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Soumya Chakravarty, MD, PhD, FACP, FACR, senior director, strategic lead, rheumatology therapeutic area, Johnson & Johnson Innovative Medicine, highlights the APEX study’s findings that Tremfya (guselkumab) is the first IL-23 inhibitor to significantly inhibit structural damage progression in biologic-naïve psoriatic arthritis patients, offering a multi-domain, early treatment option with a consistent safety profile to help preserve long-term function and quality of life.

Video Transcript:

My name is Dr. Soumya Chakravarty. I’m a rheumatologist by training and I have the privilege of leading rheumatology medical affairs for the US immunology business here at Johnson & Johnson. I’ve been with Johnson & Johnson for nearly 10 years, and prior to that was part of a clinical academic practice in the Philadelphia area and still continue to provide on a voluntary basis patient care. So have been in the rheumatology space for quite some time now, and it’s a real pleasure and I think wonderful opportunity to talk a little bit more about psoriatic arthritis and what we have been able to find with the APEX study.

We’re very excited by the results of the APEX study because it now demonstrates Tremfya to be the only IL 23 inhibitor in its class that’s been able to inhibit the progression of structural damage progression. The significance of Tremfya inhibiting structural damage progression that was measured by the erosion and joint space narrowing as well. And what we were able to show through APEX is that when you look at erosions and joint space narrowing, we actually demonstrated a two and a half time reduction in the progression of structural damage. So something that we’re very excited and I think provides now an opportunity for patients, for providers to have that conversation in terms of what this data means with respect to treatment choice in psoriatic arthritis and treating earlier and treating with an option that can cover the multiple domains of psoriatic arthritis as well as now be able to inhibit structural damage progression.

PSA, psoriatic arthritis is a heterogeneous disease. It presents in different ways. It presents across multiple domains of disease. So for example, peripheral arthritis, enthesitis dactylitis, skin involvement, axial disease, no one PSA patient presents the same exact way. And so you really want to have a therapeutic option that covers as many of those domains as possible. So that multi-domain efficacy and the ability to inhibit structural damage progression, preserve the joints over time, and despite the fact that we have multiple therapies, there’s still an unmet need. About 30% of psoriasis patients will go on to have active psoriatic arthritis. And that psoriatic arthritis, as I said, can present in a number of different ways that sort of multi, multi-domain approach. So with APEX and with the data now demonstrating FY is in addition of structural damage progression. That was statistically significant conversation and now an option for patients and their providers to think about earlier utilization of a therapy like Tremfya that can cover off on multiple domains including the radiographic progression piece.

The addition of that, unfortunately there are delays in diagnosis and with the delays in diagnosis and therefore under treatment with psoriatic arthritis, what can happen is, is that you have smoldering active disease that leads to structural damage progression over time. And of course that structural damage that progresses over time then can translate then into limitations with respect to physical function. Right? So disability as an example, we know that with respect to structural damage progression left untreated within six months, there’s been data to show that erosions can occur up to two years. We know that 50% of PSA patients can develop erosive disease based on, again, data that’s been published for quite a while now, and that there are risk factors that go into that progression of structural damage, whether it be elevated inflammatory markers like a CRP level, whether it be prior erosive disease. I like to say that damage begets damage, unfortunately. So prior erosive disease can actually be the predominant risk factor for further structural damage progression. So the whole goal here, right, is to try and identify and treat psoriatic arthritis early and intervene with a therapy that can cover off on the multiple domains that I alluded to, including in this case. Also, the ability to inhibit that structural damage progression over time so that you are being proactive in preserving the quality of life, the activities of daily living, the physical function of that patient.

I think it goes to the point around ensuring that you’re choosing a treatment option that covers off on these multiple domains of psoriatic arthritis, including the structural damage piece. Again, PsA can cause permanent joint damage if left untreated, undetected over time. And so I think as part of taking a good history, doing a physical exam, doing the appropriate lab work, getting some of the baseline imaging to be able to look and see where that patient is in his or her journey as it pertains to let’s say erosive disease or joint space narrowing, getting X-rays of the spine or the sacroiliac joints to be able to understand is there any axial disease that’s involved. I think that all goes into the workup of a psoriatic arthritis patient to understand where he or she is currently with respect to their disease. And again, you do that because you really want to understand as best as possible what is going on with the psoriatic arthritis patient in front of you in terms of the multi-domain involvement, and then have the ability, and again, I think the APEX study has demonstrated to us that if you’re treating bio-naïve  psoriatic arthritis patients with Tremfya and you’re able to inhibit the structural damage progression in those bio-naïve  psoriatic arthritis patients that you should seriously consider early treatment of these PsA patients with an option like Tremfya.

I think with the APEX data, we’ve really achieved an infection point here where we’re trying to raise the bar on efficacy as well as preserving safety. So here we, with the APEX data, have been able to demonstrate that in your bio-naïve psoriatic arthritis patient population, you’re able to not only reduce inflammation, achieve those clinical outcome measures of the ACR 20 50 70 responses, but that you’re inhibiting structural damage progression compared to placebo at week 24. Right? So in a short amount of time in a very active psoriatic arthritis patient population, AYA is able to demonstrate that inhibitional of structural damage progression. I think that’s part of phasing the bar in terms of efficacy. And at the same time having a very consistent safety profile with our moderate to severe plaque psoriasis and active psoriatic arthritis indication. You now have an option that covers off on the multi-domain efficacy that maintains a consistent safety profile, and I think that’s what should be part of that conversation between patient and his or her provider. So that long-term in terms of treating the underlying inflammation, preserving that is what allows that long-term functional independence for patients.

It goes back to the whole heterogeneity concept for PsA, because PsA is such a heterogeneous disease, that’s where the challenge lies in terms of early recognition, early diagnosis of psoriatic arthritis. And so unfortunately what ends up happening is that you have psoriatic arthritis patients that can go to multiple providers and get multiple diagnoses. Some of the treatment options that are then offered to those PsA patients may or may not work. And so that leads to a lot of frustration appropriately. So I think it leads to a lot of uncertainty in terms of, am I going to get a diagnosis? Am I going to get the right treatment? Am I going to be able to preserve my functional status, my joints at the end of the day? And so with the APEX data demonstrating in a bio-naïve  psoriatic arthritis patient population that LY can inhibit structural damage progression compared to placebo at week 24, we now are providing the data, the confidence, the reassurance to patients and their providers that in a patient population that hasn’t seen a biologic yet, based on the efficacy profile, based on the safety profile, that Tremfya should be considered for first line utilization in that patient population. After that journey, those PsA patients had to go through.

Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of Physician’s Weekly, their employees, and affiliates.