Aussie dermatologists are keen to access a new nonsteroidal cream that has been approved for use in the US.
A nonsteroidal cream designed to treat plaque psoriasis in adults has recently been approved by the FDA.
And while it is not yet available here, Australian dermatologists would be eager to offer the treatment to plaque psoriasis patients, said Dr Diana Rubel, founder and dermatologist at Woden Dermatology.
“We don’t have anything similar to tapinarof yet, but we are already looking forward to its registration and availability here and if readily affordable and/or accessible, I believe that most dermatologists will start prescribing it for plaque psoriasis patients,” she said.
Tapinarof 1%, marketed as Vtama, limits inflammation and plaque formation by modulating cytokines, regulating the skin barrier and decreasing oxidative stress.
Its absence of corticosteroids would make it an exciting option for Australians living with plaque psoriasis, particularly given limitations to the variety of treatments on offer and the potential need to switch between treatments due to tachyphylaxis, Dr Rubel noted.
It would also help address concerns regarding the possibility of harmful conditions associated with potent corticosteroid use, including epidermal and dermal atrophy, folliculitis, and vascular changes, she said.
“Because psoriasis plaques tend to be quite stable and stubborn, [corticosteroids] may end up being applied repeatedly to the same sites, increasing the risk of these adverse effects. A non-steroidal alternative will be welcomed by patients and clinicians alike,” Dr Rubel said.
Tapinarof is the first novel topical treatment developed for the skin condition in 25 years, according to a statement from its manufacturer, Dermavant Sciences.
Similar delays in treatment development have been seen in Australia, likely caused by the considerable cost, resources and effort required for clinical trials as well as a severe shortage of dermatologists nationwide, according to Dr Rubel.
The TGA was contacted regarding the registration of tapinarof for use in Australia, but did not respond by the time of publication.
The FDA based their approval of tapinarof on results from two phase III randomised clinical trials, each including over 500 patients, which measured the results of tapinarof for treating mild to severe plaque psoriasis against an inert cream over the course of 12 weeks.
In trial I, more than a third of patients who received tapinarof achieved clear or almost clear skin, the trial’s end point, and experienced a 2-point reduction on a 4-point scale of plaque severity. In the control group, only 6% achieved the same results.
Similar results were achieved in trial II with 40% of those in the tapinarof group reaching the end point, compared to 6% of control group participants.
In addition, after stopping tapinarof treatment, patients’ skin stayed clear or almost clear for a median of around four months, Dermavant Sciences said in its statement.
The adverse events patients reported when using tapinarof included folliculitis, contact dermatitis, headache, nasopharyngitis and upper respiratory tract infection.
