Evidence map›Paper›PMID 30451329›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2019

Apremilast for moderate hidradenitis suppurativa: no significant change in lesional skin inflammatory biomarkers.

A R J V Vossen, H H van der Zee, N Davelaar, A M C Mus, M B A van Doorn, E P Prens

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.4field-weighted citation impact, top 18% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 18 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. New perspectives on the treatment of hidradenitis suppurativa.Therapeutic advances in chronic disease · 2021
    Review
  9. Review
  10. Review
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 at 1 institution in 1 country.

A R J V VossenDepartment of Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands.ORCID http://orcid.org/0000-0002-1448-5972
H H van der ZeeDepartment of Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
N DavelaarLaboratory of Rheumatology & Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
A M C MusLaboratory of Rheumatology & Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
M B A van DoornDepartment of Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
E P PrensDepartment of Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Erasmus MC · NL

Funding

AbbvieAmgenBiogenCelgeneCutanea Life SciencesEli LillyIdera PharmaceuticalsJanssen-CilagNovartisPfizerUCB
6 · The paper itself

Abstract

backgroundTreatment with apremilast has recently demonstrated clinically meaningful improvement in moderate hidradenitis suppurativa (HS).

objectiveTo evaluate the change in expression of inflammatory markers in lesional skin of HS patients receiving apremilast 30 mg twice daily (n = 15) for 16 weeks compared with placebo (n = 5).

methodsAt baseline, 5-mm punch biopsies were obtained from an index lesion (HSL) and non-lesional (HSN) skin in the same anatomical area. Subsequent HSL samples were taken as close as possible to the previously biopsied site at week 4 and week 16. After sampling, biopsies were split; one half was processed for in vivo mRNA analysis using real-time quantitative PCR; the other half was cultured for ex vivo protein analysis using a proximity extension assay (Olink). Linear mixed effects models were calculated to compare the levels of inflammatory markers in HSL skin between apremilast and placebo over time.

resultsAt baseline, 17 proteins with a fold change >2 in HSL vs. HSN skin were identified in 20 patients. The top five were IL-17A (5), S100A12, CST5, IL-12/23p40, CD6 (1) with fold changes ranging from 6.6 to 1638, respectively (FDR <0.044). Linear mixed effects models for 75 assays were calculated. Protein levels of S100A12 decreased during treatment in the apremilast group compared with the placebo group (p = 0.014, FDR = 0.186). None of the 14 genes exhibited significant changes in expression over time. However, an evident downward trend in relative mRNA expression of IL-17A and IL-17F was demonstrated in patients receiving apremilast.

conclusionWe did not detect statistically significant changes in inflammatory markers in HSL skin of HS patients receiving apremilast compared with placebo, despite clinical improvement in the apremilast group. Nonetheless, S100A12 and IL-17A were significantly elevated in HSL skin and showed a decrease in response to apremilast. The translational model in clinical trials involving HS clearly needs further improvement.

Indexed as

AdultAntigens, CDAntigens, Differentiation, T-LymphocyteAnti-Inflammatory Agents, Non-SteroidalBiomarkersCystatinsFemaleHidradenitis SuppurativaHumansInterleukin-12Interleukin-17MaleMiddle AgedRNA, MessengerS100A12 ProteinThalidomideAntigens, CDAntigens, Differentiation, T-LymphocyteAnti-Inflammatory Agents, Non-SteroidalapremilastBiomarkersCD6 antigenCST5 protein, humanCystatinsIL17A protein, humanIL17F protein, humanInterleukin-12Interleukin-17RNA, MessengerS100A12 ProteinS100A12 protein, humanThalidomide

Identifiers

PMID30451329
PMCPMC6590194
OpenAlexW2901752465

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.