Dr Jeff Stark: New Bimzelx Dose Offers Simplicity and Choice

In the US, bimekizumab-bkzx (Bimzelx; UCB) is approved in 5 indications: moderate to severe hidradenitis suppurativa, psoriatic arthritis, nonradiographic axial spondyloarthritis, ankylosing spondylitis, and moderate to severe plaque psoriasis. A new single 320-mg dose in a 2-mL prefilled syringe and autoinjector was approved on October 14, 2024, to treat plaque psoriasis, psoriatic arthritis with coexistent moderate to severe plaque psoriasis, and hidradenitis suppurativa, and became commercially available in the US on January 16.

To learn more about this new treatment option and its potential impact on patient treatment adherence, we spoke with Jeff Stark, MD, vice president and head of medical oncology, UCB, who is also a rheumatologist by training and leads UCB’s medical affairs team across the key focus areas of dermatology and rheumatology.

This transcript has been lightly edited; captions are auto generated.

Transcript

Can you provide a refresher on the data that supported the approval of the single 320-mg dose of Bimzlex?

We're very excited to bring this dosing option—I should say, dosing options—because, as you noted, it is both a prefilled syringe and an autoinjector that now are available to deliver a 320-mg dose of Bimzelx. The data that support those were actually from a bioequivalence study that was performed.

In this study, we had a group of healthy volunteers who received Bimzelx, and that gave us the opportunity to compare the 320-mg dosing as a single dose vs 2 delivered 160-mg doses. Essentially, in those types of bioequivalence studies, we look at things like drug levels, for example, to make sure that the patient is achieving a similar level of drug. Because these are healthy volunteers, we're not looking at efficacy—so we're not looking at how a disease responds in terms of treatment—but we do look at safety. And so one of the important aspects of the bioequivalence study was also to look at the safety profile of 320 mg delivered as a single dose, rather than 2 separate 160-mg injections.

In fact, in that study, the safety profile was similar to what we saw in the very robust clinical program for Bimzelx across the 5 indications for which it's available today. So that was certainly nice to see. I will say, the one aspect of that safety profile that was perhaps very important for us to look at was reports of things like injection-site pain, and we did not see a difference in any signal there vs the 160-mg dosing devices that were previously available to patients.

What impact do you anticipate the single-injection option will have on patient adherence and overall treatment experience?

There are different doses approved for different disease states for Bimzelx, and as you absolutely correctly mentioned, there are 3 indications for which a 320-mg dose is indicated. Those include plaque psoriasis, patients with psoriatic arthritis who also have moderate to severe plaque psoriasis, and HS, or hidradenitis suppurativa.

So for those patients, some of whom are already receiving Bimzelx commercially since its approval for those indications, they will now have options to choose from. And perhaps rather than receiving 2 separate 160-mg injections to achieve that 320-mg dose, patients and the health care providers who treat them will now have the option to choose.

It really is about flexibility and power of choice, giving patients and the providers who care for them the option to choose what suits them best and what is in most accordance with their personal preferences.