Evidence map›Paper›PMID 32864685›Full record

Trial reportRheumatology (Oxford, England)2021

Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis.

Laura C Coates, Joseph F Merola, Philip J Mease, Alexis Ogdie, Dafna D Gladman, Vibeke Strand, Leonieke J J van Mens, Lyrica Liu, Priscilla K Yen, David H Collier and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Rheumatology (Oxford, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02376790 (A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 11% 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.

NCT02376790 phase3completednot on this map

A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis

TypeinterventionalSponsorAmgenRan2015 to 2018Enrolled851ConditionsPsoriatic ArthritisArmsEtanercept, Methotrexate, Placebo to Etanercept, Placebo to Methotrexate
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Observational
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

13 authors at 10 institutions in 4 countries.

Laura C CoatesNuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Joseph F MerolaDepartment of Dermatology and Department of Medicine, Division of Rheumatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Philip J MeaseDivision of Rheumatology Clinical Research, Swedish Medical Center/Providence St. Joseph Health and the University of Washington, Seattle, WA, USA.
Alexis OgdieDivision of Rheumatology and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Dafna D GladmanDivision of Rheumatology, Department of Medicine, University of Toronto, Toronto, ON, Canada.
Vibeke StrandDivision of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.
Leonieke J J van MensDepartment of Clinical Immunology and Rheumatology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Lyrica LiuGlobal Biostatistical Science, Amgen Inc., South San Francisco, USA.
Priscilla K YenGlobal Biostatistical Science, Thousand Oaks, CA, USA.
David H CollierUS Medical Organization, Amgen Inc., Thousand Oaks, CA, USA.
Gregory KricorianUS Medical Organization, Amgen Inc., Thousand Oaks, CA, USA.
James B ChungUS Medical Organization, Amgen Inc., Thousand Oaks, CA, USA.
Philip S HelliwellLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Amgen (United States) · USBiostatistical Consulting (United States) · USBrigham and Women's Hospital · USNuffield Orthopaedic Centre · GBStanford University · USUniversity of Amsterdam · NLUniversity of Leeds · GBUniversity of Pennsylvania · USUniversity of Toronto · CAUniversity of Washington · US

Funding

Department of Health CS-2016-16-016
6 · The paper itself

Abstract

objectivesTo examine which composite measures are most sensitive to change when measuring psoriatic arthritis (PsA) disease activity, analyses compared the responsiveness of composite measures used in a 48-week randomized, controlled trial of MTX and etanercept in patients with PsA.

methodsThe trial randomised 851 patients to receive weekly: MTX (20 mg/week), etanercept (50 mg/week) or MTX plus etanercept. Dichotomous composite measures examined included ACR 20/50/70 responses, minimal disease activity (MDA) and very low disease activity (VLDA). Continuous composite measures examined included Disease Activity Score (28 joints) using CRP (DAS28-CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Disease Activity for Psoriatic Arthritis (DAPSA) and Psoriatic Arthritis Disease Activity Score (PASDAS).

resultsAt week 24, etanercept-treated groups were significantly more effective than MTX monotherapy to achieve ACR 20 (primary end point) and MDA (key secondary end point). When examining score changes from baseline at week 24 across the five continuous composite measures, PASDAS demonstrated relatively greater changes in the etanercept-treated groups compared with MTX monotherapy and had the largest effect size and standardized response. Joint count changes drove overall score changes at week 24 from baseline in all the continuous composite measures except for PASDAS, which was driven by the Physician and Patient Global Assessments.

conclusionPASDAS was the most sensitive continuous composite measure examined with results that mirrored the protocol-defined primary and key secondary outcomes. Composite measures with multiple domains, such as PASDAS, may better quantify change in PsA disease burden. TRAIL REGISTRATION: https://ClinicalTrials.gov, number NCT02376790.

Indexed as

Patient Outcome AssessmentAdministration, OralAntirheumatic AgentsArthritis, PsoriaticC-Reactive ProteinDouble-Blind MethodDrug Therapy, CombinationEtanerceptFemaleHumansInjections, SubcutaneousMaleMethotrexateMiddle AgedSeverity of Illness IndexAntirheumatic AgentsC-Reactive ProteinEtanerceptMethotrexatecomposite measuresetanerceptmethotrexatepsoriatic arthritis

Identifiers

PMID32864685
PMCPMC7937022
OpenAlexW3082601534

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.