Dr Millie Long, one of the cochairs of the AIBD 2023 conference, reviews the challenges of positioning therapies for IBD, cautioning that there are no cut-and-dried answers and clinicians must consider the specific needs of each individual patient.

Millie Long, MD, is a professor of medicine, vice chief of education, and director of the fellowship program in the Division of Gastroenterology and Hepatology at the University of North Carolina at Chapel Hill.

TRANSCRIPT:

Hi. My name is Millie Long. I'm from University of North Carolina. And I've been asked to give a short summary of a talk I gave here at Advances in IBD 2023 on positioning and comparative effectiveness of therapies used in the treatment of inflammatory bowel disease. And this is an arena that's of utmost importance now because, thankfully, we have a number of new therapeutic options for our patients. So obviously, there are a lot of questions about how we can compare these therapies. And to do so, we have to think about 2 main, factors.

So, you know, when you're comparing 1 therapy to another, you have to think about the efficacy or the effectiveness of that therapy. When you're comparing one therapy to another, you also have to think about safety. But you can't just think about those two. You actually have to think about it in the context of the individual patient, the characteristics of their disease, and their other medical problems, There's comorbidities or other active, extraintestinal manifestations. So it's not simple. Unfortunately, it's not "Start with this, then go to this, and then go to this." And so I think we have to consider all of these factors. And one of the things that I emphasized is that when you're really thinking about the effectiveness of a therapy, it helps to have head to head data comparing those 2 drugs. We don't always have that. A lot of times, those data can be somewhat indirect, or potentially have a methodology such that you're not certain it's coming to the right answer. And so we have to use that best available evidence. And essentially, a lot of that comes from these head to head studies.

Most recently, there was a study in Crohn's disease looked at an IL-23/p19, risankizumab, as compared to an IL-12/23, ustekinumab. And this actually showed superiority in endoscopic remission after a year of therapy. And so these are helpful data. They help us to know which one may be more efficacious in our patient population. When we're thinking about safety of agents, we actually don't really want to use the clinical trial data because remember, those aren't incredibly long, they don't include patients of a lot of different backgrounds, they're very specific and very narrow patient populations. And we want to know the safety of these drugs and our patients we're treating every day in clinic. And so that's where observational data become very important.

A couple of the studies that I emphasized include the California cohort studies by Sid Singh where he was really able to combine data from across the entire California network and really look at both the effectiveness and the safety of various agents.  And the take home message there was you can't just think about the mechanism itself and the complications of the mechanism. You actually have to think about how effective it is in treating the underlying Crohn's disease or ulcerative colitis, because many of the complications can actually come from undertreated disease, or active disease that is untreated. So not only are we looking at effectiveness, we're looking at safety. And these California, data really demonstrated that even the agents that we think are the very most safe, an agent like vedolizumab, that's an anti-integrin therapy. It's very gut specific. In Crohn's disease, when you compare that to other agents, it actually may have more complications because you may be undertreating the patient from a Crohn's disease perspective. So we have to think about all of these factors together.

And I emphasized, at the end, as we're putting these factors, whether it's efficacy, whether it's safety, and individual patient factors, together, we have to do so in a fashion where we use shared decision making. And we talk about these factors with the patient and help them to guide them and provide resources to them and come to a mutual decision about what the best therapy is for the individual patient in front of you.