Pub Date : 2025-12-19DOI: 10.1007/s13555-025-01618-5
Jonathan I Silverberg, Eric Simpson, Melinda Gooderham, Stephan Weidinger, Melissa Watkins, Justine Alderfer
Atopic dermatitis (AD) is a chronic inflammatory skin condition characterized by intense itching, redness, and eczema. It significantly impacts the quality of life of affected individuals, often requiring long-term management strategies. Abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor, is approved for the treatment of moderate-to-severe AD. Phase 2 and phase 3 abrocitinib randomized clinical trials in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) clinical development program have demonstrated the efficacy and safety of abrocitinib in both adults and adolescents with moderate-to-severe AD. This review article explores the benefit-risk profile of a flexible abrocitinib dosing approach, tailoring dose based on individualized treatment of patients and highlighting the available supportive data from the JADE randomized clinical trials for healthcare professionals as part of joint provider-patient decision making. Dosing flexibility and maintenance with the lowest effective dose is necessary to treat patients according to their individual disease course while minimizing safety risks. Safety data indicate that incidence of treatment-emergent adverse events is reflective of the current dosage, with no carry-over risk from a previous higher dosage. Overall, abrocitinib represents a valuable AD therapy that can be administered according to individual patient needs.Graphical abstract available for this article.
{"title":"Tailoring Abrocitinib Treatment for Moderate-to-Severe Atopic Dermatitis to Patient Disease Course: A Narrative Review.","authors":"Jonathan I Silverberg, Eric Simpson, Melinda Gooderham, Stephan Weidinger, Melissa Watkins, Justine Alderfer","doi":"10.1007/s13555-025-01618-5","DOIUrl":"https://doi.org/10.1007/s13555-025-01618-5","url":null,"abstract":"<p><p>Atopic dermatitis (AD) is a chronic inflammatory skin condition characterized by intense itching, redness, and eczema. It significantly impacts the quality of life of affected individuals, often requiring long-term management strategies. Abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor, is approved for the treatment of moderate-to-severe AD. Phase 2 and phase 3 abrocitinib randomized clinical trials in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) clinical development program have demonstrated the efficacy and safety of abrocitinib in both adults and adolescents with moderate-to-severe AD. This review article explores the benefit-risk profile of a flexible abrocitinib dosing approach, tailoring dose based on individualized treatment of patients and highlighting the available supportive data from the JADE randomized clinical trials for healthcare professionals as part of joint provider-patient decision making. Dosing flexibility and maintenance with the lowest effective dose is necessary to treat patients according to their individual disease course while minimizing safety risks. Safety data indicate that incidence of treatment-emergent adverse events is reflective of the current dosage, with no carry-over risk from a previous higher dosage. Overall, abrocitinib represents a valuable AD therapy that can be administered according to individual patient needs.Graphical abstract available for this article.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145780398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cutaneous T cell lymphomas (CTCL) are non-Hodgkin T cell malignancies defined by malignant T cell transformation and accumulation in the skin. Limited understanding of CTCL pathogenesis, including the role of the tumor microenvironment, hinders effective treatment. Emerging evidence implicates the skin microbiota as a key modulator of disease, with microbial dysbiosis contributing to progression and representing a novel therapeutic target. This review synthesizes findings from 37 rigorously selected studies, outlining current knowledge of the CTCL-associated microbiome, mycobiome, and virome. It evaluates therapeutic strategies aimed at microbial colonization, emphasizing the potential of modulating host-microbe interactions. Additionally, we provide comprehensive clinical insight into the indications for microbial-modulating strategies of the microbiota in CTCL.
{"title":"Clinical Implications of the Skin Microbiota in the Therapy of Cutaneous T Cell Lymphoma: A Scoping Review.","authors":"Sonia Czyz, Joshua Quan, Kerry Yang, Raed Alhusayen, Jori Hardin","doi":"10.1007/s13555-025-01619-4","DOIUrl":"https://doi.org/10.1007/s13555-025-01619-4","url":null,"abstract":"<p><p>Cutaneous T cell lymphomas (CTCL) are non-Hodgkin T cell malignancies defined by malignant T cell transformation and accumulation in the skin. Limited understanding of CTCL pathogenesis, including the role of the tumor microenvironment, hinders effective treatment. Emerging evidence implicates the skin microbiota as a key modulator of disease, with microbial dysbiosis contributing to progression and representing a novel therapeutic target. This review synthesizes findings from 37 rigorously selected studies, outlining current knowledge of the CTCL-associated microbiome, mycobiome, and virome. It evaluates therapeutic strategies aimed at microbial colonization, emphasizing the potential of modulating host-microbe interactions. Additionally, we provide comprehensive clinical insight into the indications for microbial-modulating strategies of the microbiota in CTCL.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145793488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-18DOI: 10.1007/s13555-025-01617-6
Joong Heon Suh, Ji-Young Kim, Ji Young Yoon, Jun Hyo Lee, Dong Hyo Kim, Ungsik Jin, Dae Hun Suh
Introduction: Management of atrophic acne scars remains challenging, and conventional treatments often yield suboptimal or inconsistent outcomes. Stromal vascular fraction (SVF), a cell-rich fraction derived from adipose tissue, has recently gained attention as a promising regenerative therapy. Several previous studies have reported benefits of SVF when combined with other treatment modalities; however, its stand-alone efficacy for atrophic acne scars has not been clearly investigated. In addition, molecular evidence supporting the regenerative effects of SVF in acne scar treatment remains limited.
Methods: This randomized, evaluator-blinded, split-face clinical trial was conducted in 14 patients with bilateral facial atrophic acne scars. One side was treated with intradermal SVF injection, while the contralateral side received normal saline (NS). Clinical outcomes were assessed using scar counts, Évaluation Clinique des Cicatrices d'Acne (ECCA) scores, Scar Global Assessment (SGA) scores, and standardized photography at baseline, 5 weeks, and 10 weeks. Skin biopsies were analyzed via immunohistochemistry for markers of epidermal regeneration (cytokeratin 14, cytokeratin 15, p63, integrin β1) and dermal remodeling (collagen I, elastin, vimentin).
Results: At 10 weeks after initial treatment, the SVF-treated side showed a significantly greater reduction in total scar count compared to the NS-treated side (56.4% vs. 13.2%, p < 0.001). Scar subtype analysis revealed that all scar types (ice pick, boxcar, and rolling) responded more favorably to SVF treatment, with large effect sizes (Cohen's d > 0.99). ECCA and SGA scores were also significantly decreased on the SVF-treated side. Immunohistochemical analysis revealed marked upregulation of epidermal progenitor markers and increased deposition of collagen I, elastin, and vimentin in the SVF-treated tissue.
Conclusion: We clinically demonstrated that SVF injection improves atrophic acne scars and simultaneously revealed its regenerative mechanisms involving epidermal and dermal remodeling. This supports the use of SVF as an evidence-based treatment modality for atrophic acne scars.
简介:萎缩性痤疮疤痕的管理仍然具有挑战性,传统的治疗方法往往产生次优或不一致的结果。基质血管组分(SVF)是一种来源于脂肪组织的富含细胞的组分,近年来作为一种有前景的再生疗法而受到关注。先前的几项研究报告了SVF与其他治疗方式联合使用的益处;然而,其对萎缩性痤疮疤痕的独立疗效尚未得到明确的研究。此外,支持SVF在痤疮疤痕治疗中的再生作用的分子证据仍然有限。方法:对14例双侧面部萎缩性痤疮疤痕患者进行随机、评价者双盲、裂面临床试验。一侧皮下注射SVF,对侧皮下注射生理盐水。临床结果通过疤痕计数、Évaluation疤痕痤疮临床(ECCA)评分、疤痕总体评估(SGA)评分和基线、5周和10周的标准化摄影进行评估。通过免疫组化分析皮肤活检组织中表皮再生标志物(细胞角蛋白14、细胞角蛋白15、p63、整合素β1)和真皮重塑标志物(I型胶原、弹性蛋白、波形蛋白)。结果:在初始治疗后10周,svf治疗侧的疤痕总数明显比ns治疗侧减少(56.4% vs. 13.2%, p 0.99)。svf治疗侧的ECCA和SGA评分也显著降低。免疫组织化学分析显示,在svf处理的组织中,表皮祖细胞标志物明显上调,胶原I、弹性蛋白和波形蛋白的沉积增加。结论:我们临床证明SVF注射改善萎缩性痤疮疤痕,同时揭示了其涉及表皮和真皮重塑的再生机制。这支持使用SVF作为萎缩性痤疮疤痕的循证治疗方式。试验注册:ClinicalTrials.gov标识符,NCT07094958。
{"title":"Comparison of Efficacy of Intradermal Stromal Vascular Fraction Injection Versus Saline Injection in the Treatment of Atrophic Acne Scar: A 10-Week, Prospective, Randomized, Split-Face, Single-Blind Controlled Trial.","authors":"Joong Heon Suh, Ji-Young Kim, Ji Young Yoon, Jun Hyo Lee, Dong Hyo Kim, Ungsik Jin, Dae Hun Suh","doi":"10.1007/s13555-025-01617-6","DOIUrl":"https://doi.org/10.1007/s13555-025-01617-6","url":null,"abstract":"<p><strong>Introduction: </strong>Management of atrophic acne scars remains challenging, and conventional treatments often yield suboptimal or inconsistent outcomes. Stromal vascular fraction (SVF), a cell-rich fraction derived from adipose tissue, has recently gained attention as a promising regenerative therapy. Several previous studies have reported benefits of SVF when combined with other treatment modalities; however, its stand-alone efficacy for atrophic acne scars has not been clearly investigated. In addition, molecular evidence supporting the regenerative effects of SVF in acne scar treatment remains limited.</p><p><strong>Methods: </strong>This randomized, evaluator-blinded, split-face clinical trial was conducted in 14 patients with bilateral facial atrophic acne scars. One side was treated with intradermal SVF injection, while the contralateral side received normal saline (NS). Clinical outcomes were assessed using scar counts, Évaluation Clinique des Cicatrices d'Acne (ECCA) scores, Scar Global Assessment (SGA) scores, and standardized photography at baseline, 5 weeks, and 10 weeks. Skin biopsies were analyzed via immunohistochemistry for markers of epidermal regeneration (cytokeratin 14, cytokeratin 15, p63, integrin β1) and dermal remodeling (collagen I, elastin, vimentin).</p><p><strong>Results: </strong>At 10 weeks after initial treatment, the SVF-treated side showed a significantly greater reduction in total scar count compared to the NS-treated side (56.4% vs. 13.2%, p < 0.001). Scar subtype analysis revealed that all scar types (ice pick, boxcar, and rolling) responded more favorably to SVF treatment, with large effect sizes (Cohen's d > 0.99). ECCA and SGA scores were also significantly decreased on the SVF-treated side. Immunohistochemical analysis revealed marked upregulation of epidermal progenitor markers and increased deposition of collagen I, elastin, and vimentin in the SVF-treated tissue.</p><p><strong>Conclusion: </strong>We clinically demonstrated that SVF injection improves atrophic acne scars and simultaneously revealed its regenerative mechanisms involving epidermal and dermal remodeling. This supports the use of SVF as an evidence-based treatment modality for atrophic acne scars.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier, NCT07094958.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145780415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-18DOI: 10.1007/s13555-025-01600-1
Han B Kim, Ji Y Um, Bo Y Chung, Chun W Park, Hye O Kim
Chronic spontaneous urticaria (CSU) is a debilitating inflammatory skin disorder characterized by recurrent wheals and/or angioedema lasting beyond 6 weeks without identifiable triggers. Recent advances have shifted the understanding of CSU from a historically idiopathic condition to one increasingly recognized as an immune-mediated disease with distinct endotypes, including type I (autoallergic) and type IIb (autoimmune). This narrative review synthesizes contemporary insights into CSU pathophysiology, endotype classification, and systemic manifestations, while highlighting the substantial impact on quality of life, sleep, and psychological health. Advances in biomarker research, including total serum immunoglobulin E (IgE) levels, basophil activation tests (BAT), and eosinophil counts, support progress toward personalized treatment approaches. Therapeutically, management of CSU has evolved from empirical symptom control with H1 antihistamines toward mechanism-based precision medicine. Omalizumab remains the established second-line therapy, and dupilumab received US Food and Drug Administration (FDA) approval in 2025 for antihistamine-refractory disease. In parallel, several targeted therapies are under investigation, including Bruton's tyrosine kinase (BTK) inhibitors, anti-KIT antibodies, and Janus kinase (JAK) inhibitors. These therapeutic mechanisms may offer sustained benefit, though long-term outcomes require validation through controlled trials. Integration of psychological interventions, such as cognitive behavioral therapy combined with pharmacotherapy, underscores the need for holistic patient care. Despite these advances, challenges remain in biomarker validation, sequencing of new therapies, and bridging clinical trial evidence with real-world practice. Future directions include refining endotype-driven personalized care, conducting long-term real-world studies, and developing cost-effective, globally accessible treatment strategies to optimize patient outcomes.
{"title":"Advances in Pathophysiology and Therapeutic Paradigm Shifts in Chronic Spontaneous Urticaria: A Narrative Review.","authors":"Han B Kim, Ji Y Um, Bo Y Chung, Chun W Park, Hye O Kim","doi":"10.1007/s13555-025-01600-1","DOIUrl":"https://doi.org/10.1007/s13555-025-01600-1","url":null,"abstract":"<p><p>Chronic spontaneous urticaria (CSU) is a debilitating inflammatory skin disorder characterized by recurrent wheals and/or angioedema lasting beyond 6 weeks without identifiable triggers. Recent advances have shifted the understanding of CSU from a historically idiopathic condition to one increasingly recognized as an immune-mediated disease with distinct endotypes, including type I (autoallergic) and type IIb (autoimmune). This narrative review synthesizes contemporary insights into CSU pathophysiology, endotype classification, and systemic manifestations, while highlighting the substantial impact on quality of life, sleep, and psychological health. Advances in biomarker research, including total serum immunoglobulin E (IgE) levels, basophil activation tests (BAT), and eosinophil counts, support progress toward personalized treatment approaches. Therapeutically, management of CSU has evolved from empirical symptom control with H1 antihistamines toward mechanism-based precision medicine. Omalizumab remains the established second-line therapy, and dupilumab received US Food and Drug Administration (FDA) approval in 2025 for antihistamine-refractory disease. In parallel, several targeted therapies are under investigation, including Bruton's tyrosine kinase (BTK) inhibitors, anti-KIT antibodies, and Janus kinase (JAK) inhibitors. These therapeutic mechanisms may offer sustained benefit, though long-term outcomes require validation through controlled trials. Integration of psychological interventions, such as cognitive behavioral therapy combined with pharmacotherapy, underscores the need for holistic patient care. Despite these advances, challenges remain in biomarker validation, sequencing of new therapies, and bridging clinical trial evidence with real-world practice. Future directions include refining endotype-driven personalized care, conducting long-term real-world studies, and developing cost-effective, globally accessible treatment strategies to optimize patient outcomes.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin condition requiring long-term management to maintain remission and prevent relapse. Appropriate use of topical anti-inflammatory medications is an important factor in improving symptoms in patients with AD. This study aimed to investigate the treatment methods for maintaining remission and application of anti-inflammatory topical therapy.
Methods: This observational study was conducted in October 2022, using medical claims data from DeSC Healthcare Inc., linked with survey data collected from users of kencom®, a health promotion application. Eligible patients were adults aged ≥ 19 years with a confirmed AD diagnosis and prescription history. The survey evaluated (1) the actual treatment situation during the remission maintenance phase; and (2) instructions, actual status and adherence for application of anti-inflammatory topical therapy.
Results: A total of 626 patients who answered the kencom® survey and met eligibility criteria were included. Of these, 42.3% were instructed to stop medication once eczema improved, while 34.2% were instructed to continue during remission. Regarding instructions for the amount applied, the most common response was "No specific instructions" (44.2%), followed by "Fingertip-unit (FTU)" (27.2%). In actual practice, "FTU" was the most common amount (42.2%). Regarding application area, the most frequent instruction and actual practice were "Apply only to areas with eczema with remaining inflammation" at 52.6% and 62.5%, respectively, followed by "Apply not only to the eczema or remaining inflamed areas but also the surrounding areas" at 24.0% and 37.2%. Regarding the application method, "Apply thinly" was the most common instruction and actual practice at 32.7% and 48.4%, respectively. Treatment adherence rates were generally high, at over 60%.
Conclusion: Guidance from healthcare professionals has a crucial role in the proper use of topical therapies for AD. It is essential to ensure that topical medications are used properly to help patients achieve their treatment goals.
{"title":"Survey on the Actual Use of Topical Anti-Inflammatory Drugs Among Patients with Atopic Dermatitis.","authors":"Hiroyuki Murota, Shinichi Noto, Miyuki Matsukawa, Yasuhito Konishi, Daisaku Michikami, Rikiya Toda, Takeshi Nakahara","doi":"10.1007/s13555-025-01580-2","DOIUrl":"https://doi.org/10.1007/s13555-025-01580-2","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a chronic inflammatory skin condition requiring long-term management to maintain remission and prevent relapse. Appropriate use of topical anti-inflammatory medications is an important factor in improving symptoms in patients with AD. This study aimed to investigate the treatment methods for maintaining remission and application of anti-inflammatory topical therapy.</p><p><strong>Methods: </strong>This observational study was conducted in October 2022, using medical claims data from DeSC Healthcare Inc., linked with survey data collected from users of kencom®, a health promotion application. Eligible patients were adults aged ≥ 19 years with a confirmed AD diagnosis and prescription history. The survey evaluated (1) the actual treatment situation during the remission maintenance phase; and (2) instructions, actual status and adherence for application of anti-inflammatory topical therapy.</p><p><strong>Results: </strong>A total of 626 patients who answered the kencom® survey and met eligibility criteria were included. Of these, 42.3% were instructed to stop medication once eczema improved, while 34.2% were instructed to continue during remission. Regarding instructions for the amount applied, the most common response was \"No specific instructions\" (44.2%), followed by \"Fingertip-unit (FTU)\" (27.2%). In actual practice, \"FTU\" was the most common amount (42.2%). Regarding application area, the most frequent instruction and actual practice were \"Apply only to areas with eczema with remaining inflammation\" at 52.6% and 62.5%, respectively, followed by \"Apply not only to the eczema or remaining inflamed areas but also the surrounding areas\" at 24.0% and 37.2%. Regarding the application method, \"Apply thinly\" was the most common instruction and actual practice at 32.7% and 48.4%, respectively. Treatment adherence rates were generally high, at over 60%.</p><p><strong>Conclusion: </strong>Guidance from healthcare professionals has a crucial role in the proper use of topical therapies for AD. It is essential to ensure that topical medications are used properly to help patients achieve their treatment goals.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-13DOI: 10.1007/s13555-025-01615-8
Svenja Royeck, Anna Daphne Bamidis, Conrad Weckbecker, Silke C Hofmann, Sonja Ständer, Natalija Novak, Galina Balakirski, Dagmar Wilsmann-Theis
Introduction: Despite the expanding range of approved systemic therapies for atopic dermatitis (AD) and psoriasis (PSO), data on patient preferences remain limited. It is largely unknown whether patients wish to initiate systemic treatment, which route of administration (oral versus subcutaneous) they prefer, or what factors drive their treatment preferences. This study evaluated the desire for systemic therapy among systemic treatment-naïve patients with AD or PSO, including disease-specific influencing factors and preferences for administration routes (subcutaneous injections vs. tablets).
Methods: Eligible patients with AD or PSO were recruited at two German university hospitals. Questionnaires collected demographic and clinical data, including disease severity, pruritus and pain intensity, quality of life (QoL) impairment, and desire for systemic therapy. Data analysis comprised Mann-Whitney U tests (between-group comparisons), and Spearman correlations (factors influencing therapy desire).
Results: From 253 recruited patients, systemic treatment-naïve patients with moderate-to-severe disease severity exclusively using topical therapies were selected (56 with AD, 63 with PSO); 77.8% of patients with PSO and 67.9% of patients with AD desired systemic therapy, mainly for superior efficacy, QoL improvement, and pruritus reduction. Administration preferences differed significantly (PSO 57.1% injections; AD 73.7% tablets; p < 0.005). The desire for systemic therapy moderately correlated with pain intensity (ρ = 0.422, p < 0.001) and QoL impairment (ρ = 0.379, p < 0.005) in AD and with male sex in PSO (ρ = 0.347, p < 0.005).
Conclusions: Most topically treated patients with moderate-to-severe AD or PSO desire systemic therapy, with distinct disease-specific administration preferences.
{"title":"Treatment Preferences Among Systemic Therapy-Naïve Patients with Atopic Dermatitis or Psoriasis in Germany: A Multicentre Study.","authors":"Svenja Royeck, Anna Daphne Bamidis, Conrad Weckbecker, Silke C Hofmann, Sonja Ständer, Natalija Novak, Galina Balakirski, Dagmar Wilsmann-Theis","doi":"10.1007/s13555-025-01615-8","DOIUrl":"https://doi.org/10.1007/s13555-025-01615-8","url":null,"abstract":"<p><strong>Introduction: </strong>Despite the expanding range of approved systemic therapies for atopic dermatitis (AD) and psoriasis (PSO), data on patient preferences remain limited. It is largely unknown whether patients wish to initiate systemic treatment, which route of administration (oral versus subcutaneous) they prefer, or what factors drive their treatment preferences. This study evaluated the desire for systemic therapy among systemic treatment-naïve patients with AD or PSO, including disease-specific influencing factors and preferences for administration routes (subcutaneous injections vs. tablets).</p><p><strong>Methods: </strong>Eligible patients with AD or PSO were recruited at two German university hospitals. Questionnaires collected demographic and clinical data, including disease severity, pruritus and pain intensity, quality of life (QoL) impairment, and desire for systemic therapy. Data analysis comprised Mann-Whitney U tests (between-group comparisons), and Spearman correlations (factors influencing therapy desire).</p><p><strong>Results: </strong>From 253 recruited patients, systemic treatment-naïve patients with moderate-to-severe disease severity exclusively using topical therapies were selected (56 with AD, 63 with PSO); 77.8% of patients with PSO and 67.9% of patients with AD desired systemic therapy, mainly for superior efficacy, QoL improvement, and pruritus reduction. Administration preferences differed significantly (PSO 57.1% injections; AD 73.7% tablets; p < 0.005). The desire for systemic therapy moderately correlated with pain intensity (ρ = 0.422, p < 0.001) and QoL impairment (ρ = 0.379, p < 0.005) in AD and with male sex in PSO (ρ = 0.347, p < 0.005).</p><p><strong>Conclusions: </strong>Most topically treated patients with moderate-to-severe AD or PSO desire systemic therapy, with distinct disease-specific administration preferences.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145741546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This Summary of Research provides an overview of the results of a phase 3 study that assessed the efficacy and safety of apremilast in Japanese patients with moderate to severe palmoplantar pustulosis (PPP) who had not responded to topical treatment (NCT05174065). Patients were randomized to apremilast or placebo for 16 weeks, after which patients randomized to placebo transitioned to apremilast through 52 weeks. This study showed that apremilast significantly improved PPP clinical severity, symptoms, and patient-reported quality of life compared with placebo after 16 weeks of treatment. The benefits of apremilast were maintained or further improved over 52 weeks of treatment. The most common side effects (experienced by > 10% of patients) included diarrhea, nasopharyngitis, nausea, soft stool, and headache, and were consistent with previous studies of apremilast. Side effects were mainly mild to moderate. The results from this phase 3 study support apremilast as a systemic oral treatment option for patients with PPP with inadequate response to topical treatment, for whom treatment options are limited.
{"title":"Summary of Research: Apremilast in Japanese Patients with Palmoplantar Pustulosis: A Randomized, Phase 3 Trial.","authors":"Tadashi Terui, Yukari Okubo, Satomi Kobayashi, Akimichi Morita, Shinichi Imafuku, Yayoi Tada, Masatoshi Abe, Bruce Strober, Melinda Gooderham, Yasuhito Hara, Wendy Zhang, Junichiro Shimauchi, Masafumi Yaguchi, Takeshi Kimura, Ryuichi Ogawa, Hamid Amouzadeh, Masamoto Murakami","doi":"10.1007/s13555-025-01583-z","DOIUrl":"https://doi.org/10.1007/s13555-025-01583-z","url":null,"abstract":"<p><p>This Summary of Research provides an overview of the results of a phase 3 study that assessed the efficacy and safety of apremilast in Japanese patients with moderate to severe palmoplantar pustulosis (PPP) who had not responded to topical treatment (NCT05174065). Patients were randomized to apremilast or placebo for 16 weeks, after which patients randomized to placebo transitioned to apremilast through 52 weeks. This study showed that apremilast significantly improved PPP clinical severity, symptoms, and patient-reported quality of life compared with placebo after 16 weeks of treatment. The benefits of apremilast were maintained or further improved over 52 weeks of treatment. The most common side effects (experienced by > 10% of patients) included diarrhea, nasopharyngitis, nausea, soft stool, and headache, and were consistent with previous studies of apremilast. Side effects were mainly mild to moderate. The results from this phase 3 study support apremilast as a systemic oral treatment option for patients with PPP with inadequate response to topical treatment, for whom treatment options are limited.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145741544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-12DOI: 10.1007/s13555-025-01612-x
Martin Schaller, Belinda Welsh, Giuseppe Micali, Jerry Tan, James Del Rosso, Julie Harper, Thomas Dirschka, Soyun Cho, Luiz M C Almeida, Khen Kon, Wioletta Barańska-Rybak, Johannes Dayrit, Linda Stein Gold
Rosacea is a common, chronic, inflammatory disease of the skin, which predominantly (but not exclusively) affects the centrofacial region. Clinical features may include transient or persistent facial erythema, recurrent flushing, telangiectasia, papules, pustules, phymatous changes, and ocular disturbances. These can lead to significant physical and psychological burden and discomfort, which adversely affects a patient's quality of life (QoL). While current guidelines provide recommendations on treatment initiation and modification, there is a lack of information for long-term management and maintenance. The Rosacea-Expert Advice on Combined and Holistic approaches (REACH) group is an international group of experienced dermatologists, brought together to address these shortcomings. This paper summarizes discussions from three REACH Global Scientific Committee (GSC) meetings, with the objective to simplify the rosacea management pathway and ensure that healthcare professionals are aware of rosacea triggers, pathogenesis, risk factors, comorbidities, chronicity, patient satisfaction, monitoring, and treatment options. The REACH GSC developed a rosacea management pathway as a backbone for this publication-to advise on each step, including pitfalls to avoid, patient discussions to conduct, tools and guidelines to employ, and clinical factors to consider. Being able to discern all the clinical features of rosacea specific to each patient is imperative, from recognizing overriding signs and symptoms to understanding potential comorbidities and assessing impact on QoL. Clear and sensitive communication regarding these elements, and what outcomes are achievable, will help to optimize therapeutic management and foster a sense of patient empowerment and disease control. For patients, being able to engage in their own long-term care of symptoms, signs, and flares is critical. Deepening the understanding of the condition as a chronic, yet eminently manageable one, will help empower patients with rosacea and their dermatologists alike. The REACH GSC project was initiated and funded by Galderma.
{"title":"Exploring New Dimensions in Longitudinal Rosacea Management.","authors":"Martin Schaller, Belinda Welsh, Giuseppe Micali, Jerry Tan, James Del Rosso, Julie Harper, Thomas Dirschka, Soyun Cho, Luiz M C Almeida, Khen Kon, Wioletta Barańska-Rybak, Johannes Dayrit, Linda Stein Gold","doi":"10.1007/s13555-025-01612-x","DOIUrl":"https://doi.org/10.1007/s13555-025-01612-x","url":null,"abstract":"<p><p>Rosacea is a common, chronic, inflammatory disease of the skin, which predominantly (but not exclusively) affects the centrofacial region. Clinical features may include transient or persistent facial erythema, recurrent flushing, telangiectasia, papules, pustules, phymatous changes, and ocular disturbances. These can lead to significant physical and psychological burden and discomfort, which adversely affects a patient's quality of life (QoL). While current guidelines provide recommendations on treatment initiation and modification, there is a lack of information for long-term management and maintenance. The Rosacea-Expert Advice on Combined and Holistic approaches (REACH) group is an international group of experienced dermatologists, brought together to address these shortcomings. This paper summarizes discussions from three REACH Global Scientific Committee (GSC) meetings, with the objective to simplify the rosacea management pathway and ensure that healthcare professionals are aware of rosacea triggers, pathogenesis, risk factors, comorbidities, chronicity, patient satisfaction, monitoring, and treatment options. The REACH GSC developed a rosacea management pathway as a backbone for this publication-to advise on each step, including pitfalls to avoid, patient discussions to conduct, tools and guidelines to employ, and clinical factors to consider. Being able to discern all the clinical features of rosacea specific to each patient is imperative, from recognizing overriding signs and symptoms to understanding potential comorbidities and assessing impact on QoL. Clear and sensitive communication regarding these elements, and what outcomes are achievable, will help to optimize therapeutic management and foster a sense of patient empowerment and disease control. For patients, being able to engage in their own long-term care of symptoms, signs, and flares is critical. Deepening the understanding of the condition as a chronic, yet eminently manageable one, will help empower patients with rosacea and their dermatologists alike. The REACH GSC project was initiated and funded by Galderma.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145741467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-12DOI: 10.1007/s13555-025-01599-5
Diamant Thaçi, Akihiko Asahina, Wolf-Henning Boehncke, Alice B Gottlieb, Mark Lebwohl, Richard B Warren, Heather Edens, Barbara Ink, Rajan Bajracharya, Jason Coarse, Joseph F Merola
<p><strong>Introduction: </strong>Individuals with psoriatic arthritis (PsA) and plaque-type psoriasis and nail involvement have more severe disease and worse quality of life than those without. Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. Here, we assess 52-week efficacy and safety of bimekizumab in individuals with PsA who had baseline plaque-type psoriasis (≥ 3% body surface area) and nail involvement (modified Nail Psoriasis Severity Index [mNAPSI] > 0).</p><p><strong>Methods: </strong>We conducted a post hoc analysis of BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [biologic]-naïve patients) and BE COMPLETE/BE VITAL open-label extension (NCT03896581/NCT04009499; patients with prior inadequate response/intolerance to tumour necrosis factor inhibitors [TNFi-IR]). Participants were randomised to subcutaneously administered bimekizumab 160 mg every 4 weeks (Q4W), placebo or reference arm (adalimumab 40 mg Q2W; BE OPTIMAL only). At week 16, placebo-randomised participants switched to bimekizumab (PBO/BKZ). Participants who completed BE COMPLETE week 16 could enter BE VITAL. Efficacy and safety data are reported by study to week 52. Efficacy outcomes included American College of Rheumatology ≥ 50% improvement (ACR50), Psoriasis Area and Severity Index 100% improvement (PASI100) and nail psoriasis resolution (mNAPSI = 0).</p><p><strong>Results: </strong>Overall, 263 (placebo n = 88; bimekizumab n = 133; reference [adalimumab] n = 42) biologic-naïve and 159 (placebo n = 54; bimekizumab n = 105) TNFi-IR participants had baseline plaque-type psoriasis and nail involvement. In bimekizumab-randomised participants with baseline plaque-type psoriasis and nail involvement, improvements in the proportion of participants achieving efficacy responses across disease domains were sustained from week 16 to week 52, including ACR50 (65.4% biologic-naïve; 61.0% TNFi-IR), PASI100 (60.9%; 63.8%), and mNAPSI = 0 (68.4%; 70.5%). PBO/BKZ switchers demonstrated improvements from week 16 to week 52 after receiving 36 weeks of bimekizumab treatment, for ACR50 (63.6% biologic-naïve; 51.9% TNFi-IR), PASI100 (64.8%; 57.4%), and mNAPSI = 0 (73.9%; 63.0%). To week 52, exposure-adjusted incidence rates/100 patient years for ≥ 1 treatment-emergent adverse event in all bimekizumab-treated (≥ 1 dose) participants with baseline plaque-type psoriasis and nail involvement were 181.1 (biologic-naïve) and 99.2 (TNFi-IR).</p><p><strong>Conclusions: </strong>Bimekizumab treatment resulted in consistent, sustained efficacy to 52 weeks in biologic-naïve and TNFi-IR individuals with PsA and baseline plaque-type psoriasis and nail involvement. Bimekizumab was well tolerated, with a safety profile consistent with previous reports. Graphical abstract available for this article.</p><p><strong>Trial registration: </strong>BE OPTIMAL: NCT03895203; BE COMPLETE: NCT03896581; BE VITAL: NCT04009499 (ClinicalTr
{"title":"Bimekizumab Efficacy and Safety in Patients with Psoriatic Arthritis with Substantial Skin and Nail Psoriasis to 1 Year.","authors":"Diamant Thaçi, Akihiko Asahina, Wolf-Henning Boehncke, Alice B Gottlieb, Mark Lebwohl, Richard B Warren, Heather Edens, Barbara Ink, Rajan Bajracharya, Jason Coarse, Joseph F Merola","doi":"10.1007/s13555-025-01599-5","DOIUrl":"https://doi.org/10.1007/s13555-025-01599-5","url":null,"abstract":"<p><strong>Introduction: </strong>Individuals with psoriatic arthritis (PsA) and plaque-type psoriasis and nail involvement have more severe disease and worse quality of life than those without. Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. Here, we assess 52-week efficacy and safety of bimekizumab in individuals with PsA who had baseline plaque-type psoriasis (≥ 3% body surface area) and nail involvement (modified Nail Psoriasis Severity Index [mNAPSI] > 0).</p><p><strong>Methods: </strong>We conducted a post hoc analysis of BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [biologic]-naïve patients) and BE COMPLETE/BE VITAL open-label extension (NCT03896581/NCT04009499; patients with prior inadequate response/intolerance to tumour necrosis factor inhibitors [TNFi-IR]). Participants were randomised to subcutaneously administered bimekizumab 160 mg every 4 weeks (Q4W), placebo or reference arm (adalimumab 40 mg Q2W; BE OPTIMAL only). At week 16, placebo-randomised participants switched to bimekizumab (PBO/BKZ). Participants who completed BE COMPLETE week 16 could enter BE VITAL. Efficacy and safety data are reported by study to week 52. Efficacy outcomes included American College of Rheumatology ≥ 50% improvement (ACR50), Psoriasis Area and Severity Index 100% improvement (PASI100) and nail psoriasis resolution (mNAPSI = 0).</p><p><strong>Results: </strong>Overall, 263 (placebo n = 88; bimekizumab n = 133; reference [adalimumab] n = 42) biologic-naïve and 159 (placebo n = 54; bimekizumab n = 105) TNFi-IR participants had baseline plaque-type psoriasis and nail involvement. In bimekizumab-randomised participants with baseline plaque-type psoriasis and nail involvement, improvements in the proportion of participants achieving efficacy responses across disease domains were sustained from week 16 to week 52, including ACR50 (65.4% biologic-naïve; 61.0% TNFi-IR), PASI100 (60.9%; 63.8%), and mNAPSI = 0 (68.4%; 70.5%). PBO/BKZ switchers demonstrated improvements from week 16 to week 52 after receiving 36 weeks of bimekizumab treatment, for ACR50 (63.6% biologic-naïve; 51.9% TNFi-IR), PASI100 (64.8%; 57.4%), and mNAPSI = 0 (73.9%; 63.0%). To week 52, exposure-adjusted incidence rates/100 patient years for ≥ 1 treatment-emergent adverse event in all bimekizumab-treated (≥ 1 dose) participants with baseline plaque-type psoriasis and nail involvement were 181.1 (biologic-naïve) and 99.2 (TNFi-IR).</p><p><strong>Conclusions: </strong>Bimekizumab treatment resulted in consistent, sustained efficacy to 52 weeks in biologic-naïve and TNFi-IR individuals with PsA and baseline plaque-type psoriasis and nail involvement. Bimekizumab was well tolerated, with a safety profile consistent with previous reports. Graphical abstract available for this article.</p><p><strong>Trial registration: </strong>BE OPTIMAL: NCT03895203; BE COMPLETE: NCT03896581; BE VITAL: NCT04009499 (ClinicalTr","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145741460","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-10DOI: 10.1007/s13555-025-01610-z
William Göte Sindrup, Alex Birk Nielsen, Amanda Kvist-Hansen, Lone Skov
Over the past two decades, numerous highly effective biological treatments have been developed for patients with moderate-to-severe psoriasis. As a result of more effective therapies, treatment goals have shifted from a 50% to a 90% reduction in psoriasis area and severity index. Although randomized controlled trials provide some insight, they often include only a subset of patients, have short durations, and do not compare different treatments. Many patients respond well to these new treatments; however, some do not respond at all, whereas others experience a loss of effectiveness after an initial response. No definitive guidelines on the best time to start treatment or on how to choose the most suitable treatment for an individual patient have yet been established. Furthermore, it remains uncertain whether optimal treatment or specific therapy reduces the risk of developing comorbidities. Real-world data have revealed adverse effects, such as tuberculosis reactivation with tumor necrosis factor inhibitors, worsening of inflammatory bowel disease with interleukin-17 inhibitors, and potential cardiovascular events associated with particularly interleukin-12/23 inhibition. Studies from both clinical trials and real-world settings have also shown that patients with high body mass index, smokers, older individuals, and those with prior biological treatments tend to have poorer treatment outcomes. Recently, studies have indicated that genetic markers such as HLA-C*06:02, initial treatment response, and post-initiation drug concentration levels can predict treatment response. The integration of genetic markers, clinical data, and advanced technologies may aid in developing more personalized treatment plans for patients in the future.
{"title":"Drug Stratification Based on Real-World Evidence in Psoriasis: A Narrative Review.","authors":"William Göte Sindrup, Alex Birk Nielsen, Amanda Kvist-Hansen, Lone Skov","doi":"10.1007/s13555-025-01610-z","DOIUrl":"https://doi.org/10.1007/s13555-025-01610-z","url":null,"abstract":"<p><p>Over the past two decades, numerous highly effective biological treatments have been developed for patients with moderate-to-severe psoriasis. As a result of more effective therapies, treatment goals have shifted from a 50% to a 90% reduction in psoriasis area and severity index. Although randomized controlled trials provide some insight, they often include only a subset of patients, have short durations, and do not compare different treatments. Many patients respond well to these new treatments; however, some do not respond at all, whereas others experience a loss of effectiveness after an initial response. No definitive guidelines on the best time to start treatment or on how to choose the most suitable treatment for an individual patient have yet been established. Furthermore, it remains uncertain whether optimal treatment or specific therapy reduces the risk of developing comorbidities. Real-world data have revealed adverse effects, such as tuberculosis reactivation with tumor necrosis factor inhibitors, worsening of inflammatory bowel disease with interleukin-17 inhibitors, and potential cardiovascular events associated with particularly interleukin-12/23 inhibition. Studies from both clinical trials and real-world settings have also shown that patients with high body mass index, smokers, older individuals, and those with prior biological treatments tend to have poorer treatment outcomes. Recently, studies have indicated that genetic markers such as HLA-C*06:02, initial treatment response, and post-initiation drug concentration levels can predict treatment response. The integration of genetic markers, clinical data, and advanced technologies may aid in developing more personalized treatment plans for patients in the future.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145721426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}