RheumNow Podcast The Shoes Maketh The Doctor (10.25.19) Save

It's the October 25. This is the RheumNow podcast, and I'm Doctor. Jack Cush, executive editor of roomnow.com. This week, TNF inhibitors and pain. It doesn't always go away.

Psoriatic arthritis patients and liver disease is probably more common than you think. And lastly, a bevy of regulatory decisions by the FDA and EMA. More important, how many is a bevy? Well, let's count them up at the end and see. First report from the FDA, good news, it's not even all the way through the year, and they set a record on generic approvals this year.

In 2018, they had nine seventy one approvals, in 2017, nine thirty seven approvals. This year, we're, I guess, what, 80% through the year, and we already have eleven seventy one new generic drugs approved by the FDA. Is that a good thing or a bad thing? Well, the head of Health and Human Services, Alex Azar, has praised the FDA for basically improving the lives of Americans by making drugs more affordable and more available by this record number of generic approvals. Looming in the background is a prescription drug bill and pricing issues.

It's going to be a big issue in the elections here in The US. This might be the only good news on drugs and cost of drugs that we'll see in the next twelve months. Psoriatic arthritis patients and diet. I don't know if we've talked about this before, but I have this sneaky suspicion that diet can actually help psoriatic arthritis patients, maybe even spondylitis patients. I'm not so sure about fibromyalgia OA and RA.

My experience has been quite negative. But our clinic experience has been quite positive for patients taking on a paleo diet or a gluten free low carb diet. Well, an observational study of two eleven psoriatic arthritis patients looked at their adherence to a Mediterranean diet. That's, again, pretty much a paleo diet or the same as a gluten free, low carb, no carb diet. In the psoriatic arthritis patients, number of them were obese, a quarter of them had the metabolic syndrome.

When they totaled up their adherence to a Mediterranean diet, two thirds were moderately adherent to the diet. More importantly, they looked at correlations between dietary adherence and disease activity measures, the DAPSA, and the HACS score. They showed an inverse correlation between disease activity measures and diet adherence. So, diet adherence, low DAPSA scores, low HACS scores. Mike, could this be something you recommend to your patients who have psoriatic arthritis?

Would you ever use the word Mike could? Well, move to Texas and you might. Could. Toronto has been studying psoriatic arthritis for a long time, led by Daphne Klattman. They have a psoriatic arthritis clinic.

Over a thousand patients followed for a long period of time. They found that three forty three patients had liver test abnormalities, a prevalence rate of thirty two percent, an incidence rate of thirty nine per one thousand patient years makes it sound less, but it is quite prevalent. It turns out that liver test abnormalities are more likely in patients who have, as you would imagine, fatty liver and patients who are followed up over a longer period of time. Corona has looked at an issue that we talked about last week, and the issue being what happens to people who have active disease and how often are drugs changed in such patients. In their registry, a study of four zero nine biologic naive individuals followed every six months.

More than half of them had moderate to high disease activity based on standard measures at baseline. Yet when they followed them prospectively, only thirty percent had a change in their DMARR therapy despite having high disease activity, moderate disease activity. Again, what are you waiting for? Turns out that DMAR changes in this study, last study we told you about, who doesn't have changes? It's the elderly, it's those who have comorbidities.

Here, the ones who did have DMARC changes were more likely to be young, have short disease duration, have high disease activity and high pain scores, and high fatigue numbers as well. So, a very interesting study was published. I think this is from Doximity. What kind of shoes do doctors prefer? We know the saying goes, you know, give a girl the right shoes and she'll conquer the world.

Maybe the corollary to that is a man in bad shoes will ruin a relationship. But what do doctors do? Well, in this study of two twenty five patients, it turns out the number one choice of shoes by physicians, men and women, was thirty percent who went with casual or loafer type shoes. Only twenty five percent went with dress shoes. Twenty percent of you are obviously moving fast because you're wearing sneakers.

And then there's a special breed of doctor, eleven percent, who are wearing those clogs and Crocs, and I doubt that all of them are in the OR. Turns out that eighty three percent of you said the most important factor was comfort, and popular brands that were chosen by doctors were Clarks, Dansko, d a n s k o, never heard of them, Skechers, Echo, Merrill, Rockport, and Cole Haans. Looks like a lot of leather, a lot of laces on one end, a lot of sneaker and comfort and clogs on the other end, a bimodal distribution. Thankfully, nobody's wearing Velcro shoes. Hopefully, if you are, you're in radiology and soon to retire.

Know, shoes are a big issue. I think that, can you look at the shoes and say, I can judge my doctor by his shoes? The shoes maketh the doctor. If the quality of the shoe I think there might actually be a correlation here. The cost or quality of the shoe is probably related to the length of the differential diagnosis he or she can come up with.

On the other hand, if you're wearing a sneaker or clogs or Crocs, I don't think differential diagnosis is important to you. Stick with the leathers and lace ups is my my advice. But then again, don't take my advice. You know, ten years ago, twenty years ago, I was yelling at residents for not wearing a tie. I don't wear a tie at a clinic anymore.

I think there's good medical reasons for it. I've gotten old and cranky and lazy. No, I'm not wearing clogs at the clinic. There's an interesting study out about the growth of cancers in RA patients, especially cancers that would be amenable to treatment with these newer immune checkpoint inhibitors. As we know, these agents are associated with a high or substantially low rate of immune related adverse events, that they're actually a little more common in patients who actually have an autoimmune disease like RA, PSA, etc.

And it turns out that our patients are having more tumors amenable to such therapy, suggesting that when the study was started, zero percent of our tumors would have been amenable to such therapy. Now it's seven percent of the tumors affecting rheumatoid, and that's between twenty fourteen-twenty eighteen. All this to say that you probably should be familiar with the autoimmune events surrounding immune checkpoint inhibitors, because more patients will be going on these drugs that are highly effective, big game changers in diseases like melanoma. So, you should be aware of these conditions and what can be caused by those particular anticancer therapies. A lot of regulatory decisions, the EMA, specifically the Committee on Medicinal Products for Human Use, CMHP, I think it's called, they've recommended upadacitinib or RINVOQ for marketing in The EU that's not yet approved, but has been recommended for approval.

They have actually also announced a positive opinion regarding the use of Romelosizumab, the anti xcorostatin drug, in the treatment of severe osteoporosis with the proviso that it be in postmenopausal women who are at high risk for fracture and who have no prior history of MI or CVAs. You know, evaluation of that drug was held up by considerations of the data that looked at a higher rate of cardiovascular events, MACE events, in patients who were taking Romecizumab. The FDA has just approved Ustekinumab for ulcerative colitis. As you know, it's been approved previously for Crohn's disease. It's out there for many of our indications as well.

It's based on a UNIFI trial, where substitute ustekinumab was shown to cause remission in about forty percent of individuals, where it was only twenty four percent in those on placebo, suggesting its efficacy and now its availability. And then also the FDA this week came up with a new guidance document recommending that patients who are undergoing breast implantation be warned, boxed warning that is, about the hazards of breast implants and their association with a lot of different things, including, infections, hardening, revision rates, whatnot. Not so much about the autoimmune phenomenon. Again, that's all been talked about, but really not a part of the mix. There's a small chance of a strange lymphoma like condition that occurs.

In these recommendations, besides the box warning and a checklist of warning things that patients need to know about, is the recommendation that patients have imaging, either by MRI or ultrasound if they develop hardening or periodically throughout their course. So, that's kind of interesting that the FDA has gone this far. It's a guidance document. They're asking for opinions. It's not a final document.

But it will be in the near future. There's a nice study that looked at almost 2,000 patients with rheumatoid arthritis who are initiating a TNF inhibitor. And it turns out that when they looked at those patients, how many of them were on opioids for the management of their pain? Turns out that it was almost forty percent of patients. Well, you would think getting a TNF inhibitor would lead to great efficacy, control of disease, less need for opioids.

It turns out that that was partly true. So, a decrease in opioid use in patients on TNF inhibitors dropped from fifty four to fifty one percent, while not so much. Also, the number of patients who required, you know, a high dose to give you the equivalent of greater than fifteen milligrams of a morphine equivalent, that's basically high dose narcotic therapy, drops from twelve point six to ten point six following TNF inhibitor use. It says that even though TNF inhibitors we know are very, very effective, they may not be very effective in managing pain. This was seen in a lot of the JAK inhibitor trials where the JAKs were making claims that they're much better at pain control compared to their comparator drug, which was usually a TNF inhibitor.

So there's more to treating pain in RA than just effective biologic therapy. I need to rethink that. There's probably a lot of secondary fibromyalgia going on here. There's obviously structural disease and mechanical problems that contribute to this, but it may be, an unrecognized unmet need in the care of our RA patients. We'll end with the reminder that Zantac is being recalled by Sanofi, who's one of the later primary manufacturers of Zantac ranitidine.

You know, this has been in the news for quite some time now, but now it seems like everybody's pulling the drug off the shelves and it's going to grow scarce largely because of the association with not NMDA, it's NBMA, which is an incipient that's found in this drug and a lot of other drugs have been pulled from the market recently. It has been listed as a weak carcinogen. It's been recommended by the FDA. These companies study it. In the meantime, the drug.

So, you should remind your patients, stop that, use a PPI. Know, Tagamet is actually also in short supply, and that is something you'll have to deal with. Make sure you follow us at the ACR. I heard good news this week that at the ACR, forty nine point one percent of all presentations will be by women. So they'll be out in the forest, as will the men, and maybe it'll be a battle of the sexes for who does best at the ACR.

That's it. Check out the citations and more on the website, rheumnow.com. Go forth. Do good. Earn their trust.

Change the world. We'll see you next week.