Cancer Risk with Advanced Therapies in Patients with Inflammatory Bowel Diseases: An Administrative Claims-based Study.

Background

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Aims

We conducted a retrospective cohort study comparing the risk of cancer in patients with inflammatory bowel diseases (IBD) initiating advanced therapies (ATs).

Methods

Using an administrative claims database (OptumLabs® Data Warehouse), we identified patients with IBD with no prior history of cancer, who initiated TNF antagonists, vedolizumab, anti-interleukins or JAK inhibitors between 2016 and 2023 and had insurance coverage for at least 1y before and after treatment initiation. We compared risk of overall cancer (except non-melanoma skin cancer) across different ATs occurring at least 3 months after treatment initiation. Groups were balanced through multinomial propensity score-based inverse probability weighting. We calculated cause-specific hazard ratios (HR) and 95% CI.

Results

Of 15,687 patients with IBD starting an AT (45±17 years, 52% female, 76% Whites, 14% with obesity) and followed over median 2.6y, 273 developed cancer. The 3-year cumulative incidence of cancer was similar across all agents: TNF antagonists (n=8031), 2.1% (95% CI, 1.7-2.5), vedolizumab (n=3985), 2.7% (95% CI, 2.1-3.3), anti-interleukins (n=3287), 2.0% (95% CI, 1.4-2.6) and JAK inhibitors (n=384), 2.5% (95% CI, 0.5-4.6). After adjusting for confounding variables, risk of cancer with ATs was comparable (HR, vs. TNF antagonists): vedolizumab, 1.01 (95% CI, 0.71-1.42); anti-interleukins, 0.94 (95% CI, 0.61-1.46); JAK inhibitors, 0.85 (95% CI, 0.33-2.16). Findings were similar on subgroup analyses based on type of cancer (solid organ, hematological, melanoma), and on multiple sensitivity analyses. Findings were consistent in agent-level analyses and in an indirect comparison with a cohort of immunomodulator- and advanced therapy-naïve patients with newly diagnosed IBD.

Conclusions

In a real-world cohort of 15,687 patients with IBD initiating ATs, risk of incident cancer was low and comparable across advanced therapy classes.