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PBS lists once-a-day pill for chronic psoriasis
While GPs cannot initiate treatment with the medication, they still have a clear role in identifying eligible patients.
Chronic plaque psoriasis, which accounts for 90% of all psoriasis cases, commonly appears as red scaly lesions on the elbows and knees.
Australians living with severe chronic plaque psoriasis now have access to a subsidised once-daily oral treatment, following the PBS listing of deucravacitinib (sold as Sotyktu) on 1 October.
Taken as a 6 mg tablet, the oral selective allosteric tyrosine kinase 2 (TYK2) inhibitor reduces the overactive immune response causing excessive skin cell production.
It is the first treatment consisting of a new mechanism of action for adults with plaque psoriasis who are candidates for systemic therapy or phototherapy and for whom the condition has caused ‘significant interference with quality of life’, the PBS states.
Listed as a ‘priority required’ medicine, it can be prescribed by a dermatologist, accredited dermatology registrar in consultation with a dermatologist, or a GP who has been directed to continue, but not initiate, treatment by one of these practitioners.
Although GPs are not authorised to initiate treatment, Dr Jeremy Hudson, Chair of RACGP Specific Interests Dermatology, told newsGP it is still an important listing to have on their radar.
‘Deucravacitinib should be seen as a management option where GPs can monitor response to treatment and prescribe repeats of the medication,’ he said.
Chronic plaque psoriasis accounts for around 90% of all psoriasis cases. Thick, sharp-edged, red scaly lesions are the hallmark characteristics which can appear on any area of the skin, with the elbows, knees, lower back and scalp most commonly affected with itchiness or mild discomfort.
Psoriasis can also affect the appearance and brittleness of nails, as well as joints – causing pain, swelling and reduced movement. Emotional and social wellbeing can also be impacted. Severe forms of the condition are linked with a higher risk of comorbidities, including developing heart disease, type 2 diabetes, Crohn’s disease and psoriatic arthritis.
The PBS listing of deucravacitinib comes following the outcomes of two phase 3 clinical trials (POETYK PSO-1 and POETYK PSO-2), which compared the efficacy and safety of the TYK2 inhibitor versus placebo and another psoriasis medication, apremilast, in adults with moderate to severe plaque psoriasis over one year.
The results showed deucravacitinib was well tolerated and demonstrated superior efficacy when taken once-daily compared to twice-daily placebo or apremilast. Response rates were significantly higher with deucravacitinib versus placebo or apremilast at the 16-week mark, with efficacy improving and maintained until week 52.
Associate Professor Peter Foley, Head of Dermatology Research at St Vincent’s Hospital Melbourne, welcomed the drug’s listing as a novel way of treating the multisystem inflammatory condition.
‘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.
‘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.’
According to Dr Hudson, systemic medications are ‘widely underutilised’ in psoriasis management and GPs play a central role by identifying patients who are suitable for systemics by using Psoriasis Area Severity Index (PASI) scores.
‘There have been recent reviews by the RACGP on systemic medications on whether GPs can play an extended role in initiating therapy, and this is being done on a case-by-case basis,’ he said.
‘I’d recommend that any GPs who are managing psoriasis to review currently available education modules and toolkits, which can be quite beneficial to patient outcomes.’
On 1 October, bimekizumab (sold as Bimzelx) was also added to the PBS for the treatment of severe chronic plaque psoriasis, but can only be prescribed by a dermatologist treating the condition.
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chronic plaque psoriasis dermatology deucravacitinib PBS listing psoriasis
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