Evidence map›Paper›PMID 27538241›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2017

Apremilast, an oral phosphodiesterase 4 inhibitor, improves patient-reported outcomes in the treatment of moderate to severe psoriasis: results of two phase III randomized, controlled trials.

D Thaçi, A Kimball, P Foley, Y Poulin, E Levi, R Chen, S R Feldman

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.5field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  7. Article
  8. Apremilast in the Treatment of Plaque Psoriasis: Differential Use in Psoriasis.Clinical, cosmetic and investigational dermatology · 2022
    Review
  9. Review
  10. Article
  11. Article
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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

7 authors at 5 institutions in 4 countries.

D ThaçiComprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany.
A KimballHarvard Medical School, Boston, MA, USA.
P FoleySkin & Cancer Foundation Inc., St. Vincent's Hospital, The University of Melbourne, Melbourne, Vic., Australia.
Y PoulinCentre de Recherche Dermatologique du Québec métropolitain, Québec, QC, Canada.
E LeviCelgene Corporation, Summit, NJ, USA.
R ChenCelgene Corporation, Summit, NJ, USA.
S R FeldmanWake Forest University School of Medicine, Winston-Salem, NC, USA.
Centre de Recherche Dermatologique du Québec Métropolitain · CAHarvard University · USSkin and Cancer Foundation · AUUniversity Hospital Schleswig-Holstein · DEWake Forest University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApremilast, an oral phosphodiesterase 4 inhibitor, has an acceptable safety profile and is effective for treatment of plaque psoriasis and psoriatic arthritis.

objectivesTo evaluate the impact of apremilast on health-related quality of life (HRQOL), general functioning and mental health using patient-reported outcome (PRO) assessments among patients with moderate to severe plaque psoriasis in the ESTEEM 1 and 2 trials.

methodsA total of 1255 patients were randomized (2 : 1) to apremilast 30 mg BID or placebo for 16 weeks; all received apremilast through Week 32. PRO assessments included the Dermatology Life Quality Index (DLQI), 36-Item Short-Form Health Survey version 2 mental/physical component summary scores (SF-36v2 MCS/PCS), Patient Health Questionnaire-8 (PHQ-8), EuroQol-5D (EQ-5D) and Work Limitations Questionnaire-25 (WLQ-25). Post hoc analyses examined relationships between Psoriasis Area and Severity Index (PASI) scores and PHQ-8 in the apremilast-treated population at Week 16.

resultsTreatment with apremilast improved all HRQOL PROs at Week 16 (vs. placebo), except the SF-36v2 PCS, and improvements were sustained through Week 32. Mean DLQI and SF-36v2 MCS improvements exceeded minimal clinically important differences. Changes at Week 16 in PHQ-8 and PASI were weakly correlated, and only 35.8% of patients who achieved a ≥75% reduction from baseline in PASI score (PASI-75) with apremilast treatment also achieved PHQ-8 scores of 0-4.

conclusionsApremilast led to improvements in HRQOL PROs vs. placebo in patients with moderate to severe plaque psoriasis.

Indexed as

AdultAnti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodFemaleHealth StatusHumansMaleMental HealthMiddle AgedPatient Reported Outcome MeasuresPhosphodiesterase 4 InhibitorsPsoriasisQuality of LifeSeverity of Illness IndexThalidomideWork Capacity EvaluationAnti-Inflammatory Agents, Non-SteroidalapremilastPhosphodiesterase 4 InhibitorsThalidomide

Identifiers

PMID27538241
PMCPMC5363239
OpenAlexW2510680239

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.