The news is a major milestone for a patient group often undertreated.
Australian dermatologists have welcomed the inclusion of two new treatments for plaque psoriasis to the PBS from 1 October.
They include bimekizumab (Bimzelx, UCB), a new biologic injectable, and deucravacitinib (Sotyktu, Bristol Myers Squibb Australia and New Zealand), Australia’s first daily oral therapy and the only approved TYK2 inhibitor for this patient group.
As part of the approval both have been included in the Black Triangle Scheme for the next five years.
In two phase III clinical trials deucravacitinib demonstrated superior efficacy compared to placebo and twice-daily apremilast in 1684 patients aged 18 years and older living with severe chronic plaque psoriasis.
This heightened efficacy was evident at both 16 and 24 weeks, with patients remaining responsive to treatment through 52 weeks.
Associate Professor Peter Foley, a dermatologist at St Vincent’s Hospital, Melbourne, told Dermatology Republic deucravacitinib offered a new treatment alternative to injectables and topical therapy.
“With Sotyktu, we’ve got an agent that approaches the efficacy of some of the biologics without knocking the biologics out of the ranking as the most effective agents we have,” he said.
“It is the best oral agent we have available in 2023 in terms of its response rate and its safety profile.”
Professor Foley said securing a PBS listing for the drug was a major milestone.
“Plaque psoriasis is characterised by periods of relapse and remission, with patients often requiring long term (potentially lifelong) treatment to maintain symptom control and prevent flares,” he said.
“Furthermore, individuals exhibit variability in their response to different medications, highlighting the importance of tailoring treatment to patient-specific needs.”
He said plaque psoriasis could be undertreated and even untreated and a “significant portion” of patients may not be presenting to their GPs because they are not aware of new therapy options.
“The reimbursement of this first-in-class therapy option for Australians living with severe chronic plaque psoriasis represents a major milestone in helping to address the substantial, unmet, clinical need for these patients,” he said.
University of Sydney Clinical Associate Professor Stephen Shumack, a senior staff specialist at Royal North Shore Hospital, said plaque psoriasis was the most common form of psoriasis, accounting for approximately 90% of cases.
“Severe forms of the disease are associated with increased risk of comorbidities, including inflammatory bowel disease and cardiovascular disease, and may lead to the development of joint inflammation, and subsequent psoriatic arthritis,” he said.
Bristol Myers Squibb Australia and New Zealand’s medical director Dr Melinda Munns said improving patient access to affordable treatment options was paramount to overcoming the widespread impact of severe chronic plaque psoriasis.
“Psoriasis is a chronic, lifelong disease imposing a substantial physical and mental burden on patients,” she said.
“Severe plaque psoriasis can significantly reduce overall quality of life, and can compromise relationships, career, social activities, and emotional wellbeing. Bristol Myers Squibb Australia is proud to deliver a novel oral therapy for severe chronic plaque psoriasis.”
Bimekizumab is the first approved psoriasis treatment in Australia designed to selectively and directly inhibit IL-17A and IL-17F, two key cytokines driving inflammatory processes.
As reported last year in Dermatology Republic, bimekizumab was approved by the TGA and PCAC for PBS listing following research showing skin clearance was better in adults taking the drug compared with those taking a placebo, ustekinumab, secukinumab or adalimumab. Researchers also found the drug was well tolerated.
Nasopharyngitis, upper respiratory tract infection and oral candidiasis were the most frequently reported adverse events.
Specifically, faster onset of clinically meaningful responses was observed with bimekizumab than active comparators and placebo, with PASI 75 responses observed at week four after one dose. About 60% of plaque psoriasis patients treated with bimekizumab experienced complete skin clearance (PASI 100) at week 16 compared to 21-49% for active comparators across clinical studies.
It is approved by the TGA for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
“The pathogenesis of psoriasis involves inflammation driven by cytokines IL-17A and IL-17F. Current psoriasis therapies only target IL-17A, leaving unopposed activation of IL-17F resulting in suboptimal clinical control,” said Dr John Frew, staff specialist dermatologist at Liverpool Hospital in Sydney and senior lecturer at University of NSW.
“Bimekizumab is the first dual IL-17A and IL-17F monoclonal antibody with proven efficacy in plaque psoriasis. The availability of bimekizumab on the PBS will be a significant benefit for Australians suffering from plaque psoriasis and its comorbidities.”
Australia had several investigators and their clinical trial centres included in the BIMZELX psoriasis clinical trial program. Professor Foley was clinical trial investigator in this program and also welcomed the PBS listing.
“Having been involved in the bimekizumab clinical trial program, I am looking forward to the opportunity to prescribe bimekizumab in the real world,” he said.
“With bimekizumab we have a highly effective therapy with high rates of complete skin clearance, and this equates to dramatic improvement in quality of life for patients with this chronic debilitating disease.”
Francesca Bianco, head of immunology at UCB Australia’s patient value unit said the company was “pleased that the PBS has recognised the value that bimekizumab brings to patients and the healthcare system”.
“We are delighted that we can now make this innovative treatment option available to healthcare professionals and people living with psoriasis in Australia, as we believe that bimekizumab has the potential to raise expectations of what psoriasis treatment can deliver,” she said.
