Evidence map›Paper›PMID 27768242›Full record

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

The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE).

K Reich, M Gooderham, L Green, A Bewley, Z Zhang, I Khanskaya, R M Day, J Goncalves, K Shah, V Piguet and 1 more

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, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01690299 (A Phase 3B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study Of The Efficacy And Safety Of Apremilast), which is not on this map. Cited by 77 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 19 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.

NCT01690299 phase3completednot on this map

A Phase 3B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study Of The Efficacy And Safety Of Apremilast (CC-10004), Etanercept, And Placebo, In Subjects With Moderate To Severe Plaque Psoriasis

TypeinterventionalSponsorAmgenRan2012 to 2016Enrolled250ConditionsPsoriasis, Psoriatic ArthritisArmsApremilast, Etanercept, Placebo tablet, Placebo injection
3 · Its place in the literature

Who cites it

77 citing papers in PubMed, 19 syntheses or guidelines pooled it.

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  8. Risk ofInternational journal of clinical practice · 2022
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17 more citing papers are in PubMed but not listed here.

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

11 authors.

K ReichSCIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany.
M GooderhamSKiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada.
L GreenGeorge Washington University School of Medicine, Washington, DC, USA.
A BewleyWhipps Cross University Hospital & the Royal London Hospital, London, UK.
Z ZhangCelgene Corporation, Summit, NJ, USA.
I KhanskayaCelgene Corporation, Summit, NJ, USA.
R M DayCelgene Corporation, Summit, NJ, USA.
J GoncalvesCelgene Corporation, Summit, NJ, USA.
K ShahCelgene Corporation, Summit, NJ, USA.
V PiguetCardiff University and University Hospital of Wales, Wales, UK.
J SoungSouthern California Dermatology, Santa Ana, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate-to-severe psoriasis.

objectiveEvaluate efficacy and safety of apremilast vs. placebo in biologic-naive patients with moderate-to-severe plaque psoriasis and safety of switching from etanercept to apremilast in a phase IIIb, randomized, double-blind, placebo-controlled study (NCT01690299).

methodsTwo hundred and fifty patients were randomized to placebo (n = 84), apremilast 30 mg BID (n = 83) or etanercept 50 mg QW (n = 83) through Week 16; thereafter, all patients continued or switched to apremilast through Week 104. The primary efficacy endpoint was achievement of PASI-75 at Week 16 with apremilast vs. placebo. Secondary endpoints included achievement of PASI-75 at Week 16 with etanercept vs. placebo and improvements in other clinical endpoints vs. placebo at Week 16. Outcomes were assessed through Week 52. This study was not designed for apremilast vs. etanercept comparisons.

resultsAt Week 16, PASI-75 achievement was greater with apremilast (39.8%) vs. placebo (11.9%; P < 0.0001); 48.2% of patients achieved PASI-75 with etanercept (P < 0.0001 vs. placebo). PASI-75 response was maintained in 47.3% (apremilast/apremilast), 49.4% (etanercept/apremilast) and 47.9% (placebo/apremilast) of patients at Week 52. Most common adverse events (≥5%) with apremilast, including nausea, diarrhoea, upper respiratory tract infection, nasopharyngitis, tension headache and headache, were mild or moderate in severity; diarrhoea and nausea generally resolved in the first month. No new safety or tolerability issues were observed through Week 52 with apremilast.

conclusionApremilast demonstrated significant efficacy vs. placebo at Week 16 in biologic-naive patients with psoriasis, which was sustained over 52 weeks, and demonstrated safety consistent with the known safety profile of apremilast. Switching from etanercept to apremilast did not result in any new or clinically significant safety findings, and efficacy was maintained with apremilast through Week 52.

Indexed as

AdultAnti-Inflammatory Agents, Non-SteroidalDiarrheaDouble-Blind MethodEtanerceptFemaleHeadacheHumansMaleMiddle AgedNasopharyngitisNauseaPainPhosphodiesterase 4 InhibitorsPruritusPsoriasisAnti-Inflammatory Agents, Non-SteroidalapremilastEtanerceptPhosphodiesterase 4 InhibitorsThalidomide

Identifiers

PMID27768242
PMCPMC5363370

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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.