Evidence map›Paper›PMID 32804433›Full record

Trial reportThe Journal of dermatology2020

Adalimumab in Japanese patients with active ulcers of pyoderma gangrenosum: Twenty-six-week phase 3 open-label study.

Kenshi Yamasaki, Keiichi Yamanaka, Yiwei Zhao, Shunsuke Iwano, Keiko Takei, Koji Suzuki, Toshiyuki Yamamoto

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in The Journal of dermatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
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.

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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Observational
  7. Review
  8. Review
  9. Article
  10. Recalcitrant Pyoderma Gangrenosum: Clinical Burden and Unmet Needs.Clinical, cosmetic and investigational dermatology · 2023
    Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Skin manifestations in spondyloarthritis.Therapeutic advances in musculoskeletal disease · 2020
    Review
  16. Article
  17. 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 5 institutions in 2 countries.

Kenshi YamasakiDepartment of Dermatology, Tohoku University Graduate School of Medicine, Sendai, Japan.ORCID https://orcid.org/0000-0002-5495-4956
Keiichi YamanakaDepartment of Dermatology, Graduate School of Medicine, Mie University, Tsu, Japan.ORCID https://orcid.org/0000-0003-3055-5202
Yiwei ZhaoAbbVie Inc., Cambridge, Massachusetts, USA.
Shunsuke IwanoAbbVie GK, Tokyo, Japan.
Keiko TakeiAbbVie GK, Tokyo, Japan.
Koji SuzukiAbbVie GK, Tokyo, Japan.
Toshiyuki YamamotoDepartment of Dermatology, Fukushima Medical University School of Medicine, Fukushima, Japan.ORCID https://orcid.org/0000-0002-8390-2573
ABB (Japan) · JPAbbVie (United States) · USFukushima Medical University · JPMie University · JPTohoku University · JP

Funding

AbbVie
6 · The paper itself

Abstract

This phase 3 multicenter study, including 26-week treatment and extension periods, evaluated the efficacy and safety of adalimumab in Japanese patients with active ulcers due to pyoderma gangrenosum. Patients received adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every week starting at week 4. Of the 22 enrolled patients, 12 (54.5%, P < 0.001) achieved the primary efficacy end-point of pyoderma gangrenosum area reduction 100 (PGAR 100, defined as complete skin re-epithelialization) for the target ulcer at week 26 assessed by digital planimetry. PGAR 100 response was observed as early as week 6 (13.6%) and continued to increase over time. The mean percent change from baseline in target ulcer area was -31.8% at week 6 and -63.8% at week 26. A Physician's Global Assessment score of 0 (PGA 0, all ulcers completely clear) was achieved by two patients (9.1%) at week 6 and eight (36.4%) at week 26, while PGA 0/1 (completely/almost clear) was achieved by five (22.7%) and 12 patients (54.5%) at week 6 and 26, respectively. Mean changes from baseline in pain numeric rating scale (-1.8 at week 6 and -2.5 at week 26) and the Dermatology Life Quality Index (-3.1 at week 6 and -3.6 at week 26) improved over time. Adverse events were reported by 18 patients, most commonly infections (n = 11), and serious adverse events by four. These results suggest that adalimumab is effective and generally well tolerated in Japanese patients with active ulcers of pyoderma gangrenosum.

Indexed as

Pyoderma GangrenosumUlcerAdalimumabHumansJapanTreatment OutcomeAdalimumabadalimumabJapanese patientpyoderma gangrenosumskin ulcertumor necrosis factor-α

Identifiers

PMID32804433
PMCPMC7754463
OpenAlexW3062876773

What OpenQuestion holds

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LicenceCC BY
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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.