Health Canada approves Skyrizi for pediatric psoriasis

MONTREAL — Health Canada has approved the drug Skyrizi for the treatment of children and adolescents with moderate to severe plaque psoriasis.

The approval announced Monday by AbbVie Canada covers patients aged six to under 18 who are candidates for systemic therapy or phototherapy.

"Psoriasis can have a significant physical and emotional impact on children and adolescents, particularly when symptoms are visible or interfere with everyday life," said Dr. Marissa Joseph, medical director at the RKS Dermatology Centre at Women's College Hospital and AbbVie Chair in Ethnodermatology at the University of Toronto.

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"Pediatric psoriasis requires an individualized approach that considers a young person's age, disease severity and treatment needs," she said. "Having another approved treatment option gives physicians greater flexibility when considering care for children and their families."

The approval is based on results from a Phase 3 clinical trial called OptIMMize-1, which studied children and adolescents aged six to under 18 with moderate to severe plaque psoriasis.

At week 16 of the study, 79.6 percent of Skyrizi-treated patients aged 12 to under 18 had clear or almost clear skin, while 85.2 percent experienced at least a 75 percent improvement in the extent and severity of their psoriasis.

Among children aged six to under 12, 90.0 percent had clear or almost clear skin and 86.7 percent experienced at least a 75 percent improvement.

Dosing for children and adolescents is based on body weight, with treatment given initially, again four weeks later and every 12 weeks thereafter.

The study found the safety profile of Skyrizi in pediatric patients was generally consistent with that observed in adults with plaque psoriasis.

Psoriasis is a chronic inflammatory disease that can begin during childhood or adolescence, with nearly one-third of people living with psoriasis developing symptoms before age 18.

A recent systematic review and meta-analysis found that 84.8 percent of children with psoriasis and 96.1 percent of caregivers experienced some degree of health-related quality-of-life impairment.

Among children, symptoms, leisure activities and treatment-related concerns were among the areas most affected.

"Children and adolescents living with psoriasis are an underserved population, and their needs can be different from those of adults," said Dana Gies, executive director of the Canadian Skin Patient Alliance.

"At a time when young people are building confidence, friendships and independence, living with a visible chronic disease can add another layer of physical, emotional and social challenges," Gies said. "Families need treatment options and the opportunity to have informed conversations with their healthcare providers about what is right for their child."

Tanu Misra, vice-president and general manager of AbbVie Canada, said the approval reflects the company's commitment to advancing care for younger Canadians living with psoriasis.

"Childhood and adolescence should be about curiosity, learning, and discovery. Living with a chronic disease like psoriasis can add physical, emotional, and social challenges during these defining years," Misra said. "We recognize the impact this can have not only on young people, but on the families and caregivers who support them."

Skyrizi, also known by its generic name risankizumab, is a humanized monoclonal antibody that selectively inhibits interleukin-23, a key cytokine involved in inflammatory processes.

It was already approved in Canada for treating adult patients with moderate to severe plaque psoriasis, as well as for adults with moderately to severely active Crohn's disease and ulcerative colitis.

With files from Investing News Network and PR Newswire Canada