Dermatitis

PDE-4 inhibitor now available as steroid free option for atopic dermatitis


Crisaborole (Staquis) is now available in Australia for the treatment of mild to moderate atopic dermatitis in adults and children from two years of age, according to manufacturer Pfizer. 

The topical phosphodiesterase-4 (PDE-4) inhibitor provides a steroid free option which may appeal to some patients or their parents, it said in a media statement. However the treatment is currently only available as a private prescription, at a recommended cost of $139 for a 60g tube. 

Dermatologist Associate Professor John Su, from the Murdoch Children’s Research Institute, Royal Children’s Hospital Melbourne and Monash University, Eastern Health, told the limbic that phase 2 and 3 clinical trials for crisaborole were conducted in Australia.

Many participants experienced complete or near complete clearance, in keeping with the published literature where about 50% of people achieved these endpoints after 28 days. 

He said crisaborole, formulated in a moisturising base, can be used for eczema both of the face and the body which can potentially simplify treatment regimens.

“A small percentage (around 2-4%) may initially experience application site pain/discomfort that ceases to occur within a couple of days of commencement.”

A recently completed trial currently awaiting publication has also examined its safety and effectiveness in children under two years of age. 

“Given that evidence-based topical options for treating inflammation in eczema are few, crisaborole will be a very useful and welcome agent that hopefully will be soon accessible to everyone who carries the burden of eczema,” he said.

According to Pfizer, the TGA registration of crisaborole was based on evidence from two RCTs comprising about 1,000 patients. 

The studies, published in the JAAD, found a reduction in signs and symptoms of atopic dermatitis including pruritus from as early as day eight of treatment.  

Treatment-related adverse events were pain at the application site, such as stinging or burning (4.4% in treated patients versus 1.2% in the control group).

However the rates of discontinuation due to adverse reactions were the same in the crisaborole (1.2%) and control (1.2%) groups.

An application for PBS listing of crisaborole was rejected by the PBAC at the end of 2018 on the basis of  “…uncertainty regarding the appropriate place in therapy, uncertain comparative efficacy and highly uncertain cost effectiveness.”

“The PBAC noted that the proposed listing is for chronic use for an indeterminate period of time, which it considered may not be appropriate given the lack of efficacy data beyond 4 weeks.” 

“The PBAC considered that the restriction should address the use of crisaborole in terms of initiation, discontinuation and optimal duration of therapy,” the PBAC Public Summary Document said.

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