The Importance of Grasping Side Effects of IBD Therapies

Author:

Miguel Regueiro, MD

Chair of the Department of Gastroenterology, Hepatology & Nutrition and Vice Chair of the Digestive Disease and Surgery Institute at Cleveland Clinic in Ohio.

Citation: Regueiro M. The importance of grasping side effects of IBD therapies [published online February 21, 2019]. Gastroenterology Consultant.

The question of monitoring safety in inflammatory bowel disease (IBD) has really emerged over the past 10 to 15 years. It first started with the thiopurines and methotrexate, and it has evolved into the inclusion of the biologic therapies and now small molecules.

Briefly, within the biologic therapy category, there are anti- tumor necrosis factors (TNF), infliximab, adalimumab, certolizumab, and golimumab, and the anti-integrin molecules such as vedolizumab. The newest monoclonal antibody is the anti-interleukin 12/23 pathway, which includes ustekinumab. A newer category is the anti-interleukin 12/23 pathway, which includes ustekinumab. Finally, there is a new and first small molecule for IBD, tofacitinib, which was recently approved for the treatment of ulcerative colitis (UC). These are the medications that gastroenterologists use to treat IBD, and it is key that they know and understand the side effects of each of them.

Selecting the Correct Therapy

When we consider the categories of biologic therapies, we know that each can potentially have adverse events related to them. While the adverse events and side effects have been rare, some of them are significant, so we do need to pay special attention.

Anti-TNFs: Within the anti-TNF category, the side effect we have seen the most is infection, specifically opportunistic infections. These include tuberculosis (TB) and certain fungal infections. We need to monitor for infection, paying special attention to patients who present with a cough, fever, or other symptoms. If a patient has an active infection such as TB or other opportunistic infection, we need to stop the anti-TNFs, and also give great care in starting these medications in someone infected but not on these treatments.

Therapies >>

Anti-integrins: Vedolizumab is the anti-integrin used for the treatment of Crohn disease and UC. It is uniquely positioned in that it has a very good safety profile because it is gut-selective. Unlike the anti-TNFs, which may predispose patients to infections or opportunistic infections due to its systemic immunosuppression, vedolizumab is appealing since it is gut-selective, is safe, and has not been associated with infections. 

Ustekinumab: This anti-interleukin 12/23 has also been safe. It is a systemic immunosuppressant, but so far, we have seen minimal adverse events. Although, if I were to choose a medicine based on someone who has an active infection, eg, pneumonia, I would probably still choose the gut selectivity of vedolizumab over ustekinumab and anti-TNFs.

Tofacitinib: Finally, tofacitinib has been linked to herpes zoster infection (shingles). We should administer the vaccine, Shingrix, before giving tofacitinib.  This may not always be possible due to lack of payment by the insurance company for those under 50 years and a recent national shortage of the Shingrix vaccine. If we do have patients with active herpes infection, we need to pay special attention to and use caution when using this medication.

Hopefully, by describing some of the adverse and potential safety side effects, we will better position these treatments and help us make these decisions on which medicine to choose. Understanding the side effects raises awareness, and physicians should educate the patients so that they too can understand what potential side effects may occur and how to monitor for them.

Reference:

Click B, Regueiro M. A practical guide to the safety and monitoring of new IBD therapies [published online October 12, 2018]. Inflamm Bowel Dis. https://doi.org/10.1093/ibd/izy313

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