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Drug Evaluation

Guselkumab for the treatment of palmoplantar pustulosis

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Pages 841-852 | Received 30 Nov 2019, Accepted 21 Apr 2020, Published online: 12 May 2020
 

ABSTRACT

Introduction

Palmoplantar pustulosis, or pustulosis palmaris et plantaris (PPP), is a chronic, recurrent inflammatory skin disease that is sometimes unresponsive to conventional therapy. The anti-interleukin 23 antibody guselkumab is effective for treating PPP.

Areas covered

This review details the current understanding of PPP and discusses why guselkumab may be effective. Guselkumab is only approved for the treatment of PPP in Japan. In the United States, Canada, the European Union, and several other countries, it is approved for the treatment of moderate-to-severe plaque psoriasis, but not for PPP. Furthermore, guselkumab was approved only 1 year ago; its efficacy will be proven only by phase 2 and 3 clinical trials.

Expert opinion

The first double-blinded randomized placebo-controlled trial (RCT) of guselkumab for PPP has been completed. The drug was effective, and guselkumab could be used as a new agent for PPP treatment, in addition to several conventional therapeutics. However, several issues remain. For example, there is no mouse model of PPP, so careful observation of human PPP patients and establishment of a good experimental PPP model are essential.

Article Highlights

  • PPP is a chronic, recurrent inflammatory skin disease associated with erythema, scales, and sterile pustules on the palms and soles, which significantly reduce quality of life; PPP is commonly encountered in the dermatology clinic.

  • PPP has been treated using several conventional therapies, but these are often ineffective.

  • Adalimumab, etanercept, infliximab, and ustekinumab have all been tested, but the reports are typically case reports or small double-blinded randomized placebo-controlled trials. Recently, the efficacy of secukinumab as a treatment for palmoplantar pustular psoriasis was evaluated in a multicenter, randomized, double-blind clinical trial (2PRECISE).

  • Guselkumab is the first biologic agent approved for PPP (in Japan, ~1 year ago). A phase 3 clinical trial demonstrated the therapeutic potential of guselkumab in Japanese patients with moderate-to-severe PPP (type A); overall well-being and quality of life improved by week 52;

  • The PPP disease criteria used in Japan and the West should be harmonized.

This box summarizes key points contained in the article.

Declaration of interest

The author has received consultancies/speaker honoraria from, and/or participated in clinical trials sponsored by, Abbvie, Boehringer Ingelheim, Celgene, Janssen, Kyowa Kirin, Lilly, Maruho, Novartis, and Taiho Pharma. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

One of the reviewers has served as an investigator for AbbVie, Array Biopharma, Boehringer Ingelheim, Eli Lilly, Janssen-Cilag, MSD, Novartis, Pfizer and UCB Pharma, was member of advisory boards of BMS, Eli Lilly, LEO Pharma, MSD, Novartis, Pfizer, Roche and UCB Pharma, obtained honoraria from ALK-Abello, AbbVie, Biotest, BMS, Janssen-Cilag, MSD, Novartis, Pfizer, Dr. Pfleger and Roche, and received support for conferences from AbbVie, Actelion, ALK-Abello, Alma Lasers, Almirall Hermal, ARC Lasers, Asclepion, Beiersdorf, BMS, Celgene, Dermapharm, Dermasence, Eli Lilly, Galderma, GSK, Immunocore, Janssen-Cilag, L’Oreal, La Roche Posay, LEO Pharma, Medac, MSD, Mylan, Novartis, Pierre Fabre, P&M Cosmetics, Pfizer, Roche, Sanofi and Sun Pharma. The second reviewer has received research, speaking and/or consulting support from a variety of companies including Galderma, GSK/Stiefel, Almirall, Alvotech, Leo Pharma, BMS, Boehringer Ingelheim, Mylan, Celgene, Pfizer, Ortho Dermatology, Abbvie, Samsung, Janssen, Lilly, Menlo, Merck, Novartis, Regeneron, Sanofi, Novan, Qurient, National Biological Corporation, Caremark, Advance Medical, Sun Pharma, Suncare Research, Informa, UpToDate and National Psoriasis Foundation. They also consult for others through Guidepoint Global, Gerson Lehrman and other consulting organizations. They are a founder and majority owner of www.DrScore.com, and a founder and part owner of Causa Research, a company dedicated to enhancing patients’ adherence to treatment. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.

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