Risankizumab shows 52-week efficacy in pediatric psoriasis trial

Children and adolescents with moderate to severe plaque psoriasis treated with risankizumab achieved high rates of skin clearance by week 16, with responses maintained or improved through 1 year, according to full phase 3 OptIMMize-1 results published in the British Journal of Dermatology.¹ The data supported the FDA's June 2026 approval of the interleukin-23 (IL-23) inhibitor for patients aged 6 years and older.²

At the time of approval, study investigator Amy S. Paller, MD, chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine, said risankizumab showed "clinically meaningful improvements in sPGA and PASI responses" at week 16, adding that weight-based dosing may help physicians treat a broad range of children.²

OptIMMize-1 trial design and risankizumab dosing in children

The 4-part study (NCT04435600) enrolled 137 patients at 41 centers in 7 countries.¹ Parts 1 and 2 enrolled adolescents aged 12 to younger than 18 years; parts 3 and 4 enrolled children aged 6 to younger than 12 years, with parts 1 and 3 serving as pharmacokinetic lead-ins.¹ In part 2, 82 adolescents were randomized 2:1 to risankizumab or ustekinumab for 16 weeks under assessor blinding; responders were then rerandomized to continue or withdraw until flare.¹ Part 4 was a 52-week, open-label, single-arm study of 30 children.¹ Risankizumab was given subcutaneously at weeks 0 and 4, then every 12 weeks: 150 mg for patients weighing 40 kg or more and 55 mg for those under 40 kg.¹ Coprimary end points at week 16 were PASI 75 and a static Physician's Global Assessment (sPGA) score of clear or almost clear (0/1).¹

Risankizumab efficacy in adolescent and pediatric psoriasis

At week 16 in part 2, sPGA 0/1 rates were 80% with risankizumab vs 75% with ustekinumab, PASI 75 rates were 85% vs 86%, and PASI 90 rates were 65% vs 61%.¹ PASI 100 was numerically more frequent with risankizumab (41% vs 18%), despite worse baseline severity in that arm.¹

In part 4, week-16 rates among children were 90% for sPGA 0/1, 87% for PASI 75, 77% for PASI 90, and 43% for PASI 100, with responses maintained or improved at week 52.¹ Adolescents switched from ustekinumab, and initial risankizumab nonresponders improved through week 52.¹ Of 21 responders randomized to withdrawal, 8 (38%) flared and regained clearance with 16 weeks of retreatment.¹ Itch and quality-of-life scores, assessed in part 2 only, also improved.¹

Pediatric safety profile of risankizumab through 52 weeks

No adverse events led to discontinuation or death, and no serious infections, active tuberculosis, malignancies, or anaphylaxis occurred.¹ Two serious events, a fibula fracture and suicidal ideation in an adolescent with preexisting depression, were judged unrelated to treatment.¹ Nasopharyngitis (30%) was most common among adolescents in part 2, and pyrexia (13%) among children in part 4.¹ Antidrug antibody incidence was low and not considered clinically relevant.¹

Clinical context for IL-23 inhibition in pediatric psoriasis

Roughly one-third of psoriasis cases begin in childhood, often involving high-impact areas such as the face, scalp, and skin folds.¹ The authors note that real-world biologic use in children remains limited, partly because globally recognized treatment guidelines are lacking.¹ Risankizumab selectively binds the p19 subunit of IL-23, and its 12-week maintenance interval may reduce injection burden for families.¹ The FDA approval added a 55-mg prefilled syringe for patients under 40 kg.²

References

1. Magnolo N, Wine Lee L, Reich A, et al. Efficacy and safety of risankizumab in paediatric patients with psoriasis in the OptIMMize-1 phase III study. Br J Dermatol. Published online September 26, 2026. doi:10.1093/bjd/ljag403

2. AbbVie. SKYRIZI (risankizumab-rzaa) now FDA approved for pediatric use in psoriatic disease. News release. June 26, 2026. Accessed November 12, 2026. https://news.abbvie.com/2026-06-26-SKYRIZI-R-risankizumab-rzaa-Now-FDA-Approved-for-Pediatric-Use-in-Psoriatic-Disease