The RheumNow Week In Review Lupus In The News %287.27.18%29 Save
The RheumNow Week In Review Lupus In The News %287.27.18%29 by Dr. Cush
Transcription
It's the 07/27/2018. This is the RoomNow we can review. Hi. I'm doctor Jack Cush, executive editor of roomnow.com. This week, have information about new money and salaries that may fix the rheumatology manpower problem.
There might actually be a new drug and certainly there are new guidelines for lupus and a study that looks at whether PET scans might be superior to MRA in large vessel vasculitis. Before the news, I want you to know tomorrow I'm going to be going to Chicago for a weekend meeting, what's called the Great Lakes Rheumatology Review in Chicago. If you don't know about this meeting and you're in the area, sure to stop in. You can easily register at arthros.org to find out where the meeting is. Fabulous faculty, myself, Arti Cavanaugh, Mike Weinblad, Kevin Winthrop, and Joel Block.
It'll be standing room only. So this week's news begins with report from Annals of Rheumatic Disease that looked at patients in the IMPROVE study. The IMPROVE study enrolled three eighty four patients with early RA and then followed them over time. This specific analysis of that data set looked at the subset of those who became seronegative during the course of study, during the first year, and found out that actually those who turned from to zero didn't necessarily have a better outcome. In fact, remission was, achieving drug free remission was the same whether you were zero positive or zero negative.
This says a lot about the issue of zero negative and I think we have beliefs that zero negative might be milder disease, seropositive may be more severe disease. There's a lot of data out there that seropositives may do better because seropositive patients respond better to certain therapies. Seronegatives may not do better because they may have to have a whole lot of RA like disease to be called RA even though they're seronegative. So the outcomes are not quite as clear as you might think. Interesting data merits more study.
There's a new designation from the FDA wherein they are granting orphan drug status to Lenabasum, previously known as Anabasum. It's a cannabinoid receptor agonist that's used to treat a number of different disorders. The FDA has given orphan drug status for the use of Lenabasum in dermatomyositis and they're gonna be developing trials in that. It's also being studied in lupus and in scleroderma mainly for cutaneous outcomes. This cannabinoid receptor agonist has been known to have effects on immune cells and on fibroblasts may be effective in scleroderma.
Again, it's sort of interesting data has been thus far presented at meetings. Although they're only small, when you see larger studies, it may be a new line of therapy. When is DSH not DSH? I had a patient this week where they presented with DSH and a whole lot of pain, which led me to look up a number of things and report on it. Basically, found out that pain in DSH is usually not from DSH.
DSH patients are usually asymptomatic. They may have some stiffness in their lumbar or thoracic spine. They may have some stiffness in their neck, but true pain is not a part of that and usually it's going be due to something else. DISH, as you know, is a bone forming diathesis that is directed at the spine but has ossification of ligaments and tendons that gives you those big bulky osteophytes that you see on x-ray. DISH can be problematic and difficult to manage.
There is some interesting data in the last year or so about tofacitinib in pregnancy. There are a number of studies that have been reported about tofacitinib use in women who had RA and were exposed and got pregnant, and a more recent report was done in ulcerative colitis. Megan Clouse was actually an author on both these papers. They're interesting. They're basically kind of small data sets in RA forty seven women, forty four men.
In ulcerative colitis, eleven women and fourteen men were exposed to tofacitinib at the time that there was conception. Bottom line is in this data set there's only one congenital defect and the other outcomes seem to be on par with what you might expect in these disorders so somewhat encouraging although still small, this could become a drug that we might want to consider. Right now we have a lot of data on a lot of other drugs especially TNF inhibitors about their efficacy. The bottom line is in pregnancy it's more likely to be the disease that affects the fetal and maternal outcomes and not the drug. So it's important to treat the maternal disease first so you can have optimal fetal outcomes.
An interesting study looked at a cohort of women, sorry, patients who had the anti phospholipid syndrome. Two fourteen met criteria and they looked at how many people were pure primary, APS. When they excluded patients who had, SLE features, and those who had known connective tissue disease, those who had high titer ANA, testing, left them with about half the group that had primary APS. When these people were followed for up to twelve years none of them developed lupus. Very encouraging.
However, there's always a however, over a quarter of them, twenty eight percent still had three or more, actually four or more, slick criteria for the diagnosis of lupus suggesting that that still might be a possibility even though they've been followed for twelve years. This is still a confusing cohort to know what to do with. Certainly right now you treat what you have not what you don't have, but I think patients should be followed with the jaded view that they could develop an autoimmune disease, not necessarily lupus, it could be Sjogren's syndrome or other entities as well. There's good news from the recent 2018 Medscape report on resident salary and resident debt. When they looked at the salaries of residents and fellows, they found that rheumatology fellows, guess what, were number two in paid salaries.
They were paid, were second only to allergy and immunology and rheumatology fellows were getting an average of 66,200 a year. I'm thinking of quitting my job and going back to fellowship. This was better than what residents and fellows are paid in surgery, GI and critical care. Unfortunately, this total cohort of residents and trainees, over half of them had a significant amount of debt, over $200,000 in medical school debt. So these salaries are important, but it's certainly important in rheumatology where we're trying to find, more rheumatologists for the future and certainly if we can improve the salaries and get more people to go in just for a salary alone, I say do it.
It's a whole lot easier than trying to expand training programs and find funding for that. The Journal of Rheumatology has an interesting report from Denmark that looked at a cohort of lupus patients, specifically one hundred and forty seven, who, when characterized showed that those who had renal disease, which was a significant number, half of them had lupus nephritis and lupus renal disease. It turns out that if they had lupus nephritis and reduced renal function with a GFR of less than 70 cc's per minute, these were significantly higher risk, six times more likely to have coronary artery calcifications and significant coronary plaque disease. So again, we know that the ESRD patients, renal failure patients also like our inflammatory disease patients do have higher rates of this. Turns out if you have an inflammatory disorder, autoimmune disorder, and you have renal disease, guess what, you're significantly at greater risk for coronary disease.
Allergy Rheumatic Disease talks on a specific study that compares, large vessel vasculitis patients about eighty four who either had GCA or Takayasu's and they did side by side MRAs and, PET scans. And they showed that it turns out that both of them were somewhat complementary in the information that was revealed, That the agreement between the two was seen in about sixty percent of cases, sixty eight percent in disease activity, but the bottom line is MRA was better at capturing the extent and range of disease and PET scanning was better suited to assess vascular activity or disease activity. So again I know the big issue in many of you is the who's gonna pay for this and how can I get this done? It's easier to get an MRA paid for than a PET scan but it turns out PET scanning does have significant advantages in a lot of different disorders and a lot of different situations, including this one. So in problematic cases this may be something to look into.
Last week I did a recording report on the weekend review before I looked at Lancet and Lancet reported last Friday on the newly released Baricitinib study in, lupus patients. This was a study that was the lead author was Dan Wallace, three fourteen lupus patients who had to get in they had to have skin and joint disease and had to have disease activity. Six month trial where patients were treated with placebo, two milligrams or four milligrams of baricitinib, the JAK1 JAK2 inhibitor that right now is only approved at the two milligram dose for rheumatoid arthritis. It's not approved for anything else, approved for lupus, but this is an important study. It looks at the potential utility of JAK inhibition in patients with lupus.
There's a lot of biologic rationale for that. Anyway, in their trial, the two milligram dose was not significant at six months. It turns out that when the primary endpoint was SLEDI two ks joint and rash involvement being improved significantly was seen a sixty seven percent on four milligrams and fifty three percent on placebo and that was significant at point zero four. So the safety profile is exactly what you see in RA. There were no increased risk of VTEs here.
This is a good data that says that we should proceed and further examine, JAK inhibitors in lupus, where we would be nice to have another new effective oral therapy. An interesting study comes out of Leeds in the ability to predict when ANA positive patients may progress to an autoimmune disease. They studied one hundred and eighteen individuals who were ANA positive had to have one lupus manifestation and had to, be treatment naive. When they followed them over a year, it turns out that sixteen percent progressed or nineteen developed an autoimmune disease. And it turns out that the predictive factors weren't clinical, that clinical features like activity and or, any other labs were not, they weren't helpful.
What was helpful in predicting progression was finding either having a family history of an autoimmune disease which gave you an eightfold increased risk or having an interferon signature, suggesting that your dendritic cells and alpha interferon are all being turned on probably active and now and those people had a threefold increased risk of developing lupus. So I don't know if we do are going to do this in our ANA positive consults, not a good idea, but I can tell you screening all fibromyalgia patients, all anti positive patients, you do see patients who do have an interferon signature and you wonder, will they develop lupus over time? So this could end up becoming a clinical tool in the future. The last full report is from Naomi Schlesinger and Hyun Choi that looked at the incidence of erectile dysfunction in a UK database and it showed that having gout increased the risk of having erectile dysfunction by as much as fifteen-sixteen percent. If you looked at only those patients who had been treated for gout, those who were treated for gout had as much as a thirty one percent increased risk of erectile dysfunction.
You look on the website, you'll find new interesting reports on consensus guidelines, for the use of methotrexate in JIA and new Latin American clinical practice guidelines for the treatment of lupus. These are really kind of interesting to look at. You may not agree with some of the recommendations, but it's nice to know that, cohorts of concern practitioners like yourself are getting together to develop their guidelines, not necessarily waiting for the ACR or you are to do it, to do all the heavy lifting. That's it for this week at roomnow.com. Be sure to go to the website to find the links to these important reports and read more about this data.
We'll see you next week. Be good.
There might actually be a new drug and certainly there are new guidelines for lupus and a study that looks at whether PET scans might be superior to MRA in large vessel vasculitis. Before the news, I want you to know tomorrow I'm going to be going to Chicago for a weekend meeting, what's called the Great Lakes Rheumatology Review in Chicago. If you don't know about this meeting and you're in the area, sure to stop in. You can easily register at arthros.org to find out where the meeting is. Fabulous faculty, myself, Arti Cavanaugh, Mike Weinblad, Kevin Winthrop, and Joel Block.
It'll be standing room only. So this week's news begins with report from Annals of Rheumatic Disease that looked at patients in the IMPROVE study. The IMPROVE study enrolled three eighty four patients with early RA and then followed them over time. This specific analysis of that data set looked at the subset of those who became seronegative during the course of study, during the first year, and found out that actually those who turned from to zero didn't necessarily have a better outcome. In fact, remission was, achieving drug free remission was the same whether you were zero positive or zero negative.
This says a lot about the issue of zero negative and I think we have beliefs that zero negative might be milder disease, seropositive may be more severe disease. There's a lot of data out there that seropositives may do better because seropositive patients respond better to certain therapies. Seronegatives may not do better because they may have to have a whole lot of RA like disease to be called RA even though they're seronegative. So the outcomes are not quite as clear as you might think. Interesting data merits more study.
There's a new designation from the FDA wherein they are granting orphan drug status to Lenabasum, previously known as Anabasum. It's a cannabinoid receptor agonist that's used to treat a number of different disorders. The FDA has given orphan drug status for the use of Lenabasum in dermatomyositis and they're gonna be developing trials in that. It's also being studied in lupus and in scleroderma mainly for cutaneous outcomes. This cannabinoid receptor agonist has been known to have effects on immune cells and on fibroblasts may be effective in scleroderma.
Again, it's sort of interesting data has been thus far presented at meetings. Although they're only small, when you see larger studies, it may be a new line of therapy. When is DSH not DSH? I had a patient this week where they presented with DSH and a whole lot of pain, which led me to look up a number of things and report on it. Basically, found out that pain in DSH is usually not from DSH.
DSH patients are usually asymptomatic. They may have some stiffness in their lumbar or thoracic spine. They may have some stiffness in their neck, but true pain is not a part of that and usually it's going be due to something else. DISH, as you know, is a bone forming diathesis that is directed at the spine but has ossification of ligaments and tendons that gives you those big bulky osteophytes that you see on x-ray. DISH can be problematic and difficult to manage.
There is some interesting data in the last year or so about tofacitinib in pregnancy. There are a number of studies that have been reported about tofacitinib use in women who had RA and were exposed and got pregnant, and a more recent report was done in ulcerative colitis. Megan Clouse was actually an author on both these papers. They're interesting. They're basically kind of small data sets in RA forty seven women, forty four men.
In ulcerative colitis, eleven women and fourteen men were exposed to tofacitinib at the time that there was conception. Bottom line is in this data set there's only one congenital defect and the other outcomes seem to be on par with what you might expect in these disorders so somewhat encouraging although still small, this could become a drug that we might want to consider. Right now we have a lot of data on a lot of other drugs especially TNF inhibitors about their efficacy. The bottom line is in pregnancy it's more likely to be the disease that affects the fetal and maternal outcomes and not the drug. So it's important to treat the maternal disease first so you can have optimal fetal outcomes.
An interesting study looked at a cohort of women, sorry, patients who had the anti phospholipid syndrome. Two fourteen met criteria and they looked at how many people were pure primary, APS. When they excluded patients who had, SLE features, and those who had known connective tissue disease, those who had high titer ANA, testing, left them with about half the group that had primary APS. When these people were followed for up to twelve years none of them developed lupus. Very encouraging.
However, there's always a however, over a quarter of them, twenty eight percent still had three or more, actually four or more, slick criteria for the diagnosis of lupus suggesting that that still might be a possibility even though they've been followed for twelve years. This is still a confusing cohort to know what to do with. Certainly right now you treat what you have not what you don't have, but I think patients should be followed with the jaded view that they could develop an autoimmune disease, not necessarily lupus, it could be Sjogren's syndrome or other entities as well. There's good news from the recent 2018 Medscape report on resident salary and resident debt. When they looked at the salaries of residents and fellows, they found that rheumatology fellows, guess what, were number two in paid salaries.
They were paid, were second only to allergy and immunology and rheumatology fellows were getting an average of 66,200 a year. I'm thinking of quitting my job and going back to fellowship. This was better than what residents and fellows are paid in surgery, GI and critical care. Unfortunately, this total cohort of residents and trainees, over half of them had a significant amount of debt, over $200,000 in medical school debt. So these salaries are important, but it's certainly important in rheumatology where we're trying to find, more rheumatologists for the future and certainly if we can improve the salaries and get more people to go in just for a salary alone, I say do it.
It's a whole lot easier than trying to expand training programs and find funding for that. The Journal of Rheumatology has an interesting report from Denmark that looked at a cohort of lupus patients, specifically one hundred and forty seven, who, when characterized showed that those who had renal disease, which was a significant number, half of them had lupus nephritis and lupus renal disease. It turns out that if they had lupus nephritis and reduced renal function with a GFR of less than 70 cc's per minute, these were significantly higher risk, six times more likely to have coronary artery calcifications and significant coronary plaque disease. So again, we know that the ESRD patients, renal failure patients also like our inflammatory disease patients do have higher rates of this. Turns out if you have an inflammatory disorder, autoimmune disorder, and you have renal disease, guess what, you're significantly at greater risk for coronary disease.
Allergy Rheumatic Disease talks on a specific study that compares, large vessel vasculitis patients about eighty four who either had GCA or Takayasu's and they did side by side MRAs and, PET scans. And they showed that it turns out that both of them were somewhat complementary in the information that was revealed, That the agreement between the two was seen in about sixty percent of cases, sixty eight percent in disease activity, but the bottom line is MRA was better at capturing the extent and range of disease and PET scanning was better suited to assess vascular activity or disease activity. So again I know the big issue in many of you is the who's gonna pay for this and how can I get this done? It's easier to get an MRA paid for than a PET scan but it turns out PET scanning does have significant advantages in a lot of different disorders and a lot of different situations, including this one. So in problematic cases this may be something to look into.
Last week I did a recording report on the weekend review before I looked at Lancet and Lancet reported last Friday on the newly released Baricitinib study in, lupus patients. This was a study that was the lead author was Dan Wallace, three fourteen lupus patients who had to get in they had to have skin and joint disease and had to have disease activity. Six month trial where patients were treated with placebo, two milligrams or four milligrams of baricitinib, the JAK1 JAK2 inhibitor that right now is only approved at the two milligram dose for rheumatoid arthritis. It's not approved for anything else, approved for lupus, but this is an important study. It looks at the potential utility of JAK inhibition in patients with lupus.
There's a lot of biologic rationale for that. Anyway, in their trial, the two milligram dose was not significant at six months. It turns out that when the primary endpoint was SLEDI two ks joint and rash involvement being improved significantly was seen a sixty seven percent on four milligrams and fifty three percent on placebo and that was significant at point zero four. So the safety profile is exactly what you see in RA. There were no increased risk of VTEs here.
This is a good data that says that we should proceed and further examine, JAK inhibitors in lupus, where we would be nice to have another new effective oral therapy. An interesting study comes out of Leeds in the ability to predict when ANA positive patients may progress to an autoimmune disease. They studied one hundred and eighteen individuals who were ANA positive had to have one lupus manifestation and had to, be treatment naive. When they followed them over a year, it turns out that sixteen percent progressed or nineteen developed an autoimmune disease. And it turns out that the predictive factors weren't clinical, that clinical features like activity and or, any other labs were not, they weren't helpful.
What was helpful in predicting progression was finding either having a family history of an autoimmune disease which gave you an eightfold increased risk or having an interferon signature, suggesting that your dendritic cells and alpha interferon are all being turned on probably active and now and those people had a threefold increased risk of developing lupus. So I don't know if we do are going to do this in our ANA positive consults, not a good idea, but I can tell you screening all fibromyalgia patients, all anti positive patients, you do see patients who do have an interferon signature and you wonder, will they develop lupus over time? So this could end up becoming a clinical tool in the future. The last full report is from Naomi Schlesinger and Hyun Choi that looked at the incidence of erectile dysfunction in a UK database and it showed that having gout increased the risk of having erectile dysfunction by as much as fifteen-sixteen percent. If you looked at only those patients who had been treated for gout, those who were treated for gout had as much as a thirty one percent increased risk of erectile dysfunction.
You look on the website, you'll find new interesting reports on consensus guidelines, for the use of methotrexate in JIA and new Latin American clinical practice guidelines for the treatment of lupus. These are really kind of interesting to look at. You may not agree with some of the recommendations, but it's nice to know that, cohorts of concern practitioners like yourself are getting together to develop their guidelines, not necessarily waiting for the ACR or you are to do it, to do all the heavy lifting. That's it for this week at roomnow.com. Be sure to go to the website to find the links to these important reports and read more about this data.
We'll see you next week. Be good.
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