Evidence map›Paper›PMID 27483458›Full record

Trial reportArthritis care & research2016

Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis.

Proton Rahman, Lluis Puig, Alice B Gottlieb, Arthur Kavanaugh, Iain B McInnes, Christopher Ritchlin, Shu Li, Yuhua Wang, Michael Song, Alan Mendelsohn and 2 more

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Arthritis care & research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 7% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Observational
  8. Biologic and Small-Molecule Therapies for Moderate-to-Severe Psoriasis: Focus on Psoriasis Comorbidities.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Psoriasis and Co-morbidity.Acta dermato-venereologica · 2020
    Review
  15. Ustekinumab in psoriatic arthritis and related phenotypes.Therapeutic advances in chronic disease · 2018
    Review
  16. Observational
  17. Psoriasis and Psoriatic Arthritis.The Journal of clinical and aesthetic dermatology · 2017
    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

12 authors at 7 institutions in 4 countries.

Proton RahmanMemorial University, Newfoundland, Canada.
Lluis PuigHospital de la Santa Creu i Sant Pau, Universitat Autònoa de Barcelona, Barcelona, Spain.
Alice B GottliebTufts University School of Medicine, Boston, Massachusetts.
Arthur KavanaughUniversity of California, San Diego.
Iain B McInnesUniversity of Glasgow, Glasgow, Scotland.
Christopher RitchlinUniversity of Rochester, Rochester, New York.
Shu LiJanssen Research & Development, LLC, Spring House, Pennsylvania.
Yuhua WangJanssen Research & Development, LLC, Spring House, Pennsylvania.
Michael SongJanssen Research & Development, LLC, Spring House, Pennsylvania.
Alan MendelsohnJanssen Research & Development, LLC, Spring House, Pennsylvania.
Chenglong HanJanssen Global Services, LLC, Malvern, Pennsylvania.
PSUMMIT 1 and 2 Study Groups
Janssen (United States) · USHospital de Sant Pau · ESMemorial University of Newfoundland · CATufts University · USUniversity of California, San Diego · USUniversity of Glasgow · GBUniversity of Rochester · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo examine the effects of ustekinumab on patient-reported outcomes (PROs) in PSUMMIT 1 and PSUMMIT 2 patients with active psoriatic arthritis (PsA) who were methotrexate (MTX) naive, MTX experienced, or anti-tumor necrosis factor (TNF) experienced.

methodsPatients in the phase 3, PSUMMIT 1 (n = 615) and PSUMMIT 2 (n = 312) studies randomly (1:1:1) received placebo, ustekinumab 45-mg, or ustekinumab 90-mg subcutaneous injections at weeks 0, 4, 16, 28, 40, and 52. The PROs (Health Assessment Questionnaire [HAQ] disability index [DI], Dermatology Life Quality Index [DLQI], 36-Item Short Form [SF-36] health survey physical (PCS) and mental component summary scores, patient assessments of pain and disease activity, and impact of disease on productivity) were assessed at weeks 0, 24, and 52. In these post hoc analyses, outcomes were compared between the ustekinumab and placebo groups for 3 mutually exclusive antecedent-exposure populations from the combined studies: MTX/anti-TNF naive (placebo, n = 56; 45 mg, n = 58; and 90 mg, n = 66), MTX experienced, biologic agent naive (placebo, n = 192; 45 mg, n = 190; and 90 mg, n = 185), and anti-TNF experienced with or without MTX (placebo, n = 62; 45 mg, n = 60; and 90 mg, n = 58).

resultsAt week 24, mean improvements from baseline in HAQ DI, DLQI, and SF-36 PCS scores were significantly greater in both ustekinumab groups versus placebo across antecedent-exposure groups. Greater proportions of ustekinumab-treated than placebo-treated patients (all P < 0.05) had clinically meaningful improvements in HAQ DI (≥0.3), DLQI (≥5), and SF-36 (≥5) scores at week 24, irrespective of drug exposure. Improvements in pain, disease activity, and impact of disease on productivity were similar, and benefits were maintained through week 52.

conclusionSignificant improvements in PROs with ustekinumab versus placebo were observed in 3 antecedent-exposure populations of PsA patients, including those with prior MTX and anti-TNF use.

Indexed as

AdultArthritis, PsoriaticBiological FactorsDermatologic AgentsDisability EvaluationDouble-Blind MethodFemaleHumansInjections, SubcutaneousMaleMiddle AgedQuality of LifeSeverity of Illness IndexTreatment OutcomeUstekinumabBiological FactorsDermatologic AgentsUstekinumab

Identifiers

PMID27483458
PMCPMC5132036
OpenAlexW2538229745

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.