Management of Psoriatic Arthritis
In this podcast, Jeffrey Stark, MD, discusses key principles for managing patients with psoriatic arthritis, including the importance of timely diagnosis and intervention, limitations of existing therapeutic options, and prospective treatments in the pipeline.
- A study to evaluate the efficacy and safety of Bimekizumab in the treatment of subjects with active psoriatic arthritis (BE COMPLETE). National Institute of Health U.S. National Library of Medicine. April 1, 2019. Updated February 25, 2022. Accessed March 3, 2022. https://clinicaltrials.gov/ct2/show/NCT03896581
Jeffery Stark, MD, is the US Head of Medical Immunology Medical Affairs for UCB based in Atlanta, Georgia.
Jessica Bard: Hello, everyone and welcome to another installment of Podcast360, your go-to resource for medical news and clinical updates. I'm your moderator, Jessica Bard with Consultant360 Specialty Network. According to the Centers for Disease Control and Prevention, psoriatic arthritis occurs in about 10 to 20% of people with psoriasis. Dr Jeffrey Stark is here to speak with us about the challenges in the management of psoriatic arthritis. Dr Stark is the US head of medical immunology for UCB. He's based in Atlanta, Georgia. Thank you for joining us today, Dr Stark. How should patients with psoriatic arthritis be managed?
Dr Jeffrey Stark: I'm glad you asked about psoriatic arthritis. It is a disease that certainly merits our attention. And perhaps before mentioning the management of the disease, it's worthwhile to understand a little bit about the disease itself or be reminded of the features of the disease for those of us who knew it well. Psoriatic arthritis is a potential serious, very heterogeneous disease.
Although we think about it primarily affecting two domains, the joints and the skin, it is, in fact, a chronic systemic inflammatory condition with many manifestations, in fact. It's not at all uncommon. We believe that psoriatic arthritis affects about 0.25% of the population in the US. And when we look specifically at patients who have psoriasis, their lifetime risk of developing psoriatic arthritis may range as high as 40%.
We appreciate definitely these 2 main domains of disease in the skin and joints leading to arthritis, as well as skin plaque psoriasis, but there are many other manifestations of disease as well. We think about issues such as swollen toes or fingers, what we call dactylitis, as well as persistent inflammation of sites where tendons or ligaments attached to the bone, something that we call enthesitis.
And while over time we've been delighted I think as physicians and healthcare providers to see the treatment landscape for psoriatic arthritis evolve, there still are patients today who, despite the options available to them, experience portability, poor quality of life, residual pain, residual skin, manifestations, and so forth. Certainly in need even at this time for new therapeutic options for these patients.
As we think about the way that we would approach the management of psoriatic arthritis, there are, I think, a couple key principles. Those in reality are principles that are common to all inflammatory diseases. It is very important that these patients be diagnosed rapidly and that after diagnosis that they receive early and very effective therapy. In inflammatory diseases like psoriatic arthritis, there is a window of opportunity during which treatment outcomes can be optimized.
And if that window is missed, either because diagnosis is delayed, or the treatment is delayed, those patients may never achieve the same level of outcomes that they could have, had their diagnosis and treatment been optimized.
Jessica Bard: Right. I think that leads us into our next question. You mentioned the need for new options in treatment. Please give us an overview of the BE COMPLETE Study and why it's important.
Dr Jeffrey Stark: Absolutely. Thanks for the opportunity to talk about the BE COMPLETE Study. First, I'll mention that the BE COMPLETE Study is a study of a molecule in development at UCB called Bimekizumab. Bimekizumab is currently not approved for any indication in the US, but is currently under review by the FDA for the treatment of moderate to severe plaque psoriasis in adults.
The BE COMPLETE Study looked not at psoriasis, but psoriatic arthritis, and was a randomized multicenter double-blind placebo controlled parallel group phase three study that was designed to look at and evaluate the efficacy and safety of Bimekizumab in the treatment of adults with active psoriatic arthritis, specifically adults who had a history of inadequate response to tumor necrosis factor alpha therapies. TNF inhibitors, of course, are an established treatment mechanism for psoriatic arthritis.
But in keeping with my earlier comments, there still are patients who do not respond to some of those available options today and need additional options. The BE COMPLETE Study was designed specifically to look at such a patient population. BE COMPLETE enrolled 400 participants with active psoriatic arthritis. I'm happy to be able to share some of the top line findings from BE COMPLETE with you. What I think was perhaps very exciting was that the BE COMPLETE Study met its primary endpoint.
That primary endpoint was ACR50 at week 16. This is a rather stringent endpoint that really goes beyond the traditional ACR20 threshold that we see in most psoriatic arthritis clinical trials and really aims to establish a higher threshold or higher expectations for what treatment outcomes could look like in clinical trials in the interest of advancing those outcomes for patients ultimately in the real world. In addition to meeting its primary endpoint, BE COMPLETE also met all of its ranked secondary endpoints.
Those really were intended to cap the range of manifestations or ways in which psoriatic arthritis can impact patients today. Those ranked secondary endpoints captured features such as physical function, skin clearing, physical health status, and also low disease activity as measured by the MDA index. This is an important measure of disease that can be used in clinical practice and aims to capture some of those heterogeneous manifestations of disease with which we know that psoriatic arthritis patients suffer.
The BE COMPLETE Study is actually the second positive phase 3 study for Bimekizumab in active psoriatic arthritis. An earlier study in psoriatic arthritis in biologic naive patients met its primary and all ranked secondary endpoints as well. We're excited to see these results emerging from the Bimekizumab psoriatic arthritis clinical program, particularly as clinicians and their patients are continuing to seek options that may more effectively address the many manifestations of the disease.
Jessica Bard: What other medications are in the pipeline to help treat patients with psoriatic arthritis?
Dr Jeffrey Stark: As I mentioned, although patients have a spectrum of treatment options available to them today, there still are patients who need new options to help manage their psoriatic arthritis. While there are some small molecules being explored in this space, few biologics beyond Bimekizumab are in development for psoriatic arthritis at this time. There certainly I think is an opportunity and an interest in the Bimekizumab data that can continue to speak to unmet need here.
In addition to Bimekizumab, UCB also has an approved treatment for psoriatic arthritis, a medication called Cimzia or certolizumab pegol, which is an anti TNF, a different mechanism of action than Bimekizumab. I think what's important to remember as we consider the various options that are available to patients today or those that may still be in development is that every patient with PSA is absolutely unique.
It's really a strength to the clinical community to have this multiplicity of options available to them to choose for their patients who may need different options depending on their responses to therapy and the different manifestations of their disease.
Jessica Bard: Dr Stark, I believe you mentioned a few, but what would you say are the challenges in the management of psoriatic arthritis?
Dr Jeffrey Stark: Great question. There certainly are some challenges that remain for us today. The treatment of psoriatic arthritis has come a long way in the last couple decades, but certainly still some important challenges that we as the medical community still aspire to conquer. I will say that one of those is this need for more rapid diagnosis, as I mentioned.
We know that having plaque psoriasis, for example, is a significant risk factor for the development of psoriatic arthritis. Our community needs ways to more consistently and systematically screen patients with psoriasis for potential psoriatic arthritis, so that those manifestations of a musculoskeletal nature can be detected and managed appropriately and early.
We know as well that with a heterogeneous disease like psoriatic arthritis, with disease domains that stretch across different organ systems, those being, for example, skin and joints, there is a benefit to be gained from collaborative care between different members of the healthcare community. For example, with psoriatic arthritis, we know that patients may benefit from a close collaborative care model between a dermatologist and a rheumatologist.
And although that happens in some academic centers or specialized medical centers, it is something that is difficult in many cases to orchestrate in the general medical community. New ways that different specialties can come around these patients and collaborate in their care certainly is important for us to continue to explore so that these patients achieve the best possible outcomes.
And then finally, one I think important challenge remaining for us in the area of psoriatic arthritis is how to make informed medication choices. I mentioned that the treatment options for psoriatic arthritis have certainly multiplied over the last few decades, and that leads us with the choice of how to choose the right medication for the right patient.
And at this point in time, we don't have good tools in order to predict a response, but that research is underway and many across the healthcare community and the scientific establishment, and even in areas of government like the National Institutes of Health, are working to collaborate and shed some light on this question so that the right medication can be chosen for a particular patient from the outset.
Jessica Bard: With that being said, what's next for research in the management of psoriatic arthritis?
Dr Jeffrey Stark: It's a great question as well. Certainly some great work is being done around those challenges that I mentioned, looking at things like biomarkers and algorithms to help predict response to therapy and inform medication choice for the individual patient. At UCB, we're certainly moving forward with the Bimekizumab clinical program.
The results from the BE COMPLETE Study that we've discussed today, as well as results from the others psoriatic arthritis study called BE OPTIMAL in biologic naive patients will be submitted as part of a regulatory application for Bimekizumab in psoriatic arthritis later this year. We're certainly excited about that, certainly excited about the opportunity to share these data more broadly with the community.
And ultimately, we hope to bring Bimekizumab to market as a solution for patients living with psoriatic arthritis today.
Jessica Bard: Dr Stark, is there anything else that you'd like to add today?
Dr Jeffrey Stark: I think the only thing I'd like to add beyond what I've mentioned, and then we've had a great opportunity, I think, to discuss the psoriatic arthritis clinical program today, but just to let your listeners know, Bimekizumab is actually part of a very large and heterogeneous clinical program ongoing at UCB.
In addition to the plaque psoriasis application, which currently sits with the FDA, and the psoriatic arthritis data that we've discussed today, there are ongoing clinical programs examining the efficacy and safety of Bimekizumab in ankylosing spondylitis, in non-radiographic axial spondyloarthritis, and also in hidradenitis suppurativa.
We're equally excited about those ongoing clinical programs and the data that will emerge from those, and really I think ultimately with the goal of understanding the ways in which Bimekizumab may be a solution for patients living with many impactful inflammatory diseases.
Jessica Bard: Fantastic. Thank you so much for joining us on the Consultant360 Podcast today.
Dr Jeffrey Stark: Thanks, Jessica. It's great to be with you and appreciate the invitation.