In recent years, ustekinumab and tofacitinib have both been effective in treating ulcerative colitis.
Benjamin Click, MD
Investigators are hoping the TARGET-IBD study will result in a more universal practice pattern for doctors treating patients with inflammatory bowel disease.
The ongoing, registry-based, longitudinal cohort allows researchers to examine the care IBD patients receive in both community and academic settings.
In an interview with HCPLive®, Benjamin Click, MD, a staff gastroenterologist with the Cleveland Clinic, said the hope is the study will have real-world impacts on improving care for this patient population.
HCPLive: What is the main takeaway so far from the study?
Click: TARGET-IBD is a bit of a unique ID registry study in that we're collecting patients from both academic and community centers. And so, we're expanding the generalizability and hopefully enhancing what the real world applicability will be of the data collection and analyses.
Additionally, TARGET-IBD has utilized the unique registry methods that have worked both in rapid patient recruitment and population growth and then centralized data abstraction, and streamlined research efficiency for data collection.
Some of our analyses that have been previously presented include the utilization of 5 aminosalicylate compounds in treating both ulcerative colitis and Crohn's disease and how that practice pattern appears throughout the country.
In relation to the current study, we're looking at the performance of objective disease activity assessments along with therapeutic drug monitoring patients who are on biologic agents. In the guidelines, we recommend that when faced symptoms of active disease, that we perform an assessment to determine if those symptoms are from active disease.
If so, then patients who are on biologics are recommended to undergo reactive therapeutic drug monitoring to assess whether the active disease is related to a specific mechanistic or immunologic type of failure to determine the next clinical management steps.
However, in this study, we found that a significant proportion of individuals were either not having objective disease activity assessments or we're not undergoing therapeutic drug monitoring prior to change this configuration in their biologic therapy.
Overall, Target-IBD is a very nice and powerful registry tool to assess a population of participants with inflammatory bowel disease and evaluate real world practice patterns, as well as looking at subgroups in the IBD population on the whole.
HCPLive: Why weren’t some of those recommendations like disease activity assessments or therapeutic drug monitoring conducted prior to this study?
Click: We don’t know why compliance isn’t 100% and there’s likely a multitude of reasons for that. And this speaks to the variability in clinical practice that we see not only from academic compared to community centers, but from physician to physician and patient to patient.
There is a lot of practice variability. Some of the potential reasons include insurance coverage, testing capability or accessibility, reimbursement from payers or potential out of pocket costs to the patient.
So, there's a lot of potential factors that may influence whether or not patients and providers have access to these tests.
Additionally, it may be information dissemination regarding the guidance recommended practice patterns. There's a lot of potential explanations.
And one of our next steps in this research is to understand the why.
Why aren't the rates higher than what we're seeing and what long term impact does this variability in practice pattern have for patients and can we optimize outcomes based on this?
HCPLive: How do you think the TARGET-IBD will eventually play out in the next few years and what do you think the main takeaway will be?
Click: TARGET-IBD is going to shed light on a lot of unanswered questions in inflammatory bowel disease. Clinical trials are the gold standard for answering clinical and research questions.
However, many patient populations of interest are either underrepresented or excluded from clinical trials.
And so, registries like TARGET-IBD can serve a vital role in assessing these subgroups of patients with both Crohn's disease and ulcerative colitis and provide information on how best to approach managing their IBD.
Additionally, TARGET-IBD provides a granular, high definition look at real world practice of IBD and the practice patterns that we're seeing amongst providers in clinical settings, as well as identifying potentially rare out of disease treatment of disease activity, and determining what are the optimal management considerations for those patients.
Over the next several years, I expect to TARGET-IBD to grow even further and number of participants, as well as the strength of the analyses as we collect more longitudinal data, to be able to answer some of these critically remaining questions.
HCPLive: Over the last few years what do you think the most beneficial drug or treatment for IBD patients has been?
Click: The expansion of the therapeutic armamentarium is certainly exciting, and allows us the opportunity to have an array of available therapeutic options to treat inflammatory bowel disease.
The remaining challenge is there are a variety of options with how to determine which medication works best for patients. Finding predictors is a critical goal for inflammatory bowel disease research.
There have been several novel mechanisms of action that have come to market over the last several years including ustekinumab and tofacitinib for ulcerative colitis. The latter of which offers us an orally administered small molecule compound, which is an exciting development.
Over the years, there are many compounds being actively evaluated. So, with increasing options, there is a responsibility and due diligence on providers to understand the various considerations in progress, but to ensure that we're still trying to optimize our care.