Dr Charabaty discusses the poster presentation on the study of safety of ustekinumab among patients aged 60 years and older with inflammatory disease, which was shown at the recent American College of Gastroenterology meeting.

Aline Charabaty, MD, is the assistant clinical director of gastroenterology at the Johns Hopkins University School of Medicine, and clinical director of inflammatory bowel disease at the Johns Hopkins Sibley Memorial Hospital in Washington, DC.

TRANSCRIPT:

Dr. Aline Charabaty:  Hi, everyone. I'm Dr. Aline Charabaty. I'm the assistant clinical director of the division of gastroenterology at Johns Hopkins School of Medicine and a clinical director of the IBD Center at Johns Hopkins Sibley Memorial Hospital in Washington, DC.

I'm here at ACG. Dr. Maria Abreu presented the results of our poster earlier today looking at the safety of ustekinumab in people older than age 60. I'm here to share with you this information.

Why is this important to talk about? The prevalence of inflammatory bowel disease has been increasing in recent years in people over age 60. Why is that? For a couple of reasons. One is that our population with inflammatory bowel disease is aging and reaching the age 60 and above. But also, we're seeing an increase in the incidence of adult onset or later onset IBD.

It is important for us to know to treat these patients. Unfortunately, we have little data on the use of biologics in this patient population because often people above age 60 are excluded in clinical trials.

What we did here, we looked at the safety data of ustekinumab in people above age 60 who were involved in the clinical trial for ustekinumab phase 2 and phase 3 trials. Overall, 13 trials across all the indications of ustekinumab including six trials looking at people with IBD—Crohn's disease, and ulcerative colitis.

A total of 800 patients above age 60 were included. Of these 800 patients, around 200 had inflammatory bowel disease. The safety data was compared in this patient population above age 60 who were on ustekinumab compared to a similar population on placebo.

The results were very encouraging. Overall, the incidence of adverse events in people treated with ustekinumab was not higher than those on placebo. In particular, there was no increased risk of infection or serious infection in patients treated with ustekinumab compared to placebo.

There was also no increased risk of malignancy in patients treated with ustekinumab compared to those on placebo. Overall, ustekinumab's safety profile in patients above age 60 was very reassuring, since we see that there's no increased risk of serious adverse events, infection, or malignancy after a 5-year follow-up across indications.