The RheumNow Week In Review - 3 November 2017 Save
The RheumNow Week In Review - 3 November 2017 by Dr. Cush
Transcription
It's the 11/03/2017, and this is the RoomNow we can review. I'm doctor Jack Cush, executive editor of roomnow.com. It is the Friday before ACR. ACR week is upon us. Be sure to follow us on roomnow.com.
We have extensive coverage of the meeting. We've got a large faculty who will be covering psoriatic arthritis and ankylosing spondylitis and gout and lupus and rheumatoid and drug safety and everything. You can go to the website, it'll navigate you to there. Your daily email will take you there to our microsite called acr17.roomnow.com. I think you'll like what we're gonna present.
A lot of videos, a lot of tweets, lot of short take home messages, a lot of good articles from a lot of good people. So in the past week, a lot of interesting news on our website. A comparison, study was done of familial and sporadic lupus. And this was a meta analysis from 330 papers in the literature. They found seven hundred and thirty three, familial cases of lupus compared that to over fourteen hundred, sporadic lupus cases to see if there were any differences.
And they what they basically found was that things like there really was nothing really distinguishing for the familial, which I found surprising. It was really a few things for sporadic. Photosensitivity, thrombocytopenia, and renal disease were more commonly seen in sporadic lupus compared to familial lupus. An interesting study from Korea looked at rural, women, not those living in city in cities, and specifically 432, with knee OA or actually four thirty two women after the age of 40 and studied them for the development of knee OA. And they found that the risk of knee OA increased the two to fourfold increased risk in those who did manual work, farm work, those who had a family history or a history of injury.
But they also showed, which has been seen by others before, that smoking ever or current smoking reduced the risk of neo a by as much as fifty percent. You may be aware what's going on in San Diego. Since the summertime, there's been an outbreak hepatitis A there. We reported that in the last few weeks, the most recent updated information says there are there have been twenty deaths and five hundred and thirty six cases of hepatitis A in the San Diego area. Most of this comes from the homeless population.
It is fecally transmitted. Those of you who are vaccinated are okay. Those of you who not yet vaccinated, stay away from street street tacos. But the good news is that this, really peaked in the summertime and the rate of of new infections has gone down significantly. So I think this is a very low risk event.
Nonetheless, there's another infectious event going on in San Diego, and that being that, if you happen to be a marine, there's been a large outbreak of of E. Coli and diarrhea from coli from in the San Diego area. Three hundred and two cases of five hundred and fifth of fifty five hundred marines stationed in the area. Doesn't seem like it's made its way into the general population, but I thought you should know that ACR is gonna be really exciting this year. Those who take TNF inhibitors, the big issue is persistence on drug.
And it's not just for rheumatoid arthritis, it's also for psoriatic arthritis and IBD as well. But a nice study of low persistence, meaning non adherence to TNF inhibitors, was more likely in psoriatic arthritis patients who were female and those who had the metabolic syndrome or related comorbidities. Basically, what they did in the study was they compared, a cohort of 180 psoriatic starting on TNF inhibitors. They showed that at the end of one year, seventy nine percent were still taking the TNF inhibitor, at the end of two years, seventy four percent. That sounds pretty good.
But when you look at all those who discontinued the drug in the first two years, thirty five percent were a primary non response. That's interesting. Again, primary non response means you don't go back to a second TNF inhibitor, it's a gigantic waste of time. Twenty four percent for us were for a secondary nonresponse, meaning they lost their response, those people would be worth trying maybe another TNF inhibitor. And then forty three percent of those who discontinued the drug and were noninherent was because of adverse events.
These are, I think, important, factors when it comes to how we manage and what we do when patients don't take their medicine or stop their medicines. A review of RA patients, fourteen oh five RA patients from the National Ambulatory Medical Survey Study looked at their drug utilization. Now, again, everyone has their beliefs about how many patients, like I say, amongst rheumatology practices, sixty percent of RA patients are taking biologics. But in the real world, when you look at all comers, including patients not managed by rheumatoid arthritis, but by the primary care sector or whoever, the numbers are much, much lower. And that comes from this study.
It shows that sixty percent are receiving DMARDs, and that's good. But only twenty four percent are on biologics, biologic use tends to be higher in those on Medicare and those who are seeing specialists. So I found the Medicare part interesting because Medicare is older and the data is pretty good about older people not getting aggressive therapy, including biologics, often for a lot of reasons. They're reluctant. Comorbidity issue is worrisome to prescribers.
But nonetheless, if you had Medicare, meant you're more likely to get infusible biologics, I would assume, such as infliximab and tocilizumab and abatacid. A Taiwanese claims database looked at the incidence of cardiovascular events with non steroidal use. Now, we certainly know since the BIOX hearings that this has been a big warning, the cardiologists are all on this bandwagon, and we have a little bit of a fight about, you know, how to manage patients and the use of nonsteroidals. In their review of a claims data, large data, they looked at the risk of a cardiovascular event with oral nonsteroidal drugs, and the risk was two point, one per one hundred patient years, which is, you know, sizable. But it's actually lower if you look at topical nonsteroidals and significantly lower, but is it really?
It's one point eight seven per one hundred patient years. So again, this is either good information for a rheumatologist or hazardous information for a cardiologist. It's up to you to decide how you're gonna use and view it. PMR diagnosis can be a problem. It shouldn't be.
It's, you know, girdle stiffness over the age of 60, more likely over age of 70, Caucasian, high acute phase reactant, and the other associated features. But in some people, it can be difficult. One study was published this week about ninety nine consecutive potential PMR patients and they did FDG PET scans to look at inflammation and activity in 12 articular areas of the body. They basically looked at people before they got on prednisone and in the end they diagnosed sixty six or so with PMR and thirty two with other diagnoses. And they found that amongst their ninety nine patients, the sensitivity of FDG PET, very expensive by the way, was eighty five percent, a specificity of eighty seven percent, a negative predictive value of seventy four percent, a positive predictive value of seventy three percent.
I find this interesting because it might be a nice tool if it has such great sensitivity and predictive value and specificity. The problem is that this is a clinical diagnosis with simple lab tests and do we really need to trick it up with a very expensive investigation? It may be more of a research tool at this point, certainly wouldn't recommend it in the clinic, May be useful in those who have undiagnosable aches and pains, assuming they don't have fibromyalgia. Three registries have shown the risk of serious infection when using biologic. These are French registries that were established with the introduction of tocilizumab, rituximab, and abatacid.
And their data over a long period of time is really very encouraging, showing less than one, one or less SIEs per 100 patient years. For tocilizumab, it's one per one hundred patient years. For rituximab, 0.7. For abatacep, 0.6. The idea here is that, you know, at every one hundred patients who goes on a biologic, less than one is going to have a risk of a serious infection, a hospitalizeable infection.
That's real world data coming from three large French cohorts. An interesting study looked at the use of belimumab in patients with systemic sclerosis. Obviously, a disease very hard, to manage. We don't really have any approved therapies. On the other hand, belimumab, I think, is looking for a home and a better use.
I think it could be more effective than it is in lupus. But nonetheless, an early pilot trial of 20 patients with early diffuse systemic sclerosis. Everybody goes on, mycophenolate, and half of group 10 go on placebo and the other 10 go on belimumab. And what they did show was that there was some better, Rodnan Skin score outcomes, minus 10 versus minus three, but that was not significant. Anyone who does scleroderma research will tell you that's the low hanging fruit in scleroderma research and showing improvement in Rodnan Skin score is no big deal.
It's been shown hundreds of times and yet we still don't have any effective therapies. You really need to show improvement in lung outcome, GI outcome, renal outcomes, long term outcomes, Hence, these studies are really hard to do. They did look at many outcomes. Actually, only outcome that looked impressive over time comparing the two groups was HAC was better in belimumab. Skin scores weren't significant neither were changes in FVC or DLCO.
A nice teaching point, dactylitis occurs in, sorry, what do you think about it? What's your list? Ready? Here are the answers. It can occur in psoriatic arthritis, ankylosing spondylitis, SPA in general, reactive arthritis, MCTD, scleroderma patients, systemic sclerosis, or the diffuse kind, especially, tuberculosis, syphilis, juvenile arthritis, and what's the last one?
Sarcoidosis. Three four more interesting reports. The CDC has come out with an endorsement. The ACIP has looked at the data about the new approved inactive shingles vaccine called Shingrix from GSK. This is gonna compete with the current live virus vaccine, Zostavax from Merck.
And the CDC's panel voted kind of close. I think was eight to seven or seven to six in favor of endorsing the new, inactive Shingrix vaccine over Zostavax. That's important for us and our patients who are on biologics, can't take the live virus vaccine. The Shingrix vaccine, however, the new one is now available, it's FDA approved. It's going to be a few injections and these injections have a increased rate of constitutional manifestations, arthralgias, flu like symptoms, fever, etc.
It's gonna be more expensive. Think it's gonna be as much as $600 is what I've been told. So don't hold me to that. That's what I sort of street news. So again, it'll be interesting to see how this gets integrated in practice in rheumatology amongst our patients.
A very important study was published by, I believe it's Lancet. It's the CRIB study authored by Xavier Mare from France. And, this was published or presented at the meetings last year. And this is a prospective study of 16 women who are on cerdulizumab during pregnancy. At the time of delivery, and within thirty days of delivery, they had blood samples.
And then at delivery, they had the blood from the mother, from the infant, and from the cord blood. And, again, the patient had to have received the drug within thirty days of delivery. And what they showed in their 16 patients was the following. Two were excluded because the data was all screwy, but on the remaining 14, 13 and 14 had no detectable cerdulizumab in, the infant blood. There was was there in cord blood as you might expect, and, when they looked at those children at four weeks and eight weeks down the line, there was no blood in the infant later on suggesting again and proving that cerdulizumab does not cross the placenta, in women who are taking, this drug during pregnancy.
An important study, you should probably look at this quickly, from Annals Internal Medicine about death rates in lupus. They looked at death rates, between 1968 and 2013, some incredible number, like fifty thousand deaths in lupus, and compared lupus deaths to deaths in people not with lupus. There's a large population based study, and they show that there remains to be a disproportionately high rate of death in lupus while, death rates in the general population have come down. Lupus levels have not come down as much. In fact, they came down in the sixties, went back up in the seventies, and have come down since.
But more importantly, they showed that when you look at the ratio of lupus deaths to non lupus deaths that there were favorable things being seen for whites but not favorable for women, African Americans, and those living in the South. So there are geographic differences, there are race and gender related differences that may have to do with access to care and other factors. But an important study saying that we still need more aggressive therapy and education in lupus. An important study was published in Lancet this week called the CALM study. This is an adalimumab study given to patients with Crohn's disease, and they really looked at the issue of what they call tight control.
It's not quite the same as our T2T, but tight control for them was they had two cohorts, one that had decisions made but using the CDAI which is the Crohn's Disease Activity Index and that's how usual care goes. But more importantly, the trend in GI these days is to use calprotectin and CRP and other biomarkers, and they used in their tight control group, the definitions of non response or failure with three factors: the C. Dye, the CRP, and fecal calprotectin levels. They showed that when you were more stringent in your definition of control or failure to control, you had better outcomes in the tight control group, forty six percent, versus the, usual care group, thirty percent. So that's it for this week at roomnow.com.
Go to the, website. You can find these links, and to read up more on this. More importantly, you should, bookmark our website, acr.17 acr17.roomnow.com and follow us next week. We start publishing on Sunday. We'll see you at ACR in San Diego.
Bye.
We have extensive coverage of the meeting. We've got a large faculty who will be covering psoriatic arthritis and ankylosing spondylitis and gout and lupus and rheumatoid and drug safety and everything. You can go to the website, it'll navigate you to there. Your daily email will take you there to our microsite called acr17.roomnow.com. I think you'll like what we're gonna present.
A lot of videos, a lot of tweets, lot of short take home messages, a lot of good articles from a lot of good people. So in the past week, a lot of interesting news on our website. A comparison, study was done of familial and sporadic lupus. And this was a meta analysis from 330 papers in the literature. They found seven hundred and thirty three, familial cases of lupus compared that to over fourteen hundred, sporadic lupus cases to see if there were any differences.
And they what they basically found was that things like there really was nothing really distinguishing for the familial, which I found surprising. It was really a few things for sporadic. Photosensitivity, thrombocytopenia, and renal disease were more commonly seen in sporadic lupus compared to familial lupus. An interesting study from Korea looked at rural, women, not those living in city in cities, and specifically 432, with knee OA or actually four thirty two women after the age of 40 and studied them for the development of knee OA. And they found that the risk of knee OA increased the two to fourfold increased risk in those who did manual work, farm work, those who had a family history or a history of injury.
But they also showed, which has been seen by others before, that smoking ever or current smoking reduced the risk of neo a by as much as fifty percent. You may be aware what's going on in San Diego. Since the summertime, there's been an outbreak hepatitis A there. We reported that in the last few weeks, the most recent updated information says there are there have been twenty deaths and five hundred and thirty six cases of hepatitis A in the San Diego area. Most of this comes from the homeless population.
It is fecally transmitted. Those of you who are vaccinated are okay. Those of you who not yet vaccinated, stay away from street street tacos. But the good news is that this, really peaked in the summertime and the rate of of new infections has gone down significantly. So I think this is a very low risk event.
Nonetheless, there's another infectious event going on in San Diego, and that being that, if you happen to be a marine, there's been a large outbreak of of E. Coli and diarrhea from coli from in the San Diego area. Three hundred and two cases of five hundred and fifth of fifty five hundred marines stationed in the area. Doesn't seem like it's made its way into the general population, but I thought you should know that ACR is gonna be really exciting this year. Those who take TNF inhibitors, the big issue is persistence on drug.
And it's not just for rheumatoid arthritis, it's also for psoriatic arthritis and IBD as well. But a nice study of low persistence, meaning non adherence to TNF inhibitors, was more likely in psoriatic arthritis patients who were female and those who had the metabolic syndrome or related comorbidities. Basically, what they did in the study was they compared, a cohort of 180 psoriatic starting on TNF inhibitors. They showed that at the end of one year, seventy nine percent were still taking the TNF inhibitor, at the end of two years, seventy four percent. That sounds pretty good.
But when you look at all those who discontinued the drug in the first two years, thirty five percent were a primary non response. That's interesting. Again, primary non response means you don't go back to a second TNF inhibitor, it's a gigantic waste of time. Twenty four percent for us were for a secondary nonresponse, meaning they lost their response, those people would be worth trying maybe another TNF inhibitor. And then forty three percent of those who discontinued the drug and were noninherent was because of adverse events.
These are, I think, important, factors when it comes to how we manage and what we do when patients don't take their medicine or stop their medicines. A review of RA patients, fourteen oh five RA patients from the National Ambulatory Medical Survey Study looked at their drug utilization. Now, again, everyone has their beliefs about how many patients, like I say, amongst rheumatology practices, sixty percent of RA patients are taking biologics. But in the real world, when you look at all comers, including patients not managed by rheumatoid arthritis, but by the primary care sector or whoever, the numbers are much, much lower. And that comes from this study.
It shows that sixty percent are receiving DMARDs, and that's good. But only twenty four percent are on biologics, biologic use tends to be higher in those on Medicare and those who are seeing specialists. So I found the Medicare part interesting because Medicare is older and the data is pretty good about older people not getting aggressive therapy, including biologics, often for a lot of reasons. They're reluctant. Comorbidity issue is worrisome to prescribers.
But nonetheless, if you had Medicare, meant you're more likely to get infusible biologics, I would assume, such as infliximab and tocilizumab and abatacid. A Taiwanese claims database looked at the incidence of cardiovascular events with non steroidal use. Now, we certainly know since the BIOX hearings that this has been a big warning, the cardiologists are all on this bandwagon, and we have a little bit of a fight about, you know, how to manage patients and the use of nonsteroidals. In their review of a claims data, large data, they looked at the risk of a cardiovascular event with oral nonsteroidal drugs, and the risk was two point, one per one hundred patient years, which is, you know, sizable. But it's actually lower if you look at topical nonsteroidals and significantly lower, but is it really?
It's one point eight seven per one hundred patient years. So again, this is either good information for a rheumatologist or hazardous information for a cardiologist. It's up to you to decide how you're gonna use and view it. PMR diagnosis can be a problem. It shouldn't be.
It's, you know, girdle stiffness over the age of 60, more likely over age of 70, Caucasian, high acute phase reactant, and the other associated features. But in some people, it can be difficult. One study was published this week about ninety nine consecutive potential PMR patients and they did FDG PET scans to look at inflammation and activity in 12 articular areas of the body. They basically looked at people before they got on prednisone and in the end they diagnosed sixty six or so with PMR and thirty two with other diagnoses. And they found that amongst their ninety nine patients, the sensitivity of FDG PET, very expensive by the way, was eighty five percent, a specificity of eighty seven percent, a negative predictive value of seventy four percent, a positive predictive value of seventy three percent.
I find this interesting because it might be a nice tool if it has such great sensitivity and predictive value and specificity. The problem is that this is a clinical diagnosis with simple lab tests and do we really need to trick it up with a very expensive investigation? It may be more of a research tool at this point, certainly wouldn't recommend it in the clinic, May be useful in those who have undiagnosable aches and pains, assuming they don't have fibromyalgia. Three registries have shown the risk of serious infection when using biologic. These are French registries that were established with the introduction of tocilizumab, rituximab, and abatacid.
And their data over a long period of time is really very encouraging, showing less than one, one or less SIEs per 100 patient years. For tocilizumab, it's one per one hundred patient years. For rituximab, 0.7. For abatacep, 0.6. The idea here is that, you know, at every one hundred patients who goes on a biologic, less than one is going to have a risk of a serious infection, a hospitalizeable infection.
That's real world data coming from three large French cohorts. An interesting study looked at the use of belimumab in patients with systemic sclerosis. Obviously, a disease very hard, to manage. We don't really have any approved therapies. On the other hand, belimumab, I think, is looking for a home and a better use.
I think it could be more effective than it is in lupus. But nonetheless, an early pilot trial of 20 patients with early diffuse systemic sclerosis. Everybody goes on, mycophenolate, and half of group 10 go on placebo and the other 10 go on belimumab. And what they did show was that there was some better, Rodnan Skin score outcomes, minus 10 versus minus three, but that was not significant. Anyone who does scleroderma research will tell you that's the low hanging fruit in scleroderma research and showing improvement in Rodnan Skin score is no big deal.
It's been shown hundreds of times and yet we still don't have any effective therapies. You really need to show improvement in lung outcome, GI outcome, renal outcomes, long term outcomes, Hence, these studies are really hard to do. They did look at many outcomes. Actually, only outcome that looked impressive over time comparing the two groups was HAC was better in belimumab. Skin scores weren't significant neither were changes in FVC or DLCO.
A nice teaching point, dactylitis occurs in, sorry, what do you think about it? What's your list? Ready? Here are the answers. It can occur in psoriatic arthritis, ankylosing spondylitis, SPA in general, reactive arthritis, MCTD, scleroderma patients, systemic sclerosis, or the diffuse kind, especially, tuberculosis, syphilis, juvenile arthritis, and what's the last one?
Sarcoidosis. Three four more interesting reports. The CDC has come out with an endorsement. The ACIP has looked at the data about the new approved inactive shingles vaccine called Shingrix from GSK. This is gonna compete with the current live virus vaccine, Zostavax from Merck.
And the CDC's panel voted kind of close. I think was eight to seven or seven to six in favor of endorsing the new, inactive Shingrix vaccine over Zostavax. That's important for us and our patients who are on biologics, can't take the live virus vaccine. The Shingrix vaccine, however, the new one is now available, it's FDA approved. It's going to be a few injections and these injections have a increased rate of constitutional manifestations, arthralgias, flu like symptoms, fever, etc.
It's gonna be more expensive. Think it's gonna be as much as $600 is what I've been told. So don't hold me to that. That's what I sort of street news. So again, it'll be interesting to see how this gets integrated in practice in rheumatology amongst our patients.
A very important study was published by, I believe it's Lancet. It's the CRIB study authored by Xavier Mare from France. And, this was published or presented at the meetings last year. And this is a prospective study of 16 women who are on cerdulizumab during pregnancy. At the time of delivery, and within thirty days of delivery, they had blood samples.
And then at delivery, they had the blood from the mother, from the infant, and from the cord blood. And, again, the patient had to have received the drug within thirty days of delivery. And what they showed in their 16 patients was the following. Two were excluded because the data was all screwy, but on the remaining 14, 13 and 14 had no detectable cerdulizumab in, the infant blood. There was was there in cord blood as you might expect, and, when they looked at those children at four weeks and eight weeks down the line, there was no blood in the infant later on suggesting again and proving that cerdulizumab does not cross the placenta, in women who are taking, this drug during pregnancy.
An important study, you should probably look at this quickly, from Annals Internal Medicine about death rates in lupus. They looked at death rates, between 1968 and 2013, some incredible number, like fifty thousand deaths in lupus, and compared lupus deaths to deaths in people not with lupus. There's a large population based study, and they show that there remains to be a disproportionately high rate of death in lupus while, death rates in the general population have come down. Lupus levels have not come down as much. In fact, they came down in the sixties, went back up in the seventies, and have come down since.
But more importantly, they showed that when you look at the ratio of lupus deaths to non lupus deaths that there were favorable things being seen for whites but not favorable for women, African Americans, and those living in the South. So there are geographic differences, there are race and gender related differences that may have to do with access to care and other factors. But an important study saying that we still need more aggressive therapy and education in lupus. An important study was published in Lancet this week called the CALM study. This is an adalimumab study given to patients with Crohn's disease, and they really looked at the issue of what they call tight control.
It's not quite the same as our T2T, but tight control for them was they had two cohorts, one that had decisions made but using the CDAI which is the Crohn's Disease Activity Index and that's how usual care goes. But more importantly, the trend in GI these days is to use calprotectin and CRP and other biomarkers, and they used in their tight control group, the definitions of non response or failure with three factors: the C. Dye, the CRP, and fecal calprotectin levels. They showed that when you were more stringent in your definition of control or failure to control, you had better outcomes in the tight control group, forty six percent, versus the, usual care group, thirty percent. So that's it for this week at roomnow.com.
Go to the, website. You can find these links, and to read up more on this. More importantly, you should, bookmark our website, acr.17 acr17.roomnow.com and follow us next week. We start publishing on Sunday. We'll see you at ACR in San Diego.
Bye.



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