Evidence map›Paper›PMID 25973439›Full record

Trial reportJournal of immunology research2015

The pharmacodynamic impact of apremilast, an oral phosphodiesterase 4 inhibitor, on circulating levels of inflammatory biomarkers in patients with psoriatic arthritis: substudy results from a phase III, randomized, placebo-controlled trial (PALACE 1).

Peter H Schafer, Peng Chen, Lorraine Fang, Andrew Wang, Rajesh Chopra

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of immunology research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02652546 (A Phase 1 Study of CC-11050 in Human Immunodeficiency Virus-1-Infected Adults With Suppressed Plasma Viremia on Antiretroviral Therapy), which is not on this map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
3.3field-weighted citation impact, top 7% 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.

NCT02652546 phase1completednot on this mapstarted 2016, after this paper: background citation

A Phase 1 Study of CC-11050 in Human Immunodeficiency Virus-1-Infected Adults With Suppressed Plasma Viremia on Antiretroviral Therapy

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2016 to 2018Enrolled38ConditionsHIV, InflammationArmsAssess Safety, Effect of drug on viral load, Effect of drug on T-cell count, Effect of drug on inflammatory biomarkers
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 80 citations in OpenAlex.

  1. Apremilast in Japanese patients with palmoplantar pustulosis: A randomized, Phase 3 trial.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Trial
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Emerging strategies for nanomedicine in autoimmunity.Advanced drug delivery reviews · 2024
    Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
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

5 authors.

Peter H SchaferTranslational Development, Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901, USA.
Peng ChenBiostatistics, Celgene Corporation, 33 Technology Drive, Warren, NJ 07059, USA.
Lorraine FangBiostatistics, Celgene Corporation, 33 Technology Drive, Warren, NJ 07059, USA.
Andrew WangBiostatistics, Celgene Corporation, 33 Technology Drive, Warren, NJ 07059, USA.
Rajesh ChopraTranslational Development, Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated effectiveness (versus placebo) for treatment of active psoriatic arthritis in the psoriatic arthritis long-term assessment of clinical efficacy (PALACE) phase III clinical trial program. Pharmacodynamic effects of apremilast on plasma biomarkers associated with inflammation were evaluated in a PALACE 1 substudy. Of 504 patients randomized in PALACE 1, 150 (placebo: n = 51; apremilast 20 mg BID: n = 51; apremilast 30 mg BID: n = 48) provided peripheral blood plasma samples for analysis in a multiplexed cytometric bead array assay measuring 47 proteins associated with systemic inflammatory immune responses. Association between biomarker levels and achievement of 20% improvement from baseline in modified American College of Rheumatology (ACR20) response criteria was assessed by logistic regression. At Week 24, IL-8, TNF-α, IL-6, MIP-1β, MCP-1, and ferritin were significantly reduced from baseline with apremilast 20 mg BID or 30 mg BID versus placebo. ACR20 response correlated with change in TNF-α level with both apremilast doses. At Week 40, IL-17, IL-23, IL-6, and ferritin were significantly decreased and IL-10 and IL-1 receptor antagonists significantly increased with apremilast 30 mg BID versus placebo. In patients with active psoriatic arthritis, apremilast reduced circulating levels of Th1 and Th17 proinflammatory mediators and increased anti-inflammatory mediators.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalArthritis, PsoriaticBiomarkersCytokinesHumansInflammationPhosphodiesterase 4 InhibitorsPlacebosSeverity of Illness IndexTh17 CellsTh1 CellsThalidomideTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalapremilastBiomarkersCytokinesPhosphodiesterase 4 InhibitorsPlacebosThalidomide

Identifiers

PMID25973439
PMCPMC4417944
OpenAlexW1965589159

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.