Ustekinumab and Vedolizumab Are Not Associated With Subsequent Cancer in IBD Patients with Prior Malignancy

Abstract

Background There is little data regarding the risk of new or recurrent cancer in patients with inflammatory bowel disease (IBD) and a prior history of cancer who are exposed to ustekinumab or vedolizumab. We assessed the risk of subsequent cancer in patients exposed to these agents. Methods We performed a retrospective cohort study of patients with IBD and a history of cancer at an academic medical center between January 2013 and December 2020. We collected data on demographics, IBD and cancer disease characteristics, and drug exposures. The primary exposure was immunosuppressive therapy after diagnosis of cancer. The primary outcome was interval development of new or recurrent cancer. Results Of 390 patients with IBD and a previous history of cancer, 37 were exposed to vedolizumab, 14 ustekinumab, 41 antitumor necrosis factor (anti-TNF), and 31 immunomodulator; and 267 were not exposed to immunosuppression following cancer diagnosis. During a total median follow-up time of 52 months, 81 (20%) patients developed subsequent cancer: 6 (16%) were exposed to vedolizumab, 2 (14%) to ustekinumab, 3 (10%) to immunomodulators, 12 (29%) to anti-TNF, and 56 (21%) with no immunosuppression (P = .41). In a multivariable Cox model adjusting for age, IBD subtype, smoking, cancer recurrence risk, and cancer stage, there was no increase in subsequent cancer with vedolizumab (adjusted hazard ratio, 1.36; 95% CI, 0.27-7.01) or ustekinumab (adjusted hazard ratio, 0.96; 95% CI, 0.17-5.41). Patients with more than 1 biologic exposure also did not have an increased risk of subsequent cancer. Conclusions Exposure to ustekinumab or vedolizumab in patients with IBD and a prior history of cancer does not appear to be associated with an increased risk of subsequent new or recurrent cancer.

ECCO Guidelines on Inflammatory Bowel Disease and Malignancies

“…-5.41] [312]. Whilst safety signals are thus far reassuring, the numbers and duration of follow up are too limited to draw firm conclusions.…”

Personalize, participate, predict, and prevent: 4Ps in inflammatory bowel disease

“…Although a longer follow up is required, evidences suggest that their use does not increase the overall cancer risk in IBD ( 47 , 48 ).In patients with a present or prior history of cancer, one retrospective study reported that vedolizumab does not increase the risk of new/recurrent cancer ( 49 ). Comparable findings were observed using vedolizumab or ustekinumab in IBD patients with prior malignancy ( 50 ). Additional data and a longer follow up is required for assessing the risk of new/recurrent cancer using these more immunomodulators, and particularly tofacitinib (pan-JAK inhibitor) ( 51 ) in IBD patients with a history of cancer.…”

Managing IBD in patients with previous cancers

“…To answer how best to treat patients with previous cancers, we need to study patients with previous cancers. Retrospective analysis of patients with IBD with previous cancer receiving anti-TNF, ustekinumab or vedolizumab44–46 and pooled data on cancer recurrence in patients with inflammatory conditions receiving immunosuppression57 go some way to provide reassurance that we may overestimate treatment-related risks. However, we must recognise the potential for treatment selection bias in retrospective data when the factors determining that treatment choice are unknown; those seen most at risk of recurrence may not have been given perceived higher-risk treatments.…”

“…This was similar to anti-TNF or no immunosuppression. Additional reassurance is suggested by a further two recent studies that have reported that use of ustekinumab or vedolizumab45 or vedolizumab or anti-TNF46 for IBD therapy in patients with a prior history of cancer does not appear to be associated with an increased risk of new or recurrent cancer.…”