Evidence map›Paper›PMID 24482301›Full record

Trial reportAnnals of the rheumatic diseases2014

Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial.

Christopher Ritchlin, Proton Rahman, Arthur Kavanaugh, Iain B McInnes, Lluis Puig, Shu Li, Yuhua Wang, Yaung-Kaung Shen, Mittie K Doyle, Alan M Mendelsohn and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04261010 (TNF and IL23 Blocking Agents Gene Expression Ratios in the Psoriatic Arthritis Synovium), which is not on this map. Cited by 256 papers, 26 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
256citing papers in PubMed, 26 pooled it
–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.

NCT04261010 nacompletednot on this mapstarted 2020, after this paper: background citation

TNF and IL23 Blocking Agents Gene Expression Ratios in the Psoriatic Arthritis Synovium

TypeinterventionalSponsorCliniques universitaires Saint-Luc- Université Catholique de LouvainRan2020 to 2023Enrolled36ConditionsPsoriatic ArthritisArmsGlobal/single cell gene expression profiles obtained from Synovial biopsies
3 · Its place in the literature

Who cites it

256 citing papers in PubMed, 26 syntheses or guidelines pooled it.

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  9. Brazilian Society of Rheumatology 2020 guidelines for psoriatic arthritis.Advances in rheumatology (London, England) · 2021
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196 more citing papers are in PubMed but not listed here.

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

12 authors.

Christopher RitchlinAllergy, Immunology & Rheumatology Division, University of Rochester Medical Center, , Rochester, New York, USA.
Proton Rahman
Arthur Kavanaugh
Iain B McInnes
Lluis Puig
Shu Li
Yuhua Wang
Yaung-Kaung Shen
Mittie K Doyle
Alan M Mendelsohn
Alice B Gottlieb
PSUMMIT 2 Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAssess ustekinumab efficacy (week 24/week 52) and safety (week 16/week 24/week 60) in patients with active psoriatic arthritis (PsA) despite treatment with conventional and/or biological anti-tumour necrosis factor (TNF) agents.

methodsIn this phase 3, multicentre, placebo-controlled trial, 312 adults with active PsA were randomised (stratified by site, weight (≤100 kg/>100 kg), methotrexate use) to ustekinumab 45 mg or 90 mg at week 0, week 4, q12 weeks or placebo at week 0, week 4, week 16 and crossover to ustekinumab 45 mg at week 24, week 28 and week 40. At week 16, patients with <5% improvement in tender/swollen joint counts entered blinded early escape (placebo→45 mg, 45 mg→90 mg, 90 mg→90 mg). The primary endpoint was ≥20% improvement in American College of Rheumatology (ACR20) criteria at week 24. Secondary endpoints included week 24 Health Assessment Questionnaire-Disability Index (HAQ-DI) improvement, ACR50, ACR70 and ≥75% improvement in Psoriasis Area and Severity Index (PASI75). Efficacy was assessed in all patients, anti-TNF-naïve (n=132) patients and anti-TNF-experienced (n=180) patients.

resultsMore ustekinumab-treated (43.8% combined) than placebo-treated (20.2%) patients achieved ACR20 at week 24 (p<0.001). Significant treatment differences were observed for week 24 HAQ-DI improvement (p<0.001), ACR50 (p≤0.05) and PASI75 (p<0.001); all benefits were sustained through week 52. Among patients previously treated with ≥1 TNF inhibitor, sustained ustekinumab efficacy was also observed (week 24 combined vs placebo: ACR20 35.6% vs 14.5%, PASI75 47.1% vs 2.0%, median HAQ-DI change -0.13 vs 0.0; week 52 ustekinumab-treated: ACR20 38.9%, PASI75 43.4%, median HAQ-DI change -0.13). No unexpected adverse events were observed through week 60.

conclusionsThe interleukin-12/23 inhibitor ustekinumab (45/90 mg q12 weeks) yielded significant and sustained improvements in PsA signs/symptoms in a diverse population of patients with active PsA, including anti-TNF-experienced PsA patients.

Indexed as

AdalimumabAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, PsoriaticCertolizumab PegolCross-Over StudiesDouble-Blind MethodEtanerceptFemaleHumansImmunoglobulin Fab FragmentsImmunoglobulin GInfliximabInterleukin-12 Subunit p40AdalimumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsCertolizumab PegolEtanerceptgolimumabImmunoglobulin Fab FragmentsImmunoglobulin GInfliximabInterleukin-12 Subunit p40MethotrexatePolyethylene GlycolsReceptors, Tumor Necrosis FactorTumor Necrosis Factor-alphaUstekinumabAnti-TNFPsoriatic ArthritisSpondyloarthritis

Identifiers

PMID24482301
PMCPMC4033144

What OpenQuestion holds

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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.