Health Canada Approves SKYRIZI® for Children Living with Moderate to Severe Plaque Psoriasis

• Psoriasis affects 1 million Canadians, and nearly one-third of people living with psoriasis develop symptoms before age 18, meaning the disease can begin during important formative years.¹
• Pediatric psoriasis can have a significant impact on children and their families. A recent systematic review found 84.8% of children with psoriasis and 96.1% of caregivers experienced some degree of health-related quality-of-life impairment.²
• Health Canada's approval expands treatment to pediatric patients aged 6 to <18 years of age with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.³

AbbVie (NYSE: ABBV), announced today that Health Canada has approved SKYRIZI® (risankizumab) for the treatment of pediatric patients aged 6 to <18 years of age with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.3 The approval expands treatment options for eligible children and adolescents living with this chronic inflammatory disease, which can affect much more than the skin.

For children and adolescents, psoriasis can mean managing a visible, chronic disease during important formative years. Research has shown that its impact can extend to physical and psychosocial well-being and beyond the child to affect the quality of life of parents and caregivers.² A recent systematic review and meta-analysis found that 84.8% of children with psoriasis and 96.1% of caregivers experienced some degree of health-related quality-of-life impairment.² Among children, symptoms, leisure activities and treatment-related concerns were among the areas most affected.²

"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, RKS Dermatology Centre, Women's College Hospital, and AbbVie Chair in Ethnodermatology, University of Toronto. "Pediatric psoriasis requires an individualized approach that considers a young person's age, disease severity and treatment needs. Having another approved treatment option gives physicians greater flexibility when considering care for children and their families."

The Health Canada approval is supported by OptIMMize-1, a Phase 3 study of children and adolescents aged 6 to <18 years of age with moderate to severe plaque psoriasis.³ At Week 16, 79.6% of SKYRIZI^®-treated patients aged 12 to <18 years of age had clear or almost clear skin, while 85.2% experienced at least a 75% improvement in the extent and severity of their psoriasis. Among children aged 6 to <12 years of age, 90.0% had clear or almost clear skin and 86.7% experienced at least a 75% improvement.³

For children and adolescents, dosing is based on body weight, with treatment given initially, again four weeks later and every 12 weeks thereafter.³ The study found that the safety profile of SKYRIZI^® in pediatric patients was generally consistent with that observed in adults with plaque psoriasis.³ 

"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, 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. Families need treatment options and the opportunity to have informed conversations with their healthcare providers about what is right for their child."

"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," said Tanu Misra, Vice-President and General Manager, AbbVie Canada. "We recognize the impact this can have not only on young people, but on the families and caregivers who support them. This approval reflects our continued commitment to advancing care and bringing more treatment options to younger Canadians living with psoriasis."

About SKYRIZI® (risankizumab)
SKYRIZI^® (risankizumab) is a humanized monoclonal antibody that selectively inhibits interleukin-23 (IL-23), a key cytokine involved in inflammatory processes. SKYRIZI^® is approved in Canada for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and for pediatric patients aged 6 to < 18 years of age with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. SKYRIZI^® is indicated for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response, intolerance, or demonstrated dependence to corticosteroids; or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies. SKYRIZI^® is also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response, or were intolerant to conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.³

About Psoriasis
Psoriasis is a chronic inflammatory disease that can begin during childhood or adolescence. Nearly one-third of people living with psoriasis develop symptoms before age 18.¹ Pediatric psoriasis can affect both physical and psychosocial well-being, with impacts extending beyond the child to parents and caregivers.²

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acros several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie in Canada on LinkedIn, Instagram, and YouTube.

SOURCE AbbVie Canada

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