Evidence map›Paper›PMID 32143685›Full record

Trial reportArthritis research & therapy2020

Inhibition of radiographic progression across levels of composite index-defined disease activity in patients with active psoriatic arthritis treated with intravenous golimumab: results from a phase-3, double-blind, placebo-controlled trial.

Philip Mease, M Elaine Husni, Shelly Kafka, Soumya D Chakravarty, Diane D Harrison, Kim Hung Lo, Stephen Xu, Elizabeth C Hsia, Arthur Kavanaugh

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02181673 (A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Psoriatic Arthritis), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 30% 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.

NCT02181673 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorJanssen Research & Development, LLCRan2014 to 2017Enrolled480ConditionsArthritis, PsoriaticArmsPlacebo, Golimumab
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. 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

9 authors at 4 institutions in 1 country.

Philip MeaseSeattle Rheumatology Associates, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, 601 Broadway, Suite 600, Seattle, WA, 98122, USA. pmease@philipmease.com.ORCID 0000-0002-6620-0457
M Elaine HusniCleveland Clinic, Cleveland, OH, USA.
Shelly KafkaJanssen Scientific Affairs, LLC, Horsham, PA, USA.
Soumya D ChakravartyJanssen Scientific Affairs, LLC, Horsham, PA, USA.
Diane D HarrisonJanssen Research & Development, LLC, Spring House, PA, USA.
Kim Hung LoJanssen Research & Development, LLC, Spring House, PA, USA.
Stephen XuJanssen Research & Development, LLC, Spring House, PA, USA.
Elizabeth C HsiaJanssen Research & Development, LLC, Spring House, PA, USA.
Arthur KavanaughUniversity of California, San Diego, San Diego, CA, USA.
Janssen (United States) · USCleveland Clinic · USUniversity of California San Diego · USUniversity of Washington · US

Funding

Janssen Research and Development n/a
6 · The paper itself

Abstract

backgroundIn the GO-VIBRANT trial of intravenous golimumab in psoriatic arthritis (PsA), golimumab significantly inhibited radiographic progression. In post hoc analyses, we evaluated changes in total PsA-modified Sharp/van der Heijde scores (SHS) across levels of composite index-defined disease activity following treatment.

methodsIn this phase-3, double-blind, placebo-controlled trial, 480 bio-naïve patients with active PsA randomly received intravenous golimumab 2 mg/kg (N = 241; week 0, week 4, every 8 weeks [q8w]) or placebo (N = 239; week 0, week 4, week 12, week 20) followed by golimumab (week 24, week 28, q8w) through week 52. Week 24 and week 52 SHS changes in patient subgroups, defined by levels of disease activity as assessed by several composite measures (minimal disease activity [MDA], very low disease activity [VLDA], Psoriatic ArthritiS Disease Activity Score [PASDAS], Disease Activity in Psoriatic Arthritis [DAPsA], Clinical Disease Activity Index [CDAI]), were evaluated post hoc in 474 patients with evaluable radiographic data. Partially (last-observation-carried-forward methodology) and completely (nonresponder methodology) missing data were imputed.

resultsAcross indices, golimumab-treated patients demonstrated less radiographic progression than placebo-treated patients, regardless of disease activity state achieved via golimumab, from week 0 to 24 (e.g., mean changes in PsA-modified SHS were - 0.83 vs. 0.91, respectively, in patients achieving MDA and - 0.05 vs. 1.49, respectively, in those not achieving MDA). Treatment differences observed at week 24 persisted through week 52, despite placebo-randomized patients crossing over to golimumab at week 24 (e.g., mean changes in PsA-modified SHS from week 0 to 52 for golimumab- vs. placebo→golimumab-treated patients achieving MDA were - 1.16 vs. 1.19, respectively) and regardless of whether low disease activity was achieved (0.03 vs. 1.50, respectively, in those not achieving MDA). Consistent patterns were observed for disease activity assessed using VLDA, PASDAS, DAPsA, and CDAI composite endpoints.

conclusionsThe extent of structural damage inhibition afforded by up to 1 year of intravenous golimumab treatment paralleled levels of PsA activity, with greater progression of structural damage observed in patients with sustained higher disease activity. Among patients not achieving low levels of disease activity across several composite indices, golimumab-randomized patients appeared to exhibit far less progression of structural damage than placebo-randomized PsA patients, illustrating a potential disconnect between responses, wherein golimumab can inhibit structural damage independent of clinical effect.

trial registrationClinicalTrials.gov. NCT02181673. Registered 04 July 2014.

Indexed as

AdultAntibodies, MonoclonalAntirheumatic AgentsArthritis, PsoriaticDisease ProgressionDouble-Blind MethodFemaleHand JointsHumansInfusions, IntravenousMaleMiddle AgedRadiographySeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalAntirheumatic AgentsgolimumabAnti-TNF therapyBiologic therapyComposite indicesIntravenous golimumabPsoriatic arthritisRadiographic progression

Identifiers

PMID32143685
PMCPMC7059340
OpenAlexW3011906488

What OpenQuestion holds

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LicenceCC BY
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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.