Bimekizumab Trials 'Raise the Bar' for HS, Dr. Vivian Shi Says

More than half of hidradenitis suppurativa (HS) patients treated with bimekizumab (BIMZELX, UCB) had no draining tunnels (DTs) at 2 years, and 63.6% reported no or mild skin pain, compared to 10.0% at baseline, according to new data presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

Among patients with one or more DTs at baseline, the proportion who had 1–2, 3–5, or >5 DTs at two years were 26.6% (93/350), 11.1% (39/350), and 6.6% (23/350) respectively. In addition, 55.7% (195/350) had no DTs at two years. In a subgroup of patients with ≥5 DTs at baseline, 41.1% (62/151) had no DTs at two years. The majority of patients with HS experience disease-associated pain, a highly burdensome symptom that negatively impacts their quality of life. In addition to a reduction in clinical severity of skin pain with bimekizumab, measured by Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) skin pain scores, the proportion of patients reporting no impact on their Health Related Quality of Life (HRQoL) due to pain, based on HiSQOL pain item score increased from 2.7% (15/551) at baseline to 44.6% (196/439) at 2 years. Bimekizumab was well tolerated over 2 years, with no new safety signals observed in the second year.

Vivian Shi, MD, Professor and Director of Clinical Trials at the University of Washington Department of Dermatology, spoke with Practical Dermatology about the impact and implications of the new data.

HOW MUCH OF A NEED IS THERE FOR MORE EFFECTIVE THERAPIES FOR HS?

There is a tremendous need for more effective therapies for HS. While the field of HS has advanced tremendously over the last decade, we still only have three FDA-approved treatments today. HS is a chronic, progressive, and debilitating disease that can cause scarring and disability, as well as systemic comorbidities. We need timely, effective, and durable treatments for these patients to limit their disease progression before permanent sequalae occurs.

WHAT ABOUT THE MECHANISM OF ACTION (MOA) OF BIMEKIZUMAB MAKES IT WORK WELL FOR HS?

Targeting both IL-17A and IL-17F makes the MOA of bimekizumab unique for treating HS. Available evidence has demonstrated over-expression of both IL-17A and IL-17F in HS lesions. IL-17F expression is 10-fold higher compared to IL-17A. Bimekizumab is the first biologic approved for HS that targets both IL-17A and IL-17F subunits, which allows binding to all three IL-17 dimers (A/A, A/F, and F/F). Importantly, selective and effective inhibition of the inflammatory source in HS patients leads to improvement in debilitating symptoms such as pain. In a mechanistic sense, bimekizumab is a “designer” therapy for HS. Furthermore, IL-17 has also been strongly implicated in the pathoetiology of HS-associated conditions, including psoriasis, psoriatic arthritis, and ankylosis spondylitis. Therefore, bimekizumab can be an appropriate therapy for HS patients with cutaneous and extra-cutaneous comorbidities.

WHAT WERE YOUR HOPES/EXPECTATIONS IN THIS STUDY, AND HOW DID THE RESULTS MEASURE UP?

As with all providers who treat chronic inflammatory diseases, we hope to have treatments that are safe, effective, and durable. I was very pleased to learn that the trials met all my aforementioned expectations. I was hoping to see the bimekizumab trials raise the bar and take the field of HS outside of our “comfort zone,” specifically to show meaningful efficacy beyond HiSCR50. A high proportion of patients achieved and maintained HiSCR90 and 100 up to Week 96; this is especially obtainable in patients with lowest disease duration, emphasizing the importance of early intervention in HS patients. I also wanted to see no new or major safety signals in the short term and long term, beyond what we already know for the IL-17 inhibitor biologic class. The trials showed overall that exposure-adjusted incidence rates (EAIR) of treatment-emergent adverse events did not increase with longer bimikizumab exposure over 2 years, and with no new safety signals. With a patient-centric approach in mind, I wanted to see that bimekizumab can provide clinically meaningful and sustained improvement in the cardinal symptom of HS—pain. A large proportion of patients in the trial reported no/mild pain and no impact of quality of life due to HS pain up to week 96.

HOW COMFORTABLE DOES IT MAKE YOU (AND PATIENTS) THAT THIS DRUG HAS AN ESTABLISHED SAFETY PROFILE FOR OTHER CONDITIONS ALREADY?

It certainly makes my discussion with patients and their families a lot easier when there are clinical trials and real-world safety data prior to bimekizumab’s approval for HS. This also helps providers like me to feel more comfortable and confident in recommending a long-term treatment option. HS patients often have comorbid conditions, often rheumatologic; therefore, knowing the safety profile in more than one disease state is an added benefit.

WHAT DO YOU WANT TO SEE IN FURTHER STUDIES ON BIMEKIZUMAB FOR HS?

I’d like to see through real-life data:

• How bimekizumab can limit disease/symptom severity AND progression (formation of tunnels and scarring) when used in early-moderate HS patients (ie, capturing that “window of opportunity”).
• How bimekizumab can be used in conjunction with other systemic and topical immunomodulators, hormonal/metabolic treatments, and antibiotics to optimize treatment efficacy and durability.
• Whether higher doses or frequency of bimekizumab can be safely and effectively utilized in patients with higher BMI (eg, BMI >40) and more recalcitrant HS.
• Longer-term real-world data on safety and efficacy out to 5-plus years in HS patients.
• The optimal time for procedures (deroofing, excisions) for various lesion types in HS patients once they have started on bimekizumab.