RheumNow Podcast Ghastly, Ghoulish, News (10.31.19) Save
RheumNow Podcast Ghastly, Ghoulish, News (10.31.19) by Dr. Cush
Transcription
It's 11/01/2019. This is the RheumNow podcast. Hi, I'm Doctor. Jack Cush, executive editor of roomnow.com. This week, the ghastly, the ghostly news everyone's afraid to hear.
The RheumNow podcast is a little bit like the cemetery where people are dying to get in. People are just dying to hear what we have to say every week here on the podcast. Data from over fourteen thousand psoriatic arthritis patients, sort of a pooled effort from 11 European registries, looked at the success of TNF inhibitors over time. Follow-up of these patients showed that half of them were in DAS remission at six months. Really impressive.
Fifty three percent were in ACR20 response status also at six months. At one year, two thirds of patients were still taking TNF inhibitors. What does this tell you? It tells you our patients with psoriatic arthritis do pretty darn well on TNF inhibitors. That DAS remissions, which sounds great, achieved in half the patients is the same number as ACR 20 responses, which many of you think is a twenty percent response and not that much.
You want to see ACR 50, ACR 70. I'm sorry folks. An ACR 20 response is a darn good response. Twenty percent or more on five out of seven variables is very, very hard to achieve. When patients get an ESR20 response, think of it as a DAS remission.
These numbers are really impressive. It begs the question, do we need other therapies and how much do we need other therapies like IL-twelve twenty three and IL-seventeen and Primalast and other therapies for our psoriatic arthritis patients? Certainly we do need them. There are patients who do not respond to one or two TNF inhibitors, but again, my experience has been a lot of patients do really, really well with just TNF inhibition. We reported yesterday on an interesting study that looked at something unique amongst rheumatologists and that is, how often are you able to engage into something called shared decision making?
In this particular unique study, they used audio recordings of over 160 different encounters, and they scored the encounter based on the dialogue that went on between the patient and the physician on a number of different parameters and came up with something called the option score, which had a zero to 100 score, 100 being the best possible evidence of shared decision making between the physician and the patient. Well, guess what? We aren't doing so well. The median score was 28. Standard deviation here was 15.
It turns out that the highest levels of shared decision making were seen when there were longer consultations and when there was time and effort put into discussions about starting therapy, stopping therapy, changing therapy, or adjusting therapy, including steroid use. Bottom line, better shared decision making happens to take time and talk. Something that's kind of in short supply and hard to do. So, we talked about IL-seventeen and IL-twelve twenty three and new therapies for patients who have psoriatic disease. An interesting claims based analysis looked at a very large number of patients treated with psoriasis and psoriatic arthritis between 2015 and 2018 and showed for all the new biologic starts with either TNF inhibitors, any one of the two IL-seventeen inhibitors, execizumab or secukinumab, or any one of five different TNF inhibitors and the use of the IL-twelve twenty three.
Again, individually, their performance was all about the same. The overall rate in the real world claims data world of SIEs in a psoriatic population, skin or joints, was two percent. That's hospitalizable serious infections. What they found is that the SIE rates were roughly the same when comparing the IL-seventeen agents to the TNF inhibitors where the, I think it was the hazard ratio was like 0.8 or something like that, but it crossed over one saying that they were equivalent between IL-seventeen inhibitors and TNF inhibitors. However, it was lower when you looked at IL-twelve twenty three inhibitors, STELARA or ustekinumab, where there, there was a lower rate of serious infections compared to TNF inhibitors with a hazard ratio of zero point five nine, suggesting a forty one percent decreased risk of serious infections with Now, that mean ustekinumab is a much safer drug?
No. It may mean the patients who get on ustekinumab may have milder disease, less complicated disease. Maybe more skin disease and less joint disease. There are lot of factors that go into it, but the bottom line is I think the performance characteristics of these biologics in psoriatic arthritis are probably better than what we usually see in patients with either rheumatoid arthritis or Crohn's disease as far as the SIB rate. A nice report done by Ted Mickels and a bunch of colleagues looked at the associations between RA disease activity and the multi biomarker disease activity or MBDA, also known as Vectra, the commercially available test often used as a biomarker, not proven to be a biomarker folks, a lot of associations between this and this and that.
Well, looked at all the studies looking at the associations with disease activity. They found 22 studies, again, sort of a comprehensive review. And when they compared the Vectra scores to the scores achieved in disease activity, DAS ERP, DAS ESR, you know what? They showed what they called modest correlations between Vectra and disease activity. For instance, the R value, the correlation coefficient was only 0.41 for the DAS ERP.
It was lower if you looked at CDI, SDI, and Rapid three, with the Rapid three having an r value of 0.23. Folks, that's not very good. Recognize that the MBDA was developed based on the DAS28 ESR and correlated with that. So I would expect higher rates. Moreover, when you talk to sales reps for, from Myriad, talking about Vector, they say, Our doctors say it's like getting a second opinion about how the patient's doing.
Well, these numbers don't really speak very highly of the correlation coefficients. Again, I think the company is doing some tests to show the biomarker potential of this drug, but that's still not in evidence. I don't do Vectra. So, what happens to lupus patients when they go to the ER? An interesting analysis looked at a fairly large cohort and how lupus patients will use the emergency room.
And I found this to be a striking sort of analysis. They showed that lupus patients were more apt to use the emergency room for pain management. And such patients, not surprisingly, were on narcotics. We had a report a number of weeks ago about the association of lupus patients taking narcotics and it was unsurprisingly high. One doesn't think of lupus as a pain ridden structural damage condition.
Certainly they can have pain just like any patient can have pain, just like any fibromyalgia can have pain. The question is why are they on narcotics and why are lupus patients going to emergency room to manage their pain with narcotics? It's a big problem that does need to be addressed. A study looked at what happens when you give psoriatic arthritis patients biologics. Two hundred and thirty eight patients were started on a new biologic and they did kind of as you would expect.
However, when they looked at those patients who had secondary comorbid fibromyalgia in addition to their psoriatic arthritis and those who didn't have secondary fibromyalgia, there was a big difference in the outcomes. Patients who had psoriatic arthritis and comorbid fibromyalgia had lower biologic survival, fifty versus seventy four percent, that's one third less if you had fibromyalgia, and that patients were less likely to achieve remission. In fact, it was like, you know, zero and three percent at six months and three months if you had fibromyalgia, whereas those who didn't, quite commonly fifteen or twenty percent achieved remission. So it's something that you should think about when managing psoriatic arthritis. Patients are not doing well, not responding, maybe you're not treating psoriatic arthritis, maybe there's an element of fibromyalgia involved.
So another nice study was done about the issue of VTE and the therapies we use. This is a very large study looking at over two hundred and fifty thousand patients started on and switching to either conventional DMARDs or a biologic or a targeted synthetic DMARD that would mean like a JAK inhibitor. And they basically showed that when compared to the first conventional DMAR use, from biologic to biologic and from biologic to biologic a second time was associated with a higher rate of VTEs. When I say biologic, I mean biologic to either also to a JAK inhibitor or what they call a TSDMAT, a targeted synthetic DMART. So switching from these advanced therapies to other advanced therapies was associated with about a thirty percent increase, a hazard ratio of one point three six.
And then when you went from the first to the second, it went from thirty five to one point four eight, so a forty eight percent increase, suggesting, is it the drugs or is it patients that are doing poorly enough that have a lot of inflammation that get VTEs? VTEs are part of inflammation, part of rheumatoid arthritis. And hence, you're using aggressive therapy like these new drugs and biologics that may be a part of it. I think the story now with the box warning on all the JAK inhibitors is you probably shouldn't use a JAK inhibitor in someone who has a history of VTE, DVT or pulmonary embolism. But if it arises, you have to make a decision.
Is the drug working well enough that I should use it? Can you manage the VTE risk? Or do you stop it and move for something else? I think it's often based on what is available in something else. I put a nice story up which came from MD Links and one of their partners.
I scan MD Links as well for good and interesting articles. They had a nice article on common HIPAA violations. I think it's important that we think about this and consider this. There's five of them. One, forwarding personal health information via a personal email account.
If you do that, you're pretty guilty. It's not secure. It's not encrypted. Don't do that. Number two, pulling up information on a computer, getting involved, walking away from the the computer, and personal health information is being displayed.
If you leave, you either have to sign off or put that computer to sleep or make it inaccessible to outside eyes. Third, disclosing patient information to an unauthorized individual. Obviously, you know, if the UPS man comes in saying, want the records on John Smith, It's like, no, you make deliveries, you don't do pickups on personal health information. Now, if they're on his list, then fine. But what we're talking about here really is talking to someone who maybe does have the right to have personal health information, a husband, a wife, but you're now doing it in the presence of their neighbor who came along for the ride.
You need to be sure that when you're talking to someone who is authorized to receive HIPAA protected information, that you're only talking to those who are approved to do so and not their tagalongs or people in the background. And lastly, two more things, removing storage removable devices, USB sticks, which are often not encrypted, have patient information on it, that's a no no. And lastly, not engaging in password management programs. I think life has gotten complex enough. If you're dealing with patient information, have a password management program.
I think that they work very well and can help protect you and also your patients. Two more reports. These authors had a report, this is from British Columbia, they looked at seventeen thirty pregnancies over thirteen hundred rheumatoid arthritis patients and looked the continuation rates of DMARDs and other therapies, including biologics, once the patient gets pregnant. They looked at their engagement in the preconception period and what happened. More than half patients, of these patients, thirteen hundred rheumatoid patients, stopped or discontinued their DMARD or biologic therapy upon getting pregnant.
Turns out the vast majority of these, over two thirds of these occur in the first trimester as soon after they discover they're pregnant. The rates are surprising to me. Antimalarials, fifty seven percent. Azathioprine, fifty nine percent. Sulfasalazine, almost seventy percent.
Biologics, fifty one percent discontinued as soon as they learned they were pregnant. The highest rate was seen in the first trimester. Highest in patients who were multiparous, who were younger, had fewer rheumatology visits suggesting that the young and inexperienced, not well coached, not well educated are going to stop their therapies. I'll remind you, rheumatoid don't go into remission when they get pregnant. That's a 1950s, 1960s falsehood.
Eighty percent are supposed to go into remission wrong. Actually, third, one third, one third. One third get better, one third stay the same, one third get worse. That's sort of a very simplistic but something you should really consider. Lastly, methotrexate and the risk of lung disease, a very nice review in rheumatology by Elena Nicofouro and other of her Scottish colleagues did a nice review on the risk of developing methotrexate related side effect.
They talked about methotrexate hypersensitivity pneumonitis. Previous reports said it was zero point eight to eleven percent risk of methotrexate induced pneumonitis. Turns out it's far, far less. It's less than two percent, I think was the number they had. The take homes from this was that if you use methotrexate, there's a slight but reproducible increased risk of common infections, most of that being non serious infections.
But even serious lower respiratory tract infections. Number two, the risk of methotrexate pneumonitis is clearly related to methotrexate. That's true. You can't get it if you're not on methotrexate. And it may have a relative risk of seven point eight, but the actual vent rate is really very, very low and is almost not seen these days.
My own bias is that you're unlikely to get it if you're on background folic acid And that's one of the benefits of being on folic acid. But that's not part of this report. Number three, that the rate of methotrexate induced pneumonitis has fallen. Number four, that methotrexate is not associated with worsening of interstitial lung disease in those who have RA lung, but that nonetheless you should have caution when using methotrexate in patients who have pre existing lung disease because if you make them worse and they already got a bad background, baseline FVC, FEV1, very low DLCOs, any impairment that you may induce with methotrexate would not be advisable. That's it for this week.
Go to the website, check out our citations. I want to remind you, next week is ACR. We start reporting on the ninth no, on the tenth Sunday. We're going have reports every day from the ACR. We're to have a new website where you're going to find all of our content on our website, not on another page, but on our website.
I think there's going be some interesting things like polling and Twitter polls. We've got a lot of faculty, we've got a lot of KOLs and major heavy hitters that are going to get through some videos for us and panel discussions. We're going to feature content on ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, gout, and my favorite, auto inflammatory disease. Again, check out our videos and our podcasts, which will be plentiful, from ACR nineteen in Atlanta. See you next week, folks.
Happy what?
The RheumNow podcast is a little bit like the cemetery where people are dying to get in. People are just dying to hear what we have to say every week here on the podcast. Data from over fourteen thousand psoriatic arthritis patients, sort of a pooled effort from 11 European registries, looked at the success of TNF inhibitors over time. Follow-up of these patients showed that half of them were in DAS remission at six months. Really impressive.
Fifty three percent were in ACR20 response status also at six months. At one year, two thirds of patients were still taking TNF inhibitors. What does this tell you? It tells you our patients with psoriatic arthritis do pretty darn well on TNF inhibitors. That DAS remissions, which sounds great, achieved in half the patients is the same number as ACR 20 responses, which many of you think is a twenty percent response and not that much.
You want to see ACR 50, ACR 70. I'm sorry folks. An ACR 20 response is a darn good response. Twenty percent or more on five out of seven variables is very, very hard to achieve. When patients get an ESR20 response, think of it as a DAS remission.
These numbers are really impressive. It begs the question, do we need other therapies and how much do we need other therapies like IL-twelve twenty three and IL-seventeen and Primalast and other therapies for our psoriatic arthritis patients? Certainly we do need them. There are patients who do not respond to one or two TNF inhibitors, but again, my experience has been a lot of patients do really, really well with just TNF inhibition. We reported yesterday on an interesting study that looked at something unique amongst rheumatologists and that is, how often are you able to engage into something called shared decision making?
In this particular unique study, they used audio recordings of over 160 different encounters, and they scored the encounter based on the dialogue that went on between the patient and the physician on a number of different parameters and came up with something called the option score, which had a zero to 100 score, 100 being the best possible evidence of shared decision making between the physician and the patient. Well, guess what? We aren't doing so well. The median score was 28. Standard deviation here was 15.
It turns out that the highest levels of shared decision making were seen when there were longer consultations and when there was time and effort put into discussions about starting therapy, stopping therapy, changing therapy, or adjusting therapy, including steroid use. Bottom line, better shared decision making happens to take time and talk. Something that's kind of in short supply and hard to do. So, we talked about IL-seventeen and IL-twelve twenty three and new therapies for patients who have psoriatic disease. An interesting claims based analysis looked at a very large number of patients treated with psoriasis and psoriatic arthritis between 2015 and 2018 and showed for all the new biologic starts with either TNF inhibitors, any one of the two IL-seventeen inhibitors, execizumab or secukinumab, or any one of five different TNF inhibitors and the use of the IL-twelve twenty three.
Again, individually, their performance was all about the same. The overall rate in the real world claims data world of SIEs in a psoriatic population, skin or joints, was two percent. That's hospitalizable serious infections. What they found is that the SIE rates were roughly the same when comparing the IL-seventeen agents to the TNF inhibitors where the, I think it was the hazard ratio was like 0.8 or something like that, but it crossed over one saying that they were equivalent between IL-seventeen inhibitors and TNF inhibitors. However, it was lower when you looked at IL-twelve twenty three inhibitors, STELARA or ustekinumab, where there, there was a lower rate of serious infections compared to TNF inhibitors with a hazard ratio of zero point five nine, suggesting a forty one percent decreased risk of serious infections with Now, that mean ustekinumab is a much safer drug?
No. It may mean the patients who get on ustekinumab may have milder disease, less complicated disease. Maybe more skin disease and less joint disease. There are lot of factors that go into it, but the bottom line is I think the performance characteristics of these biologics in psoriatic arthritis are probably better than what we usually see in patients with either rheumatoid arthritis or Crohn's disease as far as the SIB rate. A nice report done by Ted Mickels and a bunch of colleagues looked at the associations between RA disease activity and the multi biomarker disease activity or MBDA, also known as Vectra, the commercially available test often used as a biomarker, not proven to be a biomarker folks, a lot of associations between this and this and that.
Well, looked at all the studies looking at the associations with disease activity. They found 22 studies, again, sort of a comprehensive review. And when they compared the Vectra scores to the scores achieved in disease activity, DAS ERP, DAS ESR, you know what? They showed what they called modest correlations between Vectra and disease activity. For instance, the R value, the correlation coefficient was only 0.41 for the DAS ERP.
It was lower if you looked at CDI, SDI, and Rapid three, with the Rapid three having an r value of 0.23. Folks, that's not very good. Recognize that the MBDA was developed based on the DAS28 ESR and correlated with that. So I would expect higher rates. Moreover, when you talk to sales reps for, from Myriad, talking about Vector, they say, Our doctors say it's like getting a second opinion about how the patient's doing.
Well, these numbers don't really speak very highly of the correlation coefficients. Again, I think the company is doing some tests to show the biomarker potential of this drug, but that's still not in evidence. I don't do Vectra. So, what happens to lupus patients when they go to the ER? An interesting analysis looked at a fairly large cohort and how lupus patients will use the emergency room.
And I found this to be a striking sort of analysis. They showed that lupus patients were more apt to use the emergency room for pain management. And such patients, not surprisingly, were on narcotics. We had a report a number of weeks ago about the association of lupus patients taking narcotics and it was unsurprisingly high. One doesn't think of lupus as a pain ridden structural damage condition.
Certainly they can have pain just like any patient can have pain, just like any fibromyalgia can have pain. The question is why are they on narcotics and why are lupus patients going to emergency room to manage their pain with narcotics? It's a big problem that does need to be addressed. A study looked at what happens when you give psoriatic arthritis patients biologics. Two hundred and thirty eight patients were started on a new biologic and they did kind of as you would expect.
However, when they looked at those patients who had secondary comorbid fibromyalgia in addition to their psoriatic arthritis and those who didn't have secondary fibromyalgia, there was a big difference in the outcomes. Patients who had psoriatic arthritis and comorbid fibromyalgia had lower biologic survival, fifty versus seventy four percent, that's one third less if you had fibromyalgia, and that patients were less likely to achieve remission. In fact, it was like, you know, zero and three percent at six months and three months if you had fibromyalgia, whereas those who didn't, quite commonly fifteen or twenty percent achieved remission. So it's something that you should think about when managing psoriatic arthritis. Patients are not doing well, not responding, maybe you're not treating psoriatic arthritis, maybe there's an element of fibromyalgia involved.
So another nice study was done about the issue of VTE and the therapies we use. This is a very large study looking at over two hundred and fifty thousand patients started on and switching to either conventional DMARDs or a biologic or a targeted synthetic DMARD that would mean like a JAK inhibitor. And they basically showed that when compared to the first conventional DMAR use, from biologic to biologic and from biologic to biologic a second time was associated with a higher rate of VTEs. When I say biologic, I mean biologic to either also to a JAK inhibitor or what they call a TSDMAT, a targeted synthetic DMART. So switching from these advanced therapies to other advanced therapies was associated with about a thirty percent increase, a hazard ratio of one point three six.
And then when you went from the first to the second, it went from thirty five to one point four eight, so a forty eight percent increase, suggesting, is it the drugs or is it patients that are doing poorly enough that have a lot of inflammation that get VTEs? VTEs are part of inflammation, part of rheumatoid arthritis. And hence, you're using aggressive therapy like these new drugs and biologics that may be a part of it. I think the story now with the box warning on all the JAK inhibitors is you probably shouldn't use a JAK inhibitor in someone who has a history of VTE, DVT or pulmonary embolism. But if it arises, you have to make a decision.
Is the drug working well enough that I should use it? Can you manage the VTE risk? Or do you stop it and move for something else? I think it's often based on what is available in something else. I put a nice story up which came from MD Links and one of their partners.
I scan MD Links as well for good and interesting articles. They had a nice article on common HIPAA violations. I think it's important that we think about this and consider this. There's five of them. One, forwarding personal health information via a personal email account.
If you do that, you're pretty guilty. It's not secure. It's not encrypted. Don't do that. Number two, pulling up information on a computer, getting involved, walking away from the the computer, and personal health information is being displayed.
If you leave, you either have to sign off or put that computer to sleep or make it inaccessible to outside eyes. Third, disclosing patient information to an unauthorized individual. Obviously, you know, if the UPS man comes in saying, want the records on John Smith, It's like, no, you make deliveries, you don't do pickups on personal health information. Now, if they're on his list, then fine. But what we're talking about here really is talking to someone who maybe does have the right to have personal health information, a husband, a wife, but you're now doing it in the presence of their neighbor who came along for the ride.
You need to be sure that when you're talking to someone who is authorized to receive HIPAA protected information, that you're only talking to those who are approved to do so and not their tagalongs or people in the background. And lastly, two more things, removing storage removable devices, USB sticks, which are often not encrypted, have patient information on it, that's a no no. And lastly, not engaging in password management programs. I think life has gotten complex enough. If you're dealing with patient information, have a password management program.
I think that they work very well and can help protect you and also your patients. Two more reports. These authors had a report, this is from British Columbia, they looked at seventeen thirty pregnancies over thirteen hundred rheumatoid arthritis patients and looked the continuation rates of DMARDs and other therapies, including biologics, once the patient gets pregnant. They looked at their engagement in the preconception period and what happened. More than half patients, of these patients, thirteen hundred rheumatoid patients, stopped or discontinued their DMARD or biologic therapy upon getting pregnant.
Turns out the vast majority of these, over two thirds of these occur in the first trimester as soon after they discover they're pregnant. The rates are surprising to me. Antimalarials, fifty seven percent. Azathioprine, fifty nine percent. Sulfasalazine, almost seventy percent.
Biologics, fifty one percent discontinued as soon as they learned they were pregnant. The highest rate was seen in the first trimester. Highest in patients who were multiparous, who were younger, had fewer rheumatology visits suggesting that the young and inexperienced, not well coached, not well educated are going to stop their therapies. I'll remind you, rheumatoid don't go into remission when they get pregnant. That's a 1950s, 1960s falsehood.
Eighty percent are supposed to go into remission wrong. Actually, third, one third, one third. One third get better, one third stay the same, one third get worse. That's sort of a very simplistic but something you should really consider. Lastly, methotrexate and the risk of lung disease, a very nice review in rheumatology by Elena Nicofouro and other of her Scottish colleagues did a nice review on the risk of developing methotrexate related side effect.
They talked about methotrexate hypersensitivity pneumonitis. Previous reports said it was zero point eight to eleven percent risk of methotrexate induced pneumonitis. Turns out it's far, far less. It's less than two percent, I think was the number they had. The take homes from this was that if you use methotrexate, there's a slight but reproducible increased risk of common infections, most of that being non serious infections.
But even serious lower respiratory tract infections. Number two, the risk of methotrexate pneumonitis is clearly related to methotrexate. That's true. You can't get it if you're not on methotrexate. And it may have a relative risk of seven point eight, but the actual vent rate is really very, very low and is almost not seen these days.
My own bias is that you're unlikely to get it if you're on background folic acid And that's one of the benefits of being on folic acid. But that's not part of this report. Number three, that the rate of methotrexate induced pneumonitis has fallen. Number four, that methotrexate is not associated with worsening of interstitial lung disease in those who have RA lung, but that nonetheless you should have caution when using methotrexate in patients who have pre existing lung disease because if you make them worse and they already got a bad background, baseline FVC, FEV1, very low DLCOs, any impairment that you may induce with methotrexate would not be advisable. That's it for this week.
Go to the website, check out our citations. I want to remind you, next week is ACR. We start reporting on the ninth no, on the tenth Sunday. We're going have reports every day from the ACR. We're to have a new website where you're going to find all of our content on our website, not on another page, but on our website.
I think there's going be some interesting things like polling and Twitter polls. We've got a lot of faculty, we've got a lot of KOLs and major heavy hitters that are going to get through some videos for us and panel discussions. We're going to feature content on ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, gout, and my favorite, auto inflammatory disease. Again, check out our videos and our podcasts, which will be plentiful, from ACR nineteen in Atlanta. See you next week, folks.
Happy what?
If you are a health practitioner, you may Login/Register to comment.
Due to the nature of these comment forums, only health practitioners are allowed to comment at this time.