EULAR 2019 Group One Save
EULAR 2019 Group One by Dr. Cush
Transcription
Good morning, I'm Peter Lipsky here at the EULAR poster session and I'd like to tell you something about the poster we're presenting here that tries to examine the kind of care that's given to gout patients in the real world. In order to determine that, we looked at the Symphony database, which is a claims database based upon physicians' activities and involves about two fifty million patients. From that we could obtain, identify more than a million gout patients of whom the majority had acute gout based on ICDM10 codes. Some had chronic non tofasious gout,
some
had tofasious gout, and some had an entity which, required multiple visits called uncontrolled gout. The population was pretty typical what we think of as gout, middle aged largely men, and they all had the comorbidities that we understand gout was all about. You can look here at the age distribution and see that the large number of them were beyond 65 and again mostly men. The interesting phenomenon was who saw these patients. And in each gout category more than forty percent were seen by primary care, either internal medicine or family medicine.
A fair number was seen in the emergency room and a varying number depending upon diagnosis was seen by rheumatologists. Less than five percent of those with acute gout were ever seen by a rheumatologist. Whereas about twenty percent with chronic non- tofascious gout saw a rheumatologist and about forty with tophaceous gout at any time saw a rheumatologist. Now, does it make a difference? Well, we look at things that we consider hallmarks of standard care, whether they had urate testing, whether they were put on urate lowering therapy, what we can see is that the frequency with which all of these categories were put on urate lowering therapy, had urate testing, was much higher if they saw a rheumatologist than if they didn't.
The same was true for prescriptions for urate lowering therapy. Although all of this we believe is suboptimal, there's clearly a benefit to the patient if they're seen by a rheumatologist. So we believe these kinds of information can tell us about practice habits in rheumatology and can identify checkpoints that need to be addressed that could increase care effectively and relatively efficiently. Good morning, I'm Peter Lipsky here at the EULAR poster session and I'd like to tell you something about the poster we're presenting here that tries to examine the kind of care that's given to gout patients in the real world. In order to determine that, we looked at the Symphony database, which is a claims database based upon physicians' activities and involves about two fifty million patients.
From that we could obtain, identify more than a million gout patients of whom the majority had acute gout based on ICDM10 codes. Some had chronic non tofascious gout, some had tofascious gout, and some had an entity which, required multiple visits called uncontrolled gout. The population was pretty typical what we think of as gout, middle aged largely men, and they all had the comorbidities that we understand gout was all about. You can look here at the age distribution and see that the large number of them were, beyond 65 and again mostly men. The interesting phenomenon was who saw these patients and in each bout category more than forty percent were seen by primary care either internal medicine or family medicine.
A fair number was seen in the emergency room and a varying number depending upon diagnosis was seen by rheumatologists. Less than five percent of those with acute gout were ever seen by a rheumatologist. Whereas about twenty percent with chronic non- tofascious gout saw a rheumatologist and about forty percent with tofascious gout at any time saw a rheumatologist. Now, does it make a difference? Well if we look at things that we consider hallmarks of standard care, whether they had urate testing, whether they were put on urate lowering therapy, what we can see is that the frequency with which all of these categories were put on urate lowering therapy, had urate testing, was much higher if they saw a rheumatologist than if they didn't.
The same was true for prescriptions for urate lowering therapy. Although all of this we believe is suboptimal, there's clearly a benefit to the patient if they're seen by a rheumatologist. So we believe these kinds of information can tell us about practice habits in rheumatology and can identify checkpoints that need to be addressed that could increase care effectively and relatively efficiently.
Hi, I'm Alex So, I'm speaking to you from EULA Congress in Madrid 2019 and I've been asked to tell you what I thought were the most interesting communications of this year's meeting so far in relation to UDD or urate deposition diseases and I'd like to start off with communication by Professor Perez Ruiz who talked about the importance of treating to target and the link between treating to target and cardiovascular mortality in gout patients. In his cohort of thousand patients, patients who did not get to below six had a much higher risk of dying from heart disease and I think it reinforces the importance of treating to target not just for the gout but also for other parameters and comorbidities associated with gout. The second abstract I found interesting and challenging was from Professor Lipsky who talked about a potential new gout score called GMIM and it's a composite score assessing gout not just for urate levels but also in how patients respond in terms of tender joints, joints and patients outcome and I think that's an interesting new concept which we need to think a bit more because just treating the target it may not be sufficiently reflective of what the patients are experiencing in terms of their response to treatment.
And thirdly the study I found most interesting was the one by Gaffo and colleagues from Alabama where he treated patients with hyperuricemia and high blood pressure with allopurinol and lowered the uric acid but contrary to previous publications he did not find any effect on blood pressure. Now this is a controversial result because this is not what we expect to find and I think that challenges our current dogma but I think there's one explanation which has to be taken into account which is that their patients did not have very high uric acid levels and I think maybe that was the difference that could explain why the results were different from previous reports. So thank you very much, have a good day.
Hi, I'm Kevin Winthrop from Oregon Health Science University in Portland, Oregon and I just had the luxury to be with Doctor. Jack Cush in RheumNow here at ULAr where I gave a hot session on how to risk, stratify and prevent infectious diseases in patients on DMART therapy. I wanted to highlight a couple things I just were asked by the audience afterwards. I think I had about 28 questions and half of them were on tuberculosis. Many of the people here obviously treat patients who are living in endemic areas for TB and screening is of high importance.
Screening paradigms here just the same as they are at home in The US but a little bit different and I highlighted three things. One question that was repeatedly asked was I've screened someone they've been treated for LTBI before how do I handle screening them in the future? And the answer is you don't. You can't screen them, their tests will probably stay positive if they're positive before so there's no need to repeat them. But taking risk factors or taking a history of potential exposure is important.
You know certainly if someone's been exposed a chest x-ray and thinking about treatment is something that can occur but it is a rare event. Second question, people who've been screened negative for years they keep getting screened every year every time they switch biologic. Do we need to do that? The answer is, at least in The US, no. Really re screening individuals is only necessary if they have a risk for exposure.
So in low endemic areas like The US it's really not something we need to do. I know the payer sometimes makes you do it but CDC and other TB authorities would recommend repeating it unless there's a The third question had to do with treatment of latent TB infection. One gentleman mentioned the high isoniazid resistant rates in the country he comes from and in fact that is true. We as a group or as a specialty have been moving away from using INH not necessarily due to the resistance issue but more due to the completion rates of a nine month treatment period. Completion rates are low and it's of course carries risk with hepatotoxicity and sometimes patients just don't want to take that drug.
So we have drifted towards using rifampin based regimens. The regimen I'd like to highlight is the preferred regimen at least in the eyes of the CDC in The US and that's once weekly isoniazid and rifapentine. It's only for twelve weeks. So the completion rates are high. The efficacy is better than nine months of INH and that is probably your number one regimen to go with today.
So I hope that's it. Thanks very much for listening and thanks to Doctor. Cush for being here.
Hello, my name is Gerb Wommesse. I'm from Berlin, a rheumatologist from Germany, and it's a pleasure for me to talk to you about the SEMIRA trial that we did to address two important questions. First of all, is it safe to withdraw glucocorticoids from patients who have been on that drug for quite a while? And secondly, what about the efficacy if you lose that particular drug a clinical trial. So what we did is we investigated patients who were on low disease activity on tocilizumab, which we took as the biological DMARD, and these patients were in addition on a stable dose of five mg of prednisone.
So then we withdrew prednisone in one group, it was blinded, no one knew if it was withdrawn or not, and we tapered it down from five to four to three to one to zero over the period of six months. The other group in a blinded fashion continued to have the drug on board. What were the results? Well, was quite interesting that the group who continued to take the glucocorticoid did somewhat better, so there was a difference in the DAS28 ESR of 0.6% versus the group that tapered the glucocorticoids. You may say that is not a lot because it's only 0.6%, but you may also say what is a significant amount.
The next very important item we found is there was not a single patient who had any adrenal insufficiency symptoms in this particular withdrawal scheme, so it looks as at least in these patients going from five next month, four next month, three and so on to zero appears to be quite safe. When we looked at the final additional endpoint that was clinical success, that was still a low disease activity, no adrenal insufficiency, no flares. Was roughly seventy five percent of patients who continued prednisone were in that group, while, I mean it's a significant number, two thirds of those who had tapered it were also in that group of clinical success. So what is the message of the study? Yes, you can withdraw, you can offer it to the patient and two thirds it works.
It may work a little bit better in terms of efficacy in those who continued, but I think it's worth offering the patients using that scheme to discontinue glucocorticoids.
Hi, Jack Cush, EULAR twenty nineteen. Have an interesting presentation today on anakinra in Kawasaki disease. The trial was entitled the Kawakinra Study, a Phase two multicenter trial to assess the efficacy and safety of anakinra in refractory Kawasaki patients who have been treated with IVIG. As you know, Kawasaki can be a devastating illness, mainly affecting children, mucocutaneous lesions, cardiac lesions, coronary artery lesions that can be deadly. But you know, therapy has been revolutionized.
Everybody gets aspirin, almost everybody gets IVI and Qi and that's effective in a high percentage of patients, maybe as much as eighty percent of patients. But there are some patients who still have problems and for this group, there's not a lot of options. That's why the study is being undertaken. This is an open label forty five day study that was given, where the drug was given to a handful of patients to see if it would affect the systemic outcomes and also the coronary artery outcomes. So it had to be children over eight months of age and less than 18 years of age greater than five kilograms in weight, and they had to have been seen with more than three months of symptoms and they had to have failed IVIG and have the diagnosis of Kawasaki disease.
The primary outcome here was reduction in fever, but then they looked at other measures of disease activity including coronary artery abnormalities by echocardiogram. So as I said, this was a forty five day trial. Patients were dosed with anakinra, a once a day anakinra given subcutaneously at a starting dose of two milligrams per kilogram, then was escalated to as much as six milligrams per kilogram, based on weight and response to therapy, etc. So overall in this forty five day trial where 16 patients, fulfilled inclusion criteria and were then treated, they had how many? Four that received three milligrams, five that received four milligrams, and six that received six milligrams per kilogram.
In this trial, the vast majority of patients responded briskly within forty eight hours more than eighty percent of patients responded with a reduction in their temperature and loss of fever. The other outcomes were things like Patient Global, Physician Global all doing great, CRP dropping, Physician Global as I said. But the main one that everyone is concerned about is what happens to the coronary arteries. There the story was actually quite good. There were a number of patients who had dramatic drop quickly and by day 14, a few patients actually had some very, very high levels that took a long time to come down.
There were a few patients who stopped therapy and their coronary artery lesions got worse as measured by something called a Z score. And again, that's the outcome measure that you're looking for in patients with Kawasaki disease. So So we know this disorder does have a significant effect on, this drug has a significant effect on systemic manifestations and it looks like it's somewhat protective, if not very protective against the development of coronary artery lesions. So it was safe, it was effective in this forty five day short study. The question is, would this be enough for it to supplant the standard of care which is aspirin IVIG?
I don't think so. You need a larger trial, you need a controlled trial to know that's the case. Clearly, it's going to be easier and cheaper maybe than IVIG, and there's going to be a limited amount of therapy that's going to be necessary. But again, the question is, how should these people be treated from the outset? Standard of care for right now, but it's good to know that Anakinra is a drug that can be used safely and with effect in patients with Kawasaki disease.
Tune in for more videos from EULAR twenty nineteen. Hi, this is Jack Cush coming to you from Madrid in EULAR twenty nineteen. I wanna talk to you about a presentation I saw today, OP zero one eight three. The title of the presentation was Efficacy and Safety of Riosuquat in Patients with Early Diffuse Systemic Sclerosis and Interstitial Lung Disease or ILD. As you know, this is sort of a difficult disease, difficult manifestations to treat both the skin and the lung, and Ryocequat actually is being used because it's an anti proliferative agent that, has been approved for use in some other fibrosing diseases.
It's thought to have some anti inflammatory potential, anti fibrotic potential. It's not been used previously. It started to have some studies recently and now we have some clinical trials. This one is called the RISE, R I S E S S C study and I think you will find it sort of interesting. It is a one year study, in patients, one hundred and twenty one patients with systemic sclerosis and relatively early systemic sclerosis within the first eighteen months, they had to have a, modest amount of skin involvement, and preserve lung function.
So they had to have a modified rod and skin score 10 to 22 and preserve lung function, meaning FVC and DLCOs above forty-forty five percent. And then they were randomized to receive, this drug. Now the drug was given in everybody the same way and there was a placebo control here. The number of patients in the trial who actually had some form of interstitial lung disease was about twenty percent by three different definitions of interstitial lung disease, so they went ahead and they treated them with riosequat. And the primary endpoint was the skin outcomes, the modified Rodden Skin Score, but it failed to achieve that.
But what it did show was that those that were on placebo had really no change, kind of different than most studies where they show skin scores are always going up, but there's no change here. And there was a trend towards decrease in those who are on riosequat except it didn't meet significance and it had a p value of 0.08, and that wasn't quite good enough. But, they also looked at secondary outcomes including lung function. And this is where things got interesting. And when you look at all patients in the study, one hundred and twenty one patients, it was in favor of riosequat, but again not significant.
But if they only looked at the subset who had interstitial lung disease at entry by one of three different definitions, they showed highly significant reductions in FVC as the main measure that they use for decline in lung function from ILD. So it was significant for the lung and it was significant in this one year study. There were no new surprising side effects which is an issue in this study because it looked pretty good and pretty safe. However, in another study they have going on, they had some cardiac issues, some death issues and lung patients, that's being sorted out, didn't seem like was an issue here. So we have basically a new therapy that, is potentially of use and will probably go forward with further studies.
This is sort of in line what we've seen in other studies recently where it's really hard to show improvement in the skin. But if it's a good enough drug, it'll actually affect the lungs positively and this is what's happened here with Riosuquat. So it'll be interesting to see where they go with this going forward. That's it from EULAR in Madrid. Tune in for more videos from RheumNow.
some
had tofasious gout, and some had an entity which, required multiple visits called uncontrolled gout. The population was pretty typical what we think of as gout, middle aged largely men, and they all had the comorbidities that we understand gout was all about. You can look here at the age distribution and see that the large number of them were beyond 65 and again mostly men. The interesting phenomenon was who saw these patients. And in each gout category more than forty percent were seen by primary care, either internal medicine or family medicine.
A fair number was seen in the emergency room and a varying number depending upon diagnosis was seen by rheumatologists. Less than five percent of those with acute gout were ever seen by a rheumatologist. Whereas about twenty percent with chronic non- tofascious gout saw a rheumatologist and about forty with tophaceous gout at any time saw a rheumatologist. Now, does it make a difference? Well, we look at things that we consider hallmarks of standard care, whether they had urate testing, whether they were put on urate lowering therapy, what we can see is that the frequency with which all of these categories were put on urate lowering therapy, had urate testing, was much higher if they saw a rheumatologist than if they didn't.
The same was true for prescriptions for urate lowering therapy. Although all of this we believe is suboptimal, there's clearly a benefit to the patient if they're seen by a rheumatologist. So we believe these kinds of information can tell us about practice habits in rheumatology and can identify checkpoints that need to be addressed that could increase care effectively and relatively efficiently. Good morning, I'm Peter Lipsky here at the EULAR poster session and I'd like to tell you something about the poster we're presenting here that tries to examine the kind of care that's given to gout patients in the real world. In order to determine that, we looked at the Symphony database, which is a claims database based upon physicians' activities and involves about two fifty million patients.
From that we could obtain, identify more than a million gout patients of whom the majority had acute gout based on ICDM10 codes. Some had chronic non tofascious gout, some had tofascious gout, and some had an entity which, required multiple visits called uncontrolled gout. The population was pretty typical what we think of as gout, middle aged largely men, and they all had the comorbidities that we understand gout was all about. You can look here at the age distribution and see that the large number of them were, beyond 65 and again mostly men. The interesting phenomenon was who saw these patients and in each bout category more than forty percent were seen by primary care either internal medicine or family medicine.
A fair number was seen in the emergency room and a varying number depending upon diagnosis was seen by rheumatologists. Less than five percent of those with acute gout were ever seen by a rheumatologist. Whereas about twenty percent with chronic non- tofascious gout saw a rheumatologist and about forty percent with tofascious gout at any time saw a rheumatologist. Now, does it make a difference? Well if we look at things that we consider hallmarks of standard care, whether they had urate testing, whether they were put on urate lowering therapy, what we can see is that the frequency with which all of these categories were put on urate lowering therapy, had urate testing, was much higher if they saw a rheumatologist than if they didn't.
The same was true for prescriptions for urate lowering therapy. Although all of this we believe is suboptimal, there's clearly a benefit to the patient if they're seen by a rheumatologist. So we believe these kinds of information can tell us about practice habits in rheumatology and can identify checkpoints that need to be addressed that could increase care effectively and relatively efficiently.
Hi, I'm Alex So, I'm speaking to you from EULA Congress in Madrid 2019 and I've been asked to tell you what I thought were the most interesting communications of this year's meeting so far in relation to UDD or urate deposition diseases and I'd like to start off with communication by Professor Perez Ruiz who talked about the importance of treating to target and the link between treating to target and cardiovascular mortality in gout patients. In his cohort of thousand patients, patients who did not get to below six had a much higher risk of dying from heart disease and I think it reinforces the importance of treating to target not just for the gout but also for other parameters and comorbidities associated with gout. The second abstract I found interesting and challenging was from Professor Lipsky who talked about a potential new gout score called GMIM and it's a composite score assessing gout not just for urate levels but also in how patients respond in terms of tender joints, joints and patients outcome and I think that's an interesting new concept which we need to think a bit more because just treating the target it may not be sufficiently reflective of what the patients are experiencing in terms of their response to treatment.
And thirdly the study I found most interesting was the one by Gaffo and colleagues from Alabama where he treated patients with hyperuricemia and high blood pressure with allopurinol and lowered the uric acid but contrary to previous publications he did not find any effect on blood pressure. Now this is a controversial result because this is not what we expect to find and I think that challenges our current dogma but I think there's one explanation which has to be taken into account which is that their patients did not have very high uric acid levels and I think maybe that was the difference that could explain why the results were different from previous reports. So thank you very much, have a good day.
Hi, I'm Kevin Winthrop from Oregon Health Science University in Portland, Oregon and I just had the luxury to be with Doctor. Jack Cush in RheumNow here at ULAr where I gave a hot session on how to risk, stratify and prevent infectious diseases in patients on DMART therapy. I wanted to highlight a couple things I just were asked by the audience afterwards. I think I had about 28 questions and half of them were on tuberculosis. Many of the people here obviously treat patients who are living in endemic areas for TB and screening is of high importance.
Screening paradigms here just the same as they are at home in The US but a little bit different and I highlighted three things. One question that was repeatedly asked was I've screened someone they've been treated for LTBI before how do I handle screening them in the future? And the answer is you don't. You can't screen them, their tests will probably stay positive if they're positive before so there's no need to repeat them. But taking risk factors or taking a history of potential exposure is important.
You know certainly if someone's been exposed a chest x-ray and thinking about treatment is something that can occur but it is a rare event. Second question, people who've been screened negative for years they keep getting screened every year every time they switch biologic. Do we need to do that? The answer is, at least in The US, no. Really re screening individuals is only necessary if they have a risk for exposure.
So in low endemic areas like The US it's really not something we need to do. I know the payer sometimes makes you do it but CDC and other TB authorities would recommend repeating it unless there's a The third question had to do with treatment of latent TB infection. One gentleman mentioned the high isoniazid resistant rates in the country he comes from and in fact that is true. We as a group or as a specialty have been moving away from using INH not necessarily due to the resistance issue but more due to the completion rates of a nine month treatment period. Completion rates are low and it's of course carries risk with hepatotoxicity and sometimes patients just don't want to take that drug.
So we have drifted towards using rifampin based regimens. The regimen I'd like to highlight is the preferred regimen at least in the eyes of the CDC in The US and that's once weekly isoniazid and rifapentine. It's only for twelve weeks. So the completion rates are high. The efficacy is better than nine months of INH and that is probably your number one regimen to go with today.
So I hope that's it. Thanks very much for listening and thanks to Doctor. Cush for being here.
Hello, my name is Gerb Wommesse. I'm from Berlin, a rheumatologist from Germany, and it's a pleasure for me to talk to you about the SEMIRA trial that we did to address two important questions. First of all, is it safe to withdraw glucocorticoids from patients who have been on that drug for quite a while? And secondly, what about the efficacy if you lose that particular drug a clinical trial. So what we did is we investigated patients who were on low disease activity on tocilizumab, which we took as the biological DMARD, and these patients were in addition on a stable dose of five mg of prednisone.
So then we withdrew prednisone in one group, it was blinded, no one knew if it was withdrawn or not, and we tapered it down from five to four to three to one to zero over the period of six months. The other group in a blinded fashion continued to have the drug on board. What were the results? Well, was quite interesting that the group who continued to take the glucocorticoid did somewhat better, so there was a difference in the DAS28 ESR of 0.6% versus the group that tapered the glucocorticoids. You may say that is not a lot because it's only 0.6%, but you may also say what is a significant amount.
The next very important item we found is there was not a single patient who had any adrenal insufficiency symptoms in this particular withdrawal scheme, so it looks as at least in these patients going from five next month, four next month, three and so on to zero appears to be quite safe. When we looked at the final additional endpoint that was clinical success, that was still a low disease activity, no adrenal insufficiency, no flares. Was roughly seventy five percent of patients who continued prednisone were in that group, while, I mean it's a significant number, two thirds of those who had tapered it were also in that group of clinical success. So what is the message of the study? Yes, you can withdraw, you can offer it to the patient and two thirds it works.
It may work a little bit better in terms of efficacy in those who continued, but I think it's worth offering the patients using that scheme to discontinue glucocorticoids.
Hi, Jack Cush, EULAR twenty nineteen. Have an interesting presentation today on anakinra in Kawasaki disease. The trial was entitled the Kawakinra Study, a Phase two multicenter trial to assess the efficacy and safety of anakinra in refractory Kawasaki patients who have been treated with IVIG. As you know, Kawasaki can be a devastating illness, mainly affecting children, mucocutaneous lesions, cardiac lesions, coronary artery lesions that can be deadly. But you know, therapy has been revolutionized.
Everybody gets aspirin, almost everybody gets IVI and Qi and that's effective in a high percentage of patients, maybe as much as eighty percent of patients. But there are some patients who still have problems and for this group, there's not a lot of options. That's why the study is being undertaken. This is an open label forty five day study that was given, where the drug was given to a handful of patients to see if it would affect the systemic outcomes and also the coronary artery outcomes. So it had to be children over eight months of age and less than 18 years of age greater than five kilograms in weight, and they had to have been seen with more than three months of symptoms and they had to have failed IVIG and have the diagnosis of Kawasaki disease.
The primary outcome here was reduction in fever, but then they looked at other measures of disease activity including coronary artery abnormalities by echocardiogram. So as I said, this was a forty five day trial. Patients were dosed with anakinra, a once a day anakinra given subcutaneously at a starting dose of two milligrams per kilogram, then was escalated to as much as six milligrams per kilogram, based on weight and response to therapy, etc. So overall in this forty five day trial where 16 patients, fulfilled inclusion criteria and were then treated, they had how many? Four that received three milligrams, five that received four milligrams, and six that received six milligrams per kilogram.
In this trial, the vast majority of patients responded briskly within forty eight hours more than eighty percent of patients responded with a reduction in their temperature and loss of fever. The other outcomes were things like Patient Global, Physician Global all doing great, CRP dropping, Physician Global as I said. But the main one that everyone is concerned about is what happens to the coronary arteries. There the story was actually quite good. There were a number of patients who had dramatic drop quickly and by day 14, a few patients actually had some very, very high levels that took a long time to come down.
There were a few patients who stopped therapy and their coronary artery lesions got worse as measured by something called a Z score. And again, that's the outcome measure that you're looking for in patients with Kawasaki disease. So So we know this disorder does have a significant effect on, this drug has a significant effect on systemic manifestations and it looks like it's somewhat protective, if not very protective against the development of coronary artery lesions. So it was safe, it was effective in this forty five day short study. The question is, would this be enough for it to supplant the standard of care which is aspirin IVIG?
I don't think so. You need a larger trial, you need a controlled trial to know that's the case. Clearly, it's going to be easier and cheaper maybe than IVIG, and there's going to be a limited amount of therapy that's going to be necessary. But again, the question is, how should these people be treated from the outset? Standard of care for right now, but it's good to know that Anakinra is a drug that can be used safely and with effect in patients with Kawasaki disease.
Tune in for more videos from EULAR twenty nineteen. Hi, this is Jack Cush coming to you from Madrid in EULAR twenty nineteen. I wanna talk to you about a presentation I saw today, OP zero one eight three. The title of the presentation was Efficacy and Safety of Riosuquat in Patients with Early Diffuse Systemic Sclerosis and Interstitial Lung Disease or ILD. As you know, this is sort of a difficult disease, difficult manifestations to treat both the skin and the lung, and Ryocequat actually is being used because it's an anti proliferative agent that, has been approved for use in some other fibrosing diseases.
It's thought to have some anti inflammatory potential, anti fibrotic potential. It's not been used previously. It started to have some studies recently and now we have some clinical trials. This one is called the RISE, R I S E S S C study and I think you will find it sort of interesting. It is a one year study, in patients, one hundred and twenty one patients with systemic sclerosis and relatively early systemic sclerosis within the first eighteen months, they had to have a, modest amount of skin involvement, and preserve lung function.
So they had to have a modified rod and skin score 10 to 22 and preserve lung function, meaning FVC and DLCOs above forty-forty five percent. And then they were randomized to receive, this drug. Now the drug was given in everybody the same way and there was a placebo control here. The number of patients in the trial who actually had some form of interstitial lung disease was about twenty percent by three different definitions of interstitial lung disease, so they went ahead and they treated them with riosequat. And the primary endpoint was the skin outcomes, the modified Rodden Skin Score, but it failed to achieve that.
But what it did show was that those that were on placebo had really no change, kind of different than most studies where they show skin scores are always going up, but there's no change here. And there was a trend towards decrease in those who are on riosequat except it didn't meet significance and it had a p value of 0.08, and that wasn't quite good enough. But, they also looked at secondary outcomes including lung function. And this is where things got interesting. And when you look at all patients in the study, one hundred and twenty one patients, it was in favor of riosequat, but again not significant.
But if they only looked at the subset who had interstitial lung disease at entry by one of three different definitions, they showed highly significant reductions in FVC as the main measure that they use for decline in lung function from ILD. So it was significant for the lung and it was significant in this one year study. There were no new surprising side effects which is an issue in this study because it looked pretty good and pretty safe. However, in another study they have going on, they had some cardiac issues, some death issues and lung patients, that's being sorted out, didn't seem like was an issue here. So we have basically a new therapy that, is potentially of use and will probably go forward with further studies.
This is sort of in line what we've seen in other studies recently where it's really hard to show improvement in the skin. But if it's a good enough drug, it'll actually affect the lungs positively and this is what's happened here with Riosuquat. So it'll be interesting to see where they go with this going forward. That's it from EULAR in Madrid. Tune in for more videos from RheumNow.
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