English version of Japanese guidance for use of biologics for psoriasis (the 2022 version)

Saeki, Hidehisa; Mabuchi, Tomotaka; Asahina, Akihiko; Abe, Masatoshi; Igarashi, Atsuyuki; Imafuku, Shinichi; Okubo, Yukari; Komine, Mayumi; Sano, Shigetoshi; Torii, Hideshi; Morita, Akimichi; Yotsuyanagi, Hiroshi; Watanabe, Akira; Ohtsuki, Mamitaro

doi:10.1111/1346-8138.16691

Cited by 19 publications

(23 citation statements)

References 119 publications

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“…Accordingly, only individuals who were deemed appropriate for brodalumab use were enrolled in the current study. In addition, the Japanese guidance for the use of biologics for psoriasis does not mandate the monitoring of suicidal ideation and behavior using the Columbia-Suicide Severity Rating Scale for patients treated with brodalumab [ 32 , 33 ]; thus, patient screening or study assessment using this scale was not performed.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of Long-Term Treatment with Brodalumab on Anxiety or Depressive Symptoms in Japanese Patients with Psoriasis: The ProLOGUE Study

Ohata

Kanai

Murotani

et al. 2023

Dermatol Ther (Heidelb)

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Introduction: Evidence on treatment effectiveness in patients with psoriasis having anxiety or depressive symptoms helps shared decisionmaking. This single-arm, open-label, prospective study-ProLOGUE-was conducted to assess the effectiveness of brodalumab on selfassessed anxiety and depressive symptoms in Japanese patients with psoriasis. Methods: Patients aged C 18 years with plaque psoriasis without peripheral arthritis symptoms who had responded inadequately to current therapies were enrolled at 15 Japanese facilities and received brodalumab 210 mg subcutaneously.

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Section: Discussionmentioning

confidence: 99%

Effectiveness of Long-Term Treatment with Brodalumab on Anxiety or Depressive Symptoms in Japanese Patients with Psoriasis: The ProLOGUE Study

Ohata

Kanai

Murotani

et al. 2023

Dermatol Ther (Heidelb)

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“…must also be regularly conducted to secure the safety. Basically, the interval of examination after the start of administration should be established in accordance with the guidance for the use of biologics in patients with psoriasis 18 (1, 3, and 6 months after the start of treatment, subsequently every 6 months as a reference), but for the use of these drugs we recommend that careful follow-up should be particularly performed, and that regular examinations ≥6 months after the start of administration should be conducted at adequate intervals in accordance with individual patients, regarding "every 3 months" as a reference. • As these drugs may influence the host's immune system against infectious pathogens, serious infections, such as pneumonia, sepsis, and tuberculosis, may appear.…”

Section: Inquiry/e X Aminations B Efore and During Adminis Tr Ationmentioning

confidence: 99%

English version of Japanese guidance for the use of oral Janus kinase inhibitors (JAK1 and TYK2 inhibitors) in the treatments of psoriasis

Saeki

Mabuchi

Asahina

et al. 2023

The Journal of Dermatology

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This is the English version of Japanese guidance for the use of oral Janus kinase (JAK) inhibitors (JAK1 and tyrosine kinase 2 [TYK2] inhibitors) in the treatments of psoriasis. Several cytokines, such as interleukin (IL)‐6, IL‐7, IL‐12, IL‐21, IL‐22, IL‐23, interferon (IFN)‐α, and IFN‐γ, are involved in the pathogenesis of psoriasis (including psoriatic arthritis). As oral JAK inhibitors hinder the JAK‐signal transducers and activators of transcription signal transduction routes involved in the signal transduction of these cytokines, they may be effective for the treatment of psoriasis. JAK has four types: JAK1, JAK2, JAK3, and TYK2. Regarding the use of oral JAK inhibitors for the treatment of psoriasis in Japan, indications of the JAK1 inhibitor upadacitinib were extended also to psoriatic arthritis in 2021, and the use of the TYK2 inhibitor deucravacitinib for plaque‐type psoriasis, pustular psoriasis, and erythrodermic psoriasis became covered by health insurance in 2022. This guidance was developed for board‐certified dermatologists who specialize in the treatment of psoriasis and to promote the proper use of oral JAK inhibitors. In the package inserts and guides for appropriate use, upadacitinib and deucravacitinib are classified as a “JAK inhibitor” and a “TYK2 inhibitor”, respectively, and it is possible that there may be differences in safety between the two drugs. The safety of these drugs will be evaluated for the future by the postmarketing surveillance for molecularly targeted drugs for psoriasis of the Japanese Dermatological Association.

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“…The available biologics are listed in Table 4. In children aged 6 years or older, psoriasis can currently be treated only with secukinumab because it is the only biologic approved for this use in Japan (as of December 2022) 16 . In these children, secukinumab should be subcutaneously administered every 4 weeks at a dose of 75 mg for children weighing less than 50 kg and at a dose of 150 or 300 mg for those weighing 50 kg or more 47 .…”

Section: Plaque Psoriasismentioning

confidence: 99%

“…Systemic therapies are commonly considered if the lesion covers 10% or more of the body surface area, the Psoriasis Area and Severity Index (PASI) score is greater than or equal to 10, or the Dermatology Life Quality Index (DLQI) score is greater than or equal to 10 16 . Biologics may be considered if the response to existing systemic therapies is insufficient 16 . International and Japanese clinical studies of various biologics in adults showed high efficacy of biologics, with an improvement of 75% or more in the PASI score (PASI‐75) in 59%–95% of patients, improvement of 90% or more (PASI‐90) in 33%–92% of patients, and improvement of 100% (PASI‐100) in 10%–68% of patients 16 .…”

Section: Plaque Psoriasismentioning

confidence: 99%

“…12 In Japan, guidelines for psoriasis include the 2014 guidelines for the management and treatment of generalized pustular psoriasis (GPP), 13 the 2019 guidelines for the treatment of psoriatic arthritis (PsA), 14 the 2016 guidelines for phototherapy in psoriasis, 15 and the 2022 guidance for the use of biologics for psoriasis. 16 There are currently no specific guidelines for treating pediatric psoriasis. Furthermore, the safety of some drugs has not been established for use in children with this condition, and fewer treatment options are available than for adults.…”

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Pediatric psoriasis: Understanding pathological conditions and advances in treatment

Morita,

Saeki

2023

The Journal of Dermatology

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Psoriasis is a long‐lasting skin disease that primarily affects the skin, nails, and joints and is characterized by inflammation. Genetic factors contribute to its development and environmental triggers can worsen symptoms. Pathologically, psoriasis is characterized by uncontrolled keratinocyte proliferation and abnormal differentiation, and histological features include acanthosis with inflammatory cell infiltration and neovascularization. Psoriasis often starts in childhood, with about one‐third of cases beginning during this time. Its prevalence steadily increases from the ages of 1 to 18 years in a linear fashion. Young people with psoriasis often require treatment throughout their childhood and adolescence, and into adulthood. However, prolonged treatment may increase the risk of complications and adverse events, so it is important to adopt an effective treatment approach that minimizes this risk. In addition, psoriasis is often associated with various comorbidities that may place a great burden on the physical and mental health of the children beyond those due to psoriasis itself. To ensure good long‐term health outcomes, individuals with psoriasis should undergo regular screening. Treatment should be provided not only for skin lesions, but also for any comorbidities; however, currently there is not enough evidence on the treatment of pediatric psoriasis and no globally agreed‐on guidelines exist for treating psoriasis in children. This article describes the etiology, clinical symptoms, and disease burden of pediatric psoriasis, the pathological conditions and diagnosis of plaque psoriasis, psoriatic arthritis, and generalized pustular psoriasis, and the available treatments for these conditions in Japan.

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English version of Japanese guidance for use of biologics for psoriasis (the 2022 version)

Abstract: Hidehisa Saeki is the Chairperson, and Tomotaka Mabuchi is the Vice Chairperson of the Committee for reviewing the safety of molecularly targeted drugs for psoriasis, Japanese Dermatological Association.

Cited by 19 publications

References 119 publications

Effectiveness of Long-Term Treatment with Brodalumab on Anxiety or Depressive Symptoms in Japanese Patients with Psoriasis: The ProLOGUE Study

Effectiveness of Long-Term Treatment with Brodalumab on Anxiety or Depressive Symptoms in Japanese Patients with Psoriasis: The ProLOGUE Study

English version of Japanese guidance for the use of oral Janus kinase inhibitors (JAK1 and TYK2 inhibitors) in the treatments of psoriasis

Pediatric psoriasis: Understanding pathological conditions and advances in treatment

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