OptIMMize-1: Risankizumab Clears Skin in Children, Teens with Psoriasis

Risankizumab produced durable gains in skin clearance, itch, and quality of life among children and adolescents with moderate to severe plaque psoriasis, according to 52-week results from the phase 3 OptIMMize-1 study published in the British Journal of Dermatology.¹

Risankizumab is an interleukin-23 (IL-23) p19 inhibitor and has been FDA approved for adults with moderate to severe psoriasis since 2019. Until now, no pediatric data had been reported.¹ The investigators said consensus guidance on advanced therapy for younger patients is still limited, and real-world biologic use in children trails the available evidence.¹

OptIMMize-1 (NCT04435600) enrolled 137 patients at 41 centers in 7 countries and had 4 parts.² Parts 1 and 2 enrolled adolescents aged 12 to younger than 18 years, and Parts 3 and 4 enrolled children aged 6 to younger than 12 years. Parts 1 and 3 were pharmacokinetic studies used to set weight-based dosing: 150 mg for patients weighing 40 kg or more and 55 mg for those under 40 kg.¹

How Did Risankizumab Compare with Ustekinumab in Adolescents with Psoriasis?

In Part 2, 82 adolescents were randomized 2:1 to assessor-blinded risankizumab (n = 54) or ustekinumab (n = 28). The analysis was descriptive, with no formal statistical comparisons.¹

At the 16-week mark, response rates were shown to be broadly similar between the 2 arms. A static Physician’s Global Assessment score of clear or almost clear (sPGA 0/1) was reached by 80% (43/54) of risankizumab recipients and 75% (21/28) of ustekinumab recipients. PASI 75 rates were 85% (46/54) and 86% (24/28), and PASI 90 rates were 65% (35/54) and 61% (17/28), respectively.¹

The arms separated more on complete clearance. PASI 100 was attained by 41% (22/54) of those in the risankizumab group compared with 18% (5/28) of the ustekinumab group. Most outcomes began improving as early as week 4.¹

Among 30 children treated in the open-label Part 4, week-16 rates were 90% (27/30) for sPGA 0/1, 87% (26/30) for PASI 75, 77% (23/30) for PASI 90, and 43% (13/30) for PASI 100. Responses were maintained or improved by week 52.¹

What Happened When Adolescents Stopped or Switched to Risankizumab?

Adolescents who responded at week 16 and stayed on risankizumab kept their skin clearance through week 52. Patients who had not responded initially, and those who switched from ustekinumab, continued to improve between weeks 16 and 52.¹

Of 21 responders re-randomized to treatment withdrawal, 8 (38%) lost response and entered a 16-week retreatment period, during which their skin clearance improved again. Itch scores followed a similar pattern. Children’s Dermatology Life Quality Index scores improved from baseline in every Part 2 treatment group.¹

Was Risankizumab Safe in Children and Adolescents with Psoriasis?

The authors reported risankizumab was well tolerated in all study parts, with a safety profile consistent with adult psoriasis trials. No adverse events led to discontinuation or death. There were no serious infections, cases of active tuberculosis, malignancies, or adjudicated anaphylactic reactions.¹

Part 2 had 2 serious events, both judged unrelated to treatment: a fibula fracture and a case of suicidal ideation in a patient with pre-existing depression. The most common adverse event was nasopharyngitis among adolescents in Part 2 (30%) and pyrexia among children in Part 4 (13%).¹

Antidrug antibody incidence was low and was not considered clinically relevant. The authors concluded the findings support risankizumab as a treatment option for moderate to severe psoriasis in pediatric patients.¹

Editor's Note: This summary has been edited for grammar and clarity using artificial intelligence tools.

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. ClinicalTrials.gov. A study of subcutaneous risankizumab injection for pediatric participants with moderate to severe plaque psoriasis to assess change in disease symptoms. NCT04435600. Accessed November 10, 2026. https://clinicaltrials.gov/study/NCT04435600.