ACR2018 Chicago Day4 Save
ACR2018 Chicago Day4 by Dr. Cush
Transcription
Hi. You are listening to ACR two thousand eighteen podcast. I'm Jack Cush, executive editor of RheumNow. This is a compilation of podcasts from the ACR two thousand eighteen meeting in Chicago wherein you'll hear daily reports from the experts, the KOLs, and people making the news. Hope you enjoy the recording.
Hi. I'm doctor David Borenstein. I'm at the American College of Rheumatology. I was, head of the pain management task force for the American College of Rheumatology, and so I wanted to bring you, news about, pain in general as far as the, meeting this week. I usually report on back pain, but there weren't too many abstracts on back pain this year.
But there were a significant number of abstracts and presentations dealing with pain and how it affects rheumatic diseases, all the various types of rheumatic diseases. And one point I think we really wanna take away from all the various abstracts and presentations is the importance of non pharmacologic therapy as far as pain is concerned. We know about nonsteroidals, opioids, and all those other medicines which can potentially cause side effects. That's one aspect of pain care. But another important pain therapy is in fact non pharmacologic, and that has to deal with the physical therapy aspects, the psychosocial aspects.
So this gets into the bio psychosocial model of pain. So the ARHP, another aspect of the American College of Rheumatology, had a number of presentations talking about support of the patients in regards to these cognitive behavioral therapies and the means by which we try to de stress patients. And in fact, we look at these health care partners with rheumatologists who can help us with these patients with chronic pain, we can in fact take care of a wide range of patients who have really significant difficulties in regards to coping. And when it comes down to it, being able to cope with your pain is actually one of the best means by actually taking care of it. So if you want more information about this topic, please go to roomnow.com.
Hi.
I'm Jack Cush with RheumNow. We're here in the RheumNow booth at ACR two thousand eighteen in Chicago. Exciting meeting. More exciting is I've been able to gather up the Gout Mavens and bring them together have a discussion about what's happening in Gout here at ACR twenty eighteen. Thankfully, I'm joined by Naomi Schlesinger from New Jersey, Ken Sag from Alabama, and, Nicola Dalvath from New Zealand.
And we'll start off by saying thank you and welcome and I'd like to know from each of you what is the one thing at this meeting that you've seen or looking forward to seeing that you want to bring up so that we can maybe have a little discussion. Let's start with Naomi.
Well, so there are too many to name. I'm going to actually start with the new treatments from the different uricases, the oral uricase, peglodocus and the new immunogenicity abstracts and the select actually posters, one that's going be presented today showing inflammation reduction when using uricase.
Let me add to Naomi what you're saying because I think this is really an important area. For those of us particularly in academic centers we see very severe gout. See people that come in with topaceous deposits and the use of uricase has really been a salvage therapy that we look forward to having available. The major problem is immunogenicity. You can't take it forever.
People develop immunogenicity and it loses its effectiveness. So the idea about administering either co therapy with methotrexate, which is the poster that I think you were referencing and other approaches, very exciting. More data is needed. It's certainly one of the things that we look forward to understanding more about.
I've seen a series of posters and actually one of the really interesting things is that it seems that this preparation with Rapamycin Apigylated Uricase may well have anti inflammatory effects through the effects of the Rapamycin actually. So there's co administration and then inhibition of IL-one release and reduction of flares. That's really, that is very exciting, I I
think the real question for me is what is the right immunomodulatory therapy to use? I'm not sure we really know and it may turn out that one size fits none. And we may need other options. We may be rapamycin, methotrexate, we're looking at mycophenolate in a small study we're doing. We've got to understand this better and figure out for the patient depending on their comorbidities what's the optimal thing to give with peglodecase and how safe is it to do that ultimate?
So for the audience, again the issue here is that peglodecase may be limited by its immunogenicity against PEG, even uricase in different forms may have immunogenic responses as well and how do you limit that to get the most out of the drug. The combination of your case with rapamycin is interesting because you eliminate immunogenicity as you mentioned and also be better but then if you're using peglodecase then what's the drug that you use. Why don't we start off by talking about Jeff Peterson's abstract about methotrexate. Anybody want to give us some of that result?
Sure, basically nine patients given methotrexate, as I mentioned before, peglodecase infusions and throughout their time on somewhere between six to nine weeks and this is showing that none surprisingly of these patients actually had infusion reactions or any other problems with using peglodecase so this is actually very promising here Methotrexate, the rheumatologists who are very comfortable using.
Right. 50
per For in these very severe patients Let with
me add two caveats that I think are important. One is that methotrexate, appealing because rheumatologists have a lot of experience and knowledge with it, may not be optimal in our gout patients because a lot of them also unfortunately drink. So that's a concern. Moreover, there may be some potential for drug interactions with other things they're doing and the need to titrate up. So we don't really know for sure whether that's going to work.
This is all predicated on a series of transplant patients who have had protracted efficacy of uricase therapies in combination with their use of immunosuppressive therapies and in some cases actually have had an increase in urate levels when they stop their drugs transiently such as using Imurane, azathioprine.
So that's my next question. This experiment is with nine patients, pretty interesting and it all responses, no untoward effects. As you say, that may not be the right drug. What are the other options? You have a trial that's going be starting.
What are the other options that are out there?
Well, we're looking at Mycophenolate in part because there's less interaction with other drugs. And one of the concerns is that if you're treating people with gout, sometimes there's other doctors involved and they may, for example, decide to start allopurinol even in a patient on pegloticase and it's conceivable that if you were to say use Imuran, there might be a problem with drug drug interactions there. So that was one of the reasons when we polled doctors that they were enthusiastic about Mycophenolate but it's not to say that it's the only reasonable therapeutic option. I think Rapamycin is interesting, I think Methotrexate is interesting and obviously azathioprine is the other one that has gained some traction here.
So I'd like to pause back a bit and talk about what I found interesting, which is really kind of not this group of people,
small group of people with
very severe disease, but actually the bigger gout population. And for me, some of the really interesting data has been that's been presented by in this meeting is a is a abstract from who in the oral concurrent session presented a very large survey of people with gout and asked them about, you know, in the community, asked them about actually the number of flares that they had reported to their doctor versus the number of flares that they had actually experienced over that period. And what was really striking to me was that the number of patients that were or the number of flares that patients were experiencing was in the order of what? Six per year? Something like that.
And reporting, you know, two or fewer. And so I think this really speaks to the sort of broader issue around gout management where we see and we see again, seeing lots of posters today of, you know, very and we've seen this for the last decade, maybe even longer, probably longer, is, you know, these these are these reports of very low use of allopurinol, this kind of, you know, this philosophical issue with different groups of of medical professionals saying, actually, you know, who should be getting allopurinol? You know, the patients that are treated by the rheumatologists are different to the patients treated in primary care. And actually, I think we're releasing some data to say actually we're substantially underestimating the flare burden and burden of disease if we're only looking at what the patient tells us in our office.
It underscores the under management of gout. Have a Twitter poll out right now that says, what is your max dose on allopurinol? Allopurinol? It's overwhelmingly 800mg. Who uses it even in rheumatology?
And it's shocking. There are two reports, one just in Lancet about a nurse run gout clinic and one here about pharmacist run clinics. What do you think of that?
Well actually my colleague Jeff Curtis and a collaborator Ted Michaels were involved with the pharmacist led approach within the Kaiser system. I think this is a strategy we've got to move towards. We've got to figure out how to unburden the busy clinician and to bring in arthritis health professionals that can help be it nurses, pharmacists, health system approaches to improve quality in this area. I want to come back to the flare thing because I think it's really interesting. You've talked about the clinical ramifications.
The other problem with flares is in our clinical trials. We're not doing a good job of capturing We've got to come up with better ways to be able to assess disease activity in an episode that is occurring mostly at home and is subject to a lot of recall. That's probably a big part of the problem with detecting this in studies of new therapeutics. Got a lot of noise in the There's got to be new approaches.
I'd like to add another point that here we see inflammation being common, inflammation being a major problem in gout patients, inflammation contributing to cardiovascular disease and kidney disease, and yet we're not treating it because we don't know about it. And I think this is where education is important both for patients and for physicians. We need to treat GAP better.
Absolutely. And so there's a report here and it's kind of out there right now in the literature and at the regulatory agencies about xanthine oxidase inhibitors and cardiovascular events. And there's a report here about allopurinol versus febuxostat and we're seeing more febuxostat. Where is this going in your Yeah,
well I can comment on that. I was part of that study and regrettably, think the bottom line is it raises more questions than it provides answers. There was a very high dropout rate. The primary endpoint, which was non inferiority of a combined cardiovascular safety signal, was non inferior, yet we saw this increase in all cause mortality and cardiovascular mortality. And we're just frankly not quite sure what to make of it.
There's another study that's being done in Europe that will read out and that will be very important. And there's a recent one done presented at a European Cardiology meeting this year called the FREED study, where in patients with hyperuricemia but not with gout, trabuxostat actually looked cardioprotective. I don't know that we really know. In an active comparator study where you're looking at two xanthine oxidase inhibitors, it makes it difficult to disentangle whether we're actually seeing a safety signal or we're just seeing a difference possibly due to chance or possibly due to one drug being a little more protective than the other.
I agree, but I also think we can take some things out of it. Actually, there's been
this huge fear about allopurinol dosing. If you look
at the protocol in the Cares trial, people with CKD had allopurinol dose escalation up to four hundred. Those who had normal kidney function, allopurinol up to 600, and at least as good outcomes as with fevoxacestat. So I think this is actually reassuring at least that dose escalation of allopurinol is safe and effective, and that's really what
we should And that's really been a great contribution of you and Lisa to the field of showing us that the old handy criteria really are not very evidence based and that we probably, if we go start low and go slow, we can get away with a better dose of our xanthine oxidase inhibitors, even with CKD.
One of the points in the study that there's no placebo arm could be that actually Allopurin is protective and Fidrocyte is not so bad. Had you had the placebo arm, it may have And I think that's been the free two So so I think the word is not is not out yet. I think this is not the final end for febuxostat. I think we still need to see further studies comparing
Well, it's still around at PhiloFlair. I wanna thank the panel for an interesting discussion.
Well, thanks for your interest in gout.
We're glad we got some some playing her in in AR this year. Eight point three million people in our state, so we gotta pay more
attention to it.
It's in many more over the world. Yes.
Alright. It's growing, unfortunately.
Yeah. Yeah, as we are growing.
Exactly. Right. Thank you.
Go.
Hi. Doctor Janet Pope, a RheumNow reporter. I'm going to talk to you about an abstract here at ACR two zero one eight in Chicago. So abstract number 2856, I'm telling you this to get a rise out of you, and there is a pun intended. This is an abstract looking at the rise registry which has thousands and thousands of RA patients collected and it's a registry throughout The US and they're collecting more sites.
Here's the bad news though. Of all the patients, so about 30,000 or more visits of RA patients, they only could find fifteen percent of patients that had outcome measurements that were measurable for disease activity in two or more visits. So fifteen percent. So that's a problem. Maybe it's a problem extracting data, but it is a problem.
However, there's a bigger, deeper problem. When they looked at these patients, it looked like even over the next year of follow-up that they weren't monitoring, to change treatment. They might have been monitoring, but they weren't changing treatment if the patients were in high or moderate disease activity. So a lot of patients were in high or moderate disease activity and didn't have much change going on. So get a rise out of yourself and start monitoring and changing treatment where need be.
Thank you.
Hi. I'm Nicole Bettencourt, I'm here at the American College of Rheumatology's National Conference in Chicago. And I'm here with doctor Madeleine Feldman, who's the real expert on PBMs, Pharmacy Benefit Managers and today she's going to tell us a little bit more about them. So thank you so much for being with us. I just wanted to ask you, tell us a little bit more about PBMs and what they are and what their role is in setting drug prices.
So as we all know they don't actually set the prices, the pharmaceutical manufacturers set the prices. So PBM is an intermediary sort of a middleman between the manufacturer and the health plan and the pharmacy. So they sort of sit in the middle of the drug distribution chain. They are the ones essentially that determine the what, the when, the where, and the how much drugs are available to our patients. And they do this by being the ones who construct the formularies.
Because we all can agree, if an expensive drug is not on the formulary, the patient is not going to be able to take it. So when they are able to construct the preferred lists, that determines what our patients have access to. Now, it's how those preferred lists are constructed that brings us into is this fair to blame the manufacturers for all of drug pricing. Now, I have to say, you know, I'm not shifting the blame from manufacturers to PBMs, it's I'm more sharing the blame. So very, very quickly, the preferred drug lists are based on how much money a manufacturer pays back to the PBM after the script has been filled.
So we know of those as rebates, but the one thing that we don't talk about very much are the admin fees, the administration fees the manufacturers pay. So essentially, those with the highest bid get on the preferred list. Now we'd like to think that competition brings prices down, but in this case, competition raises prices. If you're gonna buy a house and it's the favorite house on the block and everybody wants it, every put one puts in their highest bid. And that's essentially how the bidding takes place to get onto the formulary with the PBM.
Wow. Well, that sounds, like very complicated actually. And, doctor Fleming, what can we do to help, increase access to these medications for our patients? What kind of advocacy efforts and what kind of things can we get involved
So the natural ramifications of the formulary construction are step therapy and non medical switching. So a lot of advocacy now, revolves around those aspects and CSRO and the American College of Rheumatology are both very active in legislation in the states around the country to avoid patients getting switched from a stable medication to another one based on how much money a PBM gets. So obviously you can visit your state legislators, go to Washington for the fly ins, perhaps invite one of your legislators to your office to see what a rheumatologist does, but if you don't have time to do that, dropping a letter. Both the ACR and the CSRO have access on their websites to being able to drop a letter. But one of the things that might even be more important than those things, As we go to the States and trying to explain to them how bad some of these, behaviors are, we need examples of patients who've been harmed by switching, through step therapy.
So if you can gather on your own some of your patients, because I know we all have them that have had either a side effect, adverse event, or loss of efficacy, and send them CSRO, we're we're putting together a registry for that, ACR, just keep a HIPAA compliant record and that would be a great way to advocate for your patients.
Great. Well, thank you so much. And if you guys are interested in learning more, you can, log on to, RheumNow.
Hi. I'm Priyanka. I'm a second year fellow at the University of Iowa. I'm here at ACR twenty eighteen to speak about thieves market. The thieves market is a unique session where six of the top presenters about unique cases get to discuss their case presentations at an oral presentation session.
So this happened last evening, and, some of the top six cases were presented. I was the second place winner, and some of the unique cases that were presented included Gorson's disease, which was about spontaneous osteolysis of the femurs, which occurred in a patient and that mimicked osteonecrosis. The second case was a patient with erythema nodosum leprosum. Another patient that was presented was a patient with necrotizing myopathy who was on a p d one inhibitor for treatment of metastatic melanoma. The unique thing about this case was actually ocular weakness that is noted, and that's not normally seen in other patients with necrotizing myopathy.
My case was about a patient with calcineurin inhibitor pain syndrome who was on a calcineurin inhibitor and presented with bone marrow edema along with abnormal MRI findings. The winning case was actually an interesting patient with disseminated histoplasma infection who was treated for dermatomyositis and didn't improve. The muscle biopsy finally revealed fungi that were noted on it, and the urine histoplasma antigen was positive. This winning presenter was from Washington University in St. Louis.
The last case was actually from Japan and interestingly was about a patient who ingested shiitake mushrooms and developed immune mediated necrotizing myopathy. If you have any additional questions, please log on to roomnow.com. Thank you.
Hi, I'm Doctor. Rachel Tate coming to you live from ACR twenty eighteen for one of my favorite segments on RheumNow, is called the Vendor Shakedown. So, I don't know if you guys know this, but vendors beware. So we have had a group of surreptitious rheumatologists, highly skilled with decisive palates, who came to interview all of you this year. So I am here to give you the results because I cannot participate.
Obviously, I'm biased. I think that the best of both here is RheumNow. So the results are in. So let's go, guys. So best sweet treat.
For the first year in a row, we have a tie. Novartis with the brownies. Bonus points for the wait staff, but also AbbVie for number two in a row, second year in a row, their pumpkin cobbler. So just remember that, that is a winner. Best healthy snack.
Now the reason that's in quotations is because we don't have a lot of options. The ACR does provide us with some good options for our staff and for the participants, but in this case, the best healthy snack is actually the Froyo, which was found at Samu Med. Of note, they also want longest line, so at least we have some people who are interested in in eating a little bit healthier. Now the options for this froyo did include chocolate and sprinkles, things of that nature, but you could also add fresh fruit, hence the healthy snack option. So best coffee.
Guys, give us some more options. We don't want coffee. I'm not a coffee drinker and actually 30% of our panel this year was not a coffee drinker. So please give us some more options. We're looking for that.
However, frappe is from Gilead definitely stole that particular section. So best slogan. This one is pretty great. The gout and uric acid education society came up with kick gout in the acid. Mhmm.
Very clever. We really appreciated that one, but also a little bit difficult to say, so be careful with the pronunciation on some of those. Best giveaway, Epocrates hands down won every panelist. So Epocrates, if you are an ACR member and you came to ACR twenty eighteen, you actually get Epocrates for a year available to you. So just remember that guys, that's important.
Pushiest vendor, this is a new category for us this year. So Thermal X, we appreciate that you have a good product, we know you stand behind it, but please do not apply it to those just having to walk by. This actually happened to two people, not just one in the panel, and so it won this category. Now, in a room now vendor shake up first. This is awesome.
The team from Zellejans has this beautiful waterfall. We're not in Vegas, we're in Chicago, but that's okay. So the interpretation of this waterfall kind of varies between the groups. We have it listed as best schmaltz, and we also have it as unnecessary theatrics. But if you're me, I believe that All Press is good press, so hey, way to go Zellejans.
So that's all that I have for RheumNow twenty eighteen coming to you from ACR. This is the vendor shakedown, it's one of my favorites every year. I'm Doctor. Rachel Tate, check us out for more information and good things to come from ACR twenty eighteen.
Hi, I'm Nicole Betancourt and I'm here at the National Meeting in Chicago. And I'm here with Doctor. Kimberly De Quatro who's going to tell us a little bit about the difficulties with transition of care from pediatric to adult rheumatologic care. And just a little bit on the project that the work that she did and the things that she found out at her institution. So, Doctor.
De Quatro, thank you for being with us today. So tell us a little bit about why this is an important topic.
Oh, do I hold this? Sorry. Thanks, Nicole. You know, transition transfer of care is a really important topic because we have so many patients from the pediatric side that are having to grow up and mature and become adults, and it can be a tricky, process. And so the project that we were looking into was really trying to figure out whether some transition improvement measures could make a difference with regard to the time to transfer for our patients and hopefully down the line we'll set the stage for more improvements
as well. Okay. So as we know this is a very difficult area to address and sometimes these pediatric patients get kind of lost and have poor outcomes from that. So tell us a little bit about the interventions that your institution instituted that helped with the transfer of care from pediatric to adult.
So there's nothing really rocket science y about the initiatives that we started and I think it's really important to start with sort of something basic and doable. And the pediatric rheumatology group at UCSF at our institution really started putting into place transition policy. They also, worked on looking for, EHR. They looked through the EHR to see which patients were gonna be transferring, based on their age and would have a month q three months. So every three months, they would have planning rounds to discuss those patients and focus on, you know, what the next steps would be before they were going to the adult side so that there would be a smoother transfer process.
And so those were the three main things that they started with.
Okay. Well, those sound like things that could be doable for most institutions, hopefully. So tell us a little bit about what you found with the institution of those policies.
So initially, the group that we looked at from the historical time was from 1995 to 2005, and that was sort of the pre transition transfer initiatives. And then the group that we looked at more recently was from 2012 to 2017. And ultimately what we found is what we were looking for were time to transfer, which was so the time between the last pediatric visit and the first adult visit, and then successful transfer, which we defined as the time to transfer as less than six months, and then having at least two visits on the adult side within twelve months of time. And so what we we ultimately found is that we improved our transfer times from about seven and a half months in the sort of historical time to three and a half months more recently after those implementations were in place. And then we also had about fifty four percent, so a little bit more than half of the patients transferred successfully.
Okay. Well, those sounds like policies that we can all hopefully implement at our own institutions. And if you want more information on this topic, you can find us at RheumNow. Hi, I'm Nicole Betancourt and I'm here at the National Meeting in Chicago. And I'm here with Doctor.
Kimberly De Quatro who's gonna tell us a little bit about the difficulties with transition of care from pediatric to adult rheumatologic care. And just a little bit on the project, the work that she did and the things that she found out at her institution. Doctor. So DeCuatro, thank you for being with us today. So tell us a little bit about why this is an important topic.
Oh, do I hold this? Sorry. Thanks, Nicole. Know, transition and transfer of care is a really important topic because we have so many patients from the pediatric side that are having to grow up and mature and become adults, and it can be a tricky process. And so the project that we were looking into was really trying to figure out whether some transition improvement measures, could make a difference with regard to the time to transfer, for our patients, and hopefully down the line, we'll set the stage for more improvements as well.
Okay. So as we know, this is a very difficult area to address and sometimes these pediatric patients get kind of lost and you know have poor outcomes from that. So tell us a little bit about the interventions that your institution instituted that helped with the transfer of care from pediatric to adult.
So there's nothing really rocket science y about the initiatives that we started and I think it's really important to start with sort of something basic and doable. And the pediatric rheumatology group at UCSF at our institution really started putting into place transition policy. They also worked on looking for EHR. They looked through the EHR to see which patients were gonna be transferring based on their age and would have a month q three months. So every three months, they would have planning rounds to discuss those patients and focus on, you know, what the next steps would be before they were going to the adult side so that there would be a smoother transfer process.
And so those were the three main things that they started with.
Okay. Well, those sound like things that could be doable for most institutions, hopefully. So tell us a little bit about what you found with the institution of those policies.
So initially, the group that we looked at from the historical time was from 1995 to 2005 and that was sort of the pre transition transfer initiatives. And then the group that we looked at more recently was from 2012 to 2017. And ultimately what we found is what we were looking for were time to transfer, which was so the time between the last pediatric visit and the first adult visit, and then successful transfer, which we defined as the time to transfer as less than six months, and then having at least two visits on the adult side within twelve months of time. And so what we we ultimately found is that we improved our transfer times from about seven and a half months in the sort of historical time to three and a half months more recently after those implementations were in place. And then we also had about fifty four percent, so a little bit more than half of the patients transferred successfully.
Okay. Well, sounds like policies that we can all hopefully implement at our own institutions. And if you want more information on this topic, can find us at RheumNow.
Hi. I'm doctor David Borenstein. I'm at the American College of Rheumatology. I was, head of the pain management task force for the American College of Rheumatology, and so I wanted to bring you, news about, pain in general as far as the, meeting this week. I usually report on back pain, but there weren't too many abstracts on back pain this year.
But there were a significant number of abstracts and presentations dealing with pain and how it affects rheumatic diseases, all the various types of rheumatic diseases. And one point I think we really wanna take away from all the various abstracts and presentations is the importance of non pharmacologic therapy as far as pain is concerned. We know about nonsteroidals, opioids, and all those other medicines which can potentially cause side effects. That's one aspect of pain care. But another important pain therapy is in fact non pharmacologic, and that has to deal with the physical therapy aspects, the psychosocial aspects.
So this gets into the bio psychosocial model of pain. So the ARHP, another aspect of the American College of Rheumatology, had a number of presentations talking about support of the patients in regards to these cognitive behavioral therapies and the means by which we try to de stress patients. And in fact, we look at these health care partners with rheumatologists who can help us with these patients with chronic pain, we can in fact take care of a wide range of patients who have really significant difficulties in regards to coping. And when it comes down to it, being able to cope with your pain is actually one of the best means by actually taking care of it. So if you want more information about this topic, please go to roomnow.com.
Hi.
I'm Jack Cush with RheumNow. We're here in the RheumNow booth at ACR two thousand eighteen in Chicago. Exciting meeting. More exciting is I've been able to gather up the Gout Mavens and bring them together have a discussion about what's happening in Gout here at ACR twenty eighteen. Thankfully, I'm joined by Naomi Schlesinger from New Jersey, Ken Sag from Alabama, and, Nicola Dalvath from New Zealand.
And we'll start off by saying thank you and welcome and I'd like to know from each of you what is the one thing at this meeting that you've seen or looking forward to seeing that you want to bring up so that we can maybe have a little discussion. Let's start with Naomi.
Well, so there are too many to name. I'm going to actually start with the new treatments from the different uricases, the oral uricase, peglodocus and the new immunogenicity abstracts and the select actually posters, one that's going be presented today showing inflammation reduction when using uricase.
Let me add to Naomi what you're saying because I think this is really an important area. For those of us particularly in academic centers we see very severe gout. See people that come in with topaceous deposits and the use of uricase has really been a salvage therapy that we look forward to having available. The major problem is immunogenicity. You can't take it forever.
People develop immunogenicity and it loses its effectiveness. So the idea about administering either co therapy with methotrexate, which is the poster that I think you were referencing and other approaches, very exciting. More data is needed. It's certainly one of the things that we look forward to understanding more about.
I've seen a series of posters and actually one of the really interesting things is that it seems that this preparation with Rapamycin Apigylated Uricase may well have anti inflammatory effects through the effects of the Rapamycin actually. So there's co administration and then inhibition of IL-one release and reduction of flares. That's really, that is very exciting, I I
think the real question for me is what is the right immunomodulatory therapy to use? I'm not sure we really know and it may turn out that one size fits none. And we may need other options. We may be rapamycin, methotrexate, we're looking at mycophenolate in a small study we're doing. We've got to understand this better and figure out for the patient depending on their comorbidities what's the optimal thing to give with peglodecase and how safe is it to do that ultimate?
So for the audience, again the issue here is that peglodecase may be limited by its immunogenicity against PEG, even uricase in different forms may have immunogenic responses as well and how do you limit that to get the most out of the drug. The combination of your case with rapamycin is interesting because you eliminate immunogenicity as you mentioned and also be better but then if you're using peglodecase then what's the drug that you use. Why don't we start off by talking about Jeff Peterson's abstract about methotrexate. Anybody want to give us some of that result?
Sure, basically nine patients given methotrexate, as I mentioned before, peglodecase infusions and throughout their time on somewhere between six to nine weeks and this is showing that none surprisingly of these patients actually had infusion reactions or any other problems with using peglodecase so this is actually very promising here Methotrexate, the rheumatologists who are very comfortable using.
Right. 50
per For in these very severe patients Let with
me add two caveats that I think are important. One is that methotrexate, appealing because rheumatologists have a lot of experience and knowledge with it, may not be optimal in our gout patients because a lot of them also unfortunately drink. So that's a concern. Moreover, there may be some potential for drug interactions with other things they're doing and the need to titrate up. So we don't really know for sure whether that's going to work.
This is all predicated on a series of transplant patients who have had protracted efficacy of uricase therapies in combination with their use of immunosuppressive therapies and in some cases actually have had an increase in urate levels when they stop their drugs transiently such as using Imurane, azathioprine.
So that's my next question. This experiment is with nine patients, pretty interesting and it all responses, no untoward effects. As you say, that may not be the right drug. What are the other options? You have a trial that's going be starting.
What are the other options that are out there?
Well, we're looking at Mycophenolate in part because there's less interaction with other drugs. And one of the concerns is that if you're treating people with gout, sometimes there's other doctors involved and they may, for example, decide to start allopurinol even in a patient on pegloticase and it's conceivable that if you were to say use Imuran, there might be a problem with drug drug interactions there. So that was one of the reasons when we polled doctors that they were enthusiastic about Mycophenolate but it's not to say that it's the only reasonable therapeutic option. I think Rapamycin is interesting, I think Methotrexate is interesting and obviously azathioprine is the other one that has gained some traction here.
So I'd like to pause back a bit and talk about what I found interesting, which is really kind of not this group of people,
small group of people with
very severe disease, but actually the bigger gout population. And for me, some of the really interesting data has been that's been presented by in this meeting is a is a abstract from who in the oral concurrent session presented a very large survey of people with gout and asked them about, you know, in the community, asked them about actually the number of flares that they had reported to their doctor versus the number of flares that they had actually experienced over that period. And what was really striking to me was that the number of patients that were or the number of flares that patients were experiencing was in the order of what? Six per year? Something like that.
And reporting, you know, two or fewer. And so I think this really speaks to the sort of broader issue around gout management where we see and we see again, seeing lots of posters today of, you know, very and we've seen this for the last decade, maybe even longer, probably longer, is, you know, these these are these reports of very low use of allopurinol, this kind of, you know, this philosophical issue with different groups of of medical professionals saying, actually, you know, who should be getting allopurinol? You know, the patients that are treated by the rheumatologists are different to the patients treated in primary care. And actually, I think we're releasing some data to say actually we're substantially underestimating the flare burden and burden of disease if we're only looking at what the patient tells us in our office.
It underscores the under management of gout. Have a Twitter poll out right now that says, what is your max dose on allopurinol? Allopurinol? It's overwhelmingly 800mg. Who uses it even in rheumatology?
And it's shocking. There are two reports, one just in Lancet about a nurse run gout clinic and one here about pharmacist run clinics. What do you think of that?
Well actually my colleague Jeff Curtis and a collaborator Ted Michaels were involved with the pharmacist led approach within the Kaiser system. I think this is a strategy we've got to move towards. We've got to figure out how to unburden the busy clinician and to bring in arthritis health professionals that can help be it nurses, pharmacists, health system approaches to improve quality in this area. I want to come back to the flare thing because I think it's really interesting. You've talked about the clinical ramifications.
The other problem with flares is in our clinical trials. We're not doing a good job of capturing We've got to come up with better ways to be able to assess disease activity in an episode that is occurring mostly at home and is subject to a lot of recall. That's probably a big part of the problem with detecting this in studies of new therapeutics. Got a lot of noise in the There's got to be new approaches.
I'd like to add another point that here we see inflammation being common, inflammation being a major problem in gout patients, inflammation contributing to cardiovascular disease and kidney disease, and yet we're not treating it because we don't know about it. And I think this is where education is important both for patients and for physicians. We need to treat GAP better.
Absolutely. And so there's a report here and it's kind of out there right now in the literature and at the regulatory agencies about xanthine oxidase inhibitors and cardiovascular events. And there's a report here about allopurinol versus febuxostat and we're seeing more febuxostat. Where is this going in your Yeah,
well I can comment on that. I was part of that study and regrettably, think the bottom line is it raises more questions than it provides answers. There was a very high dropout rate. The primary endpoint, which was non inferiority of a combined cardiovascular safety signal, was non inferior, yet we saw this increase in all cause mortality and cardiovascular mortality. And we're just frankly not quite sure what to make of it.
There's another study that's being done in Europe that will read out and that will be very important. And there's a recent one done presented at a European Cardiology meeting this year called the FREED study, where in patients with hyperuricemia but not with gout, trabuxostat actually looked cardioprotective. I don't know that we really know. In an active comparator study where you're looking at two xanthine oxidase inhibitors, it makes it difficult to disentangle whether we're actually seeing a safety signal or we're just seeing a difference possibly due to chance or possibly due to one drug being a little more protective than the other.
I agree, but I also think we can take some things out of it. Actually, there's been
this huge fear about allopurinol dosing. If you look
at the protocol in the Cares trial, people with CKD had allopurinol dose escalation up to four hundred. Those who had normal kidney function, allopurinol up to 600, and at least as good outcomes as with fevoxacestat. So I think this is actually reassuring at least that dose escalation of allopurinol is safe and effective, and that's really what
we should And that's really been a great contribution of you and Lisa to the field of showing us that the old handy criteria really are not very evidence based and that we probably, if we go start low and go slow, we can get away with a better dose of our xanthine oxidase inhibitors, even with CKD.
One of the points in the study that there's no placebo arm could be that actually Allopurin is protective and Fidrocyte is not so bad. Had you had the placebo arm, it may have And I think that's been the free two So so I think the word is not is not out yet. I think this is not the final end for febuxostat. I think we still need to see further studies comparing
Well, it's still around at PhiloFlair. I wanna thank the panel for an interesting discussion.
Well, thanks for your interest in gout.
We're glad we got some some playing her in in AR this year. Eight point three million people in our state, so we gotta pay more
attention to it.
It's in many more over the world. Yes.
Alright. It's growing, unfortunately.
Yeah. Yeah, as we are growing.
Exactly. Right. Thank you.
Go.
Hi. Doctor Janet Pope, a RheumNow reporter. I'm going to talk to you about an abstract here at ACR two zero one eight in Chicago. So abstract number 2856, I'm telling you this to get a rise out of you, and there is a pun intended. This is an abstract looking at the rise registry which has thousands and thousands of RA patients collected and it's a registry throughout The US and they're collecting more sites.
Here's the bad news though. Of all the patients, so about 30,000 or more visits of RA patients, they only could find fifteen percent of patients that had outcome measurements that were measurable for disease activity in two or more visits. So fifteen percent. So that's a problem. Maybe it's a problem extracting data, but it is a problem.
However, there's a bigger, deeper problem. When they looked at these patients, it looked like even over the next year of follow-up that they weren't monitoring, to change treatment. They might have been monitoring, but they weren't changing treatment if the patients were in high or moderate disease activity. So a lot of patients were in high or moderate disease activity and didn't have much change going on. So get a rise out of yourself and start monitoring and changing treatment where need be.
Thank you.
Hi. I'm Nicole Bettencourt, I'm here at the American College of Rheumatology's National Conference in Chicago. And I'm here with doctor Madeleine Feldman, who's the real expert on PBMs, Pharmacy Benefit Managers and today she's going to tell us a little bit more about them. So thank you so much for being with us. I just wanted to ask you, tell us a little bit more about PBMs and what they are and what their role is in setting drug prices.
So as we all know they don't actually set the prices, the pharmaceutical manufacturers set the prices. So PBM is an intermediary sort of a middleman between the manufacturer and the health plan and the pharmacy. So they sort of sit in the middle of the drug distribution chain. They are the ones essentially that determine the what, the when, the where, and the how much drugs are available to our patients. And they do this by being the ones who construct the formularies.
Because we all can agree, if an expensive drug is not on the formulary, the patient is not going to be able to take it. So when they are able to construct the preferred lists, that determines what our patients have access to. Now, it's how those preferred lists are constructed that brings us into is this fair to blame the manufacturers for all of drug pricing. Now, I have to say, you know, I'm not shifting the blame from manufacturers to PBMs, it's I'm more sharing the blame. So very, very quickly, the preferred drug lists are based on how much money a manufacturer pays back to the PBM after the script has been filled.
So we know of those as rebates, but the one thing that we don't talk about very much are the admin fees, the administration fees the manufacturers pay. So essentially, those with the highest bid get on the preferred list. Now we'd like to think that competition brings prices down, but in this case, competition raises prices. If you're gonna buy a house and it's the favorite house on the block and everybody wants it, every put one puts in their highest bid. And that's essentially how the bidding takes place to get onto the formulary with the PBM.
Wow. Well, that sounds, like very complicated actually. And, doctor Fleming, what can we do to help, increase access to these medications for our patients? What kind of advocacy efforts and what kind of things can we get involved
So the natural ramifications of the formulary construction are step therapy and non medical switching. So a lot of advocacy now, revolves around those aspects and CSRO and the American College of Rheumatology are both very active in legislation in the states around the country to avoid patients getting switched from a stable medication to another one based on how much money a PBM gets. So obviously you can visit your state legislators, go to Washington for the fly ins, perhaps invite one of your legislators to your office to see what a rheumatologist does, but if you don't have time to do that, dropping a letter. Both the ACR and the CSRO have access on their websites to being able to drop a letter. But one of the things that might even be more important than those things, As we go to the States and trying to explain to them how bad some of these, behaviors are, we need examples of patients who've been harmed by switching, through step therapy.
So if you can gather on your own some of your patients, because I know we all have them that have had either a side effect, adverse event, or loss of efficacy, and send them CSRO, we're we're putting together a registry for that, ACR, just keep a HIPAA compliant record and that would be a great way to advocate for your patients.
Great. Well, thank you so much. And if you guys are interested in learning more, you can, log on to, RheumNow.
Hi. I'm Priyanka. I'm a second year fellow at the University of Iowa. I'm here at ACR twenty eighteen to speak about thieves market. The thieves market is a unique session where six of the top presenters about unique cases get to discuss their case presentations at an oral presentation session.
So this happened last evening, and, some of the top six cases were presented. I was the second place winner, and some of the unique cases that were presented included Gorson's disease, which was about spontaneous osteolysis of the femurs, which occurred in a patient and that mimicked osteonecrosis. The second case was a patient with erythema nodosum leprosum. Another patient that was presented was a patient with necrotizing myopathy who was on a p d one inhibitor for treatment of metastatic melanoma. The unique thing about this case was actually ocular weakness that is noted, and that's not normally seen in other patients with necrotizing myopathy.
My case was about a patient with calcineurin inhibitor pain syndrome who was on a calcineurin inhibitor and presented with bone marrow edema along with abnormal MRI findings. The winning case was actually an interesting patient with disseminated histoplasma infection who was treated for dermatomyositis and didn't improve. The muscle biopsy finally revealed fungi that were noted on it, and the urine histoplasma antigen was positive. This winning presenter was from Washington University in St. Louis.
The last case was actually from Japan and interestingly was about a patient who ingested shiitake mushrooms and developed immune mediated necrotizing myopathy. If you have any additional questions, please log on to roomnow.com. Thank you.
Hi, I'm Doctor. Rachel Tate coming to you live from ACR twenty eighteen for one of my favorite segments on RheumNow, is called the Vendor Shakedown. So, I don't know if you guys know this, but vendors beware. So we have had a group of surreptitious rheumatologists, highly skilled with decisive palates, who came to interview all of you this year. So I am here to give you the results because I cannot participate.
Obviously, I'm biased. I think that the best of both here is RheumNow. So the results are in. So let's go, guys. So best sweet treat.
For the first year in a row, we have a tie. Novartis with the brownies. Bonus points for the wait staff, but also AbbVie for number two in a row, second year in a row, their pumpkin cobbler. So just remember that, that is a winner. Best healthy snack.
Now the reason that's in quotations is because we don't have a lot of options. The ACR does provide us with some good options for our staff and for the participants, but in this case, the best healthy snack is actually the Froyo, which was found at Samu Med. Of note, they also want longest line, so at least we have some people who are interested in in eating a little bit healthier. Now the options for this froyo did include chocolate and sprinkles, things of that nature, but you could also add fresh fruit, hence the healthy snack option. So best coffee.
Guys, give us some more options. We don't want coffee. I'm not a coffee drinker and actually 30% of our panel this year was not a coffee drinker. So please give us some more options. We're looking for that.
However, frappe is from Gilead definitely stole that particular section. So best slogan. This one is pretty great. The gout and uric acid education society came up with kick gout in the acid. Mhmm.
Very clever. We really appreciated that one, but also a little bit difficult to say, so be careful with the pronunciation on some of those. Best giveaway, Epocrates hands down won every panelist. So Epocrates, if you are an ACR member and you came to ACR twenty eighteen, you actually get Epocrates for a year available to you. So just remember that guys, that's important.
Pushiest vendor, this is a new category for us this year. So Thermal X, we appreciate that you have a good product, we know you stand behind it, but please do not apply it to those just having to walk by. This actually happened to two people, not just one in the panel, and so it won this category. Now, in a room now vendor shake up first. This is awesome.
The team from Zellejans has this beautiful waterfall. We're not in Vegas, we're in Chicago, but that's okay. So the interpretation of this waterfall kind of varies between the groups. We have it listed as best schmaltz, and we also have it as unnecessary theatrics. But if you're me, I believe that All Press is good press, so hey, way to go Zellejans.
So that's all that I have for RheumNow twenty eighteen coming to you from ACR. This is the vendor shakedown, it's one of my favorites every year. I'm Doctor. Rachel Tate, check us out for more information and good things to come from ACR twenty eighteen.
Hi, I'm Nicole Betancourt and I'm here at the National Meeting in Chicago. And I'm here with Doctor. Kimberly De Quatro who's going to tell us a little bit about the difficulties with transition of care from pediatric to adult rheumatologic care. And just a little bit on the project that the work that she did and the things that she found out at her institution. So, Doctor.
De Quatro, thank you for being with us today. So tell us a little bit about why this is an important topic.
Oh, do I hold this? Sorry. Thanks, Nicole. You know, transition transfer of care is a really important topic because we have so many patients from the pediatric side that are having to grow up and mature and become adults, and it can be a tricky, process. And so the project that we were looking into was really trying to figure out whether some transition improvement measures could make a difference with regard to the time to transfer for our patients and hopefully down the line we'll set the stage for more improvements
as well. Okay. So as we know this is a very difficult area to address and sometimes these pediatric patients get kind of lost and have poor outcomes from that. So tell us a little bit about the interventions that your institution instituted that helped with the transfer of care from pediatric to adult.
So there's nothing really rocket science y about the initiatives that we started and I think it's really important to start with sort of something basic and doable. And the pediatric rheumatology group at UCSF at our institution really started putting into place transition policy. They also, worked on looking for, EHR. They looked through the EHR to see which patients were gonna be transferring, based on their age and would have a month q three months. So every three months, they would have planning rounds to discuss those patients and focus on, you know, what the next steps would be before they were going to the adult side so that there would be a smoother transfer process.
And so those were the three main things that they started with.
Okay. Well, those sound like things that could be doable for most institutions, hopefully. So tell us a little bit about what you found with the institution of those policies.
So initially, the group that we looked at from the historical time was from 1995 to 2005, and that was sort of the pre transition transfer initiatives. And then the group that we looked at more recently was from 2012 to 2017. And ultimately what we found is what we were looking for were time to transfer, which was so the time between the last pediatric visit and the first adult visit, and then successful transfer, which we defined as the time to transfer as less than six months, and then having at least two visits on the adult side within twelve months of time. And so what we we ultimately found is that we improved our transfer times from about seven and a half months in the sort of historical time to three and a half months more recently after those implementations were in place. And then we also had about fifty four percent, so a little bit more than half of the patients transferred successfully.
Okay. Well, those sounds like policies that we can all hopefully implement at our own institutions. And if you want more information on this topic, you can find us at RheumNow. Hi, I'm Nicole Betancourt and I'm here at the National Meeting in Chicago. And I'm here with Doctor.
Kimberly De Quatro who's gonna tell us a little bit about the difficulties with transition of care from pediatric to adult rheumatologic care. And just a little bit on the project, the work that she did and the things that she found out at her institution. Doctor. So DeCuatro, thank you for being with us today. So tell us a little bit about why this is an important topic.
Oh, do I hold this? Sorry. Thanks, Nicole. Know, transition and transfer of care is a really important topic because we have so many patients from the pediatric side that are having to grow up and mature and become adults, and it can be a tricky process. And so the project that we were looking into was really trying to figure out whether some transition improvement measures, could make a difference with regard to the time to transfer, for our patients, and hopefully down the line, we'll set the stage for more improvements as well.
Okay. So as we know, this is a very difficult area to address and sometimes these pediatric patients get kind of lost and you know have poor outcomes from that. So tell us a little bit about the interventions that your institution instituted that helped with the transfer of care from pediatric to adult.
So there's nothing really rocket science y about the initiatives that we started and I think it's really important to start with sort of something basic and doable. And the pediatric rheumatology group at UCSF at our institution really started putting into place transition policy. They also worked on looking for EHR. They looked through the EHR to see which patients were gonna be transferring based on their age and would have a month q three months. So every three months, they would have planning rounds to discuss those patients and focus on, you know, what the next steps would be before they were going to the adult side so that there would be a smoother transfer process.
And so those were the three main things that they started with.
Okay. Well, those sound like things that could be doable for most institutions, hopefully. So tell us a little bit about what you found with the institution of those policies.
So initially, the group that we looked at from the historical time was from 1995 to 2005 and that was sort of the pre transition transfer initiatives. And then the group that we looked at more recently was from 2012 to 2017. And ultimately what we found is what we were looking for were time to transfer, which was so the time between the last pediatric visit and the first adult visit, and then successful transfer, which we defined as the time to transfer as less than six months, and then having at least two visits on the adult side within twelve months of time. And so what we we ultimately found is that we improved our transfer times from about seven and a half months in the sort of historical time to three and a half months more recently after those implementations were in place. And then we also had about fifty four percent, so a little bit more than half of the patients transferred successfully.
Okay. Well, sounds like policies that we can all hopefully implement at our own institutions. And if you want more information on this topic, can find us at RheumNow.
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