Psoriasis Treatment Effective at Achieving Skin Clearance

Jeffrey Stark, MD, head of immunology medical affairs, UCB, breaks down the unique challenges patients with psoriasis face, and discusses the BE RADIANT and BE SURE studies, both of which indicated that bimekizumab was effective at achieving skin clearance in this patient population.

Read the full transcript:

My name is Jeff Stark. I'm a rheumatologist and the head of medical immunology at UCB. As a leader of our medical affairs group at UCB, I oversee both an office-based and a field-based team that focuses on topics like scientific communication, medical information, and evidence generation.

Our therapeutic areas of interest and focus at UCB include rheumatology and gastroenterology, but perhaps most pertinent to our discussion today, also dermatology.

What are some of the challenges associated with treating patients with psoriasis?

Psoriasis, although a very well-known disease, continues to be a burdensome disease for many patients. Because psoriasis is actually quite common, many people are familiar with the disease, and yet only appreciate its visible, and not necessarily its invisible, impacts on patients who live with it day-to-day.

Psoriasis, of course, has skin manifestations that many of us are familiar with. These include things like redness and scaling, pain and itching, and these are certainly burdensome for patients. Accompanying that is a burden that many people who don't live with the disease themselves fail to appreciate.

That includes social embarrassment, barriers to intimacy, barriers to work productivity for many of these patients. Of course, that has a resounding effect on the quality of life of patients who live with psoriasis.

I mentioned that psoriasis is common. According to our best epidemiologic estimates, approximately 125 million people are living with psoriasis around the world today. This represents nearly 3% of the world's population, making psoriasis one of the most common inflammatory diseases.

We live in a time today when we are fortunate to have several approved treatments for psoriasis at our disposal, and yet there are still patients who fail to respond to the therapies that are available to them today, and some difficulty for clinicians in choosing among the therapies as to which is likely to be the most effective or benefit their patient the most.

How can the findings from the BE RADIANT and BE SURE trials help guide providers treating this patient population?

It's very exciting to be able to talk about the BE RADIANT and the BE SURE studies, both of which were recently presented at the AAD meeting and have also both subsequently been published in the New England Journal of Medicine.

As background to those studies, I'd like to say just a brief word about the investigational product that they studied, a molecule called bimekizumab. Bimekizumab is an investigational molecule, as I mentioned. It's a humanized monoclonal antibody that selectively and directly inhibits both IL17A and IL17F.

Both of these are cytokines that are known to be key drivers of inflammatory processes, including psoriasis. We know that the two molecules have overlapping biology, but that IL17F contributes to inflammation separately from IL17A.

While there are available therapies on the market today that target IL17A alone, bimekizumab is different than those molecules in targeting both IL17A and IL17F. I mention that because one of these studies that we're discussing today, BE RADIANT, was really the first study that allowed us to look at the potential difference between the inhibition of IL17A and F versus the inhibition of IL17A alone.

BE RADIANT was the first phase III head-to-head study that compared the efficacy and safety of dual IL17A and F inhibition with IL17A inhibition alone in adult patients with moderate to severe plaque psoriasis.

In this study, bimekizumab was compared with a molecule currently available for the treatment of psoriasis today called secukinumab. Secukinumab is an inhibitor selectively of IL17A, but by comparing that molecule with bimekizumab, it gave us the opportunity to really examine the principle that inhibiting IL17F in addition would lead to greater improvements in these patients.

That's exactly what was seen. In the BE RADIANT study, we did see that the study met its primary endpoint, and significantly more patients who were treated with bimekizumab achieved PASI 100, which is complete skin clearance, compared to patients who are receiving secukinumab.

That's a very stringent efficacy measure, so not partial improvement, but rather complete clearance of the skin. It was measured quite early, at week 16, so after only 16 weeks of treatment. The numbers that were actually seen were that those receiving bimekizumab achieved that complete skin clearance 61.7% of the time, compared to those receiving secukinumab, who only achieved it 48.9% of the time.

This was very exciting. In addition to the meeting the primary endpoint, the study met all of its ranked secondary endpoints as well. These data, really for the very first time, demonstrate that inhibiting IL17F on top of inhibiting IL17A leads to a greater suppression of inflammation and greater improvement in disease activity.

This, I think, we hope, will be an important step forward ultimately for patients who continue to suffer with active psoriasis, despite access to currently available therapies. The second study that I will mention today is a study called BE SURE.

Like BE RADIANT, BE SURE was also a study in which two active forms of therapy were compared. In this case, one of those, of course, was the investigational molecule bimekizumab. The other was a TNF inhibitor called adalimumab, which is also currently available for the treatment of patients with moderate to severe plaque psoriasis.

Like BE RADIANT, BE SURE met all of its coprimary and its ranked secondary endpoints. In this case, the coprimary endpoints were the percentage of patients who achieved a PASI 90 response—that's a 90% improvement—in their psoriasis, or an investigator global assessment score of zero or one, which equates to clear or nearly-clear skin.

For PASI 90, we saw that bimekizumab patients achieved that 86.2% of the time, compared to only 47.2% of adalimumab-treated patients. For investigator global scores of zero or one, we saw that bimekizumab-treated patients achieved that 85.3% of the time, compared to only 57.2% of the time for adalimumab-treated patients.

These were also exciting results, and by comparing bimekizumab as an investigational therapy to other potential treatments available for psoriasis patients today, our hope is that ultimately these data will help to inform physicians and patients as they are making choices among the spectrum of therapies available for the treatment of plaque psoriasis.

We did see across both of these studies that the safety profile of bimekizumab was consistent with the earlier clinical trials in this program, and no new safety signals were identified.

Based on your personal experiences, what do you think is needed to improve psoriasis care? How can providers, payers, and other health care professionals aim to improve outcomes for patients?

Although psoriasis is a common disease, and although there are multiple therapies that are indicated for the treatment of psoriasis currently, there still are many gaps in care for these patients. We know, for example, that many patients, although having access to and trying available therapies, still fail to achieve adequate control of their disease.

New therapies that achieve higher thresholds of efficacy are needed, and certainly, that's something that I'm pleased much work is being done on. There are certainly other ways that the care of these patients and their outcomes could be improved.

Certainly, we know the skin manifestations of psoriasis, but as I have alluded to already, the effect and impact to patients who live with the disease is much broader. Certainly, there are those social factors which the disease affects and which impact the patient's quality of life.

Also, broader medical implications for having the disease, such as, for example, an excess burden of cardiovascular disease for patients living with psoriasis. Really, a better understanding of the full manifestations of the disease and holistic approach to treating it is something that we look forward to.

These social factors—things like embarrassment and barriers to workplace productivity—are still major issues that patients suffer with today. Education, which can be, I think, collaboratively executed by multiple partners in the health care ecosystem really can help to combat the social stigma associated with these diseases.

The players in the health care ecosystem really are several. You've mentioned, I think, a couple of those in alluding to the providers who deliver care to these patients, as well as payers who are involved in access to therapies.

I think the situation that we really hope to see in the future is a collaborative relationship between these different partners who surround these patients and ultimately deliver care to them, such that they work together to ensure that the treatments that patients receive are really tailored to the individual patient, and that patients have easy and ready access to the therapies that are best for them.

Where do you see the future of psoriasis care going?

Much progress has been made over the last several years in the approach to the treatment of psoriasis, and certainly, this has had very positive implications for patients who live with and suffer with the disease day-to-day, but there still is more work to be done.

We recognize that, although psoriasis is a very common disease, that there still are many patients who, despite that awareness, remain undiagnosed. Partly, this is because patients hide their disease, if they are able to, and may even hide it from their health care providers.

We want to see that that social stigma is removed, so that patients can be diagnosed quickly and have efficient and ready access to appropriate care for their disease.

We also hope that the development pipelines that are underway, including that for bimekizumab, really help to deliver new and better treatments that not only offer just another option, but an option that really raises the bar of efficacy expectations and leads to better outcomes for patients, compared to the treatments that are available to them today.

We, I think, would love to see in the medical community, as well, a broader understanding of the impact and manifestations of psoriasis. By that, I allude to not only the medical or clinical manifestations of disease, but also the way that patients are impacted socially by their disease as well.

Only when all of those manifestations are recognized can a true holistic approach to care be provided to these patients. Then finally, one area in which we're beginning to see some success, and we hope for more in the future, is through the coordination of care for patients with psoriasis.

I've alluded already to comorbidities that these patients have. They may include things like cardiovascular disease. We also know that up to 30% of patients with psoriasis will develop psoriatic arthritis, an arthritic inflammatory condition of the joints.

These patients certainly benefit from specialized dermatology care but have even better and optimized outcomes when their care can be coordinated with other specialists, like rheumatologists, cardiologists, primary care physicians, etc.

There are, I think, many barriers to that coordinated and collaborative approach to care in our health care ecosystem today, but as the value of that collaborative approach to care is realized, we're seeing the medical community come together more and more around the care of these patients, and certainly hope that we see that accelerate in the future.

Is there anything else you would like to add?

Really, I think, just to conclude my comments, I would just say a word about bimekizumab and the future goals for that investigational product. Although the phase III data for bimekizumab, some of which we've had the opportunity to review today, regarding psoriasis has been published, there is a very broad and diverse development program underway for the product.

In addition to exploring the utilization of bimekizumab in plaque psoriasis, UCB is also studying the molecule in other disease states that have significant burden for patients. These include another dermatologic condition called hidradenitis suppurativa, or HS, another disease which has dramatic unmet need, limited available therapies, and certainly, a high degree of burden for patients.

In the rheumatology therapeutic area, we are studying bimekizumab as well, in diseases including psoriatic arthritis, and also in the full spectrum of axial spondyloarthritis, which includes not only ankylosing spondylitis, but also nonradiographic axial spondyloarthritis.

All of those programs are in phase III and visibly underway, and so we're very excited about the additional data that will be generated for bimekizumab, and hope that it may become a differentiated solution for these patients as well.

I will also just say, perhaps as a word of update, that the FDA in the US, as well as the EMA and the European Union, have both accepted UCB's biologic license application, and review of that is underway. We hope to have news from those regulatory agencies in the near future.

We do aspire that bimekizumab will be a solution for many patients across a spectrum of inflammatory diseases as these various studies and components of the clinical program deliver data.