OptIMMize-1: New Efficacy and Safety Data on Risankizumab in Pediatric Psoriasis

New phase 3 data on risankizumab suggest the treatment is both effective and safe over 52 weeks among pediatric patients with moderate-to-severe psoriasis.1

Such findings were presented during the 2026 Maui Derm Hawaii conference in a poster titled, ‘Efficacy and Safety of Risankizumab in Pediatric Patients With Psoriasis in the OptIMMize-1 Phase 3 Study: Results Through 52 Weeks.’ These data were authored by such investigators as Nina Magnolo, MD, from the University Hospital of Münster’s Department of Dermatology.

Magnolo et al’s analysis was aimed at evaluating long-term outcomes with risankizumab therapy in children and adolescents aged 6 years and older who lived with moderate-to-severe plaque psoriasis. These patients were also eligible for systemic drugs. In their background section, the investigators highlighted the chronic nature of psoriasis and its characteristic symptoms, including dryness, pruritus (itch), irritation, and pain, all of which can significantly disrupt daily functioning.

Despite the existence of advanced systemic treatments for adults with psoriasis, therapeutic options combining robust efficacy with long-term safety data remain more limited in younger populations, underscoring the need for additional pediatric-focused research on risankizumab. The drug itself is a humanized IgG1 monoclonal antibody designed to selectively target interleukin (IL)-23 by binding to its p19 subunit.

Prior results from the pediatric OptIMMize-1 study showed, following 16 weeks of risankizumab treatment, children and adolescents experienced improvements in their levels of pruritus, skin clearance, and quality of life, with tolerability shown to be comparable to adults.2 In this report, Magnolo and coauthors extend these findings by assessing efficacy and safety outcomes through 52 weeks of treatment.

In the phase 3 OptIMMize-1 study, investigators used a multicenter, four-part clinical trial design (NCT04435600), with Parts 1 and 3 evaluating the pharmacokinetics of risankizumab to help determine appropriate dosing. These portions are not included in this analysis. In Part 2, the investigative team enrolled adolescents in a randomized, efficacy assessor–blinded design.

The study’s initial 16-week active-controlled period involved randomization of the participants in a 2:1 ratio to be treated with risankizumab or ustekinumab. During the subsequent period included, subjects would either continue their treatment for up to 36 weeks or withdraw. At the 16-week mark, those originally treated with ustekinumab, as well as risankizumab nonresponders (defined by a static Physician’s Global Assessment score of 2 or higher), transitioned to risankizumab administered every 12 weeks through the 40-week mark.

Adolescents shown to respond to risankizumab at the 16-week mark, defined as those with an sPGA score of 0 or 1, were rerandomized to either continue risankizumab dosing every 12 weeks or discontinue the drug until disease flare, defined as an sPGA score of 3 or higher on or after Week 28. Those with flares after withdrawal entered a 16-week retreatment phase.

In Part 4, investigators used an open-label component including children between 6 - 12 years, all of whom received risankizumab for a total of 52 weeks. Across pediatric participants with moderate-to-severe psoriasis, Magnolo and colleagues identified a general continuation of clinical benefits at Week 16, or further improvements, through Week 52 with ongoing risankizumab use.

Such improvements included measures of skin clearance, reduction in pruritus, and quality of life shifts.1 Most adolescents who reported disease worsening following treatment withdrawal were able to recapture clinical responses following the 16-week retreatment period. Throughout the 52-week study’s duration, the medication was well-tolerated in both children and adolescents. Additionally, Magnolo et al pointed to its safety profile being consistent with findings previously reported in adult psoriasis populations.

“Together, these findings support the use of risankizumab to treat pediatric patients with moderate-to-severe psoriasis,” Magnolo and colleagues wrote.1

References

1. Magnolo N, Lee L, Paller A, et al. Efficacy and Safety of Risankizumab in Pediatric Patients With Psoriasis in the OptIMMize-1 Phase 3 Study: Results Through 52 Weeks. Presented at: Maui Derm Hawaii 2026; January 25-29, 2026; Maui, Hawaii.

2. Pang Y, D'Cunha R, Winzenborg I, Veldman G, Pivorunas V, Wallace K. Risankizumab: Mechanism of action, clinical and translational science. Clin Transl Sci. 2024 Jan;17(1):e13706. doi: 10.1111/cts.13706. PMID: 38266061; PMCID: PMC10777435.