ACR2019 Day4 Save

Hi. I'm doctor Jack Cush, and this is the ACR two thousand nineteen podcast. We're coming to you from the annual meeting in Atlanta, Georgia. This episode is a collection of our faculty reports, interviews, and panel discussions recorded live from the RheumNow booth. I hope you enjoy and learn.

Hello, everyone. This is Olga Petrina with more updates from two thousand nineteen ACR meeting. Today, would like to highlight one of the late breaking abstracts, abstract number l 20, which present us with the results of the head to head comparison of ixekizumab and adalimumab for treatment of psoriasis and psoriatic arthritis. In this open label randomized trial, patients were divided into groups. One received ixekizumab and another one adalimumab.

Patients in this group, met, Casper criteria for active psoriatic arthritis with more than three swollen and tender joints, and they were having active psoriasis with more more than 3% of body surface area involved. Patients were allowed to use conventional DMARs like methotrexate, for example, but they were all bionnaive in this study. As a result, patients in, both groups showed really good response in terms of joint disease with ACR 50 scores being quite comparable for both groups at weeks twenty four and fifty two. But the primary endpoint of the study was simultaneous ACR fifteen passing 90 response. And in this regard, the ixekizumab group performed much better with, thirty six percent of the patients achieving, higher response in ixekizumab group as comparing, comparing to twenty eight percent in adalimumab group.

And this trend continued up to fifty two weeks, where at, fifty two weeks, exokinumab group, responded better at thirty nine percent, and adalimumab group only twenty six percent. When we looked at the when researchers looked at the patients who received methotrexate, in both groups, methotrexate improved responses, but the common trend of higher response rate in ixakinumab group remained the same. When it came to adverse events, we could can see that patients in adalimumab group had higher incidence of infections, higher rates of hypersensitivity reactions, malignancy, and cytopenias, while in ixekinumab group patients dominated in terms of injection site reactions and inflammatory bowel disease. There are one case of ulcerative colitis and one case of Crohn's disease. If you would like to learn more, please follow us on RheumNow and enjoy the meeting.

Thank you.

Hi. I'm David Lee from Melbourne Australia reporting for rheumnow.com at ACI twenty nineteen here in Atlanta, Georgia. Just wanted to tell you about something a little bit different, and particularly about the way that posters are designed and how it's affecting things here on the poster floor at ACR. Traditionally, posters have been formatted with a relatively small title and they're quite data rich. It can be hard to know what they're about when you're walking past them, and that's particularly a problem when there are thousands of posters at a conference like there are here at ACR.

You're walking past them and it can be hard to know what they mean, whether they're of interest, you stop, and by the time you do that you might only get to the first part of the poster hall. Now this isn't a problem that's unique to rheumatology. It's something that other people have been thinking about. If you go online and have a look at some of the videos of that better poster, especially the ones by Mike Morrison, it's quite interesting to see what they're talking about in terms of poster design. What does this mean at ACI twenty nineteen?

Well, there have been a few poses including one that I was involved with where the title is really big, there's a lot of negative space, and it kind of conveys a message clearly when you're walking past it. There weren't weren't many of those, and I think we're still gradually getting used the idea. I think as rheumatologists we're just a little bit more conservative as far as those things are concerned, but I'm wondering whether that might in fact be a bigger thing in ACRs to come. The ACR are very interested in this and it's going to be the of thing which we'll see at ULRs and ACRs over the course of time. Anyway, for more information, to roomnow.com.

Hi. It's David Lu here reporting for roomnow.com from ACI twenty nineteen here in Atlanta, Georgia. Day three has brought some interesting posters to the poster floor. I'd like to tell you a little bit about one regarding the influenza vaccine, particularly the high dose trivalent inactivated vaccine. We've seen data at previous meetings about how it's effective in our patients, and it really gives us better protection than the standard dose.

The question's always been it's only been registered for patients over the age of six 6five and whether it is actually effective in patients under the age 65. Maybe the data for rheumatoid arthritis patients was biased by those 65 patients. Well, some data from McGill, two seventy nine patients, looked at how the patients under the age 65 performed. And in fact, as far as immunogenicity to the influenza vaccine was concerned, they did really well. The high dose vaccine really does work quite well on those patients, and that's the kind of protection we need to be giving our rheumatoid arthritis patients, especially as we get into influenza season here in the Northern Hemisphere.

Some important lessons, hopefully this eventually gets reflected in what we can access for our patients. I'm David Liu, for more information go to roomnow.com.

Hi, I'm Doctor. Janet Pope, I'm at RheumNow at the booth here at ACR twenty nineteen in Atlanta and I'm a RheumNow reporter. I'd like to talk about abstract number 2,567 and it was really about drug levels associated with lupus flares. So Doctor. Petrie and others have actually looked at drug levels and the higher the level, the more chance of the patient doing well if it's in the therapeutic range.

This was a different take on it. There were researchers that looked, albeit a small study of under 90 patients, but they looked at drug levels at the time of lupus nephritis flare. And what I think is a little bit shocking is that the drug levels were around 200 for the other patients that didn't have a flare at the time they were about a thousand and in general, one third of the patients never had a therapeutic drug level. So this could be non adherence, could be a metabolic interaction with lupus nephritis, I'm not sure what, but it might change my practice because right now I don't do drug levels, I don't want them toxic, but I'd like them therapeutic. You might have to see if you do drug levels routinely for hydroxychloroquine on your patients with lupus.

Thank you.

I'm Jonathan Kay of the University of Massachusetts Medical School in Worcester, Massachusetts. I'm here at the ACR twenty nineteen meeting in Atlanta, and I saw a poster that Renee Westhoven's presented, number five forty eight, about the subcutaneous formulation of the biosimilar inflix imab CTP-thirteen. CTP-thirteen is a biosimilar infliximab developed by Celltrion in South Korea that has been approved in the European Union, The United States, and many other countries. In The United States, it is marketed under the brand name Inflectra. In Europe, it's marketed under the brand names Inflectra and REMSMA.

And this biosimilar infliximab was reviewed and approved according to the abbreviated biological license application in The United States as an intravenous formulation in comparison to bio originator infliximab, Remicade. The intravenous formulation was approved by the FDA as a biosimilar and has been used by patients around the world with no significant loss of efficacy, as shown in the North Switch study, and no increase in safety risk. Celltrion developed this biosimilar infliximab in a new formulation as a subcutaneous administration of one hundred and twenty mg subcutaneously every other week. They conducted a non inferiority study comparing the intravenous formulation to the subcutaneous formulation after two loading doses of infliximab, three milligrams per kilogram intravenously. Three sixty two patients were enrolled and were randomized one to one to receive either the intravenous or the subcutaneous formulation.

The results of the study were presented up to one year by Renee Westhovens, who showed that there was non inferiority of the subcutaneous formulation compared to the intravenous formulation with no safety risks identified that were novel. The steady state trough level of drug was better maintained with the subcutaneous dosing than with the intravenous dosing every eight weeks where there were peaks and troughs would be expected given intravenous dosing. The question comes up when this drug is evaluated by the United States Food and Drug Administration, is this a biosimilar? Well, to be a biosimilar medication, it has to be administered at the same dose dosing regimen, route of administration as its reference product. Certainly infliximab reference product is administered only intravenously.

Thus, it is likely that the United States Food and Drug Administration will require this subcutaneous formulation to be evaluated as a new biopharmaceutical according to the 351A pathway rather than the 351K pathway for a biosimilar. However, the FDA has not yet evaluated this medication fully and we have yet to see how this regulatory process will proceed in The United States. Regardless, this is a very interesting first time where we see a biosimilar that is administered in the traditional route of administration being developed for a different route of administration. For more information, to RheumNow. I'm Jonathan Kaye.

This is Doctor. Dow reporting for RheumNow. I'm here at the ACR twenty nineteen conference in Atlanta Georgia and you know it's pearls pearls pearls we had pearls from doctor Michelle Petrie we had pearls from doctor Sterling West well I'm going to share with you another set of pearls. And these are pearls from Doctor. John Stone.

And essentially he gave us some really good myths and pearls for vasculitis. And this is from clinical practice. Some of these pearls aren't necessarily published but from his own clinical experience. So let's go ahead and start. Number one ANCA associated vasculitis can flare even when the B cells are not measurable.

Now how is that possible? You say. Well, there's B cell somewhere. There's B cells that could be in a collection in places that are not measurable because measurable B cells are only 5% of the whole B cell population. Oh, hey, another pearl here is that if you have a patient with granulomatosis with polyangiitis, GPA, and if they still have some disease activity with rituximab, then you should go ahead and add cyclophosphamide.

Because steroids can fail also about sixty percent of patients, whether it's from side effects or it doesn't work, you want to go ahead and add tocilizumab early in patients with giant cell arteritis. Another pearl that I found was that granulomatosis with polyangiitis can cause a unilateral facial droop. It looks just like Bell's Palsy. So don't just automatically assume it's Bell's Palsy, but think about GPA as well. And then he also, gave this one pearl that I thought was really going to be useful in my practice.

So the first sign of ANCA associated vasculitis is typically migratory oligoarthritis, and it usually favors the lower extremities and where it's going be useful here is if a patient's going to have a flare this may be one of the first signs of their flare and then let's look at eosinophilic granulomatosis with polyangiitis EGPA. So we know that you can have nodules on the elbows. And usually nodules in the elbows could be from infection, be from rheumatoid arthritis, gout. But did you know that EGPA can do that too? And then finally one last, pearl that I'm going go ahead and share with you that I learned from Doctor.

Stone's, little lecture here is that you don't have to have ulcers to have Behcet's. In fact, he shared with us a few cases where a patient can present with pan uveitis and also CNS manifestations and her clinical feature features is very consistent with Behcet's, but she didn't have ulcers. They went ahead and treated her like Behcet's and then years later she finally popped up an ulcer. So ulcers may not be the predominant symptoms. So those are the pearls.

I'm going go ahead and blog about that. So follow me at rheumnow.com.