Jeffrey Stark, MD: New Sub-Category for Non-Radiographical Axial Spondyloarthritis

Rheumatology Network sat down with Jeffrey Stark, MD, to discuss the statement UCB issued endorsing the creation of a new sub-category for non-radiographical axial spondyloarthritis (nr-axSpA). Stark is the Head of US Medical Immunology at UCB. He explains why non-radiographic axial spondyloarthritis has been an underrecognized and undertreated condition, why this new sub-category is different than previous subcategories, and the clinical significance of this change.

Rheumatology Network: Hi, Dr Stark, thank you for meeting with me today.

Jeffrey Stark, MD: It's my pleasure, Lana. Thanks for having me.

RN: Why do you believe non-radiographic axial spondyloarthritis has been an underrecognized and undertreated condition?

JS: So this is a great question. Non-radiographic axial spondyloarthritis, or what we sometimes call non radiographic axSpA for short, is a disease state that is part of a larger spectrum of disease called axial spondyloarthritis. And that spectrum is roughly split into 2 conditions: 1 of those is non-radiographic axSpA and the other is ankylosing spondylitis. Ankylosing spondylitis has been well known and easily identified for many years. But that has not been the case for non-radiographic axSpA. And the reasons are actually a few. One is that unlike ankylosing spondylitis that causes deformity of the spine and is easy to spot on a physical exam, non-radiographic axSpA patients typically look normal to the visible appearance and it takes newer tests, imaging tests frequently, to identify them, such as MRI. And so really, the disease state of non-radiographic axSpA was not understood or well defined until these newer technologies became available to us. We also know that the disease tends to come on in an indolent fashion, that means gradually. The cardinal symptom of the disease is back pain, which we know is very common, and there are many other causes of back pain. And so frequently, these symptoms come on gradually. They're explained away by the patient or even their healthcare providers as due to some other cause. And so, the disease frequently is not picked up. The upshot of that is very unfortunately negative on average. Patients with non-radiographic axSpA have a delay of somewhere between 8 and 10 years from symptom onset to diagnosis and unfortunately, that leads to untreated symptoms, sometimes inappropriate treatments, but certainly pain and suffering that we don't want these patients to experience.

RN: How is the new ICD-10 sub-category, M45.A, for nr-axSpA different than previous sub-categories, such as the M46.8?

JS: We are very excited about the updates to the ICD-10 coding manual that were recently announced by the National Center for Health Statistics, who oversees the coding manual and its evolution over time. As you alluded to, there were previously no codes available to capture non-radiographic axSpA patients. Last fall, the National Center for Health Statistics did index non-radiographic axSpA to an existing set of codes. The M46.8 category that you alluded to indexing means that the committee assigned non radiographic axSpA to that code as the appropriate code to use for the condition, but the descriptor attached to that code was not non-radiographic axial spondyloarthritis. What that meant was that it lacked an element of specificity. So, people did begin to use it for non-radiographic axial spondyloarthritis. But many other types of conditions were also captured in electronic medical records using that nonspecific code. So, that was a significant step forward in at least providing some approved coding options for these patients. The subsequent step taken by NCHS actually moves the situation forward dramatically. So, in May really just hot off the press. This year, NCHS announced the creation of a new and specific set of codes, the M45.A category for non-radiographic axial spondyloarthritis. These codes will be highly specific for non-radiographic axSpA. The descriptor attached to them will read non-radiographic axial spondyloarthritis, which will provide a much needed clarity to the medical community. And I think we will see that having a dedicated set of codes like this will bring some much-needed awareness in the medical community about the disease state as well.

RN: What is the clinical significance of this inclusion and how does it benefit physicians?

JS: The benefits of having dedicated and specific codes for non-radiographic axial spondyloarthritis have benefits to multiple members of this broader healthcare community and physicians are certainly 1 of those. With the index codes in the past, physicians were able to use M46.8 as an approved code. But again, the descriptor did not read non-radiographic axial spondyloarthritis frequently in their electronic medical record databases. That lead to some confusion with the utilization of the code, not only at the site of care, but also in identifying those patients to payers and seeking access for therapy. Payers were, I think, somewhat confused in some instances when they received a code that did not match the purported indication for the therapy that was being requested. But we also are very hopeful about what long term utilization of this new and highly specific coding option will mean, now that these patients can be specifically captured and documented in electronic medical records. It really is going to open the door to generating data about them in the real world, really understanding what their journey is like what treatments they receive, what their outcomes are, and generally the way that they live with and experience their disease. Previously, this wasn't possible. Because with a non-specific code, it was difficult to know that patients who were captured with that code truly had non radiographic axSpA and not some other disease state.

RN: How does this addition of the subcategory benefit patients and their families?

JS: So, the benefit of the new and specific non radiographic axSpA ICD-10 code to patients is perhaps, I think, the most exciting aspect of this change. We know that having approved coding options really brings attention and awareness to this disease state by bringing it to the forefront. It will now be captured in a way in the coding manual that is the exact parallel of similar disease states like ankylosing spondylitis. And aside from the recognition, the other important aspect of having a specific and approved coding option is the way in which it legitimizes the disease. These patients, as I've mentioned, live with their disease, typically on average for many years before achieving an accurate diagnosis and being treated appropriately. And during that time, many of them describe an experience of being told perhaps their symptoms are not really real, or they can't identify a cause of their symptoms. And they frequently go through periods of doubt and uncertainty as to what's going on with them for their disease state to be recognized in this very formal way. In the coding manual, again, that is the exact equivalent of other well recognized and known diseases has a reassuring effect to the patient community and really legitimize his of the disease in the eyes of many. And I think for this reason, as we have sought modification of the ICD-10 coding manual to include non-radiographic axSpA, we've had some fantastic support from patient advocacy groups who appreciate just that value.

RN: How does this category allow for enhancing the quality of data available for disease related research and measuring outcomes and patient care?

JS: In the past, the non-specific coding options, or the lack of any coding option at all, for non-radiographic axSpA has been a dramatic impediment to researching and understanding patients with this disease. As you can imagine, when you look in real world databases, the way in which we identify a certain patient type to study is frequently through ICD-10 coding. Without a coding option or with a non-specific option like M46.8, it was very difficult to identify these patients. We had no confidence that the codes we were choosing actually included only non-radiographic axSpA patients and not patients with another disease. And we also presumed that there were probably many other codes which were being used to capture these patients, such that they would be missed in an effort to identify them for purposes of research. Now that we have a very specific code of 1 that is very clear, that is describe3d literally in the coding manual as non-radiographic axial spondyloarthritis, we can now have a high degree of confidence that that code truly captures and represents people with this 1 disease and no other. This will really facilitate research in an important way. In the past, research was extremely difficult, costly and labor intensive, in that patients who were suspected of non-radiographic axSpA might need to be adjudicated on a case-by-case basis to validate that diagnosis before they could be included in a study. Now, that process will be streamlined, much more easily and certainly highly efficient. So, we look forward to what these codes will bring to research possibilities to understand issues like quality of life, like the journey that these patients experience and what their outcomes may be.

RN: What is the current treatment landscape for non-radiographic axial spondyloarthritis?

JS: In the United States, the most current treatment guidelines for non-radiographic axial spondyloarthritis were co-developed by 3 important bodies: 2 a professional society and 1 a patient advocacy group. Those include the American College of Rheumatology, Spartan, the Spondyloarthritis Research and Treatment Network, which is a professional society dedicated exclusively to axial spondyloarthritis, and then a patient advocacy group called the Spondyloarthritis Association of America or the SAA. And interestingly, as an aside, all 3 of these groups, ACR, Spartan and SAA, were close partners in helping UCB to advocate for change in the ICD-10 coding manual. We're very grateful to have their support in that process. But those guidelines speak to the appropriate and recommended treatment of non-radiographic axial spondyloarthritis based on a comprehensive literature review of data on that subject. For patients with non-radiographic axial spondyloarthritis, the first line treatment are non-steroidal anti-inflammatory drugs accompanied by physical therapy. But we know from published literature that at least half of patients who are treated with that first line therapy don't achieve adequate control of their disease and need to move on to a second line approach to therapy. For those patients who need something beyond non-steroidal anti-inflammatory drugs and physical therapy, the recommended approach is tumor necrosis factor (TNF) alpha inhibitors. TNF alpha is an inflammatory molecule that we know drives the disease. And there are biologics which are approved to inhibit TNF alpha and have been demonstrated to have a beneficial effect on the disease. One of those is a molecule called certolizumab pegol, or CIMZIA. Beyond TNF inhibitors, there are other classes of biologics that have been shown to be beneficial for the treatment of non-radiographic axial spondyloarthritis. And those also include 2 other approved options that inhibit IL-17, another inflammatory molecule that we know drives this disease state, in addition to TNF alpha.

RN: Have you noticed any trends in the treatment of this condition that you'd like to address?

JS: In terms of the way that the disease is approached therapeutically, the way that it's treated today, I think we have seen certainly some positive momentum. Some of that I think has been driven by an increasing awareness of the disease, which I'd like to think is at least partially driven by decoding options that have become available to the US community over the last year. But we also know that the approval of therapies drives awareness and treatment. So, when there are therapies that are indicated formally by the FDA for the treatment of a disease, that certainly brings greater awareness and attention to the disease as well. And so, we have seen a trend, as 3 medicines are now specifically approved for the treatment of non-radiographic axial spondyloarthritis, that there is more attention around the condition. We see other molecules that are being studied for its potential treatment in the future, and so grateful that additional therapeutic options are being explored as well. We've also begun to see something that I'm very excited about, as the delay in diagnosis has been studied repeatedly over time, we're beginning to see a little downward trend in that delay. So that what was once 8 to 10 years for the average patient is now somewhat shorter than that. Certainly not as short as we would like to be. We would love for these patients to be diagnosed almost immediately after the onset of their disease. So, more work to do there. But it is a positive and exciting trend to see.

RN: Is there anything else that you'd like our audience to know before we wrap up?

JS: I think this is a great opportunity. And as we think about spreading awareness regarding non-radiographic axial spondyloarthritis, and bringing attention to the disease of this, this interview is actually, for me, just another welcome opportunity to do that. I would just encourage your listeners to be aware of this disease, certainly to recognize that it is characterized by back pain of an inflammatory nature, and that when they see a back pain that wakes patients up at night, or is worse first thing in the morning, or is occurring in a young person instead of an older person, you should all be red flags to take a closer look for non-radiographic axSpA. We're in a wonderful situation now in the US where we have approved therapies that are effective for this disease state. And so, diagnosing them efficiently and quickly has become more important than ever before.

RN: Dr Stark, thank you so much for speaking with me today. I really appreciate it.

JS: Thank you, Lana, it's my pleasure. I appreciate the invitation.