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Michael Mallinson - Discusson about Axial Spondyloarthritis
Episode 5124th May 2020 • The Axial Spondyloarthritis Podcast • Jayson Sacco
00:00:00 00:58:18

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Jayson:

Michael, welcome to this episode of the Ankylosing Spondylitis podcast. And based upon the introduction and what we're going to cover today, I may have to change that name at some point down the road. Welcome to the show.

Michael

Thank you, Jayson. And thank you for having me. And yes, there's certainly time to change terminology around our disease.

Jayson:

Well, I was diagnosed 35 years ago, things tend to change slowly. So hopefully, I'll get around to figuring that out and what I want to do and how we structure it, but you know, you and I met through a forum on Facebook that deals with ankylosing spondylitis and the whole disease structure itself. You've made multiple posts that have been met differently with people's reactions on why the correct terminology might not be calling the disease itself ankylosing spondylitis, but maybe better off calling it Axial Spondyloarthritis. Tell me a little bit about that.

Michael:

Well, I can I understand why people are married to the next Ankylosing Spondylitis because like you that's what I was diagnosed with. And after my disease onset 40 years ago, but times change the technology changes, and also the name Ankylosing Spondylitis was never a universally used name, still isn't. In many parts of Europe, especially German speaking countries, the disease is referred to as Mobis Bechterew. In Russia, for example, it's named after Vladimir Bekhterev who was a Russian doctor who documented some of the symptoms of Ankylosing Spondylitis, but it's also been called Marie-Strumpell disease as well after two researchers who described the disease but what's more important, from our point of view is that Axial Spondyloarthritis is very difficult to diagnose. Originally, it was diagnosed by X ray radio graphically. So back in 1973, people recognized that there was a very common association with the gene HLA-B27 and spondyloarthritis. And looking into that further, they started seeing that people with Axial Spondyloarthritis or then called Ankylosing Spondylitis had this radiographic stage. And that was used as a diagnostic tool. There are no diagnostic criteria for this disease, but there are lots of different classifications. So, if you had radiographic sacral sacral le itis, and you displayed some other spondyloarthritis symptoms like family history or morning stiffness, etc. You were diagnosed with Ankylosing Spondylitis, then MRI came into being in the 1970s By the 1980s it was out there in the general hospital population and in general use and people who could read MRIs started noticing that if they were taking an MRI of the sacroiliac joint, they could see sacroillitis. But was this the same as the sacroillitis evident by X ray in Ankylosing Spondylitis? And there was a long debate about that. And that debate really wasn't resolved until the last year or two. So it's now understood that what we call Axial Spondyloarthritis is a continuum of disease from what had been called non-radiographic axial spondyloarthritis through to radiographic axial spondyloarthritis. So it's all recognized as one disease. And the important thing about that is that to exclude people, from patient organizations from help and support from the treatments available for Ankylosing Spondylitis, because they have non-radiographic axial spondylitis writers is extremely unfair. The disease burden is the same. Somebody with non-radiographic axial spa has exactly the same symptoms, the same pain, the same stiffness, the same mental issues as somebody who they ankylosing spondylitis. There's a further important part and that is that we know from a lot of evidence that the earlier the treatment, the better the outcome for the patient. So if you're waiting 6,7,8,9,10 years for diagnosis, and you don't get onto a treatment plan, until you're sort of seven or eight years into your disease progress. That's pretty serious, because by then you could have disfigurement, you could have kyphosis, you could have fusion, etc. That could have been prevented if you had been diagnosed earlier. And treated earlier. So with the X ray, the big problem was that it takes about seven or eight years for sacroilitis to show up on X ray and MRI can see that sacroiliac status after about 18 months or 24 months from disease onset, so it's evidently better to get people on a treatment plan 18 or 24 months after disease onset than seven or eight years. And so as I say, I think that terminology is important to being all inclusive of this full spectrum of disease and to include those people who are diagnosed with MRI imaging in our discussion about axial spondyloarthritis, ankylosing spondylitis.




Jayson:

When you and I discussed this, obviously you're in Toronto area in Canada. I'm here just across the lake in Michigan and when I was diagnosed I was 14 years old, had had pain from about 9 or 10. It always had been attributed to, you know, “growing pains”. And when I went and saw my rheumatologist for the first time in 1984, he asked just a couple of basic questions and said, Tell me about this, this and this, this and this. He goes, you have Ankylosing Spondylitis. Now let's do the testing to prove what I think is going on. So for me, in my mind and my process, it was always you went to a rheumatologist. They asked you a few questions. You were diagnosed. They then did an MRI, which was a newer process, but he did X rays that an MRI, bloodwork and boom, you've got Ankylosing Spondylitis. 


Michael:

Yeah. 


Jayson:

Then I never met anybody else that had Ankylosing Spondylitis. So I didn't know that anybody else went through these 7,8,9,10, 20 year battles. So when I started hearing that from people I was like, wow, that's amazing. I had no clue that that even existed. It was really an eye opener for me.


Michael:

Well, maybe you're one of the lucky ones? But on the other hand, if you started with symptoms at nine, which is not altogether unusual, and weren't diagnosed until you're 14, the six years where you might have had more mental relief, because you because you could have known that it wasn't just in your head or just, you know, growing pains or something. And one of the things that you didn't quite address there didn't touch on is the male to female ratio because females are notoriously bad at being diagnosed and that doctors used to think of Ankylosing Spondylitis as a men's disease. I'll come back to that in a moment to a degree. But women take two years longer than men on average to be diagnosed. And part of it is because many of them were diagnosed erroneously, with fibromyalgia Instead of AS so when you show all these symptoms of pain and stiffness, etc Uveitis your doctor isn't up to date and doesn't know about Ankylosing Spondylitis as many GPs do not, then it's going to be a long, long, long journey to diagnosis, especially if people are looking for other reasons like Fibromyalgia or endometriosis or something and women.


Jayson:

Well, it was quite interesting. And again, a lot of my interaction with people is online. So one of the people mentioned something about women having degenerative disc disease. One of the things mentioned I saw online quite relevant was all these women kept coming back and saying I have degenerative disc disease. And I started wondering is that really the case? Or were you diagnosed with that beforehand, along with saying you had fibro or something of that nature? And then a third diagnosis of Oh now, you have non radiographic or you have Ankylosing Spondylitis, it's radiographic and really you don't have a degenerative disc disease. It's just a function of what's going on with the Ankylosing Spondylitis with the axial spindyloarthritis.


Michael:

Well, yes, and I understand the difficulty for women because some, you know, doctors some don't know a lot about Ankylosing Spondylitis to begin with, never mind the term axial spondyloarthritis. And of course, women present a little differently than men. Even with ankylosing spondylitis for men, it's usually in the sacroiliac joints, whereas women, they often start with pain in their hips and shoulders. So it doesn't actually first present actually. And so what's the doctor to do if they don't know that? And of course, the other difficulty is that about 90% of the population at some time or other, speak to their doctor about back pain. Of course 99% of that back pain is mechanical. Our interest is that 1% that is inflammatory back pain. So doctors may go off on the wrong direction right from the start and diagnose degenerative disc disease and not really be cognizant of the fact that there is an inflammatory back pain disease. But yeah, it's not an easy disease to diagnose. And what I hope the new terminology axial spondyloarthritis allows for is more an earlier diagnosis. And I also hope it's a term that's used more universally, it's used very, very widely in Europe. Now, in America, it seems that the knowledge translation is somewhat slower, and people have really not adapted this term yet.



Jayson:

Well, we take a while to change here. You latch on to something and it kind of sticks in where I was going with that is here in the States. One of the preeminent places for treatment of the spondyloarthritis is the Cleveland Clinic. And you made a very good point that I hadn't even paid attention to until I went and looked at the website was Dr. Khan, who is a very well known expert in in this disease and an author. His first book was just Ankylosing Spondylitis.


Michael:

It was 


Jayson:

His second book was then Ankylosing Spondylitis - Axial Spondylitis. Now, his third book, his most recent one is just Axial Spondyloarthritis. He's taken a more holistic or a much larger, say 30,000 foot look at the disease and said, here's what we have. And as you pointed out, it's kind of removing that term of Ankylosing Spondylitis and trying to make a more generic or a more universally used term.


Michael

Well, it is a more universally or it has a potential to be more universally used and it also gets rid of this term, non-radiographic axial spondyloarthritis which is quite a mouthful. As I mentioned before the disease burden is the same between non-radiographic and radiographic stages of axial spondylitis arthritis. But there are some interesting differences with Ankylosing Spondylitis, which is the radiographic stage of axial spondyloarthritis. It's about two-thirds to one-third men to women. And it's not really clearly understood why the non-radiographic stage doesn't always progress to the radiographic stage. But Conversely, the non-radiographic stage we see more in women so it's two-thirds women and one-third men. So if you add the two together for axial spondyloarthritis as a whole, it's a one to one relationship and that's, that's important to note because women were poorly diagnosed and had a longer time to diagnose in the past. So the non-radiographic stage allows them to be diagnosed earlier. But the other thing about calling the whole disease spectrum, axial spondyloarthritis now as researchers, leading clinicians are starting to do instead of breaking it into the two stages is that it allows people with early non-radiographic stage of disease to have the same treatments that people with ankylosing spondylitis have, in other words, biologics. I don't know about the situation in the United States, but in Canada there's only one biologic actually approved for non-radiographic axial spondoloarthritis at this moment, I think they will all be approved eventually. But as we know, the earlier the diagnosis, the earlier the treatment, the better the outcome.


Jayson:

Sure and as we mentioned biologics, there's been debate raging across a lot of places and personally, I think the debate is driven by money, but many are, but there's that new class coming out which are biosimilars. Think of biosimilars as a generic for a name brand medication. So there's a huge, I don't know if there's a huge price discrepancy between a biosimilar and the name brand, as far as you know, when you and I as patients look at the medication costs, but I know there's a lot of dollars on the line for the manufacturers. So have you noticed in the Canadian side that there's been a lot of acceptance of the biosimilars from patients how, how has it worked on there because I, I've not even had a biosimilar ever offered to me here in the States.


Michael:

It's interesting, in the states you have a very, very, what is it devious, corrupt, medical system when it comes to the payment for medications. So in the States, you do not see a big price difference between the originator biologic and the biosimilar of that biologic. In Canada, it's a much much more pronounced difference. So, for example, if I look at Humira the well that's not a good example, let's look at Remicade. The Infliximab-dyyb, the actual biosimilar is about half the price, maybe 60% of the price of the originator. And so that's pretty significant and it's why there's been quite a discussion in Canada about the uptake and the acceptance of biosimilars. We unfortunately were subject to some misinformation propoganda in fact from some of the pharmaceutical companies I won't name them, but they were the ones whose biologics were coming off patent first. And they were telling patient organizations, that these biosimilars were not the same. They were similar but not the same. They were made in crappy facilities in crappy countries like Korea and India, and that there were problems with the naming convention so that, you know, people wouldn't know what drug they are actually on if it was the originator or the biosimilar. All of these things proved to be very, very wrong. And in Canada, I think we were fairly advanced about it patient organizations, at least some of them didn't have the wool pulled over their eyes with that propaganda and accepted the fact that biosimilars are the same as originators and how can I say that when they called biosimilars, I was very fortunate to attend the National Institute for bio processing research and training in Dublin, Ireland and quite a few years ago and see how bio logics are made and understand what biosimilars are. So the thing to understand about a biologic is that the biologic that you take today is not the same as the biologic that you took last time. And that's because the manufacturing process is so complex, that they can't always get it spot on. It's not like generic drugs, which are small molecule chemical drugs, a biologic molecule, it's a large living molecule, very, very complex, and the production is allowed within tramlines variance. So that variance happens in the manufacturing process naturally, and in fact, you can get a trend in one direction or the other. So, the Humira or the Remicade that you take in North America is not the same as the Remicade or Humira that you take in Europe because of this diverging trend from the original. When biosimilars were approved, they were approved, not on the basis of chemical trial of sorry, clinical trials. They were approved on their chemical similarity to the originator by biologic, they will give tighter lines of variants. So in fact, a biosimilar of Remicade is actually closer to the original Remicade than the Remicade may be that somebody is taking at the moment. Does that make sense?


Jayson:

It does. Yes. It's squirrely, but it makes sense.


Michael:

In fact, a biosimilar is closer to the original biologic than a generic drug is to its original chemical drug. And that is because when you look at a generic drug, I don't know what it is some sort of aspirin say, it's got fillers and stuff and you don't know what else it's got in. It's got its active ingredients, and then it's got fillers and adherence and stuff in there to hold it together in pill form. So it is less like the originator drug than the biosimilar is like to its originator, biologic, so they are in you know, it's the same drug. If you are taking Remicade and you go on to inflectra which is one of the biosimilars for Remicade. It's all the same drug, it's it's there is no difference. That is of any significance whatsoever. That's the thing that patients need to understand because in Canada, we have 19 different health systems here, each province read state, each province has its own healthcare system and then there's some healthcare systems for veterans, etc. But each province within its health care system has a drug formulary. And they decide on which drugs are going to be made available. And they negotiate the prices in conjunction with the other provinces with the manufacturers. So if a manufacturer is coming along and saying, hey, I've got a biosimilar and it's 4050 60% cheaper than the originator, those drug formularies are going to look up and say, Wow, we need to do this because our medical costs are going sky high. And you know, all these so called orphan diseases with specialist drugs and biologics are hugely expensive. We To decrease our costs, there's a huge saving to the health care system and society. If we allow biologics to be paid for by the province, then if they can reduce that cost with biosimilars, that's even better. And following the scientific evidence, they said, well, we're actually going to make patients switch from the originator to the biosimilar. And there was a bit of a hue and cry about this because of the, shall we say propaganda efforts put out by the pharmaceutical companies. But in the end, in the case of British Columbia, which was the first province to do this, there was a lot of hue and cry. But in the last analysis, the switchover went very smoothly and better than anybody expected, because one of the effects of the letters that pharmaceutical companies sent out to patients on that drug, telling them to be aware of biosimilars was Those patients took that letter to their doctor. Their doctor explained it properly. And they said, Oh, sure, I'll switch to the biosimilar. So it kind of backfired on them.


Jayson:

Laws unintended consequences.


Michael:

Yes, Yes, exactly. So in British Columbia, there was a very, very good uptake of the biosimilar. And that's now rolled out in Alberta. And it's coming to all the other provinces as well. And I think that's a good thing for society, because it means less cost in the healthcare system. And it's also a good thing because you take somebody who might otherwise not have been at work if they can get on a biosimilar now because it's affordable, and they're back at work, and they're paying taxes and, you know, sustaining society.


Jayson:

So is it the case where, like, if I, if I went 20 miles away, I'm in Canada, I'm in Sarnia. Yeah, if I was living there, which is part of Ontario, if I'm a new person, like I walk in the door, I'm diagnosed and they say let's try you on Remicade infusions. Am I going to get Remicade? Am I going to get the biosimilar? I'm going or am I going to get a choice?


Michael:

You will not get a choice new patients go on the biosimilar.


Jayson:

Okay and I've not heard any complaints. I've not seen anybody welling up and saying it, besides the fact that Remicade style medication might not be the appropriate biologic for you, I've not heard anybody say, the biosimilar isn't, and I guess you really wouldn't know if you're on a biosimilar whether it was better or worse than the actual name brand version, but I've not seen any welling up of people complaining one way or...