Evidence map›Paper›PMID 30018799›Full record

ArticleRMD open2018

Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies.

Dafna D Gladman, Arthur Kavanaugh, Juan J Gómez-Reino, Jürgen Wollenhaupt, Maurizio Cutolo, Georg Schett, Eric Lespessailles, Benoit Guerette, Nikolay Delev, Lichen Teng and 3 more

4 registry-linked trialsOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in RMD open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 6% 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.

NCT01172938 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

TypeinterventionalSponsorAmgenRan2010 to 2016Enrolled504ConditionsPsoriatic ArthritisArmsApremilast 20mg, Apremilast 30mg, Placebo + 20 mg Apremilast, Placebo + 30 mg Apremilast
NCT01212757 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

TypeinterventionalSponsorAmgenRan2010 to 2017Enrolled488ConditionsPsoriatic ArthritisArmsApremilast 20mg, Apremilast 30mg, Placebo + 20 mg Apremilast, Placebo + 30 mg Apremilast
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
NCT01583374 phase3completednot on this map

A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (cc-10004) in the treatment of active ankylosing spondylitis

TypeinterventionalSponsorAmgenRan2012 to 2018Enrolled490ConditionsAnkylosing SpondyloarthritisArmsApremilast tablet 20 mg, Apremilast tablet 30 mg BID, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Article
  9. Consensus on targeted drug therapy for spondyloarthritis.Rheumatology and immunology research · 2023
    Article
  10. Observational
  11. Review
  12. Review
  13. Article
  14. Review
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  16. 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

13 authors at 11 institutions in 8 countries.

Dafna D GladmanDivision of Rheumatology, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada.
Arthur KavanaughDepartment of Rheumatology, University of California School of Medicine at San Diego, La Jolla, California, USA.
Juan J Gómez-ReinoFundación Ramón Domínguez, Hospital Clínico Universitario, Santiago, Spain.
Jürgen WollenhauptDepartment of Rheumatology and Clinical Immunology, Schön Klinik Hamburg Eilbek, Hamburg, Germany.
Maurizio CutoloResearch Laboratory and Division of Rheumatology, Department Internal Medicine, University of Genova, Genova, Italy.
Georg SchettMedizinishche Klinik 3, Rheumatologie und Immunologie, Friedrich-Alexander-Universität Erlangen-Nürnberg und Universitätsklinikum Erlangen, Erlangen, Germany.
Eric LespessaillesRheumatology Department, University Orléans and Regional Hospital of Orléans, Orléans, France.
Benoit GueretteCelgene Corporation, Summit, New Jersey, USA.
Nikolay DelevCelgene Corporation, Summit, New Jersey, USA.
Lichen TengCelgene Corporation, Summit, New Jersey, USA.
Christopher J EdwardsMusculoskeletal Research Unit, NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Charles A BirbaraDivision of Rheumatology, Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
Philip J MeaseSwedish Medical Center and University of Washington School of Medicine, Seattle, Washington, USA.
Bristol-Myers Squibb (Switzerland) · CHCenter for Rheumatology · USFundación Ramón Domínguez · ESSchön Klinik Hamburg Eilbek · DEUniversitätsklinikum Erlangen · DEUniversité d'Orléans · FRUniversity Hospital Southampton NHS Foundation Trust · GBUniversity of California, San Diego · USUniversity of Genoa · ITUniversity of Massachusetts Chan Medical School · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) clinical trial programme findings demonstrated that apremilast, an oral phosphodiesterase 4 inhibitor, is effective for treating psoriatic arthritis (PsA). Enthesitis and dactylitis are difficult-to-treat features of PsA leading to disability and affecting quality of life. PALACE 1, 2 and 3 data were pooled to assess the efficacy of apremilast on enthesitis and dactylitis outcomes in patients with these conditions at baseline.

methodsPatients with enthesitis (n=945) or dactylitis (n=633) at baseline were analysed after receiving double-blind treatment with placebo, apremilast 30 mg two times per day or apremilast 20 mg two times per day up to 52 weeks and continuing up to 5 years. Data were analysed through 156 weeks. Enthesitis was evaluated by Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) and dactylitis via dactylitis count.

resultsAt week 24, patients receiving apremilast 30 mg two times per day demonstrated a significantly greater mean change in enthesitis (-1.3 vs -0.9; p<0.05) and dactylitis (-1.8 vs -1.3; p<0.01) vs placebo. Patients in the 30 mg dose group showed significantly greater mean (-23.6% vs -7.0%; p<0.05) and median (-50.0% vs -21.1%; p<0.05) per cent changes in MASES; mean and median per cent changes in dactylitis count were numerically, but not significantly, different for either apremilast dose in patients with dactylitis. In the patient population remaining on apremilast, observed mean and median improvements in both conditions were sustained through 156 weeks.

conclusionApremilast is effective for the treatment of active PsA, including improvements in enthesitis and dactylitis up to 3 years. TRIAL REGISTRATION NUMBERS: NCT01172938, NCT01212757 and NCT01212770.

Indexed as

anti-rheumatic agentsapremilastarthritisphosphodiesterase 4 inhibitorspsoriatic

Identifiers

PMID30018799
PMCPMC6045740
OpenAlexW2810474836

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.