Evidence map›Paper›PMID 34453358›Full record

Trial reportThe Journal of dermatology2021

Sustained efficacy and safety of guselkumab in patients with palmoplantar pustulosis through 1.5 years in a randomized phase 3 study.

Yukari Okubo, Hitomi Morishima, Richuan Zheng, Tadashi Terui

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
4.5field-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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Guideline
  2. Apremilast in Japanese patients with palmoplantar pustulosis: A randomized, Phase 3 trial.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Trial
  3. Efficacy and safety of brodalumab in palmoplantar pustulosis: A 68-week randomized Phase 3 trial.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Guselkumab - In Psoriasis and Beyond.Dermatology practical & conceptual · 2024
    Review
  16. Article
  17. Article
  18. Article
  19. Review
  20. 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

4 authors at 2 institutions in 1 country.

Yukari OkuboDepartment of Dermatology, Tokyo Medical University, Tokyo, Japan.ORCID https://orcid.org/0000-0002-9526-1259
Hitomi MorishimaJanssen Pharmaceutical K.K, Tokyo, Japan.ORCID https://orcid.org/0000-0001-8118-1197
Richuan ZhengJanssen Pharmaceutical K.K, Tokyo, Japan.
Tadashi TeruiDepartment of Dermatology, Nihon University School of Medicine, Tokyo, Japan.
Nihon University · JPTokyo Medical University · JP

Funding

Janssen Pharmaceutical K.K., Tokyo, Japan
6 · The paper itself

Abstract

The safety and efficacy of guselkumab for palmoplantar pustulosis (PPP) have been established through week (W)52; however, no sufficient information is available beyond 1 year. This study was conducted to assess the efficacy and safety of guselkumab through W84, and to explore factors associated with the sustainability of its efficacy in Japanese PPP patients. Patients received guselkumab 100 or 200 mg at W0, W4, W12, and every 8 weeks (q8w) until W60, or placebo at W0, W4, and W12. At W16, patients receiving placebo were re-randomized to receive guselkumab 100/200 mg at W16, W20, and q8w until W60. Efficacy end-points included PPP Area and Severity Index (PPPASI), PPP Severity Index (PPSI), Physician's Global Assessment scores, and patient reported outcomes (PRO) (Dermatology Life Quality Index, EuroQoL-5 Dimensions, and 36-item Short Form Health Survey). Post-hoc comparison of patient characteristics was performed between PPPASI-75/90 responders and non-responders at W60, and sustained responders and non-responders at W84. Safety was evaluated through W84. A total of 45, 43, 21, and 24 patients from the guselkumab 100 mg, guselkumab 200 mg, placebo→guselkumab 100 mg, and placebo→guselkumab 200 mg groups, respectively, completed the study through W84. Overall, the mean improvement in the guselkumab groups from baseline in the PPPASI and PPSI total scores at W84 was ~79% and ~66%, respectively. All PRO improved through W84. The proportion of responders through W60 was higher in patients who had not received prior phototherapy and non-biologic systemic therapy for PPP. Non-smokers and patients with no prior non-biologic systemic treatment tended numerically towards sustained efficacy through W84. The majority of treatment-emergent adverse events (TEAE) were mild to moderate (~88%) with low incidence of serious TEAE (7.6%). Overall, guselkumab showed sustained efficacy and safety with improvement in the health-related quality of life through W84 in Japanese PPP patients.

Indexed as

PsoriasisQuality of LifeAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizedguselkumabclinical efficacyguselkumabhealth-related quality of lifeinterleukin-23palmoplantar pustulosis

Identifiers

PMID34453358
PMCPMC9290648
OpenAlexW3195402534

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.