From the Guidelines
Vedolizumab is not clearly associated with an increased risk of lymphoma, and its gut-selective mechanism may result in fewer lymphoma cases compared to other inflammatory bowel disease treatments. Current evidence suggests that vedolizumab, which works by blocking gut-specific α4β7 integrin, has a lower risk of lymphoma compared to TNF inhibitors, such as infliximab or adalimumab, which have more systemic immunosuppressive effects 1. The most recent and highest quality study, published in 2024, supports the use of vedolizumab as a treatment option for moderate-to-severe ulcerative colitis, with no significant signal for lymphoma development 1.
Some key points to consider when evaluating the risk of lymphoma with vedolizumab include:
- The drug's package insert mentions lymphoma as a potential risk based on theoretical concerns with immunosuppression, but real-world evidence has not demonstrated a significant signal for lymphoma development 1.
- Patients with inflammatory bowel disease may have a slightly elevated baseline risk of lymphoma, and long-term safety data for vedolizumab is still accumulating 1.
- Vedolizumab and anti-IL therapies may be associated with a lower rate of infectious complications than TNF antagonists, and may be preferred in patients who may be at higher risk of immunosuppression-related infections or malignancies 1.
- There are limited data on the safety of JAK inhibitors and S1P receptor modulators in pregnancy, and these drugs should be avoided in women of childbearing age contemplating pregnancy 1.
Overall, the available evidence suggests that vedolizumab is a safe and effective treatment option for patients with inflammatory bowel disease, with a potentially lower risk of lymphoma compared to other treatments. However, patients with a history of lymphoma or other malignancies should discuss their specific risk factors with their healthcare provider when considering vedolizumab therapy 1.
From the Research
Vedolizumab and Lymphoma Risk
- There is no direct evidence in the provided studies that suggests vedolizumab has a significant lymphoma risk 2, 3, 4, 5, 6.
- A study comparing the risk of malignancy between patients treated with vedolizumab and tumor necrosis factor-α antagonists found no difference in the incidence of malignancy between the two groups 5.
- Another study found that vedolizumab was not associated with an increased risk of new or recurrent cancers in patients with prior malignancy 4.
- The available evidence suggests that vedolizumab does not have a significant lymphoma risk, but more research may be needed to fully understand its effects on cancer risk.
- Key findings from the studies include:
- No increase in the risk of new or recurrent cancer with vedolizumab compared to no immunosuppressive therapy 4.
- No difference in the incidence of malignancy between vedolizumab and tumor necrosis factor-α antagonists 5.
- Vedolizumab had a lower hazard of biologic discontinuation for non-response and adverse effects compared to adalimumab 6.