IBD Drive Time: The Best of Digestive Disease Week Part 1

In the first of two episodes, Drs Millie Long and Raymond Cross discuss their choices of the best abstracts on inflammatory bowel disease from the Digestive Disease Week conference held in May.

Raymond Cross, MD, is a professor of medicine and director of the IBD Program at the University of Maryland School of Medicine in Baltimore. 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: 

Any views and opinions expressed are those of the authors and or participants and do not necessarily reflect the views, policy or position of the Gastroenterology Learning Network or HMP Global, their employees and affiliates. So you're subjected to Ray's and my opinions over the next 20 minutes.

Millie Long:

Hello and welcome to this edition of IBD Drive Time. This is Millie Long from University of North Carolina, one of your cohosts. And I have with me today as our guest slash cohost Ray Cross from University of Maryland. What we thought we'd do for this IBD Drive Time is talk about some of our favorite abstracts and presentations at DDW, which was just this past May and really the science that we're excited about moving into the rest of the year. 

And with that, I think it'd be great to go ahead and get going. So Ray, co-host, welcome to the interview chair.

Ray Cross:

Thanks for the introduction, cohost. So I picked out 3 abstracts that I thought were interesting and they, just to warn the listeners, they were not about any novel therapies, but they were about, 2 of them really focused on the pragmatic aspects of being an IBD-ologist, namely getting people initiated efficiently on an advanced therapy.

And the first one I'm going to start with, it was entitled Reduced Access to Biologic Medications in Socially Vulnerable Patients with IBD and it's from the excellent group at the University of Michigan. And they looked at over a 7-year period, 2015 to 2022, they looked at their patients and they were looking at social determinants of health to see if this influenced time to access medication. And they used a scale that I don't know very well called the Social Vulnerability Index, which is a 0 to 1 scale with higher scores meaning more vulnerability.

And then there are subscales, SES, household composition, minority and language and housing and transportation and they were able to get these scores using geocoding. And they did regression analysis and they included other factors including IBD type, age, gender, race, ethnicity, language, and comorbid conditions. And they had nearly 8000 patients with IBD. About 40% were prescribed 5-ASAs, about a third, immunomodulators, just over half biologics and about 60% corticosteroids. And perhaps not surprisingly to us, patients with a higher SVI were about 20% less likely to receive a biologic prescription and about 40% less likely to have sustained biologic access. This was particularly notable in neighborhoods with poor housing and transportation who were prescribed an intravenous advanced therapy such as infliximab or vedolizumab, which makes a lot of sense. It also, this maybe doesn't make as much sense—it was also associated with less prescriptions for 5-ASAs but not less sustained use.

It was associated with about a 40% increase likelihood of getting an immunomodulator, but again, didn't correlate to sustained use. So I think that this isn't surprising, Millie. I'd like to get your thoughts on this. I mean I think we intuitively knew this was the case and it makes sense that if poor housing and transportation's an issue, getting to an area where you have an infusion center can be a challenge. Sobering, and whether we could have an index like this calculated easily in our patients to perhaps red-flag those that are going to have a higher risk for not being able to access or stay on medications instead of just qualitatively assessing that or maybe helping us select the right drug for them, maybe moving away from intravenous agents are more likely to do oral or subcutaneous. So I'd like to get your thoughts.

Millie Long:

Yeah, no, I think it's sobering and I think we need a little bit more help in identifying some of these issues and certainly having these discussions with our patients as well. It's actually a colleague of yours who's taught me a little bit about this, Sandra Quezada, about the role that social determinants of health play. And we're starting to have more and more of these features automatic in our electronic medical record system. And I agree with you, having an alert to this would really change the discussion.

For many instances, I'm a little bit equivalent on whether I use a sub-Q or an IV medication and if I know that the patient is going to have a much better chance at being adherent because of transportation issues, then I sure as heck I'm going to try to end up with something on sub-Q maintenance. And so I think even just having this in the forefront of our minds as we're having some of these conversations could be really helpful. And potentially some of these automatic calculations based on zip code, et cetera, can help us to understand more about where our patients are coming from and that we need to ask these questions so that we can optimize their care.

Ray Cross:

I agree.

Millie Long:

I think there's a lot of work to be done in this realm.

Ray Cross:

And I think historically we've thought about the intravenous meds as being a good option in patients who you're worried about their adherence because you get directly observed therapy, but actually in this case it may make, in a subpopulation, may make that even worse, but they did highlight things like vouchers for transportation and grudgingly we're doing home infusions now. We didn't want to do them, but we realized they're really safe to do them. And so thinking about those options that don't really cost that much I think are reasonable. And also thinking about disclaimers. In Maryland, we're quite lucky we have a social worker, we have several nurses that are helping us, particularly in a nurse that manages our high-risk patient population. And I recognize that many practices, those resources are not available. So this can be a big challenge.

Millie Long:

Yeah, no, absolutely. But I think kind of awareness is the first step and asking some of these questions and kind of having that conversation about modality of delivery and helping to optimize someone's adherence from the start by choosing a therapy that will be easier for them to be successful, I think is a great take home point.

Ray Cross:

All right, you want to do the second one?

Millie Long:

Yeah, let's do the second one. I know a lot of your background is in trying to do remote monitoring and one of your abstracts had to do with kind of a passive monitoring device to track flares.

Ray Cross:

Yeah, I'm saving that for last. The next one's going to be very similar to the one we just talked about. It was from the groups at Beth Israel, Vermont, and University of Mississippi entitled A Large Multicenter Study Assessing Factors Causing Delays in Initiating Biologic or Novel Small Molecule Therapy in Patients With Diabetes.

So very similar concepts. So they were looking at a number of clinical, social, and financial variables which could result in delays in treatment initiation. Additionally, they looked at the impact of the pandemic on delays. So they had a prepandemic period and a postpandemic period. So as I said, it was 3 referral centers. They looked at a period of time from March 1st, 2019 to September 30th, 2020, and they included sort of standard variables that we would think about being associated with access. They had over 400 patients, not surprisingly about a 2-1 ratio of Crohn's to UC.

And they were pretty evenly split between the centers, although there's a few more patients from Beth Israel than the other 2 sites. About 70% were commercially insured. A third were Medicare or Medicaid, and only 1% was self-pay. So there are several high-level results really to talk about here. One is the median delay in initiating therapy. So for infliximab it was 20 days, adalimumab, 10 days, vedolizumab 21 days, and ustekinumab 21 days. So adalimumab had the shortest delay to initiation, which may be not surprising, that's why it's used so often. And you see because providers can get it much more quickly than the other therapies. Variables associated with a delay in initiating initiating therapy were race. So Black patients had a delay of 34 days on average and they were the only racial group with a delay more than 20 days. University of Mississippi had the longest delay compared to BI in Vermont.

They also found that distance away from the medical center—so if it was 50 miles or more away—that was associated with a median delay of 30 days compared to 18 days. And if insurance initially approved the therapy, the approval was about 18. But if there was an initial denial, it was 51 days. And the COVID pandemic surprisingly had a positive impact on delays. It dropped delays from 22 to 18 days, which is a little surprising and I can't really explain that and I know what you're thinking when Mississippi and Black patients stand out as having more delays, remember they were adjusting for these. They were adjusting for race, they were adjusting for multiple confounding variables. So the take-home message here is that delays in initiating advanced therapies are significant, averaging about three weeks. And that race, Black race, and distance to the medical center and the initial approval are associated with delays.

Millie Long:

I think you and I have lived this in our practices where we feel like this is taking forever, but it's nice to have some numbers on this because this really makes a huge difference if you're trying to do any kind of steroid-sparing therapy and start a drug that works quickly to help to avoid corticosteroids, it's just not going to work with these kind of delays. And so we obviously need to think through these processes, which I worry are only going to get worse with new prior approval hurdles that I know the Crohn's and Colitis Foundation and patients are really advocating against. But this is a problem and I think each office needs to figure out their best way around this. One of the themes I saw from you is that if you are getting an IV infusion, the delay is longer and that's possibly just because our chairs are so full.

Getting a time, a slot, to get someone in for that first load IV infusion may be a rate-limiting factor as well. And so having additional outsourcing resources, other infusion suites, ways you can try to get patients started on therapy. If you're not at an academic center and you can take samples, that may be a reasonable way to get people started, particularly in those scenarios where you're trying to minimize steroids. Because frankly, if it's over 30 days, there's no way a patient can hold out that long without something else to bridge them if they're flaring.

Ray Cross:

Yeah, I agree. And I think, what could the listener take from this? And maybe a patient who lives far from your center, maybe that's a patient, if you have access to samples and you just get them started on a sample right away and avoid a delay. Particularly a patient who you're thinking about prednisone and they're eligible for a JAK inhibitor. Maybe that's a patient you just get started on a JAK. I was fortunate, I was sitting next to my partners during this presentation and I just couldn't get past race being a factor. And I perseverated on it a lot and I still can't totally explain that when you're adjusting for insurance and other factors.

I always felt like if you adjusted for insurance, it would sort of even out. And I don't know if patients from other races are more likely to advocate for themselves and call the office more frequently for follow-up. It's all speculative as to why that would be. But I even asked some people that worked for payers, do you have access to race information on the authorization process? It could be some unconscious bias. And the answer there was no, it's not. So just that really bothered me and I don't have a good explanation for that.

Millie Long:

No, nor do I. And I think it just goes to show us that there are a lot of hurdles our patients do have to jump over. And maybe what I'll start doing with all of my new starts based on these data is telling the patients they need to advocate for themselves as well, not only with our office but with their insurance company. It's not going to hurt to have them calling in addition to our nurses and our authorization support. I think the more touch you can have, we've got to stay on top of this process because that's too long. We need to get this down, not up.

Ray Cross:

And the reality is there's probably unmeasured confounding, even though they did the best that they could to adjust for factors, there's probably other factors that are there that relate to that. So those were the 2 related to access. And then I have to say, I thought this was the... And it's not just because I'm interested in remote monitoring, but I thought this next abstract was super cool. I mean beyond cool. It was called Assessment of a Passive Monitoring Device to Track Flares in Individuals With Crohn's. And it was from Josh Korsnick at Brigham and a collaboration with Emerald Innovations, MIT, and a 1-study team in Boston. So this is the concept, Millie. So they took patients with Crohn's disease and they ended up following 105 throughout about a year. And they had about 40% were in remission, about a third were active.

And then they had some healthy controls. And what they did is, imagine like your cable box for your TV, but it's flat against the wall. They installed this Emerald device in the bedroom for the patient and it sends out wifi signals that measure 3 things. One is your sleep, second is your respirations, and third is your gait. So in an initial training period, it figures out who sleeps on one side of the bed. And I learned that people tend to gravitate to one side of the bed, they figure out whose gait it is in a multiperson household and the device can home in on that person. Now caveat— being if there's a big dog like you have, the big dog screws it all up, so you can't have a big dog in the bed. But what they did is they collected PROs, they collected fecal calprotectin, and they correlated what the sensor could measure with change in status.

They evaluated nearly 25,000 nights for these patients and they did see some variability here. So they had about 40% of patients went from active to inactive or vice versa. So there was some change. And importantly what they found is that distorted sleep, some more nocturnal awakenings, increased respiration, and slower gait speed were associated with flares with an area under the curve of 0.8, which is not bad. And this is really for the first iteration of this thing. So it seemed a little bit like Big Brother to me, having that things in the room collecting this information, but it was cool. And the other thing I forgot to mention was that it saw these things about 3 weeks before a flare became clinically... became manifest. So before it became symptomatic. So you could really potentially intervene quite early on patients if this is validated.

Millie Long:

That's really great. Yeah, I mean I think that we'll have to see whether it is used in the future, but it goes to show you that I think that's the way of the future is kind of early detection, remote monitoring. Being able to intervene before someone manifests significant, severe, increased symptoms. I think you and I both know that it's easier to turn things around early in the course of a flare rather than late. So this could be really valuable technology. And gosh, it would be really unique and cool to be able to have some of these data linked to our EMR and really be able to track and monitor our patients. So I think it's 'stay tuned.' We may have more tools in our toolbox in the future.

Ray Cross:

Yeah, I can't remember who was trying to do this, but they were trying to get people to use the step monitors like Fitbits and with the thought being that you're going to move less when you're flaring or when a flare is coming. And patients were not really receptive to it, felt a little bit too much like Big Brother, but apparently where Josh lives, they're receptive of this technology and it was really cool.

I just want to remind our listeners that we are sponsored by the Gastroenterology Learning Network and Advances In IBD. Speaking of Advances in IBD, the next in-person AIBD regional is in Chicago, July 21st and 22nd. It is a one and a half day course. Millie and I will both be speaking there. And also I want to remind our listeners that we are now on Apple Podcasts, Spotify, and the Gastroenterology Learning Network. And if you want to find your podcast, just put in Gastroenterology Learning Network and you'll see IBD Drive Time.

That's all the time we have today. Be sure to join us tomorrow for part 2 of IBD Drive Time's Discussion on the Best Of DDW.