The RheumNow Week In Review 14 July 2017 Save
The RheumNow Week In Review 14 July 2017 by Dr. Cush
Transcription
Hi, this is Jack Cush. I'm executive editor of roomnow.com. This is the RoomNow weekend review for the 07/14/2014. A few regulatory bits of news around new drugs, new drug approvals, and some changes in labeling. The FDA has made an announcement that it will have a hearing of the Arthritis and Advisory Committee for both cerucamib and RA and for tofacitinib in psoriatic arthritis in early August.
Follow the FDA website to actually look at those hearings and see what happens. Baricitinib, is currently under review by the FDA, has received FDA not FDA approval, but the equivalent of FDA approval in Japan where it has become approved. It has also recently been recommended by NICE for approval in The UK and you'll have to await the decision of that. Otezla has had an update to its product label. After reviewing the data, the FDA has asked Otezla to add to their warning section that other side effects may include severe diarrhea, nausea, and vomiting.
I don't think this is new information. We kind of knew this happens, and thankfully just in a minority of individuals. And then also, not yet quite out, but the FDA has accepted the new drug application of tofacitinib for the indication of ulcerative colitis. So, We'll wait and see what happens with that. An interesting review looked at meta analyses of cardiovascular risk associated with rheumatoid arthritis and showed that those published before 2000 showed an obvious and increasing risk of cardiovascular events in patients with active disease.
But after 2000, it was getting harder to document that, with maybe the suggestion that the advent of new biologic therapies, more aggressive therapies, more combination therapies may lead to better cardiovascular outcomes. An interesting hypothesis, somewhat supported indirectly by data such as this. Those of you who have seen cases of IgG4 related disease know that it can be somewhat challenging diagnosis. It can be also quite challenging to monitor such patients as acute phase reactants and even serum IgG4 levels aren't always predictive, variables in the manner of such cases. There's an interesting report, that looks at the use of, FDG PET CT to look at, organ involvement in such patients in a serial manner.
Obviously, an expensive way of doing this, but nonetheless, they showed it was useful in identifying active disease. An interesting study looked at patients who have lupus nephritis, and amongst those patients, the ones who in fact became pregnant. The question was asked, does pregnancy on top of existing lupus nephritis, albeit inactive and controlled, add to further renal disease or is that a bad combination? And their analysis actually showed that compared to thirty two patients with active lupus nephritis, inactive lupus nephritis who were pregnant compared to sixty four patients who did not get pregnant but yet had lupus nephritis showed that the number of flares were the same. There were no worse renal outcomes or progression of chronic kidney disease in those women who did have pregnancies.
And so that was sort of encouraging for those women who may want to go forward if their kidney disease is well controlled with lupus. A recent New England Journal study this week actually looked at the nurse's health study and assessed what happened in as far as their diets over a twelve year period and showed that those who exhibited an improved quality of their diet actually had a decreased rate of death. In fact, the mortality figures were lower somewhere around ten to fifteen percent, depending on which measure you used as a measure of a quality diet change. So point the is it's not too late. Change your diet, live longer, it can still happen.
Although it does take a number of years of a healthy diet to realize these benefits. The Institute of Medicine, has also taken analysis of those who are poor and uninsured and not surprisingly, you would think that that may shorten life and in fact, they showed that those individuals who did not have health insurance were at a greater risk of death. And conversely, those with health insurance, it reduced death rates in a large cohort of patients. An analysis of 40,000 Dutch patients showed that the prevalence of ANCA positivity or ACPA positivity is about one percent, and it's more likely in those who are older, those who smoke, those who are female, and those who obviously have rheumatoid like symptoms. But yet of all the patients who had ANCA, only twenty percent actually had rheumatoid arthritis.
So obviously, there's more than ANCA to getting rheumatoid arthritis. An analysis of a small cohort of patients who were pregnant and had rheumatoid arthritis looked at gene expression and showed that amongst the many gene expressions that occur and that evolved from the pre pregnancy and first trimester to the last trimester, most prominent in there is an increase in inducible type one interferon genes suggesting that that may be, in fact, associated with those women who improve their rheumatoid arthritis symptoms during the pregnancy. So the induction of type one alpha interferon, again, it's a complex story as to why people get better or there's a large number of patients who, in fact, do get worse. It's not seventy percent of people getting better with pregnancy. In fact, it's probably more like fifty percent who don't get better or get worse.
So, nonetheless, trying to figure out the immunology behind pregnancy is interesting. The FDA has, approved Orencia. I found it a little bit surprising. I knew it was up for approval, I know it's going to happen this quickly. It's approved Orencia for used psoriatic arthritis.
If you look at the data and the reports that are out there, data is good. It does show improvement in the articular symptoms of psoriatic arthritis. The skin improvements are modest and probably not a reason why you would want to use Avatacet in patients with active skin disease and psoriatic arthritis, but nonetheless, it is another option for those who have active joint disease. A large analysis of patients who were taking steroids showed that if you were on a background bisphosphonate, specifically alendronate, that you actually had a lower rate of hip fracture. This was not done in osteoporosis or high risk individuals.
These are just patients who are on steroids in a population based study. So that's sort of good news and, again, suggests that we really need to be aggressive in managing patients who are on steroids so as to prevent osteoporosis and hip fracture. And lastly, there's an interesting report that looks at patient reported outcomes in a large cohort of patients. It was eight hundred patients in the POET study. And in this study, they took patients who had more than six months of either remission or low disease activity state and two to one randomized them to either stop their TNF inhibitor or continue the TNF inhibitor.
Not surprisingly, they showed at three months, there was a significant worsening in about half the patients who stopped their drug and that some of those worsenings actually persisted out even into a longer time period, suggesting that, again, if you are going to stop or wean off of a TNF inhibitor when you have control, you have to expect that a large number of patients are going to get worse. What they also did show in that study was that upon reinstitution of TNF inhibitor, you could quickly gain control of the disease. That's it for this week at roomnow.com. Go to the website, tune in next week, we'll give you more good information on RheumNow. Bye bye.
Follow the FDA website to actually look at those hearings and see what happens. Baricitinib, is currently under review by the FDA, has received FDA not FDA approval, but the equivalent of FDA approval in Japan where it has become approved. It has also recently been recommended by NICE for approval in The UK and you'll have to await the decision of that. Otezla has had an update to its product label. After reviewing the data, the FDA has asked Otezla to add to their warning section that other side effects may include severe diarrhea, nausea, and vomiting.
I don't think this is new information. We kind of knew this happens, and thankfully just in a minority of individuals. And then also, not yet quite out, but the FDA has accepted the new drug application of tofacitinib for the indication of ulcerative colitis. So, We'll wait and see what happens with that. An interesting review looked at meta analyses of cardiovascular risk associated with rheumatoid arthritis and showed that those published before 2000 showed an obvious and increasing risk of cardiovascular events in patients with active disease.
But after 2000, it was getting harder to document that, with maybe the suggestion that the advent of new biologic therapies, more aggressive therapies, more combination therapies may lead to better cardiovascular outcomes. An interesting hypothesis, somewhat supported indirectly by data such as this. Those of you who have seen cases of IgG4 related disease know that it can be somewhat challenging diagnosis. It can be also quite challenging to monitor such patients as acute phase reactants and even serum IgG4 levels aren't always predictive, variables in the manner of such cases. There's an interesting report, that looks at the use of, FDG PET CT to look at, organ involvement in such patients in a serial manner.
Obviously, an expensive way of doing this, but nonetheless, they showed it was useful in identifying active disease. An interesting study looked at patients who have lupus nephritis, and amongst those patients, the ones who in fact became pregnant. The question was asked, does pregnancy on top of existing lupus nephritis, albeit inactive and controlled, add to further renal disease or is that a bad combination? And their analysis actually showed that compared to thirty two patients with active lupus nephritis, inactive lupus nephritis who were pregnant compared to sixty four patients who did not get pregnant but yet had lupus nephritis showed that the number of flares were the same. There were no worse renal outcomes or progression of chronic kidney disease in those women who did have pregnancies.
And so that was sort of encouraging for those women who may want to go forward if their kidney disease is well controlled with lupus. A recent New England Journal study this week actually looked at the nurse's health study and assessed what happened in as far as their diets over a twelve year period and showed that those who exhibited an improved quality of their diet actually had a decreased rate of death. In fact, the mortality figures were lower somewhere around ten to fifteen percent, depending on which measure you used as a measure of a quality diet change. So point the is it's not too late. Change your diet, live longer, it can still happen.
Although it does take a number of years of a healthy diet to realize these benefits. The Institute of Medicine, has also taken analysis of those who are poor and uninsured and not surprisingly, you would think that that may shorten life and in fact, they showed that those individuals who did not have health insurance were at a greater risk of death. And conversely, those with health insurance, it reduced death rates in a large cohort of patients. An analysis of 40,000 Dutch patients showed that the prevalence of ANCA positivity or ACPA positivity is about one percent, and it's more likely in those who are older, those who smoke, those who are female, and those who obviously have rheumatoid like symptoms. But yet of all the patients who had ANCA, only twenty percent actually had rheumatoid arthritis.
So obviously, there's more than ANCA to getting rheumatoid arthritis. An analysis of a small cohort of patients who were pregnant and had rheumatoid arthritis looked at gene expression and showed that amongst the many gene expressions that occur and that evolved from the pre pregnancy and first trimester to the last trimester, most prominent in there is an increase in inducible type one interferon genes suggesting that that may be, in fact, associated with those women who improve their rheumatoid arthritis symptoms during the pregnancy. So the induction of type one alpha interferon, again, it's a complex story as to why people get better or there's a large number of patients who, in fact, do get worse. It's not seventy percent of people getting better with pregnancy. In fact, it's probably more like fifty percent who don't get better or get worse.
So, nonetheless, trying to figure out the immunology behind pregnancy is interesting. The FDA has, approved Orencia. I found it a little bit surprising. I knew it was up for approval, I know it's going to happen this quickly. It's approved Orencia for used psoriatic arthritis.
If you look at the data and the reports that are out there, data is good. It does show improvement in the articular symptoms of psoriatic arthritis. The skin improvements are modest and probably not a reason why you would want to use Avatacet in patients with active skin disease and psoriatic arthritis, but nonetheless, it is another option for those who have active joint disease. A large analysis of patients who were taking steroids showed that if you were on a background bisphosphonate, specifically alendronate, that you actually had a lower rate of hip fracture. This was not done in osteoporosis or high risk individuals.
These are just patients who are on steroids in a population based study. So that's sort of good news and, again, suggests that we really need to be aggressive in managing patients who are on steroids so as to prevent osteoporosis and hip fracture. And lastly, there's an interesting report that looks at patient reported outcomes in a large cohort of patients. It was eight hundred patients in the POET study. And in this study, they took patients who had more than six months of either remission or low disease activity state and two to one randomized them to either stop their TNF inhibitor or continue the TNF inhibitor.
Not surprisingly, they showed at three months, there was a significant worsening in about half the patients who stopped their drug and that some of those worsenings actually persisted out even into a longer time period, suggesting that, again, if you are going to stop or wean off of a TNF inhibitor when you have control, you have to expect that a large number of patients are going to get worse. What they also did show in that study was that upon reinstitution of TNF inhibitor, you could quickly gain control of the disease. That's it for this week at roomnow.com. Go to the website, tune in next week, we'll give you more good information on RheumNow. Bye bye.
If you are a health practitioner, you may Login/Register to comment.
Due to the nature of these comment forums, only health practitioners are allowed to comment at this time.