First atopic dermatitis biologic in Australia “merits conversation with patients”

Dermatologists and immunologists can now prescribe the first biologic therapy approved to treat not only adults, but also patients as young as twelve years of age with moderate-to-severe atopic dermatitis.

Sanofi Genzyme confirmed that Dupixent (dupilumab) is now TGA registered and being made available via private prescription at a cost of $1,615.38 for two 300 mg injections – the monthly dose after an initial 600 mg loading dose.

The company also welcomed extension of the registration of Dupixent to include patients aged 12-17 years with moderate-to-severe atopic dermatitis. While efforts to secure a PBS listing for adult patients continue, Sanofi confirmed it would seek reimbursement for adolescents as soon as feasible.

Associate Professor Saxon Smith from the Department of Dermatology at Sydney’s Royal North Shore Hospital described Dupixent as, “an important treatment, especially for patients with severe disease which significantly impacts their quality of life and for whom there are limited treatment options”.

“Many of these patients are desperately seeking access to new treatment options and may have heard about Dupixent, so it’s important that specialists, GPs and pharmacists are equipped to explain its availability and cost in Australia,” Dr Smith said.

He said that while Sanofi continues to work toward reimbursement, the benefits of Dupixent, “merit a conversation with patients so that they understand the private script option”.

Unlike broad-spectrum immunosuppressants, Dupixent has a targeted action – selectively inhibiting the signaling of interleukin-4 and interleukin-13, key type 2 cytokines involved in atopic disease.

“Dermatologists are well versed in prescribing biologics for psoriasis, but this marks the first targeted biologic agent for moderate-to-severe atopic dermatitis,” Dr Smith added.

Dupixent has been studied in more than 2,500 adult patients with moderate-to-severe atopic dermatitis, both with and without topical corticosteroids, for up to 52 weeks. These studies found that around:

• One-in-two patients treated with Dupixent achieved ≥75% improvement in lesion extent and severity at 16 weeks.

• One-in-three patients treated with Dupixent achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 with a reduction of ≥2 points at 16 weeks.

• Two-in-three patients treated with Dupixent and topical corticosteroids achieved ≥75% improvement in lesion extent and severity at 52 weeks.

A study of more than 250 adolescents with moderate-to-severe atopic dermatitis found that approximately:

• Two-in-five patients treated with Dupixent achieved ≥75% improvement in lesion extent and severity at 16 weeks.

• One-in-four patients treated with Dupixent achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 with a reduction of ≥2 points at 16 weeks.

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