Latest analyses of bimekizumab phase III studies in moderate to severe hidradenitis suppurativa presented at EHSF 2024

These data are being presented at the 13th Conference of the European Hidradenitis Suppurativa Foundation (EHSF) in Lyon, France (7-9 February)

“The analyses presented at EHSF 2024 build on the Phase III data communicated to date and reinforce our belief in the potential of bimekizumab to make a meaningful difference to patients,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions, and Head of U.S., UCB. “Results presented re-affirm the high levels of sustained clinical response achieved with bimekizumab treatment, the positive impact on health-related quality of life as reported by patients, and the importance of timely treatment following diagnosis.”

“The achievement of IHS4-55 shows reduction in inflammatory nodules, abscesses and draining tunnels. This is a novel dichotomous version of the International Hidradenitis Suppurativa Severity Score System that allows for the inclusion and quantification of draining tunnels in a validated manner and reflects at least 55% improvement in the total score from baseline. With bimekizumab, the analyses showed that over 48 weeks, the majority of patients, ~7 out of 10, achieved IHS4-55,” said Professor Tzellos, Department of Dermatology, Nordland Hospital Trust, Bodø, Norway.

Highlights of the bimekizumab BE HEARD I and BE HEARD II Data Presented at EHSF 2024:

Dichotomous IHS4: At Week 16, a greater proportion of patients achieved IHS4-55 with bimekizumab treatment vs placebo (51.1-62.9% vs. 25.7–30.8%). By Week 48, these responses were sustained or increased (pooled, 71.0–77.4%). Patients that switched from placebo to bimekizumab achieved comparable responses to those receiving continuous bimekizumab treatment (pooled, 76.2%). The higher thresholds of IHS4-75 and IHS4-90 were also achieved by greater proportions of patients treated with bimekizumab vs placebo at Week 16 (IHS4-75: 30.6–44.7% vs 15.7–23.1%; IHS4-90: 16.5–23.0% vs 7.1–10.8%). By Week 48, these responses were sustained or increased (IHS4-75 pooled, 56.0-61.9%; IHS4-90 pooled, 36.2-44.1%).

Lesion Count and Clearance Across Lesion Type and Anatomical Area: At Week 16, bimekizumab treatment demonstrated improvements in overall lesion count. Following bimekizumab treatment lesion clearance also increased at Week 16. Results were sustained or improved across 48 weeks of treatment. Improvements were observed across different anatomical regions and across all three lesion types presented (abscesses, inflammatory nodules and draining tunnels).

Depth of Response and Impact on Quality of Life: The vast majority of patients (69.5–74.8%) who achieved Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 reported a Hidradenitis Suppurativa Quality of Life (HiSQoL) rating of ‘None/Mild’ at Week 16. A higher proportion of patients reported a HiSQoL rating of ‘None/Mild’ at Week 16 if they achieved HiSCR75 (77.2–84.3%) or HiSCR90 (80.0–89.3%) at Week 16.3 A similar trend was also observed at Week 48.3.

Clinical Response Across Duration Quartiles: At Week 16, patients treated with bimekizumab in the lowest ( less than 2.40 years) disease duration quartiles achieved HiSCR50/HiSCR75 of 67.5% (n=133/197)/48.2% (95/197) vs 43.8% (n=14/32)/21.9%(n=7/32) for placebo. Patients treated with bimekizumab in the highest ( greater than 10.87 years) disease duration quartiles achieved HiSCR50/HiSCR75 of 53.8% (n=99/184)/34.2% (n=63/184) vs. 28.9% (n=13/45)/20.0% (n=9/45) for placebo. Results with bimekizumab were sustained across 48 weeks of treatment.

About IHS4-55, IHS4-75 and IHS4-90: Hidradenitis suppurativa (HS) severity can be assessed using the International Hidradenitis Suppurativa Severity Score System (IHS4) that includes the number of inflammatory nodules, abscesses and draining tunnels and classifies disease severity as mild ( less than 3 points), moderate (4–10 points) or severe ( greater than 11 points). In order to discriminate between active treatment and placebo, a novel outcome measure built on the IHS4 was developed using dichotomous thresholds. IHS4-55 is a dichotomous version of IHS4 that is based on an improvement of at least 55% in the total score from baseline. IHS4-55 response is achieved if a patient’s IHS4 score improves by at least 55% from baseline. Similarly, IHS4-75 and IHS4-90 responses are achieved if a patient’s IHS4 score improves by 75% or 90%, respectively, from baseline.