Dermatitis: adolescents OK for biologic therapy

Dermatologists and immunologists can now prescribe the first biologic therapy approved to treat not only adults, but also patients as young as 12 years old with moderate to severe atopic dermatitis.

Sanofi Genzyme confirmed this week that Dupixent (dupilumab) is being made available via private prescription at a cost of $1,615.38 for two 300mg injections – the monthly dose after an initial 600mg 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 said Dupixent is an important treatment, especially for patients with severe disease that 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,” he said.

Dr Smith added that while Sanofi continues to work towards 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 signalling of interleukin-4 and interleukin-13, key type 2 cytokines involved in atopic disease.¹

“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 said.

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.¹

These studies found that about:

• One in two patients treated with Dupixent achieved ≥75 per cent improvement in lesion extent and severity at 16 weeks.¹
• 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.¹
• Two in three patients treated with Dupixent and topical corticosteroids achieved ≥75 per cent improvement in lesion extent and severity at 52 weeks.¹

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

• Two-in-five patients treated with Dupixent achieved ≥75 per cent improvement in lesion extent and severity at 16 weeks.¹
• 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.¹

Sanofi Genzyme Australia and New Zealand Head of Medical Dr Paul King said the company understands the importance of a PBS listing for doctors and their patients.

“Feedback from the PBAC has been constructive and we look forward to continuing to work with the government to obtain PBS listing for Dupixent,” he said.

Reference

1. Reference is available on request