Evidence map›Paper›PMID 42107018›Full record

ArticleDermatology and therapy2026

Safety and Effectiveness of Adalimumab for the Treatment of Pyoderma Gangrenosum: A 52-Week Real-World Prospective Observational Study.

Toshiyuki Yamamoto, Hideaki Tanizaki, Kenshi Yamasaki, Naoko Matsubara, Masahiko Nakayama, Eri Iwashita, Keiichi Yamanaka

Registry-linked trialAbstract read
In one paragraph

Article in Dermatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04750213 (Post-marketing Observational Study for Humira in Participants Diagnosed With Pyoderma Gangrenosum), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT04750213 completednot on this map

Post-marketing Observational Study for Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)

TypeobservationalSponsorAbbVieRan2021 to 2024Enrolled60ConditionsPyoderma Gangrenosum
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Toshiyuki YamamotoDepartment of Dermatology, Fukushima Medical University, Fukushima, Japan.ORCID http://orcid.org/0000-0002-8390-2573
Hideaki TanizakiDepartment of Dermatology, Kansai Medical University, Hirakata, Japan.
Kenshi YamasakiDepartment of Dermatology, Tohoku University, Sendai, Japan.ORCID http://orcid.org/0000-0002-5495-4956
Naoko MatsubaraMedical, AbbVie GK, 3-1-21 Shibaura, Minato-ku, Tokyo, 108-0023, Japan. naoko.matsubara@abbvie.com.ORCID http://orcid.org/0000-0003-2668-4853
Masahiko NakayamaMedical, AbbVie GK, 3-1-21 Shibaura, Minato-ku, Tokyo, 108-0023, Japan.
Eri IwashitaMedical, AbbVie GK, 3-1-21 Shibaura, Minato-ku, Tokyo, 108-0023, Japan.ORCID http://orcid.org/0009-0002-5176-8493
Keiichi YamanakaDepartment of Dermatology, Mie University, Graduate School of Medicine, Tsu, Mie, Japan.ORCID http://orcid.org/0000-0003-3055-5202

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPyoderma gangrenosum (PG) is a rare, autoinflammatory skin disorder characterized by painful ulcers, with scarce treatment options. Adalimumab is a recently approved tumor necrosis factor-alpha inhibitor for PG, for which real-world data remain limited. This study evaluated the long-term safety and effectiveness of adalimumab in patients with PG.

methodsThis multicenter, prospective, open-label, single-arm, postmarketing observational study enrolled patients with PG who were prescribed adalimumab and were monitored for 52 weeks. The primary outcome was safety, assessed as the incidence proportion of infections reported as adverse drug reactions (ADRs). Secondary outcomes included other safety measures and effectiveness, estimated using the Physician Global Assessment (PGA), Investigator Inflammation Assessment, and Verbal Rating Scale (VRS) for pain. Relapse rates after remission and changes in PG subtype during the observation period were also examined.

resultsSixty-seven patients with PG were enrolled in the study. The mean age was 61.9 years, and 77.6% of the patients had comorbidities, including diabetes mellitus (19.4%), ulcerative colitis (16.4%), and hypertension (14.9%); 59.7% were concomitantly receiving systemic steroids. The PG subtypes among the enrolled patients were ulcerative (n = 62), pustular (n = 2), vegetative (n = 2), and bullous (n = 1). The incidence proportions of infections reported as ADRs and serious ADRs were 14.9% and 9.0%, respectively. The proportions of patients with a PGA score (total lesions) of 0/1 at weeks 12, 26, and 52 were 36.0%, 46.2%, and 57.7%, respectively, and with a VRS score of 0 at weeks 26 and 52 were 45.7% and 52.4%, respectively. No relapses occurred among patients who discontinued treatment due to symptom improvement.

conclusionsThis real-world study demonstrated no new safety concerns with adalimumab and demonstrated its effectiveness, including pain relief, across a heterogeneous PG population. These findings support its use as a standard treatment for PG, including in patients receiving concomitant systemic steroid therapy.

trial registrationClinicalTrials.gov identifier, NCT04750213.

Indexed as

AdalimumabHumiraPostmarketing surveillancePyoderma gangrenosumReal-world evidenceSafetySteroidSubtypeTNF-α inhibitor

Identifiers

PMID42107018
PMCPMC13237327

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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.