STELARA - Use in Pediatric Patients with Juvenile Psoriatic Arthritis

Summary

• Please refer to the local labeling for relevant information on approved indications, dosage, and administration of STELARA.
• Data from PSUMMIT-Jr, a phase 3, multicenter, open-label study evaluating the efficacy and safety of STELARA in pediatric patients with juvenile psoriatic arthritis (jPsA) is summarized below.¹
• The extrapolation analysis to support the use of STELARA in pediatric patients with jPsA is described below.²
• Data from Ustekinumab Pediatric Opportunistic Pharmacokinetics Study (U-POPS), a phase 1, real-world, multicenter, open-label study evaluating the pharmacokinetics (PK) and safety of STELARA in pediatric patients with jPsA, is summarized below.³

CLInical data

Phase 3 study: PSUMMIT-Jr

Ruperto et al (2026)¹ presented efficacy and safety data for STELARA from the phase 3, multicenter, open-label study (PSUMMIT-Jr).

Study Design/Methods

• The study enrolled children aged ≥5 to <18 years with active jPsA for ≥3 months who had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs) and/or nonbiologic disease-modifying antirheumatic drugs (DMARDs).
  • Patients were not randomized.
  • jPsA was defined by Vancouver classification criteria: arthritis plus psoriasis (PsO) or ≥2 of the following: dactylitis, nail pits, PsO family history, or PsO-like rash. Active disease was defined as ≥3 joints with swelling or loss of motion with pain and/or tenderness.
• STELARA was administered according to body weight (<60 kg, 0.75 mg/kg; ≥60 to ≤100 kg, 45 mg subcutaneous [SC]; >100 kg, 90 mg SC) at weeks 0, 4, and every 12 weeks (q12w) thereafter through week 52.
• Efficacy and safety endpoints are presented in Table: Efficacy and Safety Endpoints.

Results

• A total of 18 patients were enrolled in PSUMMIT-Jr and treated with STELARA completed the week 52 study visit.
• Selected baseline demographics are summarized in Table: Selected Baseline characteristics.

Efficacy

• At week 24, 88.9% of patients achieved the primary endpoint of Juvenile Idiopathic Arthritis-American College of Rheumatology (JIA-ACR)30 response, while 83.3% and 61.1% achieved JIA-ACR50 and JIA-ACR70 responses, respectively.
• JIA-ACR30/50/70 response rates showed a slight decline between weeks 24 and 52; however, responses were generally maintained through week 52. See JIA-ACR30/50/70 response rates through 52 weeks in Table: Clinical Response Rates through 52 Weeks.

• The median time for JIA-ACR30 response was 4.3 weeks (95% confidence interval [CI], 4.1–8.1).
  • 67% of patients achieved JIA-ACR30 response by the nominal week 4 visit.
• At week 24, mean improvements from baseline were observed in cJADAS-10 (-13.3), JADAS-10 (-14.9), JADAS-27 (-13.0), and JADAS-71 (-16.2), with improvements at week 52 in cJADAS-10 (-11.6), JADAS-10 (-12.8), JADAS-27 (-10.6) and JADAS-71
  (-13.3).
• Median JADAS-71 values in oligoarthritis and polyarthritis decreased (improved) through week 52.
  • In patients with oligoarthritis, the median JADAS-71 score decreased from 16.9 at week 0, 4.4 at week 24, and 1.2 at week 52.
  • In patients with polyarthritis, the median JADAS-71 score decreased from 21.4 at week 0, 3.6 at week 24, and 4.4 at week 52.
• Mean Psoriasis Area and Severity Index (PASI) scores improved from baseline at both week 24 (-3.8) and week 52 (-4.0).

Safety

• The mean duration of follow-up was 55.6 weeks.
• Summary of adverse events are summarized in the Table: Summary of Adverse Events.

• The most frequently reported AEs were upper respiratory tract infection (28%), jPsA (22%), nausea (17%), and vomiting (17%).
• No cases of malignancy, active tuberculosis, opportunistic infection, injection-site reactions, or deaths were observed during this study.
• No new safety signals were identified throughout the study period.

Extrapolation Analysis

Leu et al (2022)² described the PK, clinical response, and safety analyses that supported the use of STELARA in patients with jPsA (>6 years old) by extrapolating data from pediatric patients with PsO in these studies and from phase 3 randomized controlled trials of STELARA in adults with PsO or psoriatic arthritis (PsA).

Study Design/Methods

• Data used in the analyses were derived from the following clinical trials:
  • CADMUS: A phase 3, randomized, placebo-controlled trial that evaluated the use of STELARA in 110 adolescent patients (aged ≥12 to <18 years) with PsO, including patients with jPsA, at the standard or half-standard SC dosing regimen at weeks 0 and 4 and then q12w.
  • CADMUS Jr: A phase 3, open-label study that assessed the PK, efficacy, and safety of STELARA in 44 patients with PsO who were aged ≥6 to <12 years, including patients with jPsA, at the standard SC dosing regimen at weeks 0 and 4 and then q12w.
  • PSUMMIT-1 and PSUMMIT-2: Phase 3, randomized, placebo-controlled trials that evaluated the use of STELARA (45 mg or 90 mg SC at weeks 0, 4, and then q12w) in 615 and 312 adult patients with PsA, respectively.
  • PSTELLAR: A phase 3, randomized, controlled trial that evaluated STELARA
    (45 mg or 90 mg SC at weeks 0, 4, 16, and then q12w up to every 24 weeks) in 478 adult patients with PsO.
• Data from pediatric patients who received the standard dosing regimen for STELARA (≤60 kg, 0.75 mg/kg; >60 to ≤100 kg, 45 mg; >100 kg, 90 mg) from the above clinical trials were included in the analyses because the demonstrated drug exposure in these pediatric patients was comparable to adults who received STELARA 45 mg.

Exposure Matching for STELARA for jPsA

• The CADMUS and CADMUS Jr trials, among the patients with PsO, included 7 patients with jPsA. Data from patients with jPsA were descriptively compared with data from adults with PsA (PSUMMIT-1).
  • Of the 7 patients with jPsA from CADMUS and CADMUS Jr, 4 received the STELARA standard dosage.
  • The STELARA steady-state trough concentrations (C_trough,ss) through week 52 in these 4 patients were compared with the following:
    • The overall population from CADMUS and CADMUS Jr who received the standard adult dosage.
    • The overall population from CADMUS and CADMUS Jr, excluding patients with jPsA.
    • Adults with PsA from PSUMMIT-1 who received the standard dosage.

Response Analyses for STELARA for jPsA

• Response rates for achievement of ≥75% improvement in PASI (PASI 75) score, ≥90% improvement in PASI (PASI 90), and 100% improvement in PASI (PASI 100) in patients with jPsA who received the standard adult STELARA dosage in CADMUS and CADMUS Jr were descriptively compared with those in adults with PsA who received the standard dosage in PSUMMIT-1.

Safety Analyses for STELARA for jPsA

• Safety was extrapolated from the established safety profile of STELARA in the 154 pediatric patients with PsO in CADMUS and CADMUS Jr, including 7 patients who also had jPsA.
• AEs were monitored through weeks 60 and 56 in the CADMUS and CADMUS Jr studies, respectively.

Results

PK Matching for STELARA for jPsA

• Among pediatric patients who received similar STELARA dosage in CADMUS and CADMUS Jr, serum ustekinumab concentrations over time in pediatric patients who had PsO with jPsA were comparable with patients who had PsO without jPsA.
• PK exposures over time in pediatric patients who had PsO with and without jPsA were comparable with adults who had PsA (PSUMMIT-1). See Figure: Observed Serum Ustekinumab C_trough,ss through Week 52 in Adult Patients with PsA (PSUMMIT-1) and Pediatric Patients with PsO with and without jPsA (CADMUS and CADMUS Jr).

Response Analyses for STELARA for jPsA

• PASI 75 response rates were comparable between 4 pediatric patients with PsO and jPsA who received standard STELARA dosage and adults with PsA (PSUMMIT-1). See Figure: PASI 75 Response Rates through Week 52 in Pediatric Patients with PsO and jPsA (CADMUS and CADMUS Jr) and Adult Patients with PsA (PSUMMIT-1).
  • PASI 90 and PASI 100 response rates were also generally similar between these patient populations.

Safety Analyses for STELARA for jPsA

• No new safety signals were observed in the 7 patients with PsO and jPsA who received standard or half-standard STELARA dosage in the CADMUS or CADMUS Jr trials.
  • Six patients reported ≥1 AE.
  • No serious adverse events (SAEs) were reported.
• The similarity in safety profiles between pediatric patients with PsO and jPsA is supported by the comparable safety profiles observed in phase 3 clinical trials in adults with PsO and adults with PsA who received similar STELARA dose regimens.

Phase 1 Study: U-POPS

Lam et al (2026)³ evaluated the PK and safety of STELARA in pediatric patients with jPsA in a phase 1, real-world, multicenter, open-label study (U-POPS), a real-world, open-label study.

Study Design/Methods

• Eligible patients were ≥5 to <18 years of age with a diagnosis of jPsA based on International Leaque of Associations for Rheumatology or Vancouver criteria, and/or ≥6 to <18 years of age with a diagnosis of pediatric PsO by a qualified HCP.
  • Both groups had to have been taking STELARA for ≥16 weeks and had received ≥3 doses prior to enrollment.
• Pediatric patients with PsO were used as the internal control group to compare with previously evaluated PsO PK data.
• The maximum study duration was approximately 16 weeks per patient, with 3 study visits (including a PK draw at each visit [≥7 days apart]) and an additional study visit for a fourth PK draw if the patient agreed.
• The primary endpoint was observed serum ustekinumab concentrations over an q12w dosing interval to compare against model-predicted median concentrations using a previously developed population PK model for adult and pediatric patients with PsO.

Results

• A total of 31 patients (jPsA=11; pediatric PsO=20) were included in the study.
  • Of the 11 patients with jPsA, 81.8% had PsO.
• The selected baseline characteristics of patients with jPsA and pediatric patients with PsO are presented in Table: Selected Baseline Characteristics and Medical History.

• The median (range) total STELARA dose received for all patients was 45 mg (18-180 mg) administered SC q12w.
• A total of 100 ustekinumab PK samples were collected from patients with jPsA (n=34) and pediatric patients with PsO (n=66).
• Ustekinumab concentrations and time profiles were similar between patients with jPsA and pediatric patients with PsO. See Figure: Ustekinumab Concentration Versus Time Since Last Dose for All Patients (A) and by Weight-based Doses (B)

• Eight patients (25.8%) reported treatment-emergent adverse events (TEAEs) (jPsA, n=1; pediatric PsO, n=7) with no deaths, serious TEAEs, opportunistic infections, active tuberculosis, malignancies, injection site and/or hypersensitivity reactions were reported.
• TEAEs of clinical interest included 2 infections (ear infection and influenza), both reported in the pediatric PsO cohort.
• The most common TEAE was vomiting, reported only in three patients in the pediatric PsO cohort.
• No TEAEs leading to study discontinuation were noted.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 02 July 2026.