Jeff Stark, MD: Insights on the Approval of Bimekizumab for HS

Jeff Stark, MD, a rheumatologist and head of Medical Immunology at UCB, shared insights with Dermatology Times on the recent approval of bimekizumab (Bimzelx) for treating hidradenitis suppurativa (HS), a chronic inflammatory skin condition.¹ Based in Atlanta, Georgia, Stark expressed excitement about this milestone, highlighting its potential to transform the lives of patients.

Addressing Unmet Needs

Stark began by emphasizing the severe impact of HS on patients’ quality of life. "HS patients are patients whose quality of life is dramatically impacted and marred by a disease that is painful, disfiguring, and socially isolating," he explained. Despite available treatments, many patients experience inadequate disease control, leaving a significant unmet need.

The approval of bimekizumab represents a promising new solution. "As a medical and scientific community, we continue to push the envelope to look for better solutions. With this approval, UCB is excited to bring another option to HS patients who need it,” he said.

Clinical Trials: BE HEARD 1 and 2

Stark highlighted the pivotal phase 3 trials, BE HEARD 1 and BE HEARD 2, which were integral to the approval process. The trials demonstrated meaningful improvements in patients treated with bimekizumab compared to placebo.²

"We saw HiSCR50 rates of 48% and 52% in those 2 studies, compared to placebo rates of 29% and 32%," Stark noted. "So, a 15 to 20% difference between the treated patients and those who receive placebo." He added that secondary endpoints, such as HiSCR75, reflected even more stringent improvements, with significant differences observed in both trials.

Tackling Pain and Social Stigma

Pain, one of HS’s most debilitating symptoms, was another area where bimekizumab showed promise. "We saw improvements in patients’ daily pain, as captured by an HS diary instrument," Stark shared. This response has been incorporated into the updated prescribing information, underscoring its clinical relevance.

Stark also touched on the social stigma faced by patients with HS. "HS is for many an embarrassing disease, and they tell us about the stigma that they have experienced over the course of many years. I hope newly approved therapies will help bring patients out of the shadows and change the way the medical community receives them."

A Breakthrough in Mechanism of Action

Stark emphasized the innovation behind the targeted therapy. “The mechanism of bimekizumab is different from any other available biologic. We have done some significant preclinical work that has demonstrated the very prominent role that not just IL-17A but also IL-17F play in driving the inflammation of HS.”

He explained the significance of this dual targeting. “To have a biologic, a targeted therapy that really addresses both of those aspects of inflammation that are driving the disease, I think is going to be quite important.”

Patient-Centered Focus and Future Directions

Stark expressed pride in UCB’s commitment to incorporating patient voices into their work. "We've had the opportunity over the last few years with our commitment to HS, to engage with the patient community, to hear directly from them to incorporate what is meaningful and important to them into our strategies at UCB,” he said. “The patient community is also very excited about this new development.”

Looking ahead, UCB is exploring additional applications for bimekizumab in other inflammatory conditions. Stark expressed optimism: "These first 5 indications for Bimzelx are really the beginning. There are probably many other places where we can explore the potential usefulness of bimekizumab for other inflammatory diseases.”

Reflecting on this achievement, Stark underscored the dedication that drove this success. "It is first and foremost patient need that drives us. It's those patient stories that inspire us to do what we do, and to be persistent and tenacious in pushing forward to these important regulatory goals of new approvals.”

As for what's next for UCB, Stark noted impressive phase 3 dapirolizumab pegol data showing a significant reduction in systemic lupus erythhematosus disease activity. Participants from this study, called the PHOENYCS GO study, will continue to be followed in a long-term open-label study.

References

1. Hebebrand M. FDA approves bimekizumab for adults with moderate to severe HS. News article. Dermatology Times. Published November 20, 2024. Accessed November 26, 2024. https://www.dermatologytimes.com/view/fda-approves-bimekizumab-for-adults-with-moderate-to-severe-hs
2. Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504-2519. doi:10.1016/S0140-6736(24)00101-6