Dr Axelrad reviews data from the SAPPHIRE registry, which studied whether exposure to IBD therapies after an index cancer increases risk of new or recurrent cancer among patients with IBD.

Jordan Axelrad, MD, is an associate professor at the NYU Grossman School of Medicine and director of Clinical and Translational Research at the IBD Center of NYU Langone Health in New York, New York.

TRANSCRIPT:

I'm Jordan Axelrad, and I'm an inflammatory bowel disease specialist at NYU Langone Health. I just presented at DDW our data from SAPPHIRE, which is a registry examining the safety of immunosuppression in a prospective cohort of inflammatory bowel disease patients with a history of cancer.

We know that in patients with inflammatory bowel disease, there's an increased risk of cancers. This is due to longstanding chronic inflammation and also our immunosuppressive therapies that we use to manage the underlying disease activity.

There have been several studies demonstrating an increased risk of specific cancers in patients exposed to specific immunosuppressives. However, the question remains, in patients with IBD who have a history of cancer, do our IBD medications increase the risk of new or recurrent cancer?

There's several considerations here. A patient with a previous cancer may have their prior cancer completely eradicated, and they're good to receive immunosuppression with no risk, or patients could experience cancer recurrence or new cancers as well. Many of our trials of IBD therapies excluded patients with active or recent malignancy.

Our retrospective data on this topic previously demonstrated that patients with IBD who were subsequently exposed to an anti-TFN agent and/or immunomodulators following a diagnosis of cancer were not at an increased risk of new or recurrent cancer exposed to these agents.

So the SAPPHIRE registry was created in 2017 as a multicenter prospective study to examine the risk of new or recurrent cancer in patients with IBD who then went on to receive immunosuppressant for their disease.

Our primary outcome was just very simple. The development of new or recurrent cancer stratified by immunosuppression exposure in patients with a history of cancer, included patients who had a confirmed first cancer within the last 10 years. We excluded patients who were undergoing cancer treatment at enrollment or already experienced a new or recurrent cancer.

So far in this multicenter registry, we've identified over 600 patients with IBD and an index cancer. The majority of index cancers were solid, extraintestinal, such as breast, prostate, and lung. However, we also had a significant representation of basal and squamous cell skin cancers as well.

During followup, we're now approaching our fifth year, 45 patients developed 53 cancers, 26 new cancers and 27 recurrent cancers. When we looked at the cohort of patients that were exposed to immunosuppression after cancer, this was about two-thirds of the group, a little more than 200 patients, we saw that there was no increased risk of new or recurrent cancer for those exposed to various agents. We specifically looked at patients who were immunomodulator exposed, biologic exposed, specific biologic therapies, including anti-TNF, vedolizumab, and ustekinumab, patients who were exposed to combo therapy with an immunomodulator and an anti-TNF agent, and even those exposed to tofacitinib, we found thus far that exposure to these agents following a diagnosis of cancer was not associated with an increased risk of new or recurrent cancer compared to patients unexposed to these agents following a cancer diagnosis.

There are several strains of this study. It's prospective, multicenter. We also examined cancer stage. However, there are several limitations. There's many factors that go into IBD and cancer decision-making that may not be captured in this registry. Unfortunately still thus far, we're underpowered to examine specific IBD therapies and specific risks of cancer subtypes.

Overall in conclusion, this study demonstrates that exposure to IBD therapies after an index cancer has so far conferred no increased risk of new or recurrent cancer compared to patients with IBD who are unexposed to these agents. We hope that further data from SAPPHIRE will permit the development of evidence-based, quantitative risk-benefit models, including cancer and IBD-related covariates to assist clinicians in managing this complex patient population.