FDA approved risankizumab for children aged 6 years or older with moderate to severe plaque psoriasis or active psoriatic arthritis.
The US Food and Drug Administration (FDA) has approved risankizumab-rzaa (Skyrizi) for children aged 6 years or older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or with active psoriatic arthritis, according to a June 26 announcement from AbbVie.¹ The action expands use of the interleukin (IL)-23 inhibitor into pediatric psoriatic disease and adds a 55-mg prefilled syringe intended to support weight-based dosing in patients weighing less than 40 kg.
“Plaque psoriasis and psoriatic arthritis can affect much more than skin and joints – these conditions can shape daily life and disrupt important childhood experiences,” Roopal Thakkar, MD, executive vice president, research and development, and chief scientific officer at AbbVie, said in the announcement.¹
The pediatric plaque psoriasis approval was supported by the phase 3 OptIMMize psoriasis clinical trial program.¹ According to the company, the program included 2 lead-in pharmacokinetic cohorts, a randomized efficacy assessor–blinded active-controlled cohort in adolescents aged 12 to younger than 18 years, and a single-arm open-label cohort in children aged 6 to younger than 12 years. The pediatric psoriatic arthritis indication was supported by the OptIMMize psoriasis program and population pharmacokinetic modeling and simulation based on adult psoriatic arthritis studies.¹
AbbVie reported that, at week 16 in part 2 of OptIMMize, risankizumab was associated with clinically meaningful improvements in static Physician Global Assessment and Psoriasis Area and Severity Index responses, with responses maintained with continued treatment.¹ The announcement did not include numerical response rates, comparator data, or detailed subgroup outcomes for the pediatric cohorts. Safety findings in pediatric plaque psoriasis were described as consistent with the established adult plaque psoriasis safety profile.¹
Pediatric psoriasis is often persistent, visible, and associated with psychosocial burden. The joint American Academy of Dermatology–National Psoriasis Foundation guidelines note that pediatric psoriasis can require topical therapy, phototherapy, conventional systemic agents, or biologic therapy depending on severity, comorbidities, and treatment response.² Approximately 30% of individuals who develop psoriasis have onset before age 18 years, according to the guideline.²
Juvenile psoriatic arthritis is less common but can be clinically heterogeneous, with peripheral arthritis, dactylitis, enthesitis, nail disease, and psoriasis variably present.³ Management in children generally requires attention to both skin and musculoskeletal disease activity, functional impact, growth, medication tolerability, and family treatment burden. The availability of a pediatric-labeled biologic that covers both plaque psoriasis and active psoriatic arthritis may simplify treatment selection for some patients, although head-to-head pediatric comparative data were not reported in the announcement.
Risankizumab is a humanized monoclonal antibody that selectively binds the p19 subunit of IL-23, a cytokine involved in inflammatory pathways relevant to psoriatic disease.¹ In adults, risankizumab is approved in the US and Europe for plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.¹ Adult plaque psoriasis efficacy has previously been demonstrated in phase 3 trials, including UltIMMa-1 and UltIMMa-2, in which risankizumab showed superior skin clearance outcomes vs placebo and ustekinumab through week 16.⁴
For pediatric use, the newly approved 55-mg prefilled syringe is intended for patients weighing less than 40 kg, whereas the currently available 150-mg prefilled syringe and pen are approved for pediatric patients weighing 40 kg or more.¹ The prescribing information also lists formulations used in adult inflammatory bowel disease, including an intravenous vial and on-body injector cartridges.¹
Safety considerations for clinicians remain consistent with IL-23 pathway inhibition and the product label. The company’s safety information warns of serious allergic reactions and increased risk of infections; clinicians are advised to evaluate for infection and tuberculosis before treatment and monitor for tuberculosis during and after therapy.¹ Live vaccines should be avoided immediately before, during, or after treatment.¹ The announcement also notes liver-related monitoring for patients treated for Crohn disease or ulcerative colitis, reflecting safety language for the inflammatory bowel disease indications rather than the newly approved pediatric psoriatic disease indication.¹
Interpretation of the pediatric expansion should be cautious until full trial results are available in a peer-reviewed publication or regulatory review documents. The approval provides an additional labeled option for children aged 6 years or older with moderate to severe plaque psoriasis or active psoriatic arthritis, but the public announcement provides limited detail on absolute efficacy, comparative effectiveness, durability by age and weight group, and longer-term pediatric safety.
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