Evidence map›Paper›PMID 31881294›Full record

ArticleJournal of the American Academy of Dermatology2020

Clinical response rates, placebo response rates, and significantly associated covariates are dependent on choice of outcome measure in hidradenitis suppurativa: A post hoc analysis of PIONEER 1 and 2 individual patient data.

John W Frew, Caroline S Jiang, Neha Singh, David Grand, Kristina Navrazhina, Roger Vaughan, James G Krueger

Open access · greenAbstract readComparative Study
In one paragraph

Article in Journal of the American Academy of Dermatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
7.2field-weighted citation impact, top 3% 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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Australasian hidradenitis suppurativa management guidelines.The Australasian journal of dermatology · 2025
    Guideline
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Towards the development of upgrade criteria for the treatment of hidradenitis suppurativa with biologics.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Article
  7. Hidradenitis Suppurativa Tunnels: Unveiling a Unique Disease Entity.JID innovations : skin science from molecules to population health · 2025
    Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Epithelialized tunnels are a source of inflammation in hidradenitis suppurativa.The Journal of allergy and clinical immunology · 2021
    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

7 authors at 2 institutions in 1 country.

John W FrewLaboratory of Investigative Dermatology, The Rockefeller University, New York, New York. Electronic address: jfrew@rockefeller.edu.
Caroline S JiangDepartment of Biostatistics, The Rockefeller University, New York, New York.
Neha SinghDepartment of Biostatistics, The Rockefeller University, New York, New York.
David GrandLaboratory of Investigative Dermatology, The Rockefeller University, New York, New York; Albert Einstein College of Medicine, Bronx, New York.
Kristina NavrazhinaLaboratory of Investigative Dermatology, The Rockefeller University, New York, New York; Weill Cornell/Rockefeller/Sloan Kettering Tri-Institutional MD-PhD Program, Weill Cornell University, New York, New York.
Roger VaughanDepartment of Biostatistics, The Rockefeller University, New York, New York.
James G KruegerLaboratory of Investigative Dermatology, The Rockefeller University, New York, New York.
Rockefeller University · USCornell University · US

Funding

Weill Cornell/Rockefeller/Sloan-Kettering MST ProgramT32GM007739 · NIGMS · WEILL MEDICAL COLL OF CORNELL UNIV · PI HSU, KATHARINE C · 1985 to 2023
$51.1M
Developing, Demonstrating, and Disseminating Innovative Programs to Achieve Translational SuccessUL1TR001866 · NCATS · ROCKEFELLER UNIVERSITY · PI COLLER, BARRY, KRUEGER, JAMES G · 2016 to 2025
$40.6M
NCATS NIH HHS UL1 TR001866NIGMS NIH HHS T32 GM007739
6 · The paper itself

Abstract

backgroundThe hidradenitis suppurativa clinical response (HiSCR) is the gold standard primary outcome measure for hidradenitis suppurativa clinical trials; however, it does not assess the presence of draining tunnels, a common finding in advanced disease. It is unclear what the effect of the presence or absence of draining tunnels has on the efficacy of adalimumab therapy in moderate and advanced disease.

objectivesWe evaluated the efficacy of adalimumab versus placebo using the International Hidradenitis Suppurativa Severity Scoring System (IHS4). Additionally, we assessed the effect of draining tunnels on therapeutic response as measured by both the HiSCR and change in nodule counts.

methodsReanalysis was conducted with the IHS4 and PIONEER 1 and 2 individual patient data. Both binary outcomes (achieving HiSCR and achieving change in IHS4 severity category) and continuous outcomes (nodule counts and IHS4 score) were calculated with R. Regression modeling was undertaken to assess the effect of draining tunnels and other variables. P < .05 was considered statistically significant.

resultsThe significance of adalimumab therapy depended on the outcome measure used. Placebo response rates were highest when binary outcome measures were used. Draining tunnels, smoking, antibiotics, and body mass index influenced HiSCR response in PIONEER 2. Significant differences in disease severity were observed between PIONEER 1 and 2 data sets.

conclusionsElevated placebo response rates in PIONEER 1 and 2 are partially attributable to the use of binary outcome measures. Draining tunnels influence clinical response as measured by HiSCR and nodule counts in PIONEER 2. Further investigation into the effect of body mass index on clinical response is required.

Indexed as

Outcome Assessment, Health CareAdalimumabAdultAgedAnti-Inflammatory AgentsCase-Control StudiesDatabases, FactualDose-Response Relationship, DrugDrug Administration ScheduleFemaleHidradenitis SuppurativaHumansLogistic ModelsMaleMiddle AgedPlacebo EffectAdalimumabAnti-Inflammatory Agentsacne inversaBMIhidradenitis suppurativaHiSCRIHS4outcome measuresplacebotunnels

Identifiers

PMID31881294
PMCPMC7167597
OpenAlexW2998567132

What OpenQuestion holds

Textmetadata
LicenceTDM
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.