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ANCA Vasculitis "Eye": Can rituximab help?:Dr. Janet Pope
Apremilast in PsA: Results from Mosaic Trial:Dr. Guillermo Valenzuela
Implantable Vagus Nerve Stimulator for RA:Dr. Guillermo Valenzuela
Treat-to-Target Improves Fertility in Women with RA:Dr. Richard Conway
Transcription
Hi. Welcome, everyone. I'm Janet Bourdeaux or doctor Janet Pope, a rheumatologist here reporting at the ACR twenty twenty four in Washington at RheumNow, and I hope you'll be following us. I wanted to talk about ANCA vasculitis and a really important complication that's difficult to treat. So I call this I, meaning I am annoyed, and rituximab can help.
So what do I mean by that? There was a nice poster 07/26 and what it was was a systematic review of cases of patients with ocular involvement for ANCA vasculitis who were treated with rituximab. So what did it show? So there is a publication bias, you usually publish your best of your cases. So eighty percent of patients had a partial or even complete response to their ocular involvement with rituximab.
How long did we have to give it? Don't know. There's a lot of things we're not sure about, what dose, what background medications, but I think it's important to note that ocular involvement is something that a person could have double vision, headaches, they could go blind, it could be a pseudo tumor, it could be proptosis, it could be, extraocular movements that are abnormal, scleritis, keratitis and even uveitis, and it is very difficult to treat and I think the penetration of drugs in this area is tough just like in sinuses. So what am I going to do as a take home? If I have a patient with really bad ocular involvement, I have in past given rituximab even though technically it might be off label for this problem.
It's on label for other problems, but I have seen it work as well and this systematic review helps me to understand that maybe there is a really good response to rituximab at least in the majority of patients. Please follow us at RheumNow. Thank you.
Hello, everyone, and I'm glad to be able to report from the February in Washington, DC. Interesting are, posters, in which I, my site had a part in the construction of data. One of them is Apremilaz reduces axial inflammation in patients with psoriatic arthritis using a CANDEM MRI scoring. This was a phase four analysis from the MOSAIC trial using a premilas as the primary agent in patients specifically with axial PSA within the cohort of the patients with overall psoriatic arthritis. The medium age of these patients was 47 years old with a duration of disease of approximately one point nine years.
These patients were all on background therapy and the important thing here to report is that psoriatic arthritis or psoriatic spondylitis is an active aspect of the life of patients with psoriasis. So the purpose of this study was to explore using, whole body MRI, the aspects of inflammation using this novel CANDEM methodology. So the patients had to have psoriatic arthritis, obviously peripheral arthritis, had to fulfill the CASPER criteria and a whole body MRI with contrast was obtained at baseline twenty four and forty eight weeks. And the purpose was again to try to establish a cause relationship or perhaps an association or an observation of the impact of Apremilas in axial disease in patients with psoriatic arthritis. So of a total of one hundred and twenty two patients in the cohort, forty patients met the criteria for axial spondylitis according to using the BasDie questionnaire.
This axial inflammation permitted patients to be involved and evaluated through the methodology the first time perhaps reported in study of this nature using whole body MRI with contrast to assess characteristics associated with axial pathology in these patients with psoriatic arthropathy. So the results showed that CANDEM analysis allowed us to demonstrate that there was evidence of significant differences between the patients who were on treatment at different time points showing superiority in all the different aspects of the readout using the CANDEN methodology. However, when the patients were subject to spark criteria, they did not meet that endpoint. What is the message that we get from this abstract is that psoriatic spondylitis is an important part of the life of patients with psoriatic arthritis. We know that the APREMILA studies were not used or they don't use radiographic methods in the registration trials, but the spirit of having this trial was to demonstrate further that PEMILAS still apparently has an impact on controlling certain aspects of inflammation as we see with this very clear methodology using the CANDEM which enables us to see not only the vertebral aspects of the inflammation but also the posterior vertebral aspect of inflammation.
The summary would be that it's important to know and important to learn what using this method teach us about the axial impact of aprimilaz in these patients. Thank you. Hello, I'm Doctor. Guillermo Valenzuela. I am reporting from a ACR twenty twenty four from Washington DC.
Today I will be discussing quickly the concepts related to the poster L10, which relates to the neuro immune modulation in adult patients with rheumatoid arthritis with BIOD DMARDs and targeted synthetic DMARDs, inadequate responses at twelve and twenty four weeks using a sham controlled double blind. So you'll be surprised to know that this is not a therapeutic intervention with a traditional oral medication or a biologic medication, but this is using an implantable device that stimulates the vagus nerve. Of concern to many and interesting aspect of the science as I will show you further. So the purpose was to evaluate essentially the safety and efficacy of an implantable device in the cervical vagus region and patients would be subject to constant daily stimulation. The total cohort in this study was two forty two patients that were randomized in a one to one ratio to a sham, which was essentially the device being turned off for the first twelve weeks and then every patient coming onto the active arm after twelve weeks of treatment.
So this double blind assessment allowed to obtain information during the first twelve weeks which were critical to understanding perhaps the signal that this therapeutic intervention could show. So the patients had to have a previous failure to at least one bio DMARC or one targeted synthetic DMARC. There were secondary endpoints that were also as important as the primary, which was the ACR20. And the secondary endpoints included DAS28, MCID, HACC and one important one that perhaps gave this study a value of objective assessment was the erosion progression score using a Rambris score. So that would work essentially as a control of the activity.
And also the DAS remission was part of the secondary endpoints. After week twelve, as I mentioned before, there was an active crossover. So every patient at week twelve received neuromodulation by this device, was surgically implanted in left, in the vagus nerve of these patients. Just a word about the demographics, patients were an average of 56 years of age and eighty six percent of these were females and the average duration of disease was close to twelve years. In terms of the breakdown of previous exposure to therapies, it's interesting to know that the patients who received bio DMARDs, thirty nine percent of them had failed one previous DMARDs, about twenty two percent DMARC and three DMARC about thirty nine percent of them.
Fifty three percent of these patients were seropositive and the high sensitivity C reactive protein was 8.2. So important now is the results. At week 12, we saw a statistically significant difference in the groups, in the active groups versus the sham groups. Was a thirty five percent of the patients who achieved a ACR twenty versus a twenty four percent in the sham group, which gave a P value of 0.02. Now, it's even important to see that week 24, fifty percent, I'm sorry, fifty one percent of the patients on the active group continue to show ACR 20s, of which fifty three percent of them were the ones who were previously in the sham group.
So all the secondary exploratory endpoints also showed a tendency that correlated with the ACR scores. In other words, there was a accomplishment of the goals of secondary endpoints. Such as one of the most important ones perhaps is week 12, the CRP low disease activity, a DAS score. There's also the progression of the erosion through MRI was demonstrated. And the most important one which we can all think about is safety.
Regardless of the surgical nature of the procedure, was a rather safe procedure. Serious adverse events were only 1.7 and we can't imagine the most common adverse event was a post surgical transient hoarseness and related symptoms to the procedure itself. There were no reported deaths and as a conclusion, I think this is a very interesting and absolutely novel way to modulate rheumatoid arthritis by a non traditional mechanism, is not an oral agent or injectable agent or infusible agent as we are accustomed to seeing our armamentarium is rather an implantable device with all the implications that it brings up. So perhaps the final word would be we are interested in knowing the long term effects of these outcomes, and I hope to be able to report those findings in the next presentation. Thank you very much.
Hello, everyone. I'm Richard Conway reporting for RheumNow from ACR twenty twenty four. I'm going to talk to you today about a study presented at Sunday's plenary session. This was from Cornelia Quack and colleagues from The Netherlands. It's abstract number sixteen forty seven.
So this was a study looking at rheumatoid arthritis and looking at treat to target. I was particularly interested in the pregnancy space. So to do this, they had a new study, which was called Pre Cara, and they were comparing this to their previous study of these patients around pregnancy, which is called Para. There were two fifteen patients in the new study, two forty five in the old study. And the difference between them was that the old study was kind of a standard of care study and the new one was this treat to target implementation in this group who were intending on becoming pregnant.
So to do that, they had this escalating regime of drugs, starting with sulfasalazine and hydroxychloroquine, and if necessary, adding in a TNF inhibitor. And they also based on previous knowledge of how medications affect pregnancy, had a real focus on trying to limit non steroidal anti inflammatories and glucocorticoids in these patients. So the first thing, did the treat to target achieve what it set out to do? Did it reduce disease activity? And it did.
So that CRP was 2.33 in the new study compared to 3.84 in the old study. And then looking at fertility. So they did this by looking at the time to pregnancy. And that was eighty four days in pre Cara in the new study compared to the historical one hundred and ninety six days. And then when they looked at kind of problems conceiving or bigger problems conceiving, so looking at twelve month cutoff, who got beyond twelve months, it was twenty three percent of patients in the new group compared to forty two percent of patients in the older cohort.
So this study, I think, really very much says that fully controlling disease activity and using the agents we need to do that improves fertility. And so now we know that it improves fertility. We already have other data showing that it improves pregnancy outcomes, reduces stillbirths, preterms, births, miscarriages, all those sorts of things we really want to avoid. I think this increasing evidence that we need to be better and need to be optimized the treatment of patients who are planning pregnancy and becoming pregnant. We need to overcome the fears that many patients have regarding these medications through education and spending the necessary time with them.
And I think we definitely also need to overcome a bit of an inertia among both physicians and patients regarding these agents and not putting things off until after pregnancy, that everything will be better. And we can confidently say that based on the data that we now have, if we treat these patients with certain of the medications we have available to us. So I'm Richard Conway. You can see me on Twitter RichardPAconway. And do check out RheumNow for all the up to date coverage from ACR twenty twenty four.
So what do I mean by that? There was a nice poster 07/26 and what it was was a systematic review of cases of patients with ocular involvement for ANCA vasculitis who were treated with rituximab. So what did it show? So there is a publication bias, you usually publish your best of your cases. So eighty percent of patients had a partial or even complete response to their ocular involvement with rituximab.
How long did we have to give it? Don't know. There's a lot of things we're not sure about, what dose, what background medications, but I think it's important to note that ocular involvement is something that a person could have double vision, headaches, they could go blind, it could be a pseudo tumor, it could be proptosis, it could be, extraocular movements that are abnormal, scleritis, keratitis and even uveitis, and it is very difficult to treat and I think the penetration of drugs in this area is tough just like in sinuses. So what am I going to do as a take home? If I have a patient with really bad ocular involvement, I have in past given rituximab even though technically it might be off label for this problem.
It's on label for other problems, but I have seen it work as well and this systematic review helps me to understand that maybe there is a really good response to rituximab at least in the majority of patients. Please follow us at RheumNow. Thank you.
Hello, everyone, and I'm glad to be able to report from the February in Washington, DC. Interesting are, posters, in which I, my site had a part in the construction of data. One of them is Apremilaz reduces axial inflammation in patients with psoriatic arthritis using a CANDEM MRI scoring. This was a phase four analysis from the MOSAIC trial using a premilas as the primary agent in patients specifically with axial PSA within the cohort of the patients with overall psoriatic arthritis. The medium age of these patients was 47 years old with a duration of disease of approximately one point nine years.
These patients were all on background therapy and the important thing here to report is that psoriatic arthritis or psoriatic spondylitis is an active aspect of the life of patients with psoriasis. So the purpose of this study was to explore using, whole body MRI, the aspects of inflammation using this novel CANDEM methodology. So the patients had to have psoriatic arthritis, obviously peripheral arthritis, had to fulfill the CASPER criteria and a whole body MRI with contrast was obtained at baseline twenty four and forty eight weeks. And the purpose was again to try to establish a cause relationship or perhaps an association or an observation of the impact of Apremilas in axial disease in patients with psoriatic arthritis. So of a total of one hundred and twenty two patients in the cohort, forty patients met the criteria for axial spondylitis according to using the BasDie questionnaire.
This axial inflammation permitted patients to be involved and evaluated through the methodology the first time perhaps reported in study of this nature using whole body MRI with contrast to assess characteristics associated with axial pathology in these patients with psoriatic arthropathy. So the results showed that CANDEM analysis allowed us to demonstrate that there was evidence of significant differences between the patients who were on treatment at different time points showing superiority in all the different aspects of the readout using the CANDEN methodology. However, when the patients were subject to spark criteria, they did not meet that endpoint. What is the message that we get from this abstract is that psoriatic spondylitis is an important part of the life of patients with psoriatic arthritis. We know that the APREMILA studies were not used or they don't use radiographic methods in the registration trials, but the spirit of having this trial was to demonstrate further that PEMILAS still apparently has an impact on controlling certain aspects of inflammation as we see with this very clear methodology using the CANDEM which enables us to see not only the vertebral aspects of the inflammation but also the posterior vertebral aspect of inflammation.
The summary would be that it's important to know and important to learn what using this method teach us about the axial impact of aprimilaz in these patients. Thank you. Hello, I'm Doctor. Guillermo Valenzuela. I am reporting from a ACR twenty twenty four from Washington DC.
Today I will be discussing quickly the concepts related to the poster L10, which relates to the neuro immune modulation in adult patients with rheumatoid arthritis with BIOD DMARDs and targeted synthetic DMARDs, inadequate responses at twelve and twenty four weeks using a sham controlled double blind. So you'll be surprised to know that this is not a therapeutic intervention with a traditional oral medication or a biologic medication, but this is using an implantable device that stimulates the vagus nerve. Of concern to many and interesting aspect of the science as I will show you further. So the purpose was to evaluate essentially the safety and efficacy of an implantable device in the cervical vagus region and patients would be subject to constant daily stimulation. The total cohort in this study was two forty two patients that were randomized in a one to one ratio to a sham, which was essentially the device being turned off for the first twelve weeks and then every patient coming onto the active arm after twelve weeks of treatment.
So this double blind assessment allowed to obtain information during the first twelve weeks which were critical to understanding perhaps the signal that this therapeutic intervention could show. So the patients had to have a previous failure to at least one bio DMARC or one targeted synthetic DMARC. There were secondary endpoints that were also as important as the primary, which was the ACR20. And the secondary endpoints included DAS28, MCID, HACC and one important one that perhaps gave this study a value of objective assessment was the erosion progression score using a Rambris score. So that would work essentially as a control of the activity.
And also the DAS remission was part of the secondary endpoints. After week twelve, as I mentioned before, there was an active crossover. So every patient at week twelve received neuromodulation by this device, was surgically implanted in left, in the vagus nerve of these patients. Just a word about the demographics, patients were an average of 56 years of age and eighty six percent of these were females and the average duration of disease was close to twelve years. In terms of the breakdown of previous exposure to therapies, it's interesting to know that the patients who received bio DMARDs, thirty nine percent of them had failed one previous DMARDs, about twenty two percent DMARC and three DMARC about thirty nine percent of them.
Fifty three percent of these patients were seropositive and the high sensitivity C reactive protein was 8.2. So important now is the results. At week 12, we saw a statistically significant difference in the groups, in the active groups versus the sham groups. Was a thirty five percent of the patients who achieved a ACR twenty versus a twenty four percent in the sham group, which gave a P value of 0.02. Now, it's even important to see that week 24, fifty percent, I'm sorry, fifty one percent of the patients on the active group continue to show ACR 20s, of which fifty three percent of them were the ones who were previously in the sham group.
So all the secondary exploratory endpoints also showed a tendency that correlated with the ACR scores. In other words, there was a accomplishment of the goals of secondary endpoints. Such as one of the most important ones perhaps is week 12, the CRP low disease activity, a DAS score. There's also the progression of the erosion through MRI was demonstrated. And the most important one which we can all think about is safety.
Regardless of the surgical nature of the procedure, was a rather safe procedure. Serious adverse events were only 1.7 and we can't imagine the most common adverse event was a post surgical transient hoarseness and related symptoms to the procedure itself. There were no reported deaths and as a conclusion, I think this is a very interesting and absolutely novel way to modulate rheumatoid arthritis by a non traditional mechanism, is not an oral agent or injectable agent or infusible agent as we are accustomed to seeing our armamentarium is rather an implantable device with all the implications that it brings up. So perhaps the final word would be we are interested in knowing the long term effects of these outcomes, and I hope to be able to report those findings in the next presentation. Thank you very much.
Hello, everyone. I'm Richard Conway reporting for RheumNow from ACR twenty twenty four. I'm going to talk to you today about a study presented at Sunday's plenary session. This was from Cornelia Quack and colleagues from The Netherlands. It's abstract number sixteen forty seven.
So this was a study looking at rheumatoid arthritis and looking at treat to target. I was particularly interested in the pregnancy space. So to do this, they had a new study, which was called Pre Cara, and they were comparing this to their previous study of these patients around pregnancy, which is called Para. There were two fifteen patients in the new study, two forty five in the old study. And the difference between them was that the old study was kind of a standard of care study and the new one was this treat to target implementation in this group who were intending on becoming pregnant.
So to do that, they had this escalating regime of drugs, starting with sulfasalazine and hydroxychloroquine, and if necessary, adding in a TNF inhibitor. And they also based on previous knowledge of how medications affect pregnancy, had a real focus on trying to limit non steroidal anti inflammatories and glucocorticoids in these patients. So the first thing, did the treat to target achieve what it set out to do? Did it reduce disease activity? And it did.
So that CRP was 2.33 in the new study compared to 3.84 in the old study. And then looking at fertility. So they did this by looking at the time to pregnancy. And that was eighty four days in pre Cara in the new study compared to the historical one hundred and ninety six days. And then when they looked at kind of problems conceiving or bigger problems conceiving, so looking at twelve month cutoff, who got beyond twelve months, it was twenty three percent of patients in the new group compared to forty two percent of patients in the older cohort.
So this study, I think, really very much says that fully controlling disease activity and using the agents we need to do that improves fertility. And so now we know that it improves fertility. We already have other data showing that it improves pregnancy outcomes, reduces stillbirths, preterms, births, miscarriages, all those sorts of things we really want to avoid. I think this increasing evidence that we need to be better and need to be optimized the treatment of patients who are planning pregnancy and becoming pregnant. We need to overcome the fears that many patients have regarding these medications through education and spending the necessary time with them.
And I think we definitely also need to overcome a bit of an inertia among both physicians and patients regarding these agents and not putting things off until after pregnancy, that everything will be better. And we can confidently say that based on the data that we now have, if we treat these patients with certain of the medications we have available to us. So I'm Richard Conway. You can see me on Twitter RichardPAconway. And do check out RheumNow for all the up to date coverage from ACR twenty twenty four.



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