Evidence map›Paper›PMID 32209721›Full record

Trial reportRMD open2020

Effects of ustekinumab on spondylitis-associated endpoints in TNFi-naïve active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials.

Philip S Helliwell, Dafna D Gladman, Soumya D Chakravarty, Shelly Kafka, Chetan S Karyekar, Yin You, Kim Campbell, Kristen Sweet, Arthur Kavanaugh, Lianne S Gensler

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in RMD open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
6.8field-weighted citation impact, top 2% 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.

NCT01009086 phase3completednot on this map

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Aanti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorJanssen Research & Development, LLCRan2009 to 2013Enrolled615ConditionsArthritis, PsoriaticArmsPlacebo, Ustekinumab 45 mg, Ustekinumab 90 mg
NCT01077362 phase3completednot on this map

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNFalpha Agent(s)

TypeinterventionalSponsorJanssen Research & Development, LLCRan2010 to 2012Enrolled312ConditionsArthritis, PsoriaticArmsplacebo, ustekinumab 45 mg, ustekinumab 90 mg
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 60 citations in OpenAlex.

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  19. IL-23 and axial disease: do they come together?Rheumatology (Oxford, England) · 2021
    Review
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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

10 authors at 5 institutions in 3 countries.

Philip S HelliwellSection of Musculoskeletal Disease, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK p.helliwell@leeds.ac.uk.ORCID 0000-0002-4155-9105
Dafna D GladmanKrembil Institute, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0002-9074-0592
Soumya D ChakravartyJanssen Scientific Affairs LLC, Horsham, Pennsylvania, USA.
Shelly KafkaJanssen Scientific Affairs LLC, Horsham, Pennsylvania, USA.
Chetan S KaryekarJanssen Global Services LLC, Horsham, Pennsylvania, USA.
Yin YouJanssen Research & Development LLC, Spring House, Pennsylvania, USA.
Kim CampbellJanssen Research & Development LLC, Spring House, Pennsylvania, USA.
Kristen SweetJanssen Research & Development LLC, Spring House, Pennsylvania, USA.
Arthur KavanaughUniversity of California San Diego, La Jolla, California, USA.
Lianne S GenslerUniversity of California San Francisco School of Medicine, San Francisco, California, USA.
Janssen (United States) · USNIHR Leeds Musculoskeletal Biomedical Research Unit · GBUniversity of California San Diego · USUniversity of California, San Francisco · USUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe interleukin-12/23p40-subunit-inhibitor ustekinumab significantly improved spondylitis-related symptoms through Week 24 in psoriatic arthritis (PsA) patients with peripheral arthritis and physician-reported spondylitis (PA-PRS) in PSUMMIT-1&2. We further evaluated ustekinumab's effect on spondylitis-related endpoints in PSUMMIT-1&2 tumour necrosis factor-inhibitor (TNFi)-naïve patients with PA-PRS.

methodsPatients with active PsA (≥5 swollen and ≥5 tender joints, C-reactive-protein ≥ 3.0 mg/L) despite conventional (PSUMMIT-1&2) and/or prior TNFi (PSUMMIT-2) therapy received subcutaneous ustekinumab 45 mg, 90 mg or placebo (Week 0, Week 4, Week 16). Changes in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) neck/back/hip pain question (#2) and modified BASDAI (mBASDAI, excluding PA) scores and Ankylosing Spondylitis Disease Activity Score (ASDAS) responses were assessed at Weeks 12 and 24.

resultsThe pooled PSUMMIT-1&2, TNFi-naïve (n=747), PA-PRS (n=223) subset (158 with human-leucocyte-antigen (

conclusionsImprovements in BASDAI neck/back/hip pain and mBASDAI among ustekinumab-treated, TNFi-naïve, PsA patients with PA-PRS were clinically meaningful and consistent across assessment tools. Numerically greater improvements in neck/back/hip pain in CLINICAL TRIAL REGISTRATION NUMBERS: PSUMMIT 1, NCT01009086; PSUMMIT 2, NCT01077362.

Indexed as

AdultAntibodies, Monoclonal, HumanizedArthritis, PsoriaticCase-Control StudiesFemaleHLA-B27 AntigenHumansInjections, SubcutaneousInterleukin-12MaleMiddle AgedPhysiciansPlacebosSpondylitisTumor Necrosis Factor InhibitorsUstekinumabAntibodies, Monoclonal, HumanizedHLA-B27 AntigenInterleukin-12PlacebosTumor Necrosis Factor InhibitorsUstekinumabaxial diseaseHLA-B27interleukin-12/23psoriatic arthritisustekinumab

Identifiers

PMID32209721
PMCPMC7046941
OpenAlexW3004889210

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.