UCB, a biopharmaceutical company based in Brussels, has released new three-year data from its BE HEARD trials for BIMZELX (bimekizumab) in patients with moderate to severe hidradenitis suppurativa (HS). The findings were presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris.
Bimekizumab is currently the only approved treatment that selectively inhibits both interleukin 17A (IL-17A) and interleukin 17F (IL-17F). According to UCB, the drug continued to be generally well tolerated over three years and showed sustained disease control and resolution of key HS symptoms.
“A crucial goal for treating people with hidradenitis suppurativa is achieving and maintaining long term disease control at the most stringent levels,” said John Ingram, Professor of Dermatology at Cardiff University. “These data for bimekizumab – including HiSCR100 and IHS4-100 – showed disease control can be maintained long-term. Importantly, the resolution of inflammatory lesions highlights the potential to prevent long-term structural damage commonly associated with this disease.”
Data from the trials indicate that improvements seen after one year were sustained or improved by year three. At three years, 90.2% of patients achieved HiSCR50, while 81.2%, 64.3%, and 50.1% reached HiSCR75, HiSCR90, and HiSCR100 respectively. Quality of life improvements also persisted; at year three, 38.1% of patients reported no effect of skin disease on their quality of life as measured by DLQI 0/1.
Patients who had a shorter duration since HS diagnosis saw better outcomes than those with longer-standing disease, especially at higher efficacy thresholds. For example, among those diagnosed less than 2.38 years prior to starting treatment, nearly half achieved complete resolution according to IHS4-100 criteria at Week 96.
The safety profile remained consistent over three years with no new safety signals identified. The most common treatment-emergent adverse events included hidradenitis itself (19.6 per 100 patient-years), coronavirus infection (14.1 per 100 patient-years), and oral candidiasis (9.3 per 100 patient-years).
Donatello Crocetta, Head of Medical and Chief Medical Officer at UCB, stated: “The three-year data on bimekizumab presented at EADV demonstrated deep and sustained responses across stringent efficacy endpoints, as well as long-term improvements in health-related quality of life – raising the treatment bar for people living with hidradenitis suppurativa.” He added: “Long-term efficacy and safety data are vital for advancing understanding of chronic inflammatory conditions like hidradenitis suppurativa, and these findings underscore UCB’s commitment to advancing science-led insights and providing transformative treatment options to improve outcomes for patients.”
Hidradenitis suppurativa is a chronic inflammatory skin condition marked by painful nodules, abscesses, and draining tunnels that can lead to scarring. It typically develops in early adulthood and affects about one percent of people in most studied countries.
The BE HEARD program consisted of two multicenter Phase 3 studies enrolling more than a thousand participants globally; those completing initial studies could enter an open-label extension study lasting up to three years.
BIMZELX is approved in the European Union for several indications including plaque psoriasis, psoriatic arthritis—either alone or combined with methotrexate—axial spondyloarthritis under certain conditions confirmed by C-reactive protein or MRI evidence when other treatments have failed or been intolerable; it is also indicated for active moderate-to-severe HS in adults not responding adequately to conventional systemic therapy.
For more information on BIMZELX’s product characteristics see https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf.
UCB employs around 9,000 people across approximately forty countries worldwide; it reported revenues totaling €6.1 billion in 2024.
