Dupilumab (Dupixent) has been listed on the PBS from March 1 for the treatment of adolescent and adult patients with severe atopic dermatitis that has not responded to topical therapies.

The long awaited listing of the monoclonal antibody comes after three applications to the PBAC, success at the March 2020 meeting, and a revisit in November 2020.

Associate Professor Peter Foley, director of research at the Skin Health Institute, Melbourne, told the limbic that dermatologists would welcome the new treatment option.

“It’s new, it’s first in class, it’s the first biologic for atopic dermatitis which in the dermatology world is going to be potentially bigger than anything else we have.”

He said in comparison there were relatively small numbers of patients requiring biologics for conditions such as hidradenitis suppurativa and chronic spontaneous urticaria.

“The epidemiology would suggest that atopic dermatitis is probably at least as twice as common as psoriasis so it is a big ticket item for the PBAC.”

He estimated there were probably 5-10,000 patients with severe disease that has not responded to topical corticosteroids.

“It’s just great to have something now after having no new therapies for atopic dermatitis for over 20 years.”

Associate Professor Foley said eligible patients were those with severe atopic dermatitis based on a Patient Global Assessment score of 4, an EASI score >20 and an inadequate response to potent topical steroids. Other clinical criteria were severe atopic dermatitis of the face or palm of hand.

Treatment must be initiated and supervised by a dermatologist or clinical immunologist

“And for the first time for dermatology, rather than written application, we can either apply directly online through PRODA or we can ring up and get authority,” he said.

Associate Professor Foley said there was no requirement for monitoring with blood tests as required for drugs for psoriasis and systemic agents used in atopic dermatitis.

“There is now controlled data for three years showing no additional safety signals after the initial studies and it seems to maintain response.”

Dupilumab has also been on the market overseas in the US and Europe for a couple of years.

“What’s very exciting also is that it is approved from age 12 years whereas in psoriasis we’ve only got biologics for adults. And we are doing studies in the paediatric population now.”

Associate Professor Foley said in another first for dermatology, a quality of life measure has also been introduced as criteria for continuing use.

“We use the Dermatology Life Quality Index (DLQI) as a measure of health-related quality of life. And one of the requirements for ongoing supply is at least a 4-point reduction in that score and a 50% reduction in EASI score.”

“It’s the first time in dermatology to have a patient reported outcome as a means of demonstrating response. It’s something we have been pushing for in psoriasis. People can be really happy with their skin but because of the nuances of the scoring system they can have scores which suggest they are non-responders.”

Disclosures: Associate Professor Foley has served on the medical advisory board for Sanofi and as an investigator on their clinical trials. He said he has also engaged with many other pharmaceutical companies with competing products for atopic dermatitis.