Evidence map›Paper›PMID 41452420›Full record

ArticleRheumatology and therapy2026

Pharmacokinetics and Safety of Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Results of the Real-World Ustekinumab Pediatric Opportunistic Pharmacokinetics Study (U-POPS).

Edwin Lam, Katherine Berezny, Corey J Bishop, Kathleen G Lomax, Sophia G Liva, Hermine I Brunner, Amy S Paller, Lucia Z Diaz, Lara Wine Lee, Cory Rubin and 7 more

Registry-linked trialAbstract read
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In one paragraph

Article in Rheumatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05252533 (Open-label Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05252533 phase1completednot on this map

Open-label Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants

TypeinterventionalSponsorJanssen Research & Development, LLCRan2022 to 2024Enrolled31ConditionsJuvenile Psoriatic Arthritis, Psoriasis, Arthritis, JuvenileArmsUstekinumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Edwin Lam *Johnson & Johnson, 1400 McKean Rd., Spring House, PA, USA.
Katherine Berezny *Johnson & Johnson, 1400 McKean Rd., Spring House, PA, USA.
Corey J BishopJohnson & Johnson, 1400 McKean Rd., Spring House, PA, USA.
Kathleen G LomaxJohnson & Johnson, 1400 McKean Rd., Spring House, PA, USA.
Sophia G LivaJohnson & Johnson, 1400 McKean Rd., Spring House, PA, USA.
Hermine I BrunnerCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Amy S PallerFeinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Lucia Z DiazDell Children's Medical Center, Austin, TX, USA.
Lara Wine LeeMedical University of South Carolina, Charleston, SC, USA.
Cory RubinMichigan Dermatology Institute, Waterford, MI, USA.
Ruy CarrascoPediatric Rheumatology Consultants of Austin, Austin, TX, USA.
Lisa ImundoColumbia University Medical Center, New York, NY, USA.
Azadeh MajlessiNewport Huntington Medical Group, Huntington Beach, CA, USA.
Valerie SmithJohnson & Johnson, 1400 McKean Rd., Spring House, PA, USA.
Renping ZhangJohnson & Johnson, La Jolla, CA, USA.
Jocelyn H LeuJohnson & Johnson, 1400 McKean Rd., Spring House, PA, USA. jleu@its.jnj.com.ORCID http://orcid.org/0000-0002-8627-6512
U-POPS Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe "Ustekinumab Pediatric Opportunistic Pharmacokinetics Study" (U-POPS) was conducted to evaluate the pharmacokinetics (PK) and safety of ustekinumab, an interleukin-12/23p40 antagonist, in patients with juvenile psoriatic arthritis (jPsA) who were already receiving ustekinumab via an opportunistic study design. U-POPS was based on the clinical hypothesis that PK should be similar in jPsA and pediatric psoriasis (PsO) populations to further strengthen the extrapolation paradigm between the two populations.

methodsThis real-world, open-label study enrolled participants 5 to < 18 years old with jPsA or 6 to < 18 years with PsO (internal control) who were on ustekinumab for ≥ 16 weeks and received ≥ 3 doses to ensure steady-state concentrations. Ustekinumab was prescribed by the treating physician and supplied outside of the study; PK samples were collected at intervals during a maximum of 16 weeks. The primary endpoint was the observed serum ustekinumab concentrations, which were compared to model-predicted values from prior PsO PK data.

resultsThe study included 11 patients with jPsA (mean age, 15.1 years) and 20 with pediatric PsO (mean age, 12.6 years), yielding 100 PK samples. The median ustekinumab dose was 45 mg every 12 weeks. Observed serum ustekinumab concentration-time profiles aligned well with model-predicted concentration-time profiles from pediatric PsO patients. Treatment-emergent adverse events (TEAEs) occurred in 25.8% of patients (jPsA, n = 1; PsO, n = 7) and were consistent with those observed in other ustekinumab studies, with no serious TEAEs reported.

conclusionsThe opportunistic U-POPS study confirmed the existing population PK model for ustekinumab and suggests that ustekinumab exposure and time course are similar between jPsA and pediatric PsO populations, with no new safety concerns.

trial registrationClinicalTrials.gov identifier, NCT05252533 (registration date: 02-16-2022); EudraCT Number, 2021-005085-18.

Indexed as

BiologicalsJuvenile idiopathic arthritisPediatric rheumatologyPsoriatic arthritis

Identifiers

PMID41452420
PMCPMC12816458

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.