 1.31–5.50) in the tofacitinib cohort than the vedolizumab cohort. There was no difference in the risk of composite outcome (aOR = 1.29, 95% CI: 0.89–1.86) but higher risk of colectomy (aOR = 2.63, 95% CI: 1.24–5.58) in the tofacitinib cohort than the ustekinumab cohort. The vedolizumab cohort had a higher risk of composite outcome (aOR = 1.67, 95% CI: 1.29–2.16) than the ustekinumab cohort.

Conclusion: Ustekinumab might be the preferred second-line therapy over tofacitinib and vedolizumab in patients with ulcerative colitis that were previously exposed to a tumor necrosis factor inhibitor.

G.S. Kochhar, M.D., Division of Gastroenterology, Hepatology & Nutrition, Allegheny Health Network, Pittsburgh, PA, USA, E-Mail: drkochhar@gmail.com

DOI: 10.1111/apt.17570

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