Bimekizumab-bkzx (Bimzelx, UCB) showed sustained improvements in skin pain and resolution of draining tunnels in patients with moderate-to-severe hidradenitis suppurativa (HS), according to three-year data from the BE HEARD trials presented at the Symposium on Hidradenitis Suppurativa Advances (SHSA) 2025 Congress in Nashville, TN.
In the post-hoc analysis of patients who had at least one draining tunnel at baseline (n=245), 48.2% (205/425) had none at one year and 62.9% (183/291) at three years. In the same analysis of patients who had at least one abscess at baseline (n=381), 75.3% (287/381) had none at one year and 83.5% (203/243) at three years. In a second analysis of patients with no draining tunnels at baseline (n=131), 87.8% (115/131) still had none at one year, and 90.8% (69/76) at three years. In a third analysis, at baseline 10.0% (55/551) of patients reported no/mild skin pain, based on HS Symptom Questionnaire (HSSQ) skin pain item scores; at year one/three, the proportion of patients reporting no/mild skin pain increased to 51.7% (287/555) and 65.8% (237/360), respectively, the study showed.
“Reduction of draining tunnels and abscesses is key for patients with HS because of the huge impact these lesions have on patients’ lives,” says Steven Daveluy, MD, Program Director Clinical Educator at Wayne State University in Detroit, MI, in a news release. “These new data, showing high rates of reduction of these painful lesions to three years, demonstrate the sustained symptom relief bimekizumab provides and suggest the possibility of reducing the structural damage frequently seen with HS that can be so devastating for patients.”
Data are reported as observed case (OC). The data reported are from an observational, open-label study. Patients completing the 48-week BE HEARD I & II studies could enroll in BE HEARD EXT and receive open-label bimekizumab 320mg every two weeks (Q2W) or Q4W based on Hidradenitis Suppurativa Clinical Response (HiSCR)90 response averaged from Weeks 36, 40, and 44. Data are reported for patients randomized to bimekizumab from baseline in BE HEARD I & II who entered BE HEARD EXT (bimekizumab total group, n=556) at Week 48. Only patients who entered the third year are included. The approved dosing regimen is bimekizumab 320mg Q2W to Week 16 and then 320mg Q4W thereafter. Results included patients receiving both Q2W and Q4W after Week 48. Per protocol, all patients who continued in the trial after Week 48 were subsequently switched to Q4W eventually by the end of year three.