IBD Drive Time: Samir Shah, on Offerings From the ACG and More!

In this episode of IBD Drive Time, Dr Samir Shah talks with hosts Raymond Cross, MD, and Millie Long, MD, about his term as president of the American College of Gastroenterology, the addition of services that benefit both providers and patients, advances in IBD therapy—and '80s music!

Raymond Cross, MD, is 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. Samir Shah, MD, is clinical professor of Medicine at the Alpert Medical School at Brown University and chief of Gastroenterology at the Miriam Hospital in Providence, Rhode Island, and the immediate past president of the American College of Gastroenterology.

TRANSCRIPT:

Hi, this is Millie Long from University of North Carolina and with me today is my cohost Dr. Ray Cross from University of Maryland. And we are excited to launch this episode of IBD Drive Time with our guest Dr. Samir Shah, who's the immediate past president of the American College of Gastroenterology. Really a fantastic organization for clinical gastroenterologists across really the world, obviously focused here in the US, and we're so thrilled to have you join us today, Samir.

Samir Shah:

Thank you, Millie. Thank you, Ray. It's really an honor to be with you guys. I'm excited to speak with you.

Millie Long:

So we thought what we'd do today is talk a little bit about the college and some things that you're proud of, things that you've learned through your leadership, and also jump into some more IBD specific content as well. So let me start off with just having you comment on some of the achievements that you're most proud of over the past years of leading the American College of Gastroenterology.

Dr. Samir Shah:

Well, it's been an amazing year and we have an amazing staff, as you well know, that help us with everything and great leadership amongst our board, our committee chairs, all the various things that we do. So we've been able to continue to have virtual grand rounds, local, regional conferences, and our national conference in Charlotte, which is very successful in person. The lectures were outstanding. We've really expanded the things that we do for our members in terms of resources for patients with patient educational tools, resources for our members, including GI OnDemand and GIQuIC, our quality registry. We've expanded, so we're going to be launching clinical slide sets based on our guidelines. So the first 2 that we release will be on ulcerative colitis and on colon cancer. And those are just some of the things. I could go on a lot longer. We had record funding for research this past year and we've opened up leadership training for our younger physicians and our physicians who've been in practice, whether academic or private for 10 or more years.

Millie Long:

It's really amazing all the resources for career development for our members, potentially for education, for quality improvement, so much. And I think I really credit the college for that. You mentioned the slide deck and our listeners may be interested in that. So these are going to be slides available for youth for educational purposes?

Samir Shah:

So if you're in practice or you're in academics and need to give a lecture on ulcerative colitis, if you're a member of the ACG, you can download those slides, they're annotated, they're updated, and then you can choose the slides that are appropriate for your audience. So if you're giving a talk to medical students, or residents, or GI fellows, or to your fellow gastroenterologists in the community who may not be as familiar with ulcerative colitis as the 2 of you are, you can choose the right slide sets. And so we're going to see how the first 2 slide sets go and my hope is we'll have some for all the major topics and then they'll be based on our clinical guidelines. So I'm really excited about that.

Millie Long:

Wow, what a great resource. What other resources? I want to make sure because I think there's so much, many of us may not know what's right at our fingertips.

Samir Shah:

Yeah, I think...

Millie Long:

Are there other... Yeah, go ahead. Yeah, are there other things you want to make sure our listeners are aware of?

Samir Shah:

Yeah, so I think we have a wonderful resource called the ACG Universe and I think it's underutilized. So we record all these lectures and then they're updated and organized in a very nice fashion on our website, if you go to the ACG Universe, and if you have a topic that you need to research, or you want to learn more about, or you're going to give a talk about, you can see, let's see, Ray Cross talking about IBD or Nick Shaheen talking about Barrett's, and then you can update your talk. If you have APPs in your practice, there's a special section. There are close to a hundred lectures now for APPs by mostly APPs to help them get acclimated to all the things we do in GI and our approach to gastroenterology. There's a wonderful section on diversity, equity, and inclusion and not all centers or practices have resources for that.

So I think the ACG Universe is really underutilized and something that I'd love to highlight for our members. I think our quality registry, GIQuIC, is fantastic. We participate. That's going to be expanding to nonendoscopic measures, including IBD and liver disease. And then finally GI OnDemand, I've been sending my patients there. Unfortunately, don't have the resources that you and Ray have in terms of having a nutritionist and psychologist built into my private practice. And so I'm able to send patients there and they can get access to high level nutritionist, high level behavioral health therapists, to help them get basically 360 degree care for their IBD.

Millie Long:

Fantastic. This is exactly what I'm sure our listeners are looking for, great resources both for patient care and education. Speaking about that education bit, I know that the ACG does a Best of India where different faculty members go to different sites in India and present the latest and greatest in IBD research. And I got a preview of that from you because I know you'll be participating in Best of ACG India, and what of some of the data that you selected to present includes several abstracts on risankizumab. So would you mind talking through the high-level results and how these data may impact your clinical practice, because obviously risankizumab is now an approved agent for Crohn's disease.

Samir Shah:

Absolutely. So there were 3 abstracts presented at our president's plenary session on risankizumab and the first one looked at symptom relief. And although we care about mucosal healing, our patients care about, do they feel better. And so the first one looked at stool frequency and abdominal pain and it showed that over 52 weeks, that there was significant improvement. And interestingly there was moderate correlation between improvement and the higher dose and endoscopic healing. So that was the first abstract. The second abstract that was presented looked at patients who didn't respond in the first 12-week induction period. Now they went on to continue to get the drug, and what was very interesting was a lot of them responded. So an additional 12 weeks you got a significant response. And so the messages don't give up after 12 weeks, keep going and you'll get additional people responding.

And then the final abstract looked at whether previous failures of biologics affected response and they looked at patients who had been on only 1 biologic, or 2, or 3, or even 3 biologics plus ustekinumab, another IL 23/12 inhibitor. And what was interesting was the delta was very similar regardless of the number of biologics. And I think the take-home message for me was that there was a higher placebo response in the patients who've only been on 1 previous biologic, and the patient who's been on multiple biologics, there was a lower placebo response, but the delta between the response and the placebo response was very similar. There wasn't a lot of numbers in the patients who had previously been on IL 23 inhibitors, specifically ustekinumab, but there still was a signal and so similar to what our colleagues in dermatology have seen with psoriasis. So the message for me is don't worry about whether patients have failed other biologics, you can still use risankizumab and expect a reasonable response.

Millie Long:

No, I think that's really important. I think one of the things that at least I, and I think many of us struggle with now, is the sequencing and positioning for the individual patient and trying to think through when you're starting that first biologic, will this potentially impact choices later on, and how do I think through this trajectory? And so obviously as you know, many other studies, particularly some of the TNFs and anti-integrins have demonstrated a lesser response with subsequent treatments. And so I think that sequencing and positioning is going to become a really important topic for us as we move forward with a lot of different choices now, thankfully, in our arsenal.

Samir Shah:

I absolutely agree. And so very, very good to have this in our back pocket.

Ray Cross:

So Samir, before I ask you a few more questions including following up on GI OnDemand, I just want to remind the listeners that IBD Drive Time is sponsored by AIBD and the Gastroenterology Learning Network and we have the first regional AIBD of 2023 coming up in Baltimore at the Inner Harbor Sheridan 3/31 in the afternoon and on April 1st all day. Millie and I are both speakers. So plenty of time to register. We hope to see you there.

Samir, I just wanted to follow up before we ask you a couple more questions about Best of ACG in India, I wanted to follow up on GI OnDemand because, I'm ashamed to say,  not familiar with the resource. So can me mechanistically, can you just walk the listeners through that? So if you have someone that needs dietary advice, pragmatically, how does it work?

Samir Shah:

So you can just send them to the website GI OnDemand and it's free, and it's a benefit. There's additional things for ACG members, but it has resources, so lectures that have been looked at but designed for patients. So it's it might have a Nutrition 101 for your patients with Crohn's disease. If your patient has EOE esophagitis and wants to do a 6-elimination diet, they'll have things for that. If they're having pain issues and wanted use cognitive behavioral therapy, they'll have some initial lectures on that and then they can try to find somebody in their area who's been vetted to either have a private session, and for that they'll have to pay for, or a group session. But that's much more affordable and it allows access to those sort of resources. So this is a resource that's growing. There's also genetics, not everyone has access to great geneticists. So in terms of if you have somebody with a strong family history of multiple cancers, et cetera. So we're hoping that this brings quaternary care to all practices.

Ray Cross:

Great. That's wonderful. I didn't know that—I learned something again today. Let's talk a little bit about upadacitinib. So I think all 3 of us are using this, and in my experience thus far, I've had a couple patients that have responded but have had an incomplete response at week 8. And I've pondered, should I keep going with 45 milligrams for another 8 weeks or go ahead and drop them down to 30 and risk them worsening? So I think there was an abstract that was presented there looking at extended induction. Can you comment on that and then maybe if you've had any clinical experience doing that, just share your experience in practice?

Samir Shah:

Sure. And I think that was a really important abstract. So there are a bunch of people listed on it, I believe Peter Higgins from University of Michigan presented it, but in any case, looked at patients who didn't have a complete response to the initial 8-week induction with 45 milligrams of upadacitinib. There were 125 patients and they got another 8 weeks of that same dose. And of the 125 patients, 73 or 58% close to two-thirds responded at that higher dose, and so the take-home message for me is if somebody's responding but not completely, to not give up and give them another 8 weeks. I wouldn't drop them. I've had one patient like that where I felt nervous, I wasn't aware of the data, but we got them through with samples to do it and then we dropped them down the 30.

The other important point when of that study was that the patients who required that extra 8 weeks, they did better on the higher dose, not surprisingly, for maintenance in terms of the 30 milligram compared to the 15 milligram dose. And I know you guys have seen this in your practice, for my patients who've had more severe disease, I dropped t0 30 and not further. I think if they're doing well on 30, I don't want to drop to 15. They're not going to do quite as well.

Ray Cross:

Yeah, I'm speaking for Millie here because she and I have had multiple discussions about this with tofa, but I don't think any of us really believe in dose reduction for these patients because they're often very refractory third- or fourth-line treatments. So we're typically leaving them at that higher dose, although oftentimes pharmacists and sometimes payers are trying to push us to lower the dose and we push back and fight. But yeah, I agree. I have a handful of cases, not enough have gotten through to the 6-month scope to see where they are, but I'm becoming more and more comfortable just extending the induction. Now I like to make...

Millie Long:

I agree. I just wanted to point out one thing, Ray, because I've had the same thing. And I've had a little bit of pushback from insurance, and I will say to the listeners out there, if you reach out to your local MSL, they'll give you a full copy of the data that were presented both at UEGW and obviously it was presented at ACG India as well. But I've found that attaching that and emphasizing your rationale for the extended induction and they actually have data for it will actually help in terms of getting it approved, because like you, these are my severest, sickest-of-the-sick patients and their next step is probably colectomy. And if they've had a response at 8 weeks, I sure as heck want to continue it moving towards that more complete response. That partial response is enough for me to hang on, and I've had a good experience with the extended 16 week induction. So just want to put it out there that there's data behind this.

Ray Cross:

That's a great point. And Samir and I are lucky we have access to samples, but I sometimes forget that not all practices have access to samples and it can be a little more challenging to do that. So that's a great point.

Samir Shah:

That reminds me of another resource that we're working on at the college. And these are letters of appeal that are preformatted with the things that our members can access to make it easier to get the insurance companies to do the right thing for our patients.

Ray Cross:

And I'd like to poke fun at Millie because she's a combination therapy advocate, and when we say combination therapy, we typically think about an anti-TNF and immune suppressant, but we all have handfuls of patients that are on combinations of biologic therapy, or a biologic and advanced therapy like a JAK or perhaps even an S1P. So the results of VEGA and ulcerative colitis were presented and for the listeners, this compared monotherapy with golimumab, guselkumab, or the combination, and I just wondered what your perspectives were on the results, Samir? Were you surprised by the results?

Samir Shah:

I wasn't surprised, but I was really pleased to see a company sponsored this trial because it needed to be done, and I think the only way we're going to get insurance approval is if both products come from the same company and that they have some way of discounting it. So guselkumab and golimumab are made by the same manufacturer, as you know. One's an anti-TNF and one's an IL-23 inhibitor, and so for our really refractory patients, it was nice to see that delta, which was in the range of 15 to 20% with both compared to either alone.

And what was really important was we didn't see any major safety signals in terms of combining. Now granted, they're only combined for the first 10, 12 weeks and then the anti-TNF was dropped and it was just the IL-23 inhibitor, but I think it's a great concept and we're going to need more of these studies. And then the question is going to be how are we going to identify the patients? It's usually patients that are coming to see people like you and Millie at tertiary referral centers that need the consideration for these combination biologic or biologic plus advanced small molecule inhibitor.

Ray Cross:

I guess I thought maybe the results would be a little better with the combination group there, but the trial design was a treat-straight-through design, so the numbers are not going to look as rosy as the candy right design where induction and then rerandomization. So that probably explained some of that. Also, they didn't continue combination therapy past week 12, so they dropped the anti-TNF in the guselkumab combo arm. So the question is, would it be even a little better if you continued both drugs for maintenance? And I guess we're going to find that out here in the near future with in the DUET CD studies.

Samir Shah:

Absolutely.

Ray Cross:

All right, Samir, time for the fun question. So tell us something about yourself that the listeners may not know, or maybe even something that Millie and I may not know.

Samir Shah:

So Millie probably knows this, you don't. I'm an aspiring musician. So I grew up in the eighties, loved eighties music. I'm a big Police, Sting fan. I got to meet Sting when he came to Brown back in 2018, that got me going. And then during the pandemic I picked up a guitar and in one of our post meetings I was talking to a couple of people on the board with me and I found out that one of them plays guitar, one of them plays bass guitar, used to be in a band. I said, "We should form a band." And they said, "Yes." And I said, "I'm kidding. I know 3 chords and I can barely sing." But we actually formed a band. I got the ACG to approve us as the official ban of the ACG, The Beacons, and Millie's heard us perform. And the other guys are really talented, they make up for me. But we've had a lot of fun. And so if you invite me back, maybe you can invite the band back and we'll do a song for you.

Ray Cross:

Amazing. Millie, what is it? A half dozen of our speakers are musicians. And I think Jimmy Limdi is an opera singer, and I'm trying to remember who else is plays an instrument, but it's very, very common.

Millie Long:

Yeah, David Rubin plays the trumpet. We have a number of great musicians in the IBD community. For example, Jeremy Adler plays the violin. Laurie Keefer plays the piano. We have a whole band waiting to join us on IBD Drive time. And their band, The Beacons, is fabulous. I've seen the ACG band in person myself, so we'll have to just at some point in the future have a musical intro.

Ray Cross:

Yeah, why don't we have an IBD Drive Time with The Beacons and just be music. Millie and I can introduce you guys and you can play four songs and then that'll be the Drive Time. It'll be done.

Samir Shah:

Perfect. We're always looking for a venue to play. And thank you, Millie. I know you had to say nice things because you're still on the board with me, so I appreciate that. I mean, plus that Jimmy Limdi is an opera singer. I didn't know that about him.

Ray Cross:

Yeah, Millie and I have gotten to do some things with him educationally, and he's delightful. He has great little terms like ‘precious remission’. He's very funny, and he is talented musically as well. So always makes me feel a little dumb that I don't have those skills, but nevertheless…

Samir, this has been wonderful. I know you're very busy. Thanks for joining us and we hope to have The Beacons back for IB Drive Time in the future.

Dr. Samir Shah:

Absolutely. Thanks for having me. Thank you, Ray. Thank you, Millie.