Evidence map›Paper›PMID 35243682›Full record

Trial reportThe Journal of dermatology2022

Adalimumab in Japanese patients with active ulcers of pyoderma gangrenosum: Final analysis of a 52-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 III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  5. Article
  6. [Pyoderma gangrenosum: pathogenesis, diagnosis, and treatment].Dermatologie (Heidelberg, Germany) · 2025
    Review
  7. Review
  8. Observational
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  11. Article
  12. Review
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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

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, Mie University Graduate School of Medicine, 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, 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

In this 52-week, phase 3 open-label study, efficacy and safety of adalimumab were evaluated in Japanese patients with active ulcers due to pyoderma gangrenosum (PG) during a 26-week treatment period and another 26-week extension period. Patients received adalimumab 160 mg at week 0, 80 mg at week 2, and 40 mg every week from week 4. At week 26, 12 of 22 patients (54.5%, p < 0.001) achieved the primary efficacy endpoint of PG area reduction 100 (PGAR 100, complete skin re-epithelialization) for the target ulcer. Nine patients with Physician's Global Assessment (PGA) score of 1, 2, or 3, including four patients achieving PGAR 100, continued into the extension period. During the extension period, six of nine patients (66.7%) achieved PGAR 100 for the target PG ulcer at 52 weeks; one patient who achieved PGAR 100 before week 26 experienced a relapse 162 days after achieving this endpoint. Six patients achieved PGA 0 by week 52, and one patient reported new ulcers at day 57 of the extension period. Continued improvements from study baseline to week 52 were observed in pain (mean [95% CI] -4.0 [-6.5 to -1.5] numeric rating scale) and Dermatology Life Quality Index (-7.3 [-15.1 to 0.4]). In addition to the adverse events (AE) reported in 18 patients (including four serious AE) through week 26 (most commonly infections [n = 11]), there was one 1 additional AE (infection) during the extension period. These results suggest that adalimumab is effective and generally well tolerated in Japanese patients with active PG ulcers.

Indexed as

AdalimumabPyoderma GangrenosumUlcerHumansJapanTreatment OutcomeAdalimumabadalimumabJapanese patientpyoderma gangrenosumskin ulcertumor necrosis factor-α

Identifiers

PMID35243682
PMCPMC9313851
OpenAlexW4214806184

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.