FDA approves risankizumab for pediatric plaque psoriasis and psoriatic arthritis

The FDA has approved risankizumab-rzaa (Skyrizi; AbbVie) for children 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as for active psoriatic arthritis in the same age group. The approval, announced June 26, 2026, adds a new 55-mg prefilled syringe to support weight-based dosing in patients under 40 kg, while the existing 150-mg syringe and pen remain indicated for those at or above that threshold.

The decision makes risankizumab the first interleukin-23 (IL-23) inhibitor approved in the United States for pediatric patients under 40 kg with either condition. "Plaque psoriasis and psoriatic arthritis can affect much more than skin and joints—these conditions can shape daily life and disrupt important childhood experiences," said Roopal Thakkar, MD, executive vice president of research and development and chief scientific officer at AbbVie, in the company's announcement.

Risankizumab trial design and efficacy in pediatric psoriasis

The pediatric psoriasis approval draws on the phase 3 OptIMMize-1 program (NCT04435600) and its open-label extension, OptIMMize-2 (NCT04862286). The multipart study included 2 pharmacokinetic lead-in cohorts, a randomized, assessor-blinded, active-controlled cohort of adolescents aged 12 to younger than 18 years, and a single-arm, open-label cohort of children aged 6 to younger than 12 years. In the adolescent cohort, participants were randomized 2:1 to risankizumab or ustekinumab for 16 weeks before continuing into a long-term extension. Among adolescents who responded to risankizumab and continued treatment through week 52, response rates remained high, including a static Physician Global Assessment score of clear or almost clear in roughly 95% of patients. Those switched from ustekinumab to risankizumab generally caught up to similar response levels by week 52, while some patients who were withdrawn from risankizumab after an initial response lost that response over time. Safety data across the program, drawn from 137 pediatric participants in a related submission, showed no new signals relative to adult psoriasis trials.

The pediatric psoriatic arthritis approval did not rely on a dedicated pediatric efficacy trial. Instead, AbbVie extrapolated from the OptIMMize psoriasis data combined with population pharmacokinetic modeling referenced against well-controlled adult psoriatic arthritis studies, an approach the FDA has accepted previously for pediatric indications in related disease states.

Disease burden and unmet need in pediatric psoriasis and psoriatic arthritis

Nearly a third of people who develop psoriasis report symptoms before age 18, and the company's release cites roughly 20,000 new pediatric psoriasis diagnoses and an estimated 14,000 children affected by psoriatic arthritis annually in the United States. Pediatric psoriatic disease carries burdens beyond the skin and joints: symptoms can interfere with mobility and daily function, and the disease's visibility raises risk for psychosocial complications, including bullying and depressive symptoms, that are often underrecognized in pediatric primary care. "For children impacted by immune-mediated diseases, childhood can become shaped by doctor appointments, uncertainty, and the emotional weight of living with a chronic disease," said Leah Howard, JD, president and CEO of the National Psoriasis Foundation, in the AbbVie announcement.

Treatment options for younger pediatric patients with psoriasis have historically been limited relative to adults, which has pushed clinicians toward off-label use of biologics approved only for older age groups or adult populations.

Mechanism and regulatory history of risankizumab

Risankizumab is a humanized IgG1 monoclonal antibody that selectively binds the p19 subunit of IL-23, a cytokine implicated in multiple immune-mediated inflammatory diseases. The drug already holds FDA and European Medicines Agency approvals for adult moderate to severe plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. The European Commission separately approved risankizumab for pediatric plaque psoriasis in patients 6 and older on June 23, 2026, just days before the US pediatric approval, based on the same OptIMMize program.

Clinical interpretation

The addition of a 6 to under 12 years age band and a low-weight dosing option addresses a specific gap: many biologics approved for adolescents have lacked formulations or dosing data suitable for younger, smaller children. The OptIMMize data suggest durability of response through 1 year in adolescents who remain on treatment, though the open-label, single-arm design in the youngest cohort and the extrapolated basis for the psoriatic arthritis indication mean the evidence base for that age group and that indication is less direct than the active-controlled adolescent psoriasis data. Clinicians should also note that some adolescents who discontinued risankizumab after initial response experienced loss of disease control, an observation relevant to counseling families about treatment continuity.

Limitations and next steps

The pediatric psoriatic arthritis approval rests on modeling rather than a dedicated randomized pediatric trial, a limitation inherent to many pediatric rheumatologic drug approvals given small patient populations. Longer-term pediatric safety data, particularly regarding infection risk and growth or developmental outcomes with sustained IL-23 inhibition, will continue to accrue through the OptIMMize-2 extension. As with other biologics, screening for tuberculosis and avoidance of live vaccines during treatment remain relevant considerations in pediatric care planning.

3 Takeaways

• Risankizumab is now FDA approved for children 6 years and older with moderate to severe plaque psoriasis or active psoriatic arthritis, with a new 55-mg syringe enabling weight-based dosing under 40 kg.
• The psoriasis approval is supported by active-controlled and open-label cohorts from the OptIMMize-1/2 program showing durable PASI and sPGA responses through 52 weeks in adolescents.
• The psoriatic arthritis approval relies on extrapolation from psoriasis efficacy data and pharmacokinetic modeling rather than a dedicated pediatric arthritis trial, an evidentiary limitation clinicians should weigh in shared decision-making.