Safety of biologics & cancer

Safety of biologics & cancer

August 29, 2023

Issue 16

Clinical Question

Do biologics increase the risk of cancer progression or recurrence in patients with IBD?

Editor’s Bottom Line

These results provide some reassurance about the safety of biologic therapy in patient with both cancer and IBD, but more data from larger cohorts enriched for specific primary cancers like melanoma and lymphoma are needed.


Holmer AK, Luo J, Russ KB, et al. Comparative Safety of Biologic Agents in Patients With Inflammatory Bowel Disease With Active or Recent Malignancy: A Multi-Center Cohort Study. Clin Gastroenterol Hepatol. 2023;21(6):1598–1606;


This multicenter retrospective cohort study compared the safety of anti-tumor necrosis factor (TNF) agents, non-TNF biologics, and immunosuppressants in 125 IBD patients with active cancer and 170 IBD patients with a recent cancer, defined as occurring within five years of study outset and in remission at the time of IBD treatment outset. All patients had started treatment with a biologic for IBD after their cancer diagnosis.

In the two groups, 44–46% of patients received an anti-TNF agent, while 32–39% received another biologic such as vedolizumab or ustekinumab, and 15–24% received an immunosuppressant alone. Additionally, 12–28% of patients in the two groups received combination treatment with a biologic and immunosuppressant.

The distribution of cancer types in the two groups were similar. Most were solid organ cancers and a smaller proportion were hematologic cancers or melanomas. Patients in the two groups were a mean 53–54 years of age at the time of study and had IBD for an average of approximately 14.5 years. The duration of cancer remission in the group with a prior cancer was a mean 18.8 months prior to starting IBD therapy,

Analysis of 484 person-years of follow-up in the active cancer group found the cumulative one-year risk of progression-free survival was 91%, 89% and 93% for individuals treated with an anti-TNF, non-TNF biologic, or an immunosuppressant, respectively (p=0.14). The difference was not statistically significant in a multivariate analysis. There was also no difference in the incidence of serious infections according to treatment type, with 16% of this group of patients requiring hospitalization for such an infection.

In the cohort of patients with a recent cancer, after 513 person-years of follow-up 11% developed a recurrent or new cancer. The cumulative one-year likelihood of recurrence-free survival in this group was 99%, 98%, and 92% for those receiving anti-TNFs, non-TNF biologics or immunosuppressants, respectively (p=0.57). The difference between treatment types was not significant in a multivariate analysis.


Study Design: Retrospective multicenter cohort

Funding: Takeda, Janssen, the Crohn’s and Colitis Foundation and the National Institutes of Health.

Allocation: Not applicable

Setting: Multicenter

Level of Evidence: 2b