The RheumNow Week In Review Why Comorbidity Is A Lot Like The Weather %285.3.18%29 Save
The RheumNow Week In Review Why Comorbidity Is A Lot Like The Weather %285.3.18%29 by Dr. Cush
Transcription
It's the 05/03/2017. This is the RheumNow we can review. Hi, I'm Doctor. Jack Cush, executive editor of roomnow.com. This week in the news, have regulatory updates.
We have news on patients being treated badly by their insurance companies. One step closer to precision medicine in Still's disease. And lastly, why comorbidity is a lot like the weather. At the top of the news is an interesting report from the FDA where they've actually issued a complete response letter to the makers of a new rituximab biosimilar. Actually, did this a few months ago with Celltrion and its biosimilar version of rituximab, and it just happened again to Sandoz.
And again, this is a bit of a setback for the biosimilar industry where the FDA is being as hard on them as they are being hard on other companies who've also received complete response letters. As you know, what that means is that the FDA cannot approve the application as is, that the company needs to review the shortfalls of their application and their research with the FDA and work around that either with new studies or analysis of new data. It's a setback. It's good news for Genentech and the makers of rituximab. But, we need to see more.
Actually, there's plenty of biosimilar rituximab being used worldwide, just not here in The United States. Other regulatory information comes from the EMA and their agency called the CHMP, the Committee on Medicinal Products for Human Use. They actually have approved two new indications, cerdulizumab being approved for plaque psoriasis and tofacitinib being approved for psoriatic arthritis. That's going to be an EU wide, approval, actually it's a recommendation for approval, it's likely that those will follow through. Creaky Joints released some data this week about surveys that they've done on patients and how that they, are being treated by their insurance companies.
And they showed data from New York State where patients have been, denied the use of medicines for basically non medical switching, meaning for non medical reasons, the insurer and the PBM are recommending other drugs than the one that was prescribed for non medical reasons, usually for financial reasons, and whatnot. Again, and the consequences of that are numerous, but nonetheless unsavory. I think that this is a growing trend, we see this in practice. I believe at some point this should be strongly outlawed. I think it'll come to a head in the biosimilar, phase of new therapeutics when that's going to be a big issue.
Will there be non medical switching allowed? Will there be legislation against that? And will that hold over to all medicines, not just biosimilars? An interesting report comes from JAMA Neurology where it talks about TNF inhibitor use in inflammatory bowel disease patients. Specifically, IBD patients have a thirty percent increased risk of Parkinson's.
Didn't know that, wouldn't expect that. But IBD patients treated with TNF inhibitors have a significant almost eighty percent reduction in the rate of Parkinson's in that population. Interesting, how it relates to RA and other disease we treat, I am not really sure. What's the mechanistic reasons? I'm not sure, but nonetheless, it's obviously says that there must be some role for TNF in the genesis of Parkinson's disease in IBD patients.
Data I did not know now includes that scleroderma patients who may have an increased risk for cancer might be identified by their autoantibody profile. So an annals of rheumatic disease article shows that patients who are positive for antibodies against RNA, RNA three polymerase, or anti polo antibodies have an increased risk, a threefold increased risk of cancer within the first three years of diagnosis. Turns out the same finding was reported, I believe mid last year, 2017 in Journal of Rheumatology showing the same thing, RNA polymerase three antibodies being associated with increased risk of cancer. This particular ARD study shows that it's also increased cancer that is in people who lack antibodies against centromere and topoisomerase one. So, heretofore, I did not know, there is a small risk of cancer in some subsets of scleroderma, but now we may have some biomarkers like we do in patients with inflammatory myositis.
An interesting study by the CDC of US death certificates and specifically looking at lupus deaths showed that between the fifteen year period 2000 to 2015, there are over twenty eight thousand deaths from lupus in women, and that SLE ranked as one of the top 20 causes of death in women, and that's unfortunate. When they broke it down by age group, that in the ten to fourteen year old group, it was the fifteenth cause of death. In the fifteen to twenty four year old group, the most common maybe worrisome group in lupus, it was a tenth leading cause of death. In those between the ages of 25 and 45, it was the fourteenth leading cause of death. Death and lupus is not a good thing, and we need measures to more carefully address this.
Interesting breakthroughs in the world of pediatric JIA, specifically systemic JIA. Michael Umbrella and colleagues from NIAMS and the NIH have actually found that the expression of IL-1RN, the gene that encodes for the acute phase reactant protein, the IL1RA gene, a protein that regulates IL1 activity in humans and in disease. They showed that, high expression of this gene is associated with, is actually protective against the disease, that low expression is associated with an increased disease susceptibility. And of course, this is all interesting because this involves the treatment that we use exogenously, the IL-one RA protein, also known as anakinra, that's human recombinant IL-one RA. The IL-one RA RN locus, is also when it's homozygous, and when there's a high expression of that gene, it is associated with a non response to anakinra.
This is interesting because I think it takes us one step closer to what we may, ultimately view as precision medicine or a smarter way of treating a very difficult disease. They actually did studies looking at IL-one RA non responders or responders and it turns out that this gene did play an important role in that subset. There's interesting data that comes from the VA administration and the National Data Bank over 25,000 patients studied looking at, BMIs in relationship to disability and they showed that severe obesity was associated with progressive disability in RA patients, maybe not surprising, but nonetheless, worth noting. They also noted that unintentional weight loss may be, an important marker for those who have progressive disability, and that's unexpected. I think that this is not surprising.
This is one of the bad comorbidities and obesity while it has its consequences, it's not necessarily associated with a higher death rate in our patients, especially in RA, but it is associated with a lot of quality of life deterioration in this case of your disability, and is probably something that needs more attention. Also in the spectrum of comorbidities, a number of reports have appeared recently about the influence of comorbidity and outcomes in patients with psoriatic arthritis. One particular study that was recently reported showed that, when they looked at a cohort of psoriatic arthritis patients and categorize them according to their Charleston Comorbidity Index CCI scores, they showed that those who had high CCI scores of greater than two or higher was associated with higher disease activity at baseline, a higher incidence of depression and anxiety, shorter persistence time on TNF inhibitors. There are other studies out there showing the same thing recently reported and going back in the last two years showing that metabolic syndrome and obesity are associated with lower persistence on drug, less adherence to TNF inhibitors, higher disease activity, and diminished responses to TNF inhibitors in patients with psoriatic arthritis. This is why comorbidities are a lot like the weather.
What? Is it the weather being a hot topic? No. And that it's hard to predict? Not quite.
That if you just wait a while, it'll go away. No, it doesn't. It doesn't go away. It's a lot like the weather because everybody talks about comorbidity and does nothing about it. This is a big issue for us.
We often talk comorbidity, especially to patients and things we're worried about and why we need more aggressive therapy, but yet rheumatologists are not very engaged in comorbidity management or even identification. I know you're all busy, know you assume this is going be done by primary care, but the data is also clear that your patients think you're the smartest guy amongst all their doctors, and they often don't go to primary care doctors. We need a better plan and a better strategy to manage comorbidity in our patients. That's it for this week on RheumNow. Tune in next week, we'll give you more good news in rheumatology.
Bye now.
We have news on patients being treated badly by their insurance companies. One step closer to precision medicine in Still's disease. And lastly, why comorbidity is a lot like the weather. At the top of the news is an interesting report from the FDA where they've actually issued a complete response letter to the makers of a new rituximab biosimilar. Actually, did this a few months ago with Celltrion and its biosimilar version of rituximab, and it just happened again to Sandoz.
And again, this is a bit of a setback for the biosimilar industry where the FDA is being as hard on them as they are being hard on other companies who've also received complete response letters. As you know, what that means is that the FDA cannot approve the application as is, that the company needs to review the shortfalls of their application and their research with the FDA and work around that either with new studies or analysis of new data. It's a setback. It's good news for Genentech and the makers of rituximab. But, we need to see more.
Actually, there's plenty of biosimilar rituximab being used worldwide, just not here in The United States. Other regulatory information comes from the EMA and their agency called the CHMP, the Committee on Medicinal Products for Human Use. They actually have approved two new indications, cerdulizumab being approved for plaque psoriasis and tofacitinib being approved for psoriatic arthritis. That's going to be an EU wide, approval, actually it's a recommendation for approval, it's likely that those will follow through. Creaky Joints released some data this week about surveys that they've done on patients and how that they, are being treated by their insurance companies.
And they showed data from New York State where patients have been, denied the use of medicines for basically non medical switching, meaning for non medical reasons, the insurer and the PBM are recommending other drugs than the one that was prescribed for non medical reasons, usually for financial reasons, and whatnot. Again, and the consequences of that are numerous, but nonetheless unsavory. I think that this is a growing trend, we see this in practice. I believe at some point this should be strongly outlawed. I think it'll come to a head in the biosimilar, phase of new therapeutics when that's going to be a big issue.
Will there be non medical switching allowed? Will there be legislation against that? And will that hold over to all medicines, not just biosimilars? An interesting report comes from JAMA Neurology where it talks about TNF inhibitor use in inflammatory bowel disease patients. Specifically, IBD patients have a thirty percent increased risk of Parkinson's.
Didn't know that, wouldn't expect that. But IBD patients treated with TNF inhibitors have a significant almost eighty percent reduction in the rate of Parkinson's in that population. Interesting, how it relates to RA and other disease we treat, I am not really sure. What's the mechanistic reasons? I'm not sure, but nonetheless, it's obviously says that there must be some role for TNF in the genesis of Parkinson's disease in IBD patients.
Data I did not know now includes that scleroderma patients who may have an increased risk for cancer might be identified by their autoantibody profile. So an annals of rheumatic disease article shows that patients who are positive for antibodies against RNA, RNA three polymerase, or anti polo antibodies have an increased risk, a threefold increased risk of cancer within the first three years of diagnosis. Turns out the same finding was reported, I believe mid last year, 2017 in Journal of Rheumatology showing the same thing, RNA polymerase three antibodies being associated with increased risk of cancer. This particular ARD study shows that it's also increased cancer that is in people who lack antibodies against centromere and topoisomerase one. So, heretofore, I did not know, there is a small risk of cancer in some subsets of scleroderma, but now we may have some biomarkers like we do in patients with inflammatory myositis.
An interesting study by the CDC of US death certificates and specifically looking at lupus deaths showed that between the fifteen year period 2000 to 2015, there are over twenty eight thousand deaths from lupus in women, and that SLE ranked as one of the top 20 causes of death in women, and that's unfortunate. When they broke it down by age group, that in the ten to fourteen year old group, it was the fifteenth cause of death. In the fifteen to twenty four year old group, the most common maybe worrisome group in lupus, it was a tenth leading cause of death. In those between the ages of 25 and 45, it was the fourteenth leading cause of death. Death and lupus is not a good thing, and we need measures to more carefully address this.
Interesting breakthroughs in the world of pediatric JIA, specifically systemic JIA. Michael Umbrella and colleagues from NIAMS and the NIH have actually found that the expression of IL-1RN, the gene that encodes for the acute phase reactant protein, the IL1RA gene, a protein that regulates IL1 activity in humans and in disease. They showed that, high expression of this gene is associated with, is actually protective against the disease, that low expression is associated with an increased disease susceptibility. And of course, this is all interesting because this involves the treatment that we use exogenously, the IL-one RA protein, also known as anakinra, that's human recombinant IL-one RA. The IL-one RA RN locus, is also when it's homozygous, and when there's a high expression of that gene, it is associated with a non response to anakinra.
This is interesting because I think it takes us one step closer to what we may, ultimately view as precision medicine or a smarter way of treating a very difficult disease. They actually did studies looking at IL-one RA non responders or responders and it turns out that this gene did play an important role in that subset. There's interesting data that comes from the VA administration and the National Data Bank over 25,000 patients studied looking at, BMIs in relationship to disability and they showed that severe obesity was associated with progressive disability in RA patients, maybe not surprising, but nonetheless, worth noting. They also noted that unintentional weight loss may be, an important marker for those who have progressive disability, and that's unexpected. I think that this is not surprising.
This is one of the bad comorbidities and obesity while it has its consequences, it's not necessarily associated with a higher death rate in our patients, especially in RA, but it is associated with a lot of quality of life deterioration in this case of your disability, and is probably something that needs more attention. Also in the spectrum of comorbidities, a number of reports have appeared recently about the influence of comorbidity and outcomes in patients with psoriatic arthritis. One particular study that was recently reported showed that, when they looked at a cohort of psoriatic arthritis patients and categorize them according to their Charleston Comorbidity Index CCI scores, they showed that those who had high CCI scores of greater than two or higher was associated with higher disease activity at baseline, a higher incidence of depression and anxiety, shorter persistence time on TNF inhibitors. There are other studies out there showing the same thing recently reported and going back in the last two years showing that metabolic syndrome and obesity are associated with lower persistence on drug, less adherence to TNF inhibitors, higher disease activity, and diminished responses to TNF inhibitors in patients with psoriatic arthritis. This is why comorbidities are a lot like the weather.
What? Is it the weather being a hot topic? No. And that it's hard to predict? Not quite.
That if you just wait a while, it'll go away. No, it doesn't. It doesn't go away. It's a lot like the weather because everybody talks about comorbidity and does nothing about it. This is a big issue for us.
We often talk comorbidity, especially to patients and things we're worried about and why we need more aggressive therapy, but yet rheumatologists are not very engaged in comorbidity management or even identification. I know you're all busy, know you assume this is going be done by primary care, but the data is also clear that your patients think you're the smartest guy amongst all their doctors, and they often don't go to primary care doctors. We need a better plan and a better strategy to manage comorbidity in our patients. That's it for this week on RheumNow. Tune in next week, we'll give you more good news in rheumatology.
Bye now.
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