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Efficacy and Safety of Zabedosertib, an Interleukin-1 Receptor-Associated Kinase 4 Inhibitor, in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase II Randomized Study. 白介素-1受体相关激酶4抑制剂Zabedosertib治疗中重度特应性皮炎的疗效和安全性:一项II期随机研究
IF 4.2 3区 医学
Dermatology and Therapy Pub Date : 2025-11-01 Epub Date: 2025-09-04 DOI: 10.1007/s13555-025-01505-z
Stefan J Jodl, Margitta Worm, Frauke Friedrichs, Ulrike Heinzel-Pleines, Andrea Wagenfeld, Maximilian Feldmüller, Stefan Klein, Ruiping Zhang, Kaweh Shakery, Ruth D Holzmann, Beate Rohde, Vidya Perera
{"title":"Efficacy and Safety of Zabedosertib, an Interleukin-1 Receptor-Associated Kinase 4 Inhibitor, in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase II Randomized Study.","authors":"Stefan J Jodl, Margitta Worm, Frauke Friedrichs, Ulrike Heinzel-Pleines, Andrea Wagenfeld, Maximilian Feldmüller, Stefan Klein, Ruiping Zhang, Kaweh Shakery, Ruth D Holzmann, Beate Rohde, Vidya Perera","doi":"10.1007/s13555-025-01505-z","DOIUrl":"10.1007/s13555-025-01505-z","url":null,"abstract":"<p><strong>Introduction: </strong>Interleukin-1 receptor-associated kinase 4 (IRAK4) is expressed in various immune cells and regulates proinflammatory cytokine production. Its inhibition represents a novel, promising therapeutic option in the treatment of atopic dermatitis (AD). Zabedosertib (BAY1834845) is a potent, selective IRAK4 inhibitor that suppresses markers of local and systemic immune responses. This study aimed to evaluate the efficacy and safety of zabedosertib in adults with moderate-to-severe AD.</p><p><strong>Methods: </strong>DAMASK was a randomized, double-blind, 12-week, placebo-controlled, phase 2a, proof-of-concept study. Patients were randomized 2:1 to receive oral zabedosertib 120 mg twice daily or placebo. The primary efficacy endpoint was a composite of 75% reduction from baseline on the Eczema Area and Severity Index (EASI-75), no discontinuation of study medication for lack of efficacy, no rescue medication during the 4 weeks before Day 84, and no initiation of systemic AD treatment. Other efficacy assessments included validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD), Peak Pruritus numerical rating scale score, and affected body surface area (BSA); for safety, it included frequency and severity of treatment-emergent adverse events (TEAEs).</p><p><strong>Results: </strong>Of 77 randomized patients, 69 were included in the primary efficacy analysis (zabedosertib, n = 47; placebo, n = 22); 55 patients completed treatment. At Week 12, there was no significant difference between zabedosertib and placebo in the primary efficacy endpoint (32.3% vs. 37.4%) or percentage change in EASI from baseline (- 44.6% vs. - 55.9%). There were also no significant differences between zabedosertib and placebo at Week 12 in vIGA-AD response (15.9% vs. 28.5%), Peak Pruritus response (16.4% vs. 25.0%), percentage change in Peak Pruritus (- 20.7% vs. - 27.3%), or percentage change in BSA affected by AD (- 13.3% vs. - 20.3%). No severe or serious TEAEs were reported throughout the study.</p><p><strong>Conclusions: </strong>Zabedosertib was safe and well tolerated in adults with moderate-to-severe AD but showed no evidence of efficacy in reducing disease severity or pruritus in this placebo-controlled study.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05656911.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3329-3345"},"PeriodicalIF":4.2,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144991774","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}
引用次数: 0
The Safety, Tolerability, and Pharmacokinetics of ALT-BB4 (A Novel Recombinant Hyaluronidase): A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study in Healthy Volunteers. ALT-BB4(一种新型重组透明质酸酶)的安全性、耐受性和药代动力学:一项随机、双盲、安慰剂对照的健康志愿者一期研究
IF 4.2 3区 医学
Dermatology and Therapy Pub Date : 2025-11-01 Epub Date: 2025-09-02 DOI: 10.1007/s13555-025-01507-x
Ji Su Lee, WonSerk Kim, Chong-Hyun Won, Yang-Won Lee, SeungHwan Lee, Heejae Won, Soon-Jae Park, Sunbae Lee, Seol-Hee Kim, Jiwon Yang, Gahee Bahn, Dong Hun Lee
{"title":"The Safety, Tolerability, and Pharmacokinetics of ALT-BB4 (A Novel Recombinant Hyaluronidase): A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study in Healthy Volunteers.","authors":"Ji Su Lee, WonSerk Kim, Chong-Hyun Won, Yang-Won Lee, SeungHwan Lee, Heejae Won, Soon-Jae Park, Sunbae Lee, Seol-Hee Kim, Jiwon Yang, Gahee Bahn, Dong Hun Lee","doi":"10.1007/s13555-025-01507-x","DOIUrl":"10.1007/s13555-025-01507-x","url":null,"abstract":"<p><strong>Introduction: </strong>Hyaluronidase has been used as an adjuvant to facilitate subcutaneous drug delivery by degrading hyaluronic acid, a viscoelastic barrier in subcutaneous tissue. However, traditional animal-derived hyaluronidases raise safety concerns, including risk of anaphylaxis and zoonoses. This study aimed to evaluate the safety, tolerability, and pharmacokinetics of ALT-BB4, a novel recombinant hyaluronidase derived from human hyaluronidase PH20, in healthy adults.</p><p><strong>Methods: </strong>This first-in-human, multicenter, randomized, double-blinded, placebo-controlled phase 1 study included 244 participants who received single intradermal or subcutaneous injections of ALT-BB4 or placebo. The study was conducted in three parts: part I assessed drug allergy reactions, part II-A evaluated pharmacokinetics, and part II-B assessed safety and tolerability.</p><p><strong>Results: </strong>Intradermal injection of ALT-BB4 exhibited a low incidence of drug allergy reactions (0.4%), with no significant difference compared with placebo (p = 0.317). Subcutaneous injection of ALT-BB4 resulted in more frequent injection site treatment emergent adverse events (TEAEs) compared with placebo (16.9% versus 0%; p < 0.001). All injection site TEAEs were mild, self-resolving, and did not require treatment. Systemic TEAEs were less frequent in the ALT-BB4 group compared with placebo (0.7% versus 5.6%; p = 0.045), and no serious adverse events were reported. Notably, no antidrug antibodies were detected. Pharmacokinetic analysis revealed minimal systemic absorption of ALT-BB4.</p><p><strong>Conclusions: </strong>Both intradermal and subcutaneous injection of ALT-BB4 demonstrated excellent safety and tolerability, supporting its potential as a promising alternative to traditional animal-derived hyaluronidases. Future studies are warranted to confirm these findings in broader clinical settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05232175.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3301-3311"},"PeriodicalIF":4.2,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946337","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}
引用次数: 0
Long-Term Effectiveness and Safety of Bimekizumab in Patients with Moderate to Severe Hidradenitis Suppurativa Under Real Clinical Practice Conditions: The Importance of Combined Treatment in Hurley III Patients and Potential Factors Associated with Complete Response. 在真实临床条件下,比美珠单抗治疗中重度化脓性汗腺炎的长期有效性和安全性:Hurley III型患者联合治疗的重要性和完全缓解相关的潜在因素
IF 4.2 3区 医学
Dermatology and Therapy Pub Date : 2025-11-01 Epub Date: 2025-08-27 DOI: 10.1007/s13555-025-01521-z
Miguel Mansilla-Polo, Carmen García-Moronta, Pablo Fernández-Crehuet, Patricia Garbayo-Salmons, Martí Pons-Benavent, Lucía Aguilar-González, David Jiménez-Gallo, Rebeca Alcalá-García, Gemma Martín-Ezquerra, Antonio Martorell, Laura Mahiques-Santos, Fernando Alfageme-Roldán, Begoña Escutia-Muñoz, Antonio Sahuquillo-Torralba, Rafael Fayos-Gregori, Alberto Soto-Moreno, Irene Sánchez-Gutiérrez, Rafael Botella-Estrada, Eva Vilarrasa, Alejandro Molina-Leyva
{"title":"Long-Term Effectiveness and Safety of Bimekizumab in Patients with Moderate to Severe Hidradenitis Suppurativa Under Real Clinical Practice Conditions: The Importance of Combined Treatment in Hurley III Patients and Potential Factors Associated with Complete Response.","authors":"Miguel Mansilla-Polo, Carmen García-Moronta, Pablo Fernández-Crehuet, Patricia Garbayo-Salmons, Martí Pons-Benavent, Lucía Aguilar-González, David Jiménez-Gallo, Rebeca Alcalá-García, Gemma Martín-Ezquerra, Antonio Martorell, Laura Mahiques-Santos, Fernando Alfageme-Roldán, Begoña Escutia-Muñoz, Antonio Sahuquillo-Torralba, Rafael Fayos-Gregori, Alberto Soto-Moreno, Irene Sánchez-Gutiérrez, Rafael Botella-Estrada, Eva Vilarrasa, Alejandro Molina-Leyva","doi":"10.1007/s13555-025-01521-z","DOIUrl":"10.1007/s13555-025-01521-z","url":null,"abstract":"<p><strong>Introduction: </strong>Hidradenitis suppurativa (HS) is a debilitating, chronic inflammatory skin disease that severely impacts patients' quality of life. Bimekizumab, the first dual inhibitor of interleukin (IL)-17A and IL-17F, has shown efficacy in phase 3 clinical trials and is currently approved for moderate-to-severe HS. However, long-term data in real-world clinical settings are lacking.</p><p><strong>Methods: </strong>This was a multicenter, retrospective observational study of 78 adult patients with moderate-to-severe HS treated with bimekizumab. Outcomes included International Hidradenitis Suppurativa Severity Score System (IHS4), IHS4-55/75/90/100 response, pain, flare frequency, and safety through week 48.</p><p><strong>Results: </strong>The mean age was 48.5 years, 60.3% (47/78) were classified as Hurley stage III. At week 24, results for IHS4-55, IHS4-75, and IHS4-90 were 54.7% (29/53), 41.5% (22/53), and 3.8% (2/53), respectively. At week 24, results for IHS4-55, IHS4-75, and IHS4-90 were 67.9% (53/78), 30.7% (24/78), and2.5% (2/78), respectively. At week 48, 56 patients were included, of whom 82.1% (46/56) reached an IHS4-55 response, 62.5% (35/56) an IHS4-75, 32,1% (18/56) an IHS4-90, and 23.2% (13/56) a complete response (IHS4-100). Patients unavailable for analysis had either not yet reached follow-up, 72.7% (16/22), or had discontinued treatment, 27.2% (6/22). Combination therapy in any form was more frequent in Hurley III patients, who had similar efficacy compared to Hurley II patients in terms of IHS4-55 at week 48. Adverse events occurred in 43.6% (34/78) of patients, mostly mild to moderate fungal infections (26.9%, 21/78) and eczematous reactions (9%, 6/78). During follow-up, eight patients (10.3%) discontinued treatment, primarily as a result of lack of efficacy (6.4%, 5/78).</p><p><strong>Conclusion: </strong>Bimekizumab shows sustained clinical effectiveness and a manageable safety profile for moderate-to-severe HS in real-world practice up to 48 weeks. In our setting, the combination of medical and surgical treatment is frequently used and may contribute to improved effectiveness, particularly in patients with extensive structural damage.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3267-3283"},"PeriodicalIF":4.2,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946369","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}
引用次数: 0
Systematic Literature Reviews on the Disease Burden of Pediatric Psoriasis. 小儿牛皮癣疾病负担的系统文献综述。
IF 4.2 3区 医学
Dermatology and Therapy Pub Date : 2025-11-01 Epub Date: 2025-09-12 DOI: 10.1007/s13555-025-01541-9
Santiago Zuluaga Sanchez, Tiffanie Tran, Andrea Garcia, Vyshnavi Telukuntla, Sumi Pillai, Jake Horgan, Cynthia Deignan
{"title":"Systematic Literature Reviews on the Disease Burden of Pediatric Psoriasis.","authors":"Santiago Zuluaga Sanchez, Tiffanie Tran, Andrea Garcia, Vyshnavi Telukuntla, Sumi Pillai, Jake Horgan, Cynthia Deignan","doi":"10.1007/s13555-025-01541-9","DOIUrl":"10.1007/s13555-025-01541-9","url":null,"abstract":"<p><strong>Introduction: </strong>Pediatric psoriasis is a chronic, inflammatory skin disease that substantially impacts the quality of life (QoL) of affected children and their families. Despite numerous literature reviews on psoriasis, data on pediatric populations remain sparse. We aimed to systematically identify and synthesize evidence on the epidemiological, humanistic, and economic burden of pediatric psoriasis, focusing on moderate-to-severe cases.</p><p><strong>Methods: </strong>We conducted two systematic literature reviews (SLRs) of studies on pediatric psoriasis: one focusing on the epidemiological and disease burden of psoriasis of any severity, and one focusing on the humanistic and economic burden in moderate-to-severe psoriasis only. Data were collected from multiple databases, supplemented by additional sources.</p><p><strong>Results: </strong>We identified 56 studies across two SLRs, including interventional studies and observational real-world data from diverse geographic regions. The findings are consistent with the characterization of pediatric psoriasis as a multisystem disease, with higher burden in more severe cases. Prevalence appears to increase with age, and key risk factors are commonly associated with obesity and asthma. Comorbidities span mental health (depression, anxiety), metabolic (obesity, diabetes, hyperlipidemia), musculoskeletal (psoriatic arthritis), and gastrointestinal (celiac disease, ulcerative colitis, Crohn's disease) conditions. Disease severity correlates with higher rates of metabolic syndrome, poorer health-related QoL, and increased caregiver burden, including emotional distress and sleep disturbances. Economic data were limited, with no comprehensive cost-effectiveness analyses or utility measures identified.</p><p><strong>Conclusions: </strong>Our findings indicate limited evidence on the full spectrum of the pediatric psoriasis burden, particularly in moderate-to-severe psoriasis. Data are limited on the prevalence of moderate-to-severe cases, as well as healthcare resource utilization and economic impacts in this population, highlighting the need for further research to inform disease management and resource allocation. Emerging therapies may improve the lives of affected children and their caregivers, but further research is needed to fully capture their potential benefits.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3195-3212"},"PeriodicalIF":4.2,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039389","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}
引用次数: 0
Network Meta-analysis of 1.5% Ruxolitinib Cream Versus Systemic Agents in the Treatment of Moderate Atopic Dermatitis. 1.5% Ruxolitinib乳膏与全身药物治疗中度特应性皮炎的网络meta分析。
IF 4.2 3区 医学
Dermatology and Therapy Pub Date : 2025-11-01 Epub Date: 2025-09-04 DOI: 10.1007/s13555-025-01503-1
Melinda J Gooderham, H Chih-Ho Hong, Di Wang, Becky Hooper, Avery Hughes-Martin, Heather Cameron, Laura Pastor, Alicia Pepper, Ping Wu, Ali Mojebi, Grace Wong, Rafael Marino, Marie-Lise Dion, Mehdi Larbi
{"title":"Network Meta-analysis of 1.5% Ruxolitinib Cream Versus Systemic Agents in the Treatment of Moderate Atopic Dermatitis.","authors":"Melinda J Gooderham, H Chih-Ho Hong, Di Wang, Becky Hooper, Avery Hughes-Martin, Heather Cameron, Laura Pastor, Alicia Pepper, Ping Wu, Ali Mojebi, Grace Wong, Rafael Marino, Marie-Lise Dion, Mehdi Larbi","doi":"10.1007/s13555-025-01503-1","DOIUrl":"10.1007/s13555-025-01503-1","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a chronic, highly pruritic, relapsing inflammatory disease associated with high quality-of-life burden. Topical 1.5% ruxolitinib cream is a selective Janus kinase (JAK)1/JAK2 inhibitor that is well tolerated and effective in improving itch and lesion clearance in patients ≥ 12 years old. This analysis estimates comparative efficacy for 1.5% ruxolitinib cream relative to systemic therapies for treatment of patients ≥ 12 years with AD.</p><p><strong>Methods: </strong>A systematic literature review (SLR) identified randomized controlled trials evaluating 1.5% ruxolitinib cream, oral JAK inhibitors, monoclonal antibodies, phosphodiesterase 4 inhibitors, and systemic immunosuppressants. A feasibility assessment evaluated whether indirect treatment comparison (ITC) was appropriate and determined appropriate ITC methods. This network meta-analysis (NMA) assessed the comparative efficacy of 1.5% ruxolitinib cream against systemic therapies in a \"systemic-eligible moderate AD\" subgroup defined as ≥ 12 years old and eligible for topical and systemic therapies (Investigator's Global Assessment [IGA] = 3, Eczema Area and Severity Index [EASI] ≥ 16, and body surface area ≥ 10%); an ITC with the full study populations was not feasible. A frequentist framework using a penalized likelihood NMA included outcomes of IGA 0/1 with at least a 2-point improvement from baseline, EASI-75, and Itch Numerical Rating Scale 4 (NRS4).</p><p><strong>Results: </strong>The SLR identified 25 studies, of which 12 reported outcomes for the relevant subgroup for four interventions: 1.5% ruxolitinib cream, dupilumab 300 mg, upadacitinib (15 mg, 30 mg), and abrocitinib (100 mg, 200 mg), which were compared against placebo or placebo + topical corticosteroids. There were no statistically significant differences between active comparators for IGA 0/1, EASI-75, and Itch NRS4, although point estimates numerically favored 1.5% ruxolitinib cream for IGA 0/1 and EASI‑75.</p><p><strong>Conclusion: </strong>For patients with moderate AD who are eligible for systemic therapies, 1.5% ruxolitinib cream might provide disease control comparable to systemic treatments, such as dupilumab, regarding IGA 0/1, EASI-75, and Itch NRS4.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3313-3328"},"PeriodicalIF":4.2,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12549442/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144991768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Strategies for Optimal Use of Biological Therapies in Managing Psoriasis: Focus on Secukinumab. 银屑病生物治疗的最佳使用策略:关注Secukinumab
IF 4.2 3区 医学
Dermatology and Therapy Pub Date : 2025-11-01 Epub Date: 2025-09-04 DOI: 10.1007/s13555-025-01515-x
Anna Balato, Martina Burlando, Anna Campanati, Antonio Costanzo, Andrea Chiricozzi, Paolo Gisondi, Piergiorgio Malagoli, Giuseppe Micali
{"title":"Strategies for Optimal Use of Biological Therapies in Managing Psoriasis: Focus on Secukinumab.","authors":"Anna Balato, Martina Burlando, Anna Campanati, Antonio Costanzo, Andrea Chiricozzi, Paolo Gisondi, Piergiorgio Malagoli, Giuseppe Micali","doi":"10.1007/s13555-025-01515-x","DOIUrl":"10.1007/s13555-025-01515-x","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis (PsO) is a common inflammatory dermatological condition with a substantial negative impact on patient quality of life. Several biological agents are available for the treatment of PsO, and clinicians and patients must consider various factors when deciding on the most appropriate biological agent.</p><p><strong>Methods: </strong>Here, we report a set of consensus statements developed by an Italian PsO advisory board on use of the anti-interleukin-17A biological secukinumab in routine clinical practice.</p><p><strong>Results: </strong>The statements were developed under three main topics, the first of which was \"characteristics of secukinumab and criteria for patient selection to achieve long-term benefits\". This statement helps to identify patients most likely to benefit from secukinumab, including biological-naïve patients with moderate PsO; patients with PsO involving sensitive sites; patients in whom biosimilar anti-tumour necrosis factor-alpha treatment has proved ineffective; patients at high risk of developing psoriatic arthritis; lean or normal-weight patients; patients with active disease receiving conventional disease-modifying antirheumatic drugs; and patients with comorbidities, including cardiovascular disease. Under the second topic, \"strategies to maintain secukinumab effectiveness in the long term\", the advisors highlighted the importance of patient support to promote adherence; weight control; understanding that PsO can worsen for reasons unrelated to treatment; and understanding that appropriate treatment should depend on the severity of any disease worsening. The third topic, \"strategies for patient support to promote adherence to therapy\", noted the importance of patient education, accurate disease assessments and treatment tailoring.</p><p><strong>Conclusion: </strong>These consensus statements will help guide dermatologists in the selection of patients with PsO for whom secukinumab is the most appropriate treatment in real-world clinical practice in Italy.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3089-3108"},"PeriodicalIF":4.2,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12550097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144991777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rocatinlimab: A Novel T-Cell Rebalancing Therapy Targeting the OX40 Receptor in Atopic Dermatitis. 罗卡替利单抗:一种针对OX40受体治疗特应性皮炎的新型t细胞再平衡疗法。
IF 4.2 3区 医学
Dermatology and Therapy Pub Date : 2025-11-01 Epub Date: 2025-09-06 DOI: 10.1007/s13555-025-01492-1
Emma Guttman-Yassky, Eric Simpson, Ehsanollah Esfandiari, Hirotaka Mano, Jillian Bauer, Prista Charuworn, Kenji Kabashima
{"title":"Rocatinlimab: A Novel T-Cell Rebalancing Therapy Targeting the OX40 Receptor in Atopic Dermatitis.","authors":"Emma Guttman-Yassky, Eric Simpson, Ehsanollah Esfandiari, Hirotaka Mano, Jillian Bauer, Prista Charuworn, Kenji Kabashima","doi":"10.1007/s13555-025-01492-1","DOIUrl":"10.1007/s13555-025-01492-1","url":null,"abstract":"<p><p>Atopic dermatitis (AD) is a chronic inflammatory disease characterized by eczematous skin lesions, intense pruritus, skin pain, sleep disruption, and mental health disturbances. There remains a need for a therapeutic option that delivers durable efficacy, safety, and convenient dosing across the AD patient population. This review provides an overview of AD pathogenesis driven by T-cell imbalance and describes a novel therapeutic option targeting the OX40 receptor, a costimulatory molecule expressed specifically on activated T cells. Expression of the OX40 receptor on skin-homing T cells is increased in AD. OX40-mediated activation of pathogenic T cells drives inflammation in AD and is critical for the formation of memory T cells, leading to persistent disease. Rocatinlimab (AMG 451/KHK4083) is a novel T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting the OX40 receptor. By reducing pathogenic T-cell number and activity, rocatinlimab has the potential to limit AD flares and modify the course of disease. Rocatinlimab showed promise for the treatment of moderate-to-severe AD in a phase 2b trial, significantly improving overall disease severity, skin involvement, pruritus, sleep disturbance, and quality of life compared with placebo at week 16. Improvements continued through week 36 during active treatment, and notably, were largely maintained in responders throughout a subsequent 20-week off-treatment period, providing evidence for durable on and off treatment responses. Rocatinlimab has also demonstrated a favorable safety and tolerability profile. A large, global phase 3 program (ROCKET) including eight studies is underway to further assess the efficacy, safety, maintenance of response, extended dosing, and off-treatment durability of rocatinlimab in adults and adolescents with moderate-to-severe AD.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3153-3171"},"PeriodicalIF":4.2,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12549474/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145005961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Benefit-Risk Assessment of GLP-1 Receptor Agonists: Implications for Dermatologists and Plastic Surgeons. GLP-1受体激动剂的利弊评估:对皮肤科医生和整形外科医生的启示。
IF 4.2 3区 医学
Dermatology and Therapy Pub Date : 2025-11-01 Epub Date: 2025-09-09 DOI: 10.1007/s13555-025-01537-5
Stephano Cedirian, Monia Donati, Luca Rapparini, Francesca Pampaloni, Michelangelo La Placa, Rossella Sgarzani, Luca Negosanti, Emanuel Raschi, Michela Starace
{"title":"Benefit-Risk Assessment of GLP-1 Receptor Agonists: Implications for Dermatologists and Plastic Surgeons.","authors":"Stephano Cedirian, Monia Donati, Luca Rapparini, Francesca Pampaloni, Michelangelo La Placa, Rossella Sgarzani, Luca Negosanti, Emanuel Raschi, Michela Starace","doi":"10.1007/s13555-025-01537-5","DOIUrl":"10.1007/s13555-025-01537-5","url":null,"abstract":"<p><p>Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have gained prominence for their efficacy in treating type 2 diabetes and obesity. Recent evidence suggests that their pleiotropic effects-beyond glycemic control and weight loss-include anti-inflammatory, immunomodulatory, and antioxidative effects, which may beneficially support various dermatologic conditions such as psoriasis, hidradenitis suppurativa, acanthosis nigricans, and Hailey-Hailey disease. However, GLP-1 RAs are also associated with emerging cutaneous adverse drug reactions, including bullous, exanthematous and vasculitic manifestations, and other rare side effects. In aesthetic and reconstructive surgery, rapid weight loss induced by these agents has raised concerns regarding facial volume depletion, skin laxity, and impaired wound healing. In addition, perioperative management of patients on GLP-1 RAs requires careful assessment as a result of delayed gastric emptying and the associated potential risk of pulmonary aspiration. This narrative review summarizes current knowledge on the benefit/risk profile of GLP-1 RAs, highlighting their impact for dermatologists and plastic surgeons in relevant contexts.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3173-3193"},"PeriodicalIF":4.2,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12549488/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145023109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Habitual Scratching in Atopic Dermatitis and Its Association with Disease Severity: Findings from Japanese Health Insurance Claims and App-Based Data. 特应性皮炎的习惯性抓挠及其与疾病严重程度的关系:来自日本健康保险索赔和基于应用程序的数据的发现
IF 4.2 3区 医学
Dermatology and Therapy Pub Date : 2025-11-01 Epub Date: 2025-08-21 DOI: 10.1007/s13555-025-01525-9
Takeshi Nakahara, Shinichi Noto, Miyuki Matsukawa, Yasuhito Konishi, Rikiya Toda, Daisaku Michikami, Hiroyuki Murota
{"title":"Habitual Scratching in Atopic Dermatitis and Its Association with Disease Severity: Findings from Japanese Health Insurance Claims and App-Based Data.","authors":"Takeshi Nakahara, Shinichi Noto, Miyuki Matsukawa, Yasuhito Konishi, Rikiya Toda, Daisaku Michikami, Hiroyuki Murota","doi":"10.1007/s13555-025-01525-9","DOIUrl":"10.1007/s13555-025-01525-9","url":null,"abstract":"<p><strong>Introduction: </strong>In atopic dermatitis (AD), scratching sustains inflammation and impairs the skin barrier. Beyond scratching driven by itch, affected individuals may engage in habitual scratching, defined as repetitive, unconscious scratching that occurs without itch. The extent and clinical significance of habitual scratching in Japanese patients remain unclear. This study aimed to assess the frequency of habitual scratching and its association with AD severity in the Japanese population.</p><p><strong>Methods: </strong>This cross-sectional study was conducted in Japan using data from anonymized health insurance claims and a nationwide app-based questionnaire administered in October 2022. Included individuals were adults (aged 19-74 years) and children (aged ≤ 18 years) with a self-reported diagnosis of AD and either symptoms or treatment within the previous 6 months. Habitual scratching was assessed using two yes/no questions. Disease severity was measured using the Patient-Oriented Eczema Measure (POEM), and associations were tested using the Cochran-Armitage trend test.</p><p><strong>Results: </strong>A total of 1507 adults and 525 children were included. Among adults, 44.5% reported scratching without feeling itchy, and 30.0% reported only noticing scratching when it was pointed out; among children, these proportions were 57.5% and 53.3%, respectively. The proportion of patients exhibiting both behaviors increased significantly with POEM severity. For scratching without itch, rates ranged from 35.1% to 62.9% in adults and from 44.5% to 82.6% in children (p < 0.001 for both). For unnoticed scratching, rates ranged from 19.0% to 50.3% in adults and from 41.2% to 69.6% in children (p < 0.001 for both).</p><p><strong>Conclusions: </strong>Habitual scratching was commonly reported across all severity levels of AD in Japan and was associated with greater disease severity. These findings highlight the importance of recognizing/noticing and actively managing unconscious scratching behaviors as part of comprehensive AD care.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3409-3417"},"PeriodicalIF":4.2,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12550088/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy of Skin Patting and Iontophoresis with Dutasteride Gel in Male and Menopausal Female Androgenetic Alopecia: A Pilot Study. 杜他雄胺凝胶皮肤拍打和离子导入治疗男性和绝经期女性雄激素性脱发的疗效:一项初步研究。
IF 4.2 3区 医学
Dermatology and Therapy Pub Date : 2025-11-01 Epub Date: 2025-09-03 DOI: 10.1007/s13555-025-01532-w
Stephano Cedirian, Francesca Pampaloni, Federico Quadrelli, Luca Rapparini, Francesca Bruni, Ginevra Martelli, Bianca Maria Piraccini, Michela Starace
{"title":"Efficacy of Skin Patting and Iontophoresis with Dutasteride Gel in Male and Menopausal Female Androgenetic Alopecia: A Pilot Study.","authors":"Stephano Cedirian, Francesca Pampaloni, Federico Quadrelli, Luca Rapparini, Francesca Bruni, Ginevra Martelli, Bianca Maria Piraccini, Michela Starace","doi":"10.1007/s13555-025-01532-w","DOIUrl":"10.1007/s13555-025-01532-w","url":null,"abstract":"<p><strong>Introduction: </strong>Androgenetic alopecia (AGA) is a chronic, progressive condition often resistant to conventional treatments. Transdermal delivery systems such as iontophoresis and skin patting (SPi) may enhance drug penetration and follicular targeting. Dutasteride, a potent dual 5α-reductase inhibitor, has shown superior efficacy to finasteride, but topical delivery is limited by variable absorption. In this pilot study, we evaluated the efficacy and safety of dutasteride gel delivered via SPi and iontophoresis in men and postmenopausal women with treatment-resistant AGA.</p><p><strong>Methods: </strong>In this single-center pilot study, 20 adults (10 males, 10 postmenopausal females) with AGA unresponsive to ≥ 12 months of standard therapy underwent four monthly sessions of SPi and iontophoresis with 6% dutasteride gel. Hair density, shaft diameter, and pull test results were assessed at baseline and 8 weeks post-treatment; patient satisfaction (0-4 scale) and safety were recorded. Paired tests were used to analyze the results, with p < 0.05 considered to indicate significance.</p><p><strong>Results: </strong>Hair density improved significantly in frontal (p < 0.001) and vertex (p < 0.001) regions. Shaft diameter increased in vertex (p < 0.001) and frontal areas (p = 0.046). Pull test scores improved (p < 0.001). Mean satisfaction was 3.4/4. No adverse events occurred.</p><p><strong>Conclusion: </strong>SPi with iontophoresis effectively delivered topical dutasteride, yielding significant clinical improvement and excellent safety in treatment-resistant AGA. Larger randomized trials are warranted to confirm these findings.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3419-3424"},"PeriodicalIF":4.2,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12549499/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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