Evidence map›Paper›PMID 23663752›Full record

Trial reportHealth and quality of life outcomes2013

Improvements in patient-reported outcomes with apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of moderate to severe psoriasis: results from a phase IIb randomized, controlled study.

Vibeke Strand, David Fiorentino, ChiaChi Hu, Robert M Day, Randall M Stevens, Kim A Papp

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

Trial report in Health and quality of life outcomes, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00773734 (A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Apremilast), which is not on this map. Cited by 28 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 8 pooled it
–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.

NCT00773734 phase2completednot on this map

A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)

TypeinterventionalSponsorAmgenRan2008 to 2015Enrolled352ConditionsPsoriasis, Plaque-type PsoriasisArmsApremilast 10mg, Apremilast 20mg, Apremilast 30 mg, Placebo, Apremilast 30mg
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  8. Drug treatments for pruritus in adult palliative care.Deutsches Arzteblatt international · 2014
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  18. Treatment Options for Troublesome Itch.Pharmaceuticals (Basel, Switzerland) · 2022
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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

6 authors.

Vibeke StrandDivision of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA. vstrand@stanford.edu
David Fiorentino
ChiaChi Hu
Robert M Day
Randall M Stevens
Kim A Papp

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApremilast, a specific inhibitor of phosphodiesterase 4, modulates pro-inflammatory and anti-inflammatory cytokine production.

objectivesApremilast's effect on patient-reported outcomes (PROs) in patients with moderate to severe psoriasis was evaluated in a phase IIb randomized, controlled trial (NCT00773734).

methodsIn this 16-week, placebo-controlled study, 352 patients with moderate to severe plaque psoriasis received placebo or apremilast (10, 20, or 30 mg BID). PROs included Dermatology Life Quality Index (DLQI), pruritus visual analog scale (VAS), and Short-Form Health Survey (SF-36) to assess health-related quality of life (HRQOL). Changes from baseline and patients reporting improvements ≥minimum clinically important differences (MCID) were analyzed. Correlations between changes across various PRO instruments were explored.

resultsBaseline DLQI (>10 points) and SF-36 MCS and domain scores indicated impairments in HRQOL. At 16 weeks, greater improvements from baseline in DLQI scores were reported with apremilast 20 (-5.9) and 30 mg BID (-4.4) compared with placebo (1.9; P≤0.005 for both), and a greater proportion of patients reported improvements ≥MCID (20 mg BID, 49.4%, 30 mg BID, 44.3%) versus placebo (25.0%; P<0.04). Greater improvements from baseline in pruritus VAS scores were reported with apremilast 20 (-35.5%) and 30 mg BID (-43.7%) versus placebo (-6.1%; P≤0.005). Significant and clinically meaningful improvements in SF-36 mental component summary scores (P≤0.008) and Bodily Pain, Mental Health, and Role-Emotional domains were reported with all apremilast doses (P<0.05), and Social Functioning with 20 and 30 mg BID (P<0.05) and Physical Functioning with 20 mg BID (P<0.03). Correlations between SF-36 scores and DLQI were moderate (r>0.30 and ≤0.60) and low between SF-36 and pruritus VAS (r≤0.30), indicating they measure different aspects of the disease.

conclusionsApremilast treatment resulted in improved HRQOL, including DLQI and pruritus VAS over 16 weeks of treatment, in patients with moderate to severe psoriasis.

Indexed as

Quality of LifeAdultFemaleHumansMaleMiddle AgedPhosphodiesterase 4 InhibitorsPsoriasisQuality Indicators, Health CareSelf ReportSurveys and QuestionnairesThalidomideTreatment OutcomeapremilastPhosphodiesterase 4 InhibitorsThalidomide

Identifiers

PMID23663752
PMCPMC3661377

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.