The RheumNow Week In Review - 23 February 2018 Part II Save

Of our society, has to do with wider use of diuretics and renal disease, and it may have something to do with dietary changes as well. So this is a sort of epidemiologic issue that has its manifestations with downstream associations with gout. There's an interesting study that came out this last week, which was a survey of dentists. Now, why bother might be one question, but another question is, what did they find? And not surprisingly, is that dentists are generally very, very afraid of bisphosphonates.

The idea of jaw osteonecrosis, osteonecrosis of the jaw is a major buzz in their brains and at their meetings. And when this survey of like almost 500 dentists showed that sixty three percent of them asked about whether patients take bisphosphonates that of the ones that are on bisphosphonates over eighty five percent are reluctant to do any kind of dental surgery. And again, the numbers are sort of staggering here about the fear. The problem is that there's a lack of education amongst the I think dentists and amongst maybe all physicians about the absolute risk of osteonecrosis of the jaw, which is probably closer to one in one thousand than anything. The bottom line is even though the rates are there and they might be up in some people, the question is, does the patient need the drug and would the benefits of the drug be more important than the potential minuscule risk of osteonecrosis of the jaw or for that matter, atypical femoral fractures.

But again, it means that rheumatologists are going to have to have a careful conversation and communication with their patients on bisphosphonates as they go to the dentist. You might even think about drawing up a letter ahead of time outlining the risks, taking some of the content off of RheumNow. Hey, I might even write that up for you so that you can give that to your dentist. Something to do. There's an interesting study that appeared in New England Journal today on oral anticoagulation therapy.

As you know, patients undergoing, hip replacement or knee replacement, often will go on, Coumadin or other anticoagulants, prophylactically for the first month, right after surgery and for the first month. This particular study looked at a more aggressive approach using Xarelto also called, sorry, Rivaroxaran. I don't even know how to say it, but it's Xarelto, sorry, that's the trade name. And they what they did in this study was they took almost 3,000 patients who were randomized to receive one or two therapies. Everybody right after their hip replacement or knee replacement received five days of Xarelto at the standard dose ten milligrams a day in oral pill.

But after the fifth day, they then either randomized patients to a week or a month of aspirin or a week or a month of Xarelto and they basically showed with their primary endpoint being three months later, the rate of DVTs and PEs was very, very low in patients who are continuing on aspirin or on Xarelto. The rate was about seven per one thousand patients. So very, very low rate. About half that number actually had significant bleeding in the three month follow-up period. So it seems that this might be an alternative regimen, easier regimen doesn't require PT monitoring, etc.

And it might even be shorter in the long run for patients who are undergoing hip and knee replacement. A very interesting report appeared this week, this month in Annals Rheumatic Disease by Doctor. David Pizzetsky, Peter Lipsky and a few others, where they actually looked at one hundred and three patients who had established lupus and they looked at the performance characteristics of the ANA test. Specifically, they looked at three different kits for ANA's. They did another one that was an ELISA, another one that was I can't remember the actual assay.

Did a total of five different kits. And the bottom line in these patients who had very well established lupus, that's, in the three kits they found five to twenty two percent who were ANA negative on one time testing. Using the other assays they found eleven to fourteen percent who were ANA negative. Thereby questioning why do we see ANA negativity in people with well established disease? Do patients lose their ANA positivity over time?

We know that happens in patients who for instance go into renal failure. We know that happens sometimes in patients who get very old. We know that happens when they really don't have lupus. The question is, do these patients really have lupus and what does it mean? Sterling West wrote in and said, what's the deal?

Will these patients be when they were first diagnosed? Were they ANA positive? David Pizzetsky wrote back and that's he says that's part of their ongoing study to find out what is the natural history of ANA positivity in a patient with lupus and what does it mean? Because one of the early studies of belimumab actually was sort of disqualified or critiqued because a high percentage of patients, a higher than expected percentage of patients were ANA negative at entry, even though they were entered into the study by lupus experts. So this is sort of a very controversial area.

I still assert you shouldn't be making the diagnosis of lupus without an ANA, but I think that the natural history of the ANA in someone who has disease remains to be determined and we need more research on this. It makes for a nice fellow project if you ask me. There's another interesting study that appeared this week in adults internal medicine, the hero study. This is hydroxychloroquine given the patients with hand osteoarthritis. They studied a large number of patients, and basically showed again, hydroxychloroquine does not work in hand OA.

These were not erosive OAs, these were just OA of the hand without erosive characteristics. And there's all we got a slew of studies that don't work in hand OA. Given the frequency of OA, twenty seven million Americans compared to eight point three with gout compared to one point three with RA. Why is there no more aggressive therapies? Why is there no more aggressive research being done in hand OA?

It's desperately needed. You know what my regimen is for hand OA? Tylenol, tape them up, and maybe two point five milligrams of prednisone. I don't have anything else that works as well. Nonsteroidal is fine, but there's no role for methotrexate or biologics or Plaquenil in these patients.

It's very disappointing. There's an interesting report about the pediatric population, treated with TNF inhibitors. This is a nice study from Jeff Curtis and colleagues. It was a claims based study where they actually looked at, patients with JIA and juvenile, inflammatory bowel disease and juvenile plaque psoriasis, and they compared fifteen thousand pediatric patients on a TNF inhibitor, first time TNF inhibitor used to over seventy four thousand patients who were not on a TNF inhibitor with those same diagnoses. In the end, they saw that the risk of malignancy had an adjusted hazard ratio of one point five, but it crossed one from with a confidence interval 0.8 to 2.85, suggesting that there is no significant risk of malignancy.

This is a big issue because you know, you read about malignancy and TNF inhibitors in the package inserts, it pretty much says that these tumors occur in, adults with rheumatoid arthritis or other inflammatory diseases. It's a little bit more indictful when it comes to pediatric population because it's hard to assess that population. This data goes a long way towards maybe giving us another step of confidence in that by giving a TNF inhibitor, you're probably not increasing the child's risk for a neoplasm and includes all neoplasms, not just lymphoma. Our last report actually is a press release from Celgene about their next study in patients with Behcet. So Primalast has originally been studied in a, I think it was 150 patient trial shown to be very effective.

And now they have a follow-up study. This is called the relief study. It's two zero seven patients who randomized to receive a primalast or placebo, for their Behcet syndrome and their primary endpoints were met. There was a reduction in the total number of, oral ulcers in oral ulcer pain and in a Behcet's disease activity score suggesting this is going to be an effective therapy. I like this drug, in Behcet's, I think it by its effects on neutrophils, probably has going to is going to have an effect in small vessel vasculitis, which is what Behcet's is.

And I think it'll be interesting to see where a Primalas gets developed once it gets approval for Behcet's. The company intends to submit its application to the FDA for Behcet's after they finish up the analysis and probably report this at a major meeting likely I would assume at EULAR. So second half of this year this might get submitted to the FDA. So look for this probably be six months later so it would be early twenty nineteen before it would become FDA approved in patients with Bichette's. That's it for this week on roomnow.com.

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