What to Know About Bimekizumab for HS: Update from James Q. Del Rosso, DO

Approved late last year to treat HS, bimekizumab was the subject of several publications in 2024, including phase 3 pivotal trial data. AARS President James Q. Del Rosso, DO gives an update on key data considerations. You can watch Dr. Del Rosso's full discussion of trial design, efficacy data, and safety findings online at acneandrosacea.org.

The American Acne and Rosacea Society (AARS) is the only professional society focused on acne, hidradenitis suppurativa, and rosacea. Support AARS by becoming a member!

Transcript

This transcript has not been reviewed for accuracy and is provided as a courtesy only.

This is Hot Topics from the American Acne & Rosacea Society. Welcome to our first episode of 2025. Happy New Year.

This fall saw publications exploring the role of bimekizumab in the management of hidradenitis suppurativa. This followed publication of the Phase III trial results for bimekizumab in hidradenitis suppurativa in the Lancet in June. In November, the FDA approved Bimzelx from UCB for the treatment of adults with moderate to severe hidradenitis suppurativa, marking the fifth new indication for the drug over the course of 13 months.

This month we hear from AARS president, Dr. James Del Rosso, as he provides an overview of some of the key efficacy data for bimekizumab in hidradenitis suppurativa. This audio is excerpted from a fuller video presentation on trial design, efficacy and safety that you can view online at acneandrosacea.org. Dr. Del Rosso practices dermatology and conducts clinical research in Las Vegas, Nevada. He previously served a term as president of the AARS and is a prolific author and lecturer.

Dr. James Del Rosso:

So I have been involved with the evaluation of bimekizumab which is the brand name Bimzelx, the hidradenitis suppurativa, really throughout its course. And with this particular agent was involved in a lot of the preparation discussions even before it gained its first approval for moderate to severe plaque psoriasis in patients who are candidates for systemic therapy. So it does have that previous approval and also has approval in adults for psoriatic arthritis and axial spondyloarthritis.

So the dosing is different between these three distinct indications. So it's important to recognize that when you're looking at a patient with hidradenitis suppurativa, and we'll get into the dosing for that disease individual.

So it's approved for moderate to severe hidradenitis suppurativa in adults based on pivotal trials. And you could find the results of the multicenter Phase III trials with bimekizumab for moderate to severe hidradenitis suppurativa. They're called the BE HEARD I and the BE HEARD II trials. And they were published by Alexa Kimball and other colleagues in the Lancet in the May 22nd, 2024 issue. This information is public knowledge and out there for publication, and that's the source of a lot of the data that we're going to be talking about here.

So what types of patients were in the trial? They had to be rated as having at least moderate or severe hidradenitis suppurativa, and they had to be adults, meaning they were 18 years of age and older. They used the Hurley stages, which are the classic stages of looking at patients with hidradenitis suppurativa and rating them as either Hurley stage 1, 2, or 3. And that's based on the visible appearance of what you're seeing in these patients. And Hurley stage 1 is where patients can have abscesses and nodules, but no sinus tracts or scarring. So that's Hurley stage 1.

To be in this study, these patients were Hurley stage 2 or Hurley stage 3, in which case they've had abscesses or nodules. They had them at the time of evaluation, but already had visible evidence or clinical evidence of sinus tracts and scarring. And the difference between Hurley stage 2 and Hurley stage 3 was the extent of that involvement. So Hurley stage 3 was very diffuse in the areas of involvement. Now recognize these patients typically have involvement of the axilla, the groin genital area, under the breasts, places where they have friction. And very importantly if you look at the patients that were in the study, these patients had a pretty high body mass index which is something that is common in patients with hidradenitis suppurativa. They tend to be overweight and obese, which is actually a risk factor for development and progression of the disease as is smoking. And many of the patients in the trial were also smokers, either past or current smokers.

So the way this is done in the evaluations is first of all, these patients had a mean age of about 72 years of age. There was about a 60/40 split of females to males. And they had a mean number of draining tunnels of about 3.6 or so, entering into the study, and a mean access to nodule count of 16 to 17, depending on which group they were in each of those trials. So they had a significant amount of clinical involvement. The breakdown between Hurley stage 2 and Hurley stage 3 in the trials was 56% Hurley stage 2 and 44% Hurley stage 3. Remember, these patients had abscesses and nodules, and also sinus tracts and scarring. The median duration of disease prior to entering into the study was five years.

Now these patients are often treated with concomitant antibiotics. So in order to allow concomitant antibiotics in the trial, they had to be on a stable dose of an antibiotic. Let's say a doxycycline, for example, would be commonly used in this situation. They had to be on a stable dose for at least 28 days before coming into the trial, and could be maintained on that throughout the trial at that same dose. If you look at the study, about one out of 10 patients were on those concomitant antibiotics. So most of the patients were not on any concomitant antibiotics.

If they needed an antibiotic initiated during the study but they did not enter into the study on that antibiotic, then that would be considered a nonresponder. Also, about two out of 10 patients had previously been on biologic agents for hidradenitis suppurativa, but they had to be off of those for a requisite period of time before entering to the study. Most of the patients had not been treated with previous biologic therapy. That was most likely going to be a TNF inhibitor because adalimumab has been approved for hydradenitis in this type of patient for quite some time. More recently, secukinumab which is an anti IL-17A inhibitor does not also inhibit IL-17F like bimekizumab does, was approved more recently and not likely included in the past in these patients.

So if you look at the demographic breakdown, you had about one third were actually Black or African American in the United States. Even though if you look across all the study sites, it was about 11%. So we had a pretty good view of not only Caucasian patients in the study, at least in the United States, and 46% of them were current smokers. So about half of them were smokers. And smoking is a risk factor for increased severity and progression of hidradenitis suppurativa. So there wasn't cherry-picking of patients that would be more likely to respond.

In the first trial, BE HEARD I, just shy of 50%, 48% of the patients reached that high score of 50% reduction in the disease as compared to 29%. So about five out of 10 reached that endpoint that received the Bimzelx versus three out of 10 in the placebo, and it was very close to that in the second study. It was 52 with Bimzelx, 52% versus 32% with placebo.

Now they also looked at 75% reduction in that hydradenitis clinical response score. What's called the high score, you'll see that written as HiSCR. And the number next to it tells you the reduction in that score. So the high score 75 is a 75% reduction. And that was achieved in 33 to 36% of the patients treated with Bimzelx in both the studies as compared to 16 to 18% in the placebo group, the range in both of the studies. So based on the high score 50 and the high score of 75, you can see here that the Bimzelx was superior to the placebo and that supported its FDA approval based on efficacy.

There's quality of life data that was collected. The mean score in looking at the hidradenitis quality of life parameters which is more precise to hidradenitis suppurativa, evaluating pain, interfering with function, psychosocial effects, itching, all the different things that can affect these patients. They went from a severe score of 24 in the beginning to mild over 48 weeks, and by week 16 got to mild. So these patients improved in terms of quality of life and also significant reductions in pain.

Speaker 1:

Thank you for joining us for Hot Topics from the AARS, and thank you Dr. Del Rosso for participating. Don't forget to check out Dr. Del Rosso's full video commentaries online at acneandrosacea.org. The Hot Topics from AARS podcast is a complement to the semi-monthly Hot Topics e-newsletter. The Hot Topics e-newsletter is an AARS member benefit delivered to your email inbox. Get information at acneandrosacea.org. We'll see you next month.