Evidence map›Paper›PMID 25611084›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2015

Improvements in patient-reported outcomes in patients with psoriasis receiving etanercept plus topical therapies: results from REFINE.

K A Papp, K Barber, R Bissonnette, M Bourcier, C W Lynde, Y Poulin, J Shelton, K Garces, J Toole, M Poulin-Costello

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01313221 (A Randomized, Blinded Assessor Study to Evaluate the Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent Versus Etanercept 50 mg Twice Weekly in Subjects With Moderate to Severe Plaque Psoriasis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT01313221 phase3completednot on this map

A Randomized, Blinded Assessor Study to Evaluate the Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent Versus Etanercept 50 mg Twice Weekly in Subjects With Moderate to Severe Plaque Psoriasis

TypeinterventionalSponsorAmgenRan2011 to 2013Enrolled310ConditionsPsoriasisArmsetanercept, Topical agents
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. PDE4 Inhibition and Inflammatory Bowel Disease: A Novel Therapeutic Avenue.International journal of molecular sciences · 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

10 authors.

K A PappProbity Medical Research, Waterloo, ON, Canada.
K BarberKirk Barber Research, Calgary, AB, Canada.
R BissonnetteInnovaderm Research, Montreal, QC, Canada.
M BourcierDermatology Clinic, Moncton, NB, Canada.
C W LyndeLynde Centre for Dermatology, Markham, ON, Canada.
Y PoulinCentre Dermatologique du Quebec Metropolitain, Quebec, QC, Canada.
J SheltonAmgen Canada Inc., Mississauga, ON, Canada.
K GarcesAmgen Canada Inc., Mississauga, ON, Canada.
J TooleUniversity of Manitoba, Winnipeg, MB, Canada.
M Poulin-CostelloAmgen Canada Inc., Mississauga, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe REFINE study examined the efficacy and safety of adding topical corticosteroid therapy to etanercept when stepping down from the initial dose of etanercept to the maintenance dose. Clinical responses were shown to be similar in patients who remained on etanercept 50 mg twice weekly (BIW) and those who received etanercept 50 mg once weekly (QW) plus topical therapies through week 24.

objectiveThe purpose of this analysis was to evaluate the effect of treatment on health-related quality of life (HRQoL) for patients in REFINE.

methodsAll patients received etanercept 50 mg BIW for 12 weeks and were then randomized to etanercept 50 mg BIW or etanercept 50 mg QW plus topical corticosteroid as required to clear through week 24. HRQoL measures included the Dermatology Life Quality Index (DLQI), Treatment Satisfaction Questionnaire for Medication (TSQM) and the Economic Implications of Psoriasis Patient Questionnaire. No comparative testing was performed for this descriptive analysis. Missing data were imputed using the last observation carried forward.

resultsFor 287 randomized patients (144 etanercept; 143 etanercept plus topical), the mean change [standard deviation (SD)] in DLQI from baseline to week 24 was 10.7 (7.8) for etanercept and 9.9 (6.9) for etanercept plus topical. Mean change (SD) in TSQM effectiveness, convenience, side-effects and global satisfaction was 27.1 (36.1), 14.8 (25.9), -0.7 (22.0) and 26.7 (32.5) for the etanercept arm and 32.5 (40.3), 18.5 (29.0), 1.3 (19.4) and 28.4 (35.9) for etanercept plus topical. Economic implications, including healthcare visits, employment status, work productivity, ability to perform daily activities and out-of-pocket expenses were similar between treatment arms.

conclusionAt week 24 of REFINE, measures of HRQoL were numerically similar in patients who stayed on etanercept 50 mg BIW and patients who received etanercept 50 mg QW plus topical therapies.

Indexed as

Administration, TopicalAdrenal Cortex HormonesDrug Therapy, CombinationEtanerceptFemaleHumansImmunosuppressive AgentsMaleMiddle AgedPatient SatisfactionPsoriasisQuality of LifeSurveys and QuestionnairesTreatment OutcomeAdrenal Cortex HormonesEtanerceptImmunosuppressive Agents

Identifiers

PMID25611084
PMCPMC5024053

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.