Evidence map›Paper›PMID 33452180›Full record

Trial reportRMD open2021

Patient-reported outcomes data in patients with psoriatic arthritis from a randomised trial of etanercept and methotrexate as monotherapy or in combination.

Vibeke Strand, Philip J Mease, Ervant J Maksabedian Hernandez, Bradley S Stolshek, Lyrica X H Liu, David H Collier, Gregory Kricorian, Joseph F Merola

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in RMD open, 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 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 42% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Article
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

8 authors at 4 institutions in 1 country.

Vibeke StrandImmunology/Rheumatology, Stanford University, Stanford, California, USA.ORCID 0000-0003-4978-4072
Philip J MeaseSchool of Medicine, Swedish Medical Center and University of Washington, Seattle, Washington, USA.ORCID 0000-0002-6620-0457
Ervant J Maksabedian HernandezGlobal Health Economics, Amgen Inc, Thousand Oaks, California, USA emaksabe@amgen.com.ORCID 0000-0003-1945-3061
Bradley S StolshekGlobal Health Economics, Amgen Inc, Thousand Oaks, California, USA.
Lyrica X H LiuGlobal Biostatistical Science, Amgen Inc, Thousand Oaks, California, USA.
David H CollierUS Medical Organization, Amgen Inc, Thousand Oaks, California, USA.
Gregory KricorianUS Medical Organization, Amgen Inc, Thousand Oaks, California, USA.
Joseph F MerolaBrigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Amgen (United States) · USBrigham and Women's Hospital · USStanford University · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesWe examined patient-reported outcomes (PROs) in The Study of Etanercept And Methotrexate in Patients with Psoriatic Arthritis (PsA); a 48-week, phase 3, randomised controlled trial that compared outcomes with methotrexate (MTX) monotherapy, etanercept monotherapy, and MTX+ etanercept in patients with PsA.

methodsEfficacy endpoints included: mean changes from baseline and proportion of patients who reported improvements≥minimal clinically important difference (MCID) at week 24 in treatment groups for Health Assessment Questionnaire-Disability Index, Patient Global Assessment (PtGA), Patient Global Assessment of Joint Pain (PtGAJP) and Medical Outcomes Study Short Form-36 Questionnaire (SF-36) Physical Component Summary (PCS), and Mental Component Summary, and eight domain scores. PROs were analysed as reported (observed), without multiplicity adjustment; therefore, p values are descriptive.

resultsAt week 24, patients receiving etanercept monotherapy or MTX+ etanercept combination reported greater improvements (p≤0.05) in PtGA, PtGAJP and SF-36 PCS scores compared with those receiving MTX monotherapy. Compared with MTX monotherapy, higher proportions of patients receiving etanercept monotherapy and combination therapy reported improvements≥MCID in PtGA (etanercept vs MTX, p=0.005) and PtGAJP (MTX +etanercept vs MTX, p=0.038). Across PROs, proportions of patients reporting scores≥age and gender-matched normative values at week 24 ranged from 20.8% to 51.0% with MTX monotherapy, 30.9% to 48.8% with etanercept monotherapy, and 30.6% to 52.3% with MTX+ etanercept combination.

conclusionsPatients receiving etanercept monotherapy or MTX+ etanercept reported greater improvements from baseline in several PROs compared with those receiving MTX monotherapy. PROs should be incorporated in discussions between patients and clinicians regarding their treatment choices as they can help determine which treatments are more beneficial in patients with PsA.

Indexed as

Antirheumatic AgentsArthritis, PsoriaticArthritis, RheumatoidEtanerceptHumansMethotrexatePatient Reported Outcome MeasuresAntirheumatic AgentsEtanerceptMethotrexatearthritisetanerceptmethotrexatepatient reported outcome measurespsoriatic

Identifiers

PMID33452180
PMCPMC7813325
OpenAlexW3120165990

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.