2-Year Data Shows Relief with Bimekizumab for HS Symptoms, Draining Tunnels

New 2-year findings presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando suggest that bimekizumab-bkzx (Bimzelx) is effective in promoting sustained control of moderate-to-severe hidradenitis suppurativa (HS), relief of key symptoms, and prevention of long-term damage with draining tunnels.1,2

The findings, released by UCB, resulted from the BE HEARD trials evaluating bimekizumab in patients suffering from HS.1 Bimekizumab is known to be the first and only approved therapy that can selectively inhibit both interleukin (IL)-17A and IL-17F among patients, and the findings regarding its preventative potential for long-term draining tunnel-related structural damage are considered significant.

“Draining tunnels cause debilitating symptoms such as pain and malodorous discharge, and can often result in irreversible scarring,” said Christopher Sayed, MD, an investigator and professor at the University of North Carolina School of Medicine. “These exciting results reveal that treatment with bimekizumab-bkzx reduces draining tunnels and the associated disease burden in patients with moderate-to-severe HS.”1

Patients who finished the 48-week BE HEARD I and II studies were permitted to take part in the BE HEARD EXT study and, thus, receive open-label BIMZELX 320 mg every two weeks (Q2W) or Q4W. This would be based on patients’ HS Clinical Response (HiSCR90), averaged from the 36, 40, and 44-week marks.

Those treated with bimekizumab Q2W to the 16-week mark, then Q4W thereafter were considered to be in the approved dosing regimen (Q2W/Q4W). In the investigators’ findings participants receiving both Q2W and Q4W after the 48-week mark were included.

During the BE HEARD study, among individuals involved with at least a single draining tunnel at baseline, 26.6% had 1–2 tunnels, 11.1% reported 3–5, and 6.6% were shown to have more than 5 by the 2-year mark. Notably, however, 55.7% reported no draining tunnels after 2 years. Sayed and colleagues also found that among a subgroup of trial participants who had first presented with 5 or more tunnels, 41.1% were shown to have none by the conclusion of the study period.1

The investigators of BE HEARD highlighted that, given that pain is 1 of the most burdensome HS symptoms, they had evaluated improvements in HS-related pain severity via the participants’ Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) skin pain scores. In their findings, a substantial rise in the proportion of participants indicating no pain-related effect on their Health-Related Quality of Life (HRQoL), as evaluated by the HiSQOL pain item score, was shown to have risen from 2.7% at the point of baseline to 44.6% by the 2-year mark.

Additionally, treatment with bimekizumab was shown to result in a favorable safety profile over the course of BE HEARD’s 2-year length. Specifically, the investigative team reported no new safety signals by the second year. These findings were all presented through 7 posters at the AAD meeting.

The team’s latest results add to prior data on bimekizumab that had been shared at AAD for other immune-mediated inflammatory conditions, including ankylosing spondylitis, psoriatic arthritis, psoriasis, and non-radiographic axial spondyloarthritis.

The approval by the US Food and Drug Administration (FDA) for bimekizumab was granted in November 2024 for the treatment of adult patients suffering from moderate-to-severe HS. The UCB release noted that additional data drawn from the BE HEARD trial results that further evaluate bimekizumab’s efficacy and safety are slated to be presented later in 2025.1

References

1. BIMZELX® (bimekizumab-bkzx) Two-Year Data at AAD Showed Potential to Eliminate Draining Tunnels in Hidradenitis Suppurativa, and Reduction in Disease Burden. UCB. March 7, 2025. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelxr-bimekizumab-bkzx-two-year-data-at-aad-showed-potential-to-eliminate-draining-tunnels-in-hidradenitis-suppurativa-and-reduction-in-disease-burden.

2. Tzellos T, Sayed C, Porter M, et al. Bimekizumab impact on draining tunnel reduction over 2 years in moderate to severe hidradenitis suppurativa: Results from BE HEARD EXT. Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.