29 September 2017 - The RheumNow Week in Review Save
29 September 2017 - The RheumNow Week in Review by Dr. Cush
Transcription
Hi, everyone. I'm Jack Cush, executive editor of roomnow.com. It's the 09/29/2017, and this is the RoomNow Weekend Review. This week on the Weekend Review, we're gonna talk about regulatory news from abroad and from the FDA. We're going talk about two common diseases not thought to be such a big deal, but you know what?
They're deadly. That includes rheumatoid arthritis and psoriatic arthritis. And we're going to talk about good news from Mayo Clinic and maybe the best meeting of the year. At the top of the news, there's smoking and rheumatoid arthritis. An interesting group from Wisconsin actually looked at how well we record smoking history amongst our rheumatoid arthritis patients.
They looked at a cohort, I think over 300 patients in their clinic, and they noted that smoking status was only noted in forty percent of the records that they reviewed, and they reviewed all of them. More importantly, for those that were smoking, they noted that only ten percent had some counseling on smoking cessation. I find that rheumatologists almost always ask about smoking when I ask that question, But I guess the question is, do you go the next step and actually counsel patients on how to stop smoking? Do you know how to get patients to stop smoking? The data is pretty clear that you need, like, a 12 step program, instruction, and maybe even medication support for a lot of people.
The interesting data here was that, not only was it just ten percent that were getting counseled, but those who needed it most, were getting it less. So it was less likely to happen when their disease was controlled. So I think that again, this is something that we need to pay more attention to. So what's the deal with patients and their doctors having a discordant opinion about their rheumatoid arthritis activity? A study showed that about only thirty percent of patients, who were followed by rheumatoid arthritis, this is rheumatoid arthritis patients, by the way, who were followed by their rheumatoid arthritis ranked their disease activities being much higher than that ranked by the rheumatologist.
And this is not an uncommon phenomenon. Physicians have a fixation on swollen joints and tender joints and labs, whereas patients are more concerned with fatigue and pain and quality of life. But in this one third of patients who actually had a much higher level of disease activity by their assessment compared to the rheumatologists, and these were Gestalt measures. It turns out that that was made up of an interesting cohort that's easily identifiable. This includes mostly serine negative RA patients, those who have very high pain scores, those who are actually more likely to be in low disease activity state, not high, and have fibromyalgia and depression.
So that's the profile of people that you may think you're doing well in, but in fact, the patient doesn't think you are. So a better discussion about what's driving their pain in those people seems in order. An interesting study looked at an enthesitis index, the Massey Index, or the Massey Index? The Massey Index. I don't know why I'm calling Massey Eye, sorry, to Mr.
Massey. Higher Massey indices in psoriatic arthritis, not surprisingly, are associated with more joint damage, a greater risk of joint ankylosis, arthritis mutilans, periosteitis, and even more axial disease amongst psoriatic arthritis patients. Doesn't seem like it's a stretch to make this claim, but nonetheless, it is an important and clinical marker of disease severity and a disease that is often difficult to treat. So it may be worth doing a more detailed, enthesitis assessment in patients with psoriatic arthritis. An interesting review of the literature looked at the association of antiphospholipid antibodies in patients who have pulmonary hypertension.
After a careful review of the literature, the authors came up with 47 articles and found pretty good agreement that antiphospholipid antibodies are associated with a higher risk of both idiopathic and connective tissue disease related pulmonary hypertension. Also left sided valvular heart disease and venous thromboembolic induced pulmonary hypertension. All these are identifiable. I think the takeaway from this particular report, although it's just an interesting review, says that if you see idiopathic pulmonary hypertension, you should be thinking antiphospholipid antibodies and vice versa. It may help you clinically and diagnostically.
The CDC has released new information saying that congratulations, 2,016 is a record setting year as far as sexually transmitted diseases. Not important to rheumatologists. However, the biggest of the three that they that they record, chlamydia, gonorrhea, and syphilis, is chlamydia affecting one point six million people in The United States in 2016. As we know, chlamydia has significant rheumatologic manifestations, including reactive arthritis, ocular disease, etcetera. So it is important to know these numbers and it is important, I think, in counseling patients, especially your younger patients.
There needs to be more, in general, better education about STDs. A review of Australia and some of the projected numbers for their arthritic conditions in their population looked at the numbers seen in 2015. I think the number was somewhere around, two point one million people with osteoarthritis in Australia. And they projected that by 2030, it was going to grow to three point one million with basically a forty one percent increase in their numbers of osteoarthritis. Also, showed and projected that there's gonna be an increase in rheumatoid arthritis by thirty seven percent in the same fifteen year period from 2015 to 2030, and that the cost of care for both conditions is going to rise thirty seven percent.
As not surprisingly, in rheumatoid arthritis, the cost of care is being driven substantially by biologics. These are important growth numbers, I think that they'll be seen in other continents, including Europe and UK and even The United States. Two interesting reports from the Mayo Clinic. One looked at the incidence of ANCA associated vasculitis in a period from 1996 to 2013 in Olmsted County. They found over this period twenty three cases of GPA, twenty eight cases of MPA, micros microscopic polyangiitis, and seven cases of EGPA, the old Churg Strauss syndrome.
Sixty percent were NPO positive, thirty percent were PR three positive. And the overall prevalence of these ANCA associated vasculitides was forty two cases per one hundred thousand, in Olmsted County. They did show in their analysis comparing death rates in this population to the general population that the presence of microscopic polyangiitis and EGPA and NPO associated ANCAs were associated with a greater mortality rate compared to the general population. What wasn't higher was GPA, the condition we probably see more of. I thought it an interesting report.
Another interesting report, totally different report, shows that, asthma is associated with a higher risk of rheumatoid arthritis. They looked at a cohort of patients with rheumatoid arthritis, with and without, asthma, and they actually showed that the presence of asthma did increase the odds of getting rheumatoid arthritis by as much as seventy four percent, odds ratio of one point seven four. This was in comparing two hundred twenty one RA patients to, those without two hundred and eighteen. They were matched and whatnot. It's interesting because the biology of rheumatoid arthritis, a Th one disease, is quite different than the biology of asthma, a Th2 disease.
How these two get together and play in our backyard is not well known. We do know that lung disease is very prevalent amongst rheumatoid and is a bad player in ultimate outcomes. Amongst the many things we see, which would include BOOP and ILD and rheumatoid lung and rheumatoid pericardial disease or pleural disease, there's a lot of people with asthma and I've always assumed that was just because asthma is a common condition. These data suggest that actually it may be a risk factor for RA. Regulatory information from The UK.
NICE has recommended the approval of Kevzara, which is sorrelimab, another IL-six inhibitor, for use in patients, adult patients with active, moderate to severe rheumatoid arthritis. It's likely that it will follow through in the months to come. In The United States, we've been talking recently about the FDA's, panel hearing on the new herpes zoster vaccine, the herpes subunit vaccine, which is gonna be called Shingrix. It comes from GSK recommended by the panel a few months ago, now the FDA is actually, considering the approval of the Shingrix vaccine. I think that's gonna happen probably before the end of the year would be my guess.
The interesting thing about this particular vaccine is that it is free injections. It is superior to, Zostavax, the live virus vaccine, and this new subunit vaccine is a non live virus and can therefore can be used in patients who are on biologics, patients who are receiving DMARDs, and even patients who are immunosuppressed. But it is three injections, it's probably going be more expensive. It does have a lot more constitutional manifestations, you know, achiness, arthralgias, you know, feeling flu like. I think that may be the one challenge with this.
We'll see how it plays out once it actually gets into wider use. It has not been studied in patients with, autoimmune diseases like rheumatoid arthritis. And again, it is better. It has a ninety percent success rate compared to, a fifty percent success rate of the Zostavax and the success rate is not lost as the patient gets older and older. So that's a nice, benefit of this particular vaccine.
Another FDA action happened this past week. Cirricumab was turned down by the FDA. They received a complete response letter dictating that they do not have sufficient evidence to approve, cirricumab, and, that's based on the hearing that occurred a few months ago where the panel was almost unanimous. I think it was 11 to one, voting down the, actually I think it was unanimous, voting down the approval of circuimab in active RA. The efficacy of the drug was great, the safety was almost as expected.
There were more safety signals with cirucomab, but unfortunately, more deaths associated with cirucomab. A lot of reasons for that, but in general, the panel said, even though we can't explain why there's an increase and an imbalance here in death rates, It's hard to approve a third IL-six inhibitor in the marketplace when we don't really need one, and especially one that may have some signals. Again, this will go back to the manufacturer Janssen for further action, whether they will do more studies to prove the safety of drug growth, whether they'll drop this at this time is unknown. Interesting data about death rates and cardiovascular event rates. Psoriasis report just this week in the Journal of the Academy of of it's one of the dermatology journals.
It's actually a good dermatology journal. It actually looked at the risk of MACE or major adverse cardiovascular events in patients with psoriasis. They did it two ways. They looked at one hundred and nine patients with psoriasis, not psoriatic arthritis, psoriasis, and they did FDG PETs on them looking at the vasculature of the heart. And the patients who had vascular inflammation were actually more was more likely to be seen with increasing duration of psoriatic disease.
The longer the duration, the more likely the FDG PET scans were gonna be abnormal as far as heart heart inflammation. So that was, sort of interesting and it was backed up by a much larger population based study where they looked at, I think, eighty seven thousand psoriasis patients and compared them to one point four million, a general population. And they basically showed that for every one year you had psoriasis, you had a one percent increase in MACE events over and above that seen in the general population. So basically, although these are not related studies really, they kind of show the same thing. The longer you have psoriasis, hence, the longer you have inflammation, the more you're gonna have an increased risk of maybe the cardiovascular consequences of that inflammation.
Also, RA, another population based study from the Swedish registry, between 'ninety seven and 2014 looked at over seventeen thousand RA patients and matched to like four to one to the general population control group. And they showed that both in the general population and in RA patients over this, what is that, seventeen year period, there's been a steady decline in the mortality rates. RA equal to that of the general population. However, RA patients, unlike the general population, actually has an increased rate of cardiovascular events. What they showed that was with increasing time or duration of disease, there was an increasing death rate amongst rheumatoid patients such that, in a ten year period of having rheumatoid arthritis, the mortality rate rose almost forty three percent.
So again, both of these are telling us the same story that duration of inflammation is not a good thing for one's cardiovascular and cardiac outcomes. One of my favorite topics is cancer risk associated with disease and with biologics. An interesting, very large population based study from Sweden looked at cancer rates in 2006 to 2015, looking at all the biologics, the TNF inhibitors, tocilizumab, abetacept, rituximab, and each group was represented by at least 2,000 and as high as ten thousand patients on those drugs, and they were followed longitudinally over time and compared to over a hundred and seven thousand general population patients and forty seven thousand, DMAR taken rheumatoid patients. And you know what? They did not show an increased rate of cancer, whether it was first solid cancer or first hematologic cancer in patients taking any one of these biologics.
I think the overall risk of cancer for all the drugs range from point from about well, basically one per one hundred patient years. And the hazard ratio, when you compare those on drug to those on DMARD, were less than one. They were point eight eight to point nine three, an overlap one suggesting no increased risk and a slight trend towards it, maybe even a lower risk would be my, overly optimistic interpretation of that. But again, many rheumatologists are afraid to use biologics, for fear that there could be some association, that we don't have enough time, and we don't have enough patients. Boy, that was a story back almost fifteen years ago.
We've got tons of data these days that really say it's your job to treat the inflammation, whether it be psoriatic disease or rheumatoid disease, and let someone else manage cancer if and when it shows up. Lastly, the Down Eastern meeting. This is a meeting I've been working on for a number of months. It's gonna be in Westborough, Massachusetts on October 14. If you're from Maine, New Hampshire, Vermont, Massachusetts, Connecticut or Rhode Island, the New England area, we got a down eastern CME rheumatology meeting for you.
It's an all day Saturday meeting. I think you'll find it great. The faculty include myself, John Kay, William Rigby, Sergio Schwartzman, cases, legislative stuff. If you're in the region, come out. You can go to arthros.org, I think, and look under meetings, and you can register for it.
That's it for this week on roomnow.com. You can go to the website and click on the citations we have to find more information about the things discussed herein. We'll see you next week. Have a good week. Bye bye.
They're deadly. That includes rheumatoid arthritis and psoriatic arthritis. And we're going to talk about good news from Mayo Clinic and maybe the best meeting of the year. At the top of the news, there's smoking and rheumatoid arthritis. An interesting group from Wisconsin actually looked at how well we record smoking history amongst our rheumatoid arthritis patients.
They looked at a cohort, I think over 300 patients in their clinic, and they noted that smoking status was only noted in forty percent of the records that they reviewed, and they reviewed all of them. More importantly, for those that were smoking, they noted that only ten percent had some counseling on smoking cessation. I find that rheumatologists almost always ask about smoking when I ask that question, But I guess the question is, do you go the next step and actually counsel patients on how to stop smoking? Do you know how to get patients to stop smoking? The data is pretty clear that you need, like, a 12 step program, instruction, and maybe even medication support for a lot of people.
The interesting data here was that, not only was it just ten percent that were getting counseled, but those who needed it most, were getting it less. So it was less likely to happen when their disease was controlled. So I think that again, this is something that we need to pay more attention to. So what's the deal with patients and their doctors having a discordant opinion about their rheumatoid arthritis activity? A study showed that about only thirty percent of patients, who were followed by rheumatoid arthritis, this is rheumatoid arthritis patients, by the way, who were followed by their rheumatoid arthritis ranked their disease activities being much higher than that ranked by the rheumatologist.
And this is not an uncommon phenomenon. Physicians have a fixation on swollen joints and tender joints and labs, whereas patients are more concerned with fatigue and pain and quality of life. But in this one third of patients who actually had a much higher level of disease activity by their assessment compared to the rheumatologists, and these were Gestalt measures. It turns out that that was made up of an interesting cohort that's easily identifiable. This includes mostly serine negative RA patients, those who have very high pain scores, those who are actually more likely to be in low disease activity state, not high, and have fibromyalgia and depression.
So that's the profile of people that you may think you're doing well in, but in fact, the patient doesn't think you are. So a better discussion about what's driving their pain in those people seems in order. An interesting study looked at an enthesitis index, the Massey Index, or the Massey Index? The Massey Index. I don't know why I'm calling Massey Eye, sorry, to Mr.
Massey. Higher Massey indices in psoriatic arthritis, not surprisingly, are associated with more joint damage, a greater risk of joint ankylosis, arthritis mutilans, periosteitis, and even more axial disease amongst psoriatic arthritis patients. Doesn't seem like it's a stretch to make this claim, but nonetheless, it is an important and clinical marker of disease severity and a disease that is often difficult to treat. So it may be worth doing a more detailed, enthesitis assessment in patients with psoriatic arthritis. An interesting review of the literature looked at the association of antiphospholipid antibodies in patients who have pulmonary hypertension.
After a careful review of the literature, the authors came up with 47 articles and found pretty good agreement that antiphospholipid antibodies are associated with a higher risk of both idiopathic and connective tissue disease related pulmonary hypertension. Also left sided valvular heart disease and venous thromboembolic induced pulmonary hypertension. All these are identifiable. I think the takeaway from this particular report, although it's just an interesting review, says that if you see idiopathic pulmonary hypertension, you should be thinking antiphospholipid antibodies and vice versa. It may help you clinically and diagnostically.
The CDC has released new information saying that congratulations, 2,016 is a record setting year as far as sexually transmitted diseases. Not important to rheumatologists. However, the biggest of the three that they that they record, chlamydia, gonorrhea, and syphilis, is chlamydia affecting one point six million people in The United States in 2016. As we know, chlamydia has significant rheumatologic manifestations, including reactive arthritis, ocular disease, etcetera. So it is important to know these numbers and it is important, I think, in counseling patients, especially your younger patients.
There needs to be more, in general, better education about STDs. A review of Australia and some of the projected numbers for their arthritic conditions in their population looked at the numbers seen in 2015. I think the number was somewhere around, two point one million people with osteoarthritis in Australia. And they projected that by 2030, it was going to grow to three point one million with basically a forty one percent increase in their numbers of osteoarthritis. Also, showed and projected that there's gonna be an increase in rheumatoid arthritis by thirty seven percent in the same fifteen year period from 2015 to 2030, and that the cost of care for both conditions is going to rise thirty seven percent.
As not surprisingly, in rheumatoid arthritis, the cost of care is being driven substantially by biologics. These are important growth numbers, I think that they'll be seen in other continents, including Europe and UK and even The United States. Two interesting reports from the Mayo Clinic. One looked at the incidence of ANCA associated vasculitis in a period from 1996 to 2013 in Olmsted County. They found over this period twenty three cases of GPA, twenty eight cases of MPA, micros microscopic polyangiitis, and seven cases of EGPA, the old Churg Strauss syndrome.
Sixty percent were NPO positive, thirty percent were PR three positive. And the overall prevalence of these ANCA associated vasculitides was forty two cases per one hundred thousand, in Olmsted County. They did show in their analysis comparing death rates in this population to the general population that the presence of microscopic polyangiitis and EGPA and NPO associated ANCAs were associated with a greater mortality rate compared to the general population. What wasn't higher was GPA, the condition we probably see more of. I thought it an interesting report.
Another interesting report, totally different report, shows that, asthma is associated with a higher risk of rheumatoid arthritis. They looked at a cohort of patients with rheumatoid arthritis, with and without, asthma, and they actually showed that the presence of asthma did increase the odds of getting rheumatoid arthritis by as much as seventy four percent, odds ratio of one point seven four. This was in comparing two hundred twenty one RA patients to, those without two hundred and eighteen. They were matched and whatnot. It's interesting because the biology of rheumatoid arthritis, a Th one disease, is quite different than the biology of asthma, a Th2 disease.
How these two get together and play in our backyard is not well known. We do know that lung disease is very prevalent amongst rheumatoid and is a bad player in ultimate outcomes. Amongst the many things we see, which would include BOOP and ILD and rheumatoid lung and rheumatoid pericardial disease or pleural disease, there's a lot of people with asthma and I've always assumed that was just because asthma is a common condition. These data suggest that actually it may be a risk factor for RA. Regulatory information from The UK.
NICE has recommended the approval of Kevzara, which is sorrelimab, another IL-six inhibitor, for use in patients, adult patients with active, moderate to severe rheumatoid arthritis. It's likely that it will follow through in the months to come. In The United States, we've been talking recently about the FDA's, panel hearing on the new herpes zoster vaccine, the herpes subunit vaccine, which is gonna be called Shingrix. It comes from GSK recommended by the panel a few months ago, now the FDA is actually, considering the approval of the Shingrix vaccine. I think that's gonna happen probably before the end of the year would be my guess.
The interesting thing about this particular vaccine is that it is free injections. It is superior to, Zostavax, the live virus vaccine, and this new subunit vaccine is a non live virus and can therefore can be used in patients who are on biologics, patients who are receiving DMARDs, and even patients who are immunosuppressed. But it is three injections, it's probably going be more expensive. It does have a lot more constitutional manifestations, you know, achiness, arthralgias, you know, feeling flu like. I think that may be the one challenge with this.
We'll see how it plays out once it actually gets into wider use. It has not been studied in patients with, autoimmune diseases like rheumatoid arthritis. And again, it is better. It has a ninety percent success rate compared to, a fifty percent success rate of the Zostavax and the success rate is not lost as the patient gets older and older. So that's a nice, benefit of this particular vaccine.
Another FDA action happened this past week. Cirricumab was turned down by the FDA. They received a complete response letter dictating that they do not have sufficient evidence to approve, cirricumab, and, that's based on the hearing that occurred a few months ago where the panel was almost unanimous. I think it was 11 to one, voting down the, actually I think it was unanimous, voting down the approval of circuimab in active RA. The efficacy of the drug was great, the safety was almost as expected.
There were more safety signals with cirucomab, but unfortunately, more deaths associated with cirucomab. A lot of reasons for that, but in general, the panel said, even though we can't explain why there's an increase and an imbalance here in death rates, It's hard to approve a third IL-six inhibitor in the marketplace when we don't really need one, and especially one that may have some signals. Again, this will go back to the manufacturer Janssen for further action, whether they will do more studies to prove the safety of drug growth, whether they'll drop this at this time is unknown. Interesting data about death rates and cardiovascular event rates. Psoriasis report just this week in the Journal of the Academy of of it's one of the dermatology journals.
It's actually a good dermatology journal. It actually looked at the risk of MACE or major adverse cardiovascular events in patients with psoriasis. They did it two ways. They looked at one hundred and nine patients with psoriasis, not psoriatic arthritis, psoriasis, and they did FDG PETs on them looking at the vasculature of the heart. And the patients who had vascular inflammation were actually more was more likely to be seen with increasing duration of psoriatic disease.
The longer the duration, the more likely the FDG PET scans were gonna be abnormal as far as heart heart inflammation. So that was, sort of interesting and it was backed up by a much larger population based study where they looked at, I think, eighty seven thousand psoriasis patients and compared them to one point four million, a general population. And they basically showed that for every one year you had psoriasis, you had a one percent increase in MACE events over and above that seen in the general population. So basically, although these are not related studies really, they kind of show the same thing. The longer you have psoriasis, hence, the longer you have inflammation, the more you're gonna have an increased risk of maybe the cardiovascular consequences of that inflammation.
Also, RA, another population based study from the Swedish registry, between 'ninety seven and 2014 looked at over seventeen thousand RA patients and matched to like four to one to the general population control group. And they showed that both in the general population and in RA patients over this, what is that, seventeen year period, there's been a steady decline in the mortality rates. RA equal to that of the general population. However, RA patients, unlike the general population, actually has an increased rate of cardiovascular events. What they showed that was with increasing time or duration of disease, there was an increasing death rate amongst rheumatoid patients such that, in a ten year period of having rheumatoid arthritis, the mortality rate rose almost forty three percent.
So again, both of these are telling us the same story that duration of inflammation is not a good thing for one's cardiovascular and cardiac outcomes. One of my favorite topics is cancer risk associated with disease and with biologics. An interesting, very large population based study from Sweden looked at cancer rates in 2006 to 2015, looking at all the biologics, the TNF inhibitors, tocilizumab, abetacept, rituximab, and each group was represented by at least 2,000 and as high as ten thousand patients on those drugs, and they were followed longitudinally over time and compared to over a hundred and seven thousand general population patients and forty seven thousand, DMAR taken rheumatoid patients. And you know what? They did not show an increased rate of cancer, whether it was first solid cancer or first hematologic cancer in patients taking any one of these biologics.
I think the overall risk of cancer for all the drugs range from point from about well, basically one per one hundred patient years. And the hazard ratio, when you compare those on drug to those on DMARD, were less than one. They were point eight eight to point nine three, an overlap one suggesting no increased risk and a slight trend towards it, maybe even a lower risk would be my, overly optimistic interpretation of that. But again, many rheumatologists are afraid to use biologics, for fear that there could be some association, that we don't have enough time, and we don't have enough patients. Boy, that was a story back almost fifteen years ago.
We've got tons of data these days that really say it's your job to treat the inflammation, whether it be psoriatic disease or rheumatoid disease, and let someone else manage cancer if and when it shows up. Lastly, the Down Eastern meeting. This is a meeting I've been working on for a number of months. It's gonna be in Westborough, Massachusetts on October 14. If you're from Maine, New Hampshire, Vermont, Massachusetts, Connecticut or Rhode Island, the New England area, we got a down eastern CME rheumatology meeting for you.
It's an all day Saturday meeting. I think you'll find it great. The faculty include myself, John Kay, William Rigby, Sergio Schwartzman, cases, legislative stuff. If you're in the region, come out. You can go to arthros.org, I think, and look under meetings, and you can register for it.
That's it for this week on roomnow.com. You can go to the website and click on the citations we have to find more information about the things discussed herein. We'll see you next week. Have a good week. Bye bye.
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