Akimichi Morita

Background: Treatment options for paediatric patients with psoriasis are limited, and additional, more advanced therapies are needed. Risankizumab is an interleukin-23 inhibitor approved to treat moderate-to-severe psoriasis in adults. Objectives: To evaluate efficacy and safety of risankizumab through 52 weeks in paediatric patients with moderate-to-severe psoriasis. Methods: OptIMMize-1 (Clinical Trial Registration NCT04435600) was a phase III, multicentre, four-part study. Parts 1, 3 and 4 were 52-week, open-label studies. Part 2 consisted of a 16-week initial treatment period (Period A; 2 : 1 risankizumab: ustekinumab randomization), followed by up to 36-week randomized treatment or withdrawal period (Period B) for patients whose disease responded to risankizumab, with a potential 16-week retreatment period (Period C) for patients who experienced a disease flare. Patients whose disease did not respond to risankizumab and patients randomized to ustekinumab in Period A received risankizumab during Period B. Key outcomes were a static Physician’s Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1), sPGA 0 or 1 with ≥ 2-grade improvement (sPGA 0/1 + ≥ 2GI) or achievement of ≥ 75%, ≥ 90% or 100% improvement in Psoriasis Area and Severity Index (PASI 75/90/100). The study also assessed itch severity, quality of life and safety. Results: A total of 137 patients enrolled. In Part 2 (risankizumab, n = 54; ustekinumab, n = 28), week 16 response rates were similar: sPGA 0/1 was 80% (n = 43/54) for risankizumab and 75% (n = 21/28) for ustekinumab; sPGA 0/1 + ≥ 2GI rates were 69% (n = 37/54) vs. 68% (n = 19/28); PASI 75 rates were 85% (n = 46/54) vs. 86% (n = 24/28); and PASI 90 rates were 65% (n = 35/54) vs. 61% (n = 17/28). PASI 100 responses were higher with risankizumab (41%, n = 22/54) than with ustekinumab (18%, n = 5/28). In Part 4 (n = 30), week 16 rates were sPGA 0/1: 90% (n = 27/30), sPGA 0/1 + ≥ 2GI: 83% (n = 25/30), PASI 75: 87% (n = 26/30), PASI 90: 77% (n = 23/30) and PASI 100: 43% (n = 13/30); week 52 responses were maintained or improved. Skin clearance outcomes in Parts 1 and 3 were consistent with those observed with continuous risankizumab treatment in Parts 2 and 4. Improvements in itch and quality of life (assessed in Part 2 only) were observed at weeks 16 and 52. Risankizumab safety profiles were consistent with those observed in prior adult psoriasis studies. Conclusions: Risankizumab was well tolerated in paediatric patients, with marked improvements in skin clearance, itching and quality of life. Efficacy was maintained or improved at week 52, supporting risankizumab use for moderate-to-severe psoriasis in this population.

Prior to the approval of spesolimab as the first treatment for generalized pustular psoriasis (GPP), it was made available to patients via expanded access programmes in Japan, China and Argentina. As a secondary objective, the safety and tolerability of spesolimab was evaluated in a real-world population of patients with GPP.

Wound healing is a complex process, and although there are existing wound management therapies, they can be limited by poor response rate, cosmetic concerns and other procedure‐related risks. Umbilical cord (UC) and umbilical cord blood (UCB)‐based therapies have therefore emerged as an area of research interest that aims to address current limitations in wound management. This scoping review summarises the extent of research into these therapies, including mechanisms of action, clinical translation and artificial modifications. A systematic search of two electronic databases (PubMed and Embase‐Ovid) was carried out before supplementation with reference list screening and citation tracking. Of the 133 included articles, there were 20 in vitro studies, 19 review articles, 1 editorial, 16 human studies and 77 animal studies. UC and UCB‐based therapies consist of cellular and acellular factors that act through paracrine mechanisms rather than direct differentiation. Immunomodulation, growth stimulation, angiogenesis and anti‐apoptosis are the main mechanisms by which these therapies exert their effect, and initial reports provide some evidence that these therapies could be useful clinically. Nevertheless, such preliminary evidence is limited by study heterogeneity, short follow‐up durations and small sample sizes. Various modifications to these therapies, such as preconditioning, are also being explored to increase treatment yield. Although infection and multi‐organ effects are common safety concerns, current literature has also yet to establish long‐term safety. Preclinical data on UC‐based therapies appear promising; however, larger multicentric human trials are essential to validate clinical efficacy. Furthermore, comprehensive evaluations of safety and standardisation protocols will be critical for clinical translation.

Deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, is approved in multiple countries for the treatment of moderate to severe plaque psoriasis, as well as generalized pustular and erythrodermic psoriasis in Japan. Deucravacitinib 6 mg once daily was efficacious and well tolerated through 3 years in the pooled population of Japanese patients in the POETYK PSO‐1 and PSO‐4 trials who entered the ongoing open‐label POETYK long‐term extension trial. Safety and efficacy of deucravacitinib were evaluated through 5 years (256 weeks; data cutoff September 2, 2024) in Japanese patients who received continuous deucravacitinib in PSO‐1 or PSO‐4 or who crossed over from placebo to deucravacitinib at Week 16 in PSO‐1. Safety was evaluated via adverse event (AE) exposure‐adjusted incidence rates (EAIRs); efficacy was evaluated via endpoints including ≥ 75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) and static Physician Global Assessment (sPGA) score of 0/1 (clear/almost clear). At data cutoff, 136 patients had received at least one deucravacitinib dose; 77.2% had > 48 months and 39.7% had > 60 months of total deucravacitinib exposure. EAIRs per 100 person‐years were 182.1 (any AEs), 6.9 (serious AEs), 3.0 (discontinuations due to AEs), 1.6 (serious infections), 1.6 (herpes zoster events), 0.5 (major adverse cardiovascular events), and 1.4 (malignancies). Clinical responses (as observed) were maintained over 5 years in PSO‐1 patients receiving continuous deucravacitinib treatment from baseline (PASI 75: Year 1, 88.9%; Year 5, 85.7%; sPGA 0/1: Year 1, 74.1%; Year 5, 71.4%); results were consistent regardless of imputation method (modified nonresponder imputation, treatment failure rule). Year 1 response rates were also maintained through Year 5 in PSO‐4 patients and in PSO‐1 patients who crossed over from placebo. These findings support the long‐term safety and durable efficacy profile of deucravacitinib through 5 years in Japanese patients with psoriasis.

Topical therapy is the typical first‐line treatment for psoriasis, with the International Psoriasis Council recommending systemic therapy for patients with body surface area > 10%, high‐impact site involvement, or topical therapy failure. A recent Japanese Delphi Consensus Study proposed a definition for topical failure that considers time on therapy, failure to respond, flare on therapy, and other concepts. Using 2 real‐world data sources, this study aimed to describe topical cycling and evaluate systemic therapy eligibility among patients with psoriasis in Japan. With DeSC insurance claims data (January 1, 2017, to August 31, 2024), we evaluated topical therapy treatment patterns before systemic treatment initiation. With data from the Japanese subgroup of the UPLIFT survey, we applied recommendations from the Japan Delphi Study to estimate the proportion of patients receiving topical therapy who may be eligible for systemic treatment. Of 6361 patients with psoriasis from the DeSC database, at least 1 dispensing of a topical therapy (index event) and no systemic treatment at index, 9.5% initiated systemic therapy during follow‐up (mean time to initiation 712.5 days). Most patients began with strong/very strong corticosteroids (35.0%) or combinations of topical therapies (± vitamin D; 41.8%), with a shift toward predominantly combination regimens during follow‐up. Most patients received multiple topical therapy classes before initiating systemic therapy (mean unique classes: 3.8). Of 137 Japanese UPLIFT survey respondents with psoriasis with or without psoriatic arthritis using only topical therapy, 92.7% met at least 1 of the 7 Delphi consensus recommendations assessed, indicating potential eligibility for systemic treatment; 87.6% met more than 1 recommendation and 57.7% met 3 or more. Our findings suggest that many Japanese adults with psoriasis who may be eligible for systemic therapy may be undertreated and highlight the need to apply eligibility criteria for systemic treatment in clinical practice, which could improve long‐term patient outcomes.

Infantile hemangioma (IH) characteristically progresses through proliferative, involuting, and involuted phases, and typically undergoes spontaneous regression after the age of five. Therefore, the traditional management strategy has been based on a “wait‐and‐see policy”. However, the degree and tempo of proliferation vary considerably among individuals, and rapid enlargement can lead to functional impairment or ulceration. Moreover, in some cases, significant residual skin changes may persist even after involution. In Japan, pulsed dye laser (PDL) therapy was approved for insurance coverage in 1996, and early intervention during the proliferative phase has since become the standard approach to prevent such complications. At our institution, we have also actively implemented early PDL therapy, with oral propranolol added in selected cases. We conducted a retrospective analysis of 92 patients with 107 IH lesions who initiated PDL therapy at our dermatology department between January 2014 and December 2022. Earlier initiation of laser treatment was significantly associated with an earlier peak in tumor size ( r = 0.80, p < 0.0001). Furthermore, evaluation of residual skin changes after treatment completion revealed that the nodular type exhibited significantly more severe residual skin changes than the other morphological subtypes (Fisher's exact test, p < 0.0001). A peak size ≥ 3 cm ² was also identified as a risk factor for severe residual skin changes (multivariate logistic regression analysis, odds ratio 21.6, 95% confidence interval 2.93–358, p = 0.0090). In contrast, low birth weight and prematurity were not associated with an increased risk of severe residual skin changes when laser treatment was initiated. In conclusion, early PDL initiation was associated with earlier peak lesion size in IHs. Nodular‐type lesions and peak size ≥ 3 cm ² predicted severe long‐term residual skin changes, supporting early risk stratification and timely consideration of systemic therapy in high‐risk cases.

Inflammatory skin diseases and ocular disorders frequently coexist due to shared embryological origins, overlapping immune pathways, and common barrier functions. The increasing use of targeted systemic therapies in dermatology has further highlighted the skin - eye interface, introducing both therapeutic benefits and iatrogenic ocular complications. This review outlines the shared embryological and immunological mechanisms linking the skin and ocular surface, with emphasis on major inflammatory pathways, including TNF-α, Th17, and JAK-STAT signaling. We summarize the prevalence and spectrum of ocular involvement across common inflammatory skin diseases such as psoriasis, atopic dermatitis, rosacea, pemphigus vulgaris, and ocular mucous membrane pemphigoid. In addition, we evaluate ocular adverse effects associated with commonly used dermatologic therapies, highlighting the emerging phenomenon of iatrogenic and paradoxical inflammation. Ocular manifestations arising from both disease-associated and iatrogenic etiologies remain underrecognized in clinical practice. Early recognition, interdisciplinary collaboration, and risk-adapted strategies, including care accessibility and patient education, are essential to prevent vision-threatening complications. A shift from reactive care to proactive, risk-stratified screening based on individual patient risk profiles can improve clinical outcomes across the skin - eye axis.

Palmoplantar pustulosis (PPP) is an inflammatory skin disease characterized by chronic and relapsing eruptions of multiple sterile pustules on the palms and soles, which subsequently crust and desquamate. In addition to pustules, vesicles and pustulo‐vesicles are often observed simultaneously. It is more prevalent among Japanese individuals, and the number of affected patients in Japan is estimated to be approximately 140,000 based on national health insurance claims data in Japan. Sterile osteitis occurs in 10%–30% of patients with PPP or a history of PPP, a condition referred to as pustulotic arthro‐osteitis. Because it has become evident that focal infections act as triggering factors in approximately 80% of both conditions, their therapeutic algorithms differ fundamentally from those for psoriasis. The aim of the Treatment Guidance for Palmoplantar Pustulosis 2022 was to clarify the clinical manifestations and histopathological findings supporting the diagnosis of PPP, and to explain treatment algorithms and recommendation grades based on differences in triggering factors and pathophysiology between PPP and psoriasis. Although the level of evidence is limited due to the ethical and practical difficulties in conducting rigorous double‐blinde clinical trials to evaluate the efficacy of focal infection treatment, the treatment recommendations were determined through expert consensus based on extensive clinical experience accumulated in Japan, together with relevant basic research findings.