TOPLINE

Among patients with inflammatory bowel disease (IBD) initiating advanced therapies — TNF antagonists, vedolizumab, anti-interleukin (IL) therapies, or JAK inhibitors — the incidence of cancer was low and comparable across all treatment classes, with no class associated with a higher risk for cancer than TNF antagonists.

METHODOLOGY

• Although the risk for malignancy in patients with IBD has been studied extensively with TNF antagonists and thiopurines, comparative real-world data on the risk for cancer with newer advanced therapies, including vedolizumab, anti-IL agents, and JAK inhibitors, remain limited.
• Researchers conducted a retrospective cohort study using data from a large administrative claims database to compare the risk for cancer among patients with IBD initiating different advanced therapies between 2016 and 2023.
• They analyzed data from 15,687 patients with IBD (mean age, 45 years; 52% women) with no prior history of cancer who had at least one diagnosis of ulcerative colitis (42%) or Crohn's disease (58%); patients were required to have continuous health plan enrollment with pharmacy benefits, no prescription for the respective advanced therapy in the previous 12 months, and remained enrolled for a minimum of 12 months after treatment initiation.
• Advanced therapies included TNF antagonists (n = 8031), vedolizumab (n = 3985), anti-ILs (n = 3287), or JAK inhibitors (n = 384). Patients were followed up for a median of 2.6 years; statistical weighting balanced baseline differences across treatment groups, with TNF antagonists as the reference.
• The primary outcome was incident cancer (excluding nonmelanoma skin cancer) occurring more than 3 months after the initiation of advanced therapy; incident cancer was defined as at least two diagnostic codes for cancer in the same organ system, recorded during separate inpatient or outpatient visits within 60 days of each other.

TAKEAWAY

• During follow-up, 1.7% of the patients developed cancer. The most common solid organ cancers were prostate cancer, breast cancer, and colorectal cancer, while essential thrombocythemia and lymphoma were the most frequent hematologic cancers. 
• The 3-year cumulative incidence was 2.1% with TNF antagonists, 2.7% with vedolizumab, 2.0% with anti-ILs, and 2.5% with JAK inhibitors.
• After adjustment, the risk for cancer remained comparable across vedolizumab (hazard ratio [HR], 1.01; 95% CI, 0.71-1.42), anti-ILs (HR, 0.94; 95% CI, 0.61-1.46), and JAK inhibitors (HR, 0.85; 95% CI, 0.33-2.16), compared with TNF antagonists. 
• Findings remained consistent across cancer subtypes, including solid organ cancers, hematologic cancers, and melanoma, and in subgroup analyses stratified based on the IBD phenotype (Crohn's disease and ulcerative colitis).

IN PRACTICE

"Our results support the use of ATs [advanced therapies] when clinically indicated, emphasizing that concerns about overall cancer risk should not, in isolation, preclude their use, while underscoring the continued need for individualized risk assessment, vigilant cancer surveillance, and longer-term studies to clarify malignancy risks associated with specific agents and patient subgroups," the authors wrote.

SOURCE

The study was led by Dhruv Ahuja, Indira Gandhi Hospital in New Delhi, India. It was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS

As an observational study, this analysis could not exclude residual confounding, and it could only verify prior cancer history within the 1-year period before treatment initiation. Limited follow-up for newer therapies may have reduced the detection of long-latency cancers. The overall rarity of cancer events limited statistical power for subtype-specific analyses and precluded reliable evaluation of individual drugs within each class.

DISCLOSURES

The study was supported through an award from the Crohn's and Colitis Foundation. Two authors received support from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the National Institute on Aging. Some authors disclosed receiving consulting fees and lecture fees from, participating on advisory boards for, and serving as principal investigators on projects supported by multiple companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.