Gil Y. Melmed, MD, on Personalizing Care Through Standardizing Care With Biologic Therapies in IBD

Dr Melmed discusses his presentation from the virtual 2021 Interdisciplinary Autoimmune Summit on how standardizing some aspects of biologic therapies can lead to more personalized care for patients with inflammatory bowel disease.

Gil Y. Melmed, MD, is codirector of clinical IBD at Cedars-Sinai Medical Center in Los Angeles, California.

TRANSCRIPT

Dr. Gil Melmed:  I'm Dr. Gil Melmed from Cedar-Sinai Medical Center in Los Angeles. It's my pleasure to recap with you what we've discussed at the IAS meeting regarding biologics for inflammatory bowel disease.

The title of my talk is "Personalizing Care Through Standardizing Care." The basis for this talk came from an article a few years ago by Atul Gawande, where he compared the health care industry to the restaurant industry.

In talking to one of the CEOs of the Cheesecake Factory, understanding that how is it when you have hundreds of restaurants throughout the country, you can pretty much walk into any one of those restaurants and get the same item on the menu that tastes pretty much the same anywhere you get it, same number of calories, same ingredients, same standards, same quality, but yet it's different.

You can choose anything you want from the menu, and you pretty much are going to get that experience. How can we, in health care, try to achieve those same quality standards where you can walk into any hospital in the country, and get the same care, get the same colonoscopy experience, get the same surgical experience, or whatever care experience or service that might be offered?

Of course, there's limitations to this analogy, but try to understand what are those elements that we can learn from. Recognizing that standardization is not a bad word when it comes medicine. It means that we're adhering to certain quality. It means that we're adhering to certain algorithms and protocols.

Also, we recognize in health care that every patient is different. Every patient has nuances. In fact, most patients won't fall into a specific algorithm, but we can still and should still be using algorithms to help guide how and, perhaps more importantly, when, we do this.

In IBD, there have been a few key trials that I'd like to highlight that really focus on the concept of standardizing intervals in which assessments are made in order to understand what do we do next. This comes from the concept of a treat-to-target paradigm.

A treat-to-target paradigm is when we're actually making decisions about treating towards achieving a specific target and then reassessing the patient during the defined interval and then making treatment changes again at the time of reassessment if we're not achieving that target.

The first study that I highlight is the so called Top-Down versus Step-Up trial, which is over 10 years old. In this trial, patients were treated according to an algorithm and then reassessed at predefined time frames in order to decide about whether to make changes in treatment.

One group was assigned to receiving infliximab upfront. Another group was assigned to receiving standard of care and then only receiving step-up therapy if needed.

What we learned from that trial is that receiving infliximab upfront was associated with better outcomes. That also over time the people in the other group, because they were reassessed over time, and not achieving the outcomes at these predefined intervals, were eventually offered infliximab such as the 2 curves of patient outcomes of clinical remission eventually merged.

A second trial to highlight is the REACT trial, where 60 centers were randomized to be treating patients with Crohn's disease with an algorithm using adalimumab with re-evaluation every 12 weeks and then a predefined change being made with that algorithm. Meaning, patients were initially treated with adalimumab at 40 milligrams every other week after induction.

If they didn't achieve predefined clinical remission 12 weeks later, then they had a change in their therapy. They either had escalation to weekly, or they had addition of an immunomodulator.

Again, every 12 weeks a reassessment was made. If the patient did not achieve the outcome that was desired, there was a change that was made, and that was compared against usual care. The outcomes were shown to be better by improved hospitalizations, improved surgeries, improved rate of complications for Crohn's disease.

A third trial is the COMM trial where decisions were made, again, every 12 weeks in the COMM trial for patients with predefined end points looking at biologic or clinical parameters of improvement using CRP, fecal calprotectin, and clinical symptoms.

When a patient did not meet these prespecified criteria for improvement, there was a change that was made. Again, in this case, it was also with adalimumab, with those escalations, and/or adding of an immunomodulator.

We've learned through all of these trials and in the COMM trial, the algorithm approach was associated with better outcomes. We've learned with all 3 of these is that the concept of treat-to-target is associated with better outcomes.

The treat-to-target approach does require a standardized interval for when we are evaluating the patient and also importantly recognizing what is our next move, what are we going to do differently if the patient does not actually achieve that target. What's critically important to understand is that this needs to happen in conjunction with a patient.

Recognizing that a conversation with a patient upfront, not waiting for the patient to come back with symptoms, not waiting to surprise them with the need for a reassessment, perhaps with a colonoscopy at the time of their next visit, but really upfront at the time of starting a therapy to set with the patient what are the targets that we are aiming to achieve, when will we be assessing those targets, and what will we do if we don't achieve those targets.

Having that conversation with the patient upfront and using this standardized algorithmic approach of when we reassess, what are we going to do, and why are we going to do it will hopefully allow us all to achieve better outcomes in our clinical practices.