Evidence map›Paper›PMID 26792812›Full record

Trial reportAnnals of the rheumatic diseases2016

Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3).

Christopher J Edwards, Francisco J Blanco, Jeffrey Crowley, Charles A Birbara, Janusz Jaworski, Jacob Aelion, Randall M Stevens, Adele Vessey, Xiaojiang Zhan, Paul Bird

2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 132 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
132citing papers in PubMed, 15 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.

NCT01212770 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis and a Qualifying Psoriasis Lesion

TypeinterventionalSponsorAmgenRan2010 to 2017Enrolled505ConditionsPsoriatic ArthritisArmsApremilast 20mg, Apremilast 30mg, Placebo
NCT04645420 nacompletednot on this mapstarted 2020, after this paper: background citation

Molecular Effects of Apremilast in the Synovium of Psoriatic Arthritis Patients (MEAS Study)

TypeinterventionalSponsorCliniques universitaires Saint-Luc- Université Catholique de LouvainRan2020 to 2023Enrolled19ConditionsPsoriatic ArthritisArmsGlobal gene expression profiles obtained from synovial biopsies.
3 · Its place in the literature

Who cites it

132 citing papers in PubMed, 15 syntheses or guidelines pooled it.

  1. La Tunisie medicale · 2025
    Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Guideline
  12. Pooled it
  13. Guideline
  14. Guideline
  15. Pooled it
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

72 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

10 authors.

Christopher J EdwardsNIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton, Southampton, UK.
Francisco J BlancoINIBIC-Hospital Universitario A Coruña, Galicia, Spain.
Jeffrey CrowleyBakersfield Dermatology, Bakersfield, California, USA.
Charles A BirbaraUniversity of Massachusetts Medical School, Worcester, Massachusetts, USA.
Janusz JaworskiReumatika Centrum Reumatologi, Warszawa, Poland.
Jacob AelionWest Tennessee Research Institute, Jackson, Tennessee, USA.
Randall M StevensCelgene Corporation, Summit, New Jersey, USA.
Adele VesseyCelgene Corporation, Summit, New Jersey, USA.
Xiaojiang ZhanCelgene Corporation, Summit, New Jersey, USA.
Paul BirdCombined Rheumatology Practice, University of New South Wales, Kogarah, New South Wales, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate apremilast treatment in patients with active psoriatic arthritis, including current skin involvement, despite prior therapy with conventional disease-modifying antirheumatic drugs and/or biologic agents.

methodsPatients (N=505) were randomised (1:1:1) to placebo, apremilast 20 mg twice daily, or apremilast 30 mg twice daily. Rescue therapy with apremilast was designated at week 16 for placebo patients not achieving 20% improvement in swollen and tender joint counts. At week 24, the remaining placebo patients were then randomised to apremilast 20 mg twice daily or 30 mg twice daily. The efficacy and safety of apremilast were assessed over 52 weeks.

resultsAt week 16, significantly more patients receiving apremilast 20 mg twice daily (28%) and 30 mg twice daily (41%) achieved 20% improvement in American College of Rheumatology response criteria versus placebo (18%; p=0.0295 and p<0.0001, respectively), and mean decrease in the Health Assessment Questionnaire-Disability Index score was significantly greater with apremilast 30 mg twice daily (-0.20) versus placebo (-0.07; p=0.0073). In patients with baseline psoriasis body surface area involvement ≥3%, significantly more apremilast 30 mg twice daily patients achieved 50% reduction from baseline Psoriasis Area and Severity Index score (41%) versus placebo (24%; p=0.0098) at week 16. At week 52, observed improvements in these measures demonstrated sustained response with continued apremilast treatment. Most adverse events were mild to moderate in severity; the most common were diarrhoea, nausea, headache and upper respiratory tract infection.

conclusionsApremilast demonstrated clinically meaningful improvements in psoriatic arthritis and psoriasis at week 16; sustained improvements were seen with continued treatment through 52 weeks. Apremilast was generally well tolerated and demonstrated an acceptable safety profile. TRIAL REGISTRATION NUMBER: NCT01212770.

Indexed as

AdultAnti-Inflammatory Agents, Non-SteroidalArthritis, PsoriaticDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedPhosphodiesterase 4 InhibitorsSeverity of Illness IndexSkinThalidomideTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalapremilastPhosphodiesterase 4 InhibitorsThalidomideAnkylosing SpondylitisPsoriatic ArthritisTreatment

Identifiers

PMID26792812
PMCPMC4893110

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.