Rocco Serrao, MD Looks Ahead to Bimekizumab’s Approval

Rocco Serrao, MD, is a board-certified dermatologist practicing with DOCS Dermatology in Cincinnati and Dayton, Ohio. His passion is in inflammation, especially psoriasis solutions. During his presentation at Maui Derm NP+PA Fall 2023 in Asheville, North Carolina, he looked at current data surrounding bimekizumab.¹

Bimekizumab will be able to block signaling through the IL-17A/IL-17A, IL-17A/IL-17F, IL-17F/IL17F heterodimers and homodimers. The phase 3 clinical trial program is looking at bimekizumab compared to a placebo, adalimumab, ustekimumab, and secukinumab. At week 16 in trials, Psoriasis Area and Severity Index (PASI) 90 was achieved. PASI 100 rates were achieved through week 16.

As UCB waits for further details on timing of bimekizumab’s approval, it will continue to work with the FDA to complete the full review of bimekizumab’s BLA and its label. According to UCB, “The next update for the bimekizumab BLA will be shared at the time of the FDA action. UCB’s previously communicated 2023 financial guidance range remains unchanged.”²

Dermatology Times® had the opportunity to connect with Serrao before he took the stage. He explained why dermatology clinicians should keep their eyes on bimekizumab’s data and shared opportunities for further research.

Dermatology Times: You participate in clinical trials and are zeroed in on psoriasis treatments for the session “Psoriasis and Psoriatic Arthritis 2023.” What are the important takeaways?

Serrao: My practice is predominantly medical dermatology, along with general dermatology, and I participate in clinical trials. My presentation at Maui Derm is going to really focus on therapeutic updates in psoriasis. Some topics I'm going to discuss are potential oral treatment options, oral treatment for our patients suffer from psoriasis that are 7-18 years of age and younger, but an oral option. We're going to revisit bimekizumab. Hopefully someday, we're able to use it for our patients with plaque psoriasis, if it gets FDA approval. I'm going to talk about data on bimekizumab and look at National Psoriasis Foundation guidelines on treat-to-target acceptable response rates. So a lot of different concepts are going to be brought into this presentation. You know, treating psoriasis may portend a mortality benefit.

Dermatology Times: Bimekizumab is on the verge of FDA approval. Why is this a gamechanger?

Serrao: So going back to the whole bimekizumab programs. Bimekizumab is a monoclonal antibody that works a little differently that targets IL-17 A/F. And we've all been anticipating bimekizumab's approval for the past 3 to 4 years, but it's just not approved yet in the United States. Hopefully that happens before the end of the year. So I'm following those studies closely because it adds a new therapy to the armamentarium in which we can really help our patients with plaque psoriasis that have not responded to current therapies, or even our patients with plaque psoriasis, it can be a novel, a new, treatment option for them that may be better than the current options we have now.

Dermatology Times: What are challenges of psoriasis treatment and research opportunities to address them?

Serrao: One pediatric patients. We don't have an oral option available. So hopefully we have an oral option available for our pediatric patients. You know, I'm recently a new dad. And I know that with my daughter, she may not want an injectable therapy, even though it may be more effective. She may want an oral option for her if she had psoriasis for psoriasis. So that that's, I think, a really hot topic and an area of interest.

Also, topical therapies in psoriasis—steroids, certainly for treating long term diseases, can have long term problems. And in psoriasis, looking at novel agents, such as tapinarof to treat psoriasis, and avoiding those potential side effects of steroids can be helpful. I think what's what's really unique about psoriasis as compared to atopic dermatitis, is we can get the majority of our patients well controlled with our current therapeutics, but there are subsets of patients in which either we can't get efficacy right, or their safety restrictions, or we can't have joint improvement and skin improvement in which novel agents can be helpful. And that's what's exciting to know that the continued research is still being focused on these patients to help them long term.

References

1. Bergman M, Serrao R, Young M. Psoriasis and Psoriatic Arthiritis 2023. Presented at: Maui Derm NP+PA Fall 2023; September 27-30, 2023; Asheville, NC.

2. UCB provides update on US regulatory review of bimekizumab. UCB. News release. September 20, 2023. Accessed September 28, 2023. https://www.ucb.com/stories-media/Press-Releases/article/UCB-Provides-Update-on-US-Regulatory-Review-of-Bimekizumab