Evidence map›Paper›PMID 41472501›Full record

ArticleThe Journal of dermatology2026

Real-World Safety Profile of Spesolimab in Generalized Pustular Psoriasis: Insights From Japan as Part of a Multinational Expanded Access Program (EAP).

Akimichi Morita, Yayoi Tada, Yuichiro Tsunemi, Mayumi Komine, Takuro Kanekura, Shinichi Imafuku, Toshiya Takahashi, Xuemei Ding, Nichiren Pillai, Morihisa Saitoh and 3 more

Abstract readMulticenter Study
In one paragraph

Article in The Journal of dermatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Review
  2. 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

13 authors.

Akimichi MoritaDepartment of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.ORCID https://orcid.org/0000-0001-8372-3754
Yayoi TadaDepartment of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.ORCID https://orcid.org/0000-0003-3743-135X
Yuichiro TsunemiSaitama Medical University Hospital, Saitama, Japan.
Mayumi KomineJichi Medical University Hospital, Tochigi, Japan.ORCID https://orcid.org/0000-0002-1086-1803
Takuro KanekuraDepartment of Dermatology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Shinichi ImafukuFukuoka University Hospital, Fukuoka, Japan.ORCID https://orcid.org/0000-0001-8568-4349
Toshiya TakahashiTohoku University Hospital, Miyagi, Japan.ORCID https://orcid.org/0000-0001-9742-2282
Xuemei DingBoehringer Ingelheim (China), Investment Co. Ltd, Shanghai, China.
Nichiren PillaiBoehringer Ingelheim International Gmbh, Ingelheim Am Rhein, Germany.
Morihisa SaitohNippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan.
Rafael Sani SimoesBoehringer Ingelheim International Gmbh, Ingelheim Am Rhein, Germany.
Nora PöntynenBoehringer Ingelheim International Gmbh, Ingelheim Am Rhein, Germany.
Keiichi YamanakaDepartment of Dermatology, Mie University Graduate School of Medicine, Tsu, Japan.

Funding

Boehringer Ingelheim
6 · The paper itself

Abstract

Generalized pustular psoriasis (GPP) is a heterogeneous, systemic neutrophilic inflammatory disease, characterized by chronic symptoms and recurrent flares, which can be potentially life-threatening. Spesolimab, an interleukin-36 receptor antagonist, has been approved to treat GPP flares in many countries including Japan. An expanded access program (EAP) in Japan provided early access to spesolimab for patients aged 18-75 years unable to participate in a clinical trial with no other treatment options. Patients received a single dose of 900 mg intravenous spesolimab for flare treatment, with an optional second dose after 1 week if symptoms persisted. Safety was monitored for 16 weeks post-treatment. Eleven patients (54.5% female; 51 years mean age; 26.7 kg/m

Indexed as

Antibodies, Monoclonal, HumanizedDermatologic AgentsInterleukinsPsoriasisAdolescentAdultAgedFemaleHumansJapanMaleMiddle AgedSymptom Flare UpTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedDermatologic AgentsIL36RN protein, humanInterleukinsexpanded access programgeneralized pustular psoriasisinterleukin (IL)‐36real‐world evidencespesolimab

Identifiers

PMID41472501
PMCPMC12877984

What OpenQuestion holds

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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.