Evidence map›Paper›PMID 41239899›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2026

Efficacy and safety of brodalumab in palmoplantar pustulosis: A 68-week randomized Phase 3 trial.

Masamoto Murakami, Yukari Okubo, Satomi Kobayashi, Natsuko Kikuta, Yoshiumi Ouchi, Kenta Shishido, Tadashi Terui

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. 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
  2. Observational
  3. Could the IL-17 cytokine family be a promising target for the treatment of palmoplantar pustulosis?Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Article
  4. Review
  5. 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

7 authors.

Masamoto MurakamiDepartment of Anatomy, Histochemistry and Cell Biology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Yukari OkuboDepartment of Dermatology, Tokyo Medical University, Tokyo, Japan.ORCID https://orcid.org/0000-0002-9526-1259
Satomi KobayashiDepartment of Dermatology, Seibo International Catholic Hospital, Tokyo, Japan.
Natsuko KikutaKyowa Kirin Co., Ltd., Tokyo, Japan.
Yoshiumi OuchiKyowa Kirin Co., Ltd., Tokyo, Japan.
Kenta ShishidoKyowa Kirin Co., Ltd., Tokyo, Japan.ORCID https://orcid.org/0009-0001-4364-1399
Tadashi TeruiDivision of Dermatological Science, Department of Dermatology, Nihon University School of Medicine, Tokyo, Japan.

Funding

Kyowa Kirin Co. Ltd., Japan
6 · The paper itself

Abstract

backgroundThe efficacy and safety of brodalumab in Japanese patients with palmoplantar pustulosis (PPP) were demonstrated during the 16-week double-blind phase of a randomized controlled trial. However, long-term data are unavailable.

objectivesTo assess the efficacy and safety of brodalumab 210 mg administered subcutaneously (SC) repeatedly until Week 68 in PPP patients with moderate or severe pustules/vesicles in an open-label extension study.

methodsIn a multicentre, Phase 3, randomized, double-blind, placebo-controlled trial, Japanese adults having a diagnosis of PPP for ≥24 weeks, PPP Area Severity Index (PPPASI) of ≥12, PPPASI subscore of pustules/vesicles of ≥2 and inadequate response to therapy were included. Patients completing the double-blind phase with brodalumab 210 mg or placebo (1:1) SC once every 2 weeks (Q2W) for 16 weeks were invited to enter the open-label extension to receive brodalumab for the subsequent 52 weeks.

resultsBy Week 68, 35 patients in the brodalumab group and 43 patients in the placebo-to-brodalumab group completed the study, with discontinuations (28 and 20 patients, respectively) primarily due to patient withdrawal. At Week 68, the mean ± SD improvement of the PPPASI total score from baseline was 23.83 ± 12.28 and 22.37 ± 13.09 in the brodalumab and placebo-to-brodalumab groups, respectively. Continued improvement or trend for improvement was seen in the secondary endpoints such as PPPASI 50/75/90 responses and Dermatology Life Quality Index. The incidence of adverse events was 849.3/100 person-years. Otitis externa had the highest incidence (44.0/100 person-years; Grade 1 or 2 only). Infection-related events were frequent but controllable.

conclusionsBrodalumab SC 210 mg Q2W administered for 68 weeks showed a long-term benefit to both dermatological and quality of life indices in these patients. It is expected to be used in appropriate patients, considering both safety risks and efficacy benefits.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedDermatologic AgentsPsoriasisAdultAgedDouble-Blind MethodFemaleHumansInjections, SubcutaneousMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedbrodalumabDermatologic AgentsbrodalumabIL‐17 inhibitorJapaneseopen‐label extensionpalmoplantar pustulosis

Identifiers

PMID41239899
PMCPMC13109765

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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.