The high-efficacy monoclonal antibody expands options for Australians with severe disease.
Australian dermatologists now have a new option for managing hidradenitis suppurativa following the listing of bimekizumab on the Pharmaceutical Benefits Scheme.
The listing, which was effective on 1 December, applies to adults with moderate to severe disease who have not responded adequately to conventional systemic therapy.
Staff specialist dermatologist at Sydney’s Liverpool Hospital and director of research at The Skin Hospital in Sydney, Associate Professor John Frew, said the listing was an important advance for a patient population that often faced long delays to diagnosis, limited treatment choices and substantial impacts on quality of life.
He said the listing brought the number of PBS-subsidised biologic treatments for HS to three.
“This is certainly one of the agents that has really high, and what we call deep, levels of efficacy,” Professor Frew told Dermatology Republic.
“So not only is it able to achieve reduction [in active disease], but where patients that do have a reduction actually have quite a deep reduction.
“So not just getting a 50% reduction in symptoms, but a large proportion getting 75 to 90% reduction in symptoms. That really makes it stand out. It’s certainly the most exciting development in recent years for the treatment of HS.”
Bimekizumab is a humanised monoclonal antibody which selectively inhibits interleukin 17F and interleukin 17A, two cytokines that play an important role in driving the inflammatory processes underlying HS. It was approved for some patients with HS by the TGA earlier this year.
The TGA approval and PBS listing were based on the results of the Phase 3 clinical trials known as BE HEARD I and BE HEARD II, that assessed the efficacy and safety of bimekizumab (Bimzelx, UCB Australia) in patients with moderate to severe HS.
Data presented at last year’s European Academy of Dermatology and Venerology Congress suggested the HS clinical response improvements following bimekizumab treatment lasted for up to 12 months.
The primary endpoint was met in both trials, with higher rates of HS clinical response of at least 50% (HiSCR50) at week 16 observed in bimekizumab-treated patients (320mg dose every two weeks), compared to the placebo group.
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Additionally, the primary endpoint was met for those patients randomised to the less frequent 320mg dosing schedule every four weeks in the BE HEARD II trial (not met for BE HEARD I).
Across both trials, bimekizumab 320mg also showed numerical improvements in patient-reported outcomes (secondary endpoints). Clinically meaningful improvements in Dermatology Life Quality Index (DLQI) were observed at week 16 in bimekizumab treatment groups, but not with placebo (nominal p-value).
Using the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) worst pain response, more patients receiving bimekizumab saw improvements in skin pain than those on placebo (not statistically significant).
Long-term efficacy and safety data on BIMZELX out to three years, were presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris in September.
Bimekizumab was generally well-tolerated in patients with HS. Serious treatment emergent adverse events (TEAEs) were reported for bimekizumab in 6.4% of patients (n=64) in the BE HEARD clinical trials over 48 weeks.
The most frequently reported TEAEs over this period were hidradenitis in both BE HEARD I and II (related to HS worsening), in addition to coronavirus infection and diarrhoea in BE HEARD I, and oral candidiasis and headache in BE HEARD II.
Discontinuation rates due to TEAEs remained low at 6.7%.
Professor Frew told DR the impact on quality of life from HS was often severe.
“We know from many previous studies that HS has the greatest impact on patient quality of life, more than any other skin disease,” he said.
“There’s been some studies that have compared to the impact of patients as being comparable to a cancer diagnosis. It is a chronic relapsing condition, and there is no cure. And it’s a very, very painful condition as well.
“That’s something that many people don’t often recognise, that it comes with excruciating, chronic, unrelenting levels of pain, and that’s certainly something that really impacts patients significantly as well.
“So the need for effective therapies has been around for a long time, but certainly now, with a new agent being listed on the PBS, and especially an agent that has a much greater depth of efficacy, it certainly brings much closer the aim of having these patients with well controlled disease.”
Until the advent of biologic agents, HS treatment usually involved large surgical incisions to drain wounds and antibiotics which were mostly ineffective long term, said Professor Frew.
“Patients who underwent large degrees of surgery would often have very slow healing wounds or non-healing wounds,” he said.
“They would have long hospitalisations for months, even close to 12 months of hospitalisations with these surgeries and very high rates of recurrence, both in the area of surgery and in other areas.
“So, in terms of quality of life, having a highly effective targeted biologic agent reduces pain rapidly and significantly. It also reduced malodorous drainage and discharge, which is a really significant impact to patients.
“It also improves self-confidence, reduces the impact on relationships, and the psychosocial and psychosexual issues which arise from having a chronic inflammatory disease that predisposes to the groins and the flexures.
“There are many patients who report stories saying that having a disease like this has basically stopped them from having relationships [and] having children, and knowing that there’s now a treatment is something that really changes their lives.”
