Dermatology and Therapy最新文献

{"title":"Brodalumab: Seven-Year US Pharmacovigilance Report.","authors":"Mark G Lebwohl, John Y Koo, April W Armstrong, Bruce E Strober, Soo Han Yoon, Nicole N Rawnsley, Earl L Goehring, Abby A Jacobson","doi":"10.1007/s13555-025-01497-w","DOIUrl":"10.1007/s13555-025-01497-w","url":null,"abstract":"<p><strong>Introduction: </strong>Brodalumab, a human interleukin-17 receptor A antagonist, is approved for treating adults with moderate-to-severe plaque psoriasis who qualify for systemic therapy or phototherapy and have experienced treatment failure or loss of response to other systemic treatments. Although brodalumab is distributed in the USA under a Risk Evaluation and Mitigation Strategy that includes a boxed warning regarding suicidal ideation and behavior, a direct causal relationship has not been established. This report examines pharmacovigilance data collected over 7 years of clinical usage to provide an assessment of the long-term safety characteristics of brodalumab.</p><p><strong>Methods: </strong>This report evaluated adverse events (AEs) submitted to Ortho Dermatologics from US healthcare providers and patients during the period spanning August 15, 2017 to August 14, 2024. We calculated crude AE reporting rates per 100 patients using Medical Dictionary for Regulatory Activities (MedDRA) v27.0 Preferred Terms and standardized MedDRA queries. Treatment duration was determined by measuring the time between initial and latest prescription-dispensing authorization dates.</p><p><strong>Results: </strong>The study encompassed 5449 US patients, representing approximately 7845 patient-years of exposure across the 7-year reporting period. There were no new adjudicated cases of major adverse cardiovascular events in year 7 (0.24/100 patients for the 7-year reporting period), and serious infection cases occurred at a rate of 2.17/100 patients. Among 64 reported malignancies in 55 patients, 4 were assessed as potentially treatment related. Throughout the 7-year period, no completed suicides were reported, and one suicide attempt occurred in year 3.</p><p><strong>Conclusion: </strong>The 7-year pharmacovigilance dataset reinforces the safety profile of brodalumab previously established through clinical trials and earlier pharmacovigilance reports, with no completed suicides and a low fungal infection rate.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3025-3035"},"PeriodicalIF":4.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454691/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144741613","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}

{"title":"Clinically Meaningful Improvements in Adolescents with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab who did not Achieve Clear or Almost Clear Skin at Week 16.","authors":"Amy S Paller, Andrew Blauvelt, Weily Soong, H Chih-Ho Hong, Marie L A Schuttelaar, Shannon K R Schneider, Eric L Simpson","doi":"10.1007/s13555-025-01484-1","DOIUrl":"10.1007/s13555-025-01484-1","url":null,"abstract":"<p><strong>Introduction: </strong>Investigator's Global Assessment (IGA) of clear/almost clear (0/1) skin is a high standard to achieve after 16 weeks of treatment for patients with moderate-to-severe atopic dermatitis (AD) and does not capture clinically meaningful responses in other patient domains, such as improvement in itch and/or quality of life. To better evaluate the effect of tralokinumab in adolescents, we assessed the clinically meaningful impact of tralokinumab versus placebo in patients who did not meet IGA 0/1 at week 16 without rescue medication in ECZTRA 6.</p><p><strong>Methods: </strong>These post hoc analyses included adolescents from the ECZTRA 6 (NCT03526861) phase 3 trial who did not achieve IGA 0/1 at week 16 without rescue medication (referred to as IGA >1). Clinically meaningful responses were defined as either ≥50% improvement from baseline in Eczema Area and Severity Index (EASI-50), ≥3-point improvement in Adolescent Worst Pruritus Numeric Rating Scale (itch NRS), or ≥6-point improvement in Children's Dermatology Life Quality Index (CDLQI) at week 16.</p><p><strong>Results: </strong>Among IGA >1 patients (n = 247), significantly greater percentages receiving tralokinumab (150 mg or 300 mg) versus placebo achieved EASI-50 (31.2% or 41.3% versus 10.0%), ≥3-point improvement in itch NRS (21.6% or 22.8% versus 8.0%), or ≥1 clinically meaningful measure (36.4% or 52.5% versus 21.1%) at week 16. The majority of IGA >1 patients who continued with open-label tralokinumab beyond week 16 achieved EASI-50 and ≥3-point improvement in itch NRS and about 40% met EASI-90 at week 52.</p><p><strong>Conclusions: </strong>Clinically meaningful responses in both clinician-measured and patient-reported outcomes were observed in tralokinumab-treated (150 mg or 300 mg) adolescents who did not achieve IGA 0/1 at week 16 without rescue medication. Utilizing validated outcome measures of both efficacy and patient quality of life, alongside IGA scores, can enhance clinical decision-making regarding tralokinumab treatment responses in adolescents with moderate-to-severe AD.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT03526861 (ECZTRA 6); study start date: 19 June 2018; primary completion date: 15 April 2020; study completion date: 16 March 2021. A Graphical Abstract is available for this article.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2879-2896"},"PeriodicalIF":4.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454845/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728568","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}

{"title":"Regenerative Skin Remodeling through Exosome-Based Therapy: A Case Study Demonstrating 21-Month Sustained Outcomes in Pore Size, Erythema, and Hyperpigmentation.","authors":"Young Seob Lee","doi":"10.1007/s13555-025-01501-3","DOIUrl":"10.1007/s13555-025-01501-3","url":null,"abstract":"<p><strong>Introduction: </strong>Visible signs of skin aging, including enlarged pores, rosacea, and melasma, are often difficult to treat due to their multifactorial etiology. Most conventional therapies offer only temporary improvement and require ongoing maintenance. Exosome-based treatments present a regenerative approach that targets key biological dysfunctions associated with aging skin.</p><p><strong>Case report: </strong>A healthy female in her late 40s with Grade 3 pore enlargement, Subtype I rosacea, and epidermal-type melasma (MASI score 10) underwent two sessions of topical exosome application following superficial microneedling at 0.3 mm depth, performed on Day 1 and Day 21. Clinical progress was documented at baseline, 3 weeks, 5.5 months, and 21 months using standardized photography, AI-assisted 3D imaging, and validated scales (MASI, CEA, GAIS). Progressive, multidimensional improvements were observed: pore size reduced by up to 41%, erythema by 42%, and melanin deposition by 31% at 5.5 months. These effects were largely sustained at 21 months. Surface roughness metrics (Ra, Rq, Rmax, Rz, Rp, Rv) also improved significantly.</p><p><strong>Discussion: </strong>The results indicate that topical exosome therapy combined with superficial microneedling promotes lasting improvements in key clinical markers of skin aging. The sustained effects over 21 months suggest biological remodeling rather than transient cosmetic correction. No adverse events occurred throughout the follow-up period, confirming the safety and tolerability of the protocol.</p><p><strong>Conclusion: </strong>A short protocol of topical exosomes with superficial microneedling achieved durable improvements in pore size, redness, and pigmentation that persisted for nearly two years without retreatment. These findings support its potential as a low-risk, regenerative modality for long-term facial rejuvenation.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3055-3064"},"PeriodicalIF":4.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454781/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144793751","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}

{"title":"The Lived Experience of Patients Diagnosed with Vitiligo and a Preliminary Conceptual Disease Model: Insights from Patients, Patient Advocates, and Clinicians.","authors":"Khaled Ezzedine, Ahmed M Soliman, Mary Kathleen Ladd, Stavonnie Patterson, Rohini Sen, Sarah Ofori, Karin S Coyne, Robin Pokrzywinski","doi":"10.1007/s13555-025-01510-2","DOIUrl":"10.1007/s13555-025-01510-2","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with vitiligo experience high disease and psychosocial burden, and dissatisfaction with current treatment options, highlighting a need to understand the disease from a patient perspective. This study gathered insights from key opinion leaders (KOLs) and patient advocates on a conceptual disease model of vitiligo and gained patient perspectives through qualitative interviews on the disease burden and concepts important to patients with nonsegmental vitiligo (NSV), and what degree and anatomical location of repigmentation may constitute a meaningful change with treatment.</p><p><strong>Methods: </strong>This cross-sectional, observational study involved virtual, semi-structured, qualitative interviews with expert KOLs treating patients with vitiligo, patient advocates, and patients diagnosed with NSV.</p><p><strong>Results: </strong>Patient advocates (n = 5) and KOLs (n = 6) felt that the conceptual disease model comprehensively captured the signs, symptoms, and impact of vitiligo, and had minor changes including reordering symptoms. Of 22 patients interviewed, most experienced depigmentation on their arms, trunk, hands, feet; and 86.4% had vitiligo on their face. The most frequently reported sign or symptom was increased sensitivity to the sun (82%). Patients reported that vitiligo broadly impacts many facets of life, most commonly emotional well-being (82%). Patients reported that perceived treatment success is driven by the extent of vitiligo repigmentation, especially on the face and hands, and would consider 20-25% repigmentation a meaningful improvement.</p><p><strong>Conclusion: </strong>This study provides insight into the lived experience of patients with NSV, and alignment from patient advocates and KOLs on the conceptual disease model of vitiligo. The findings increase our understanding and inform vitiligo clinical studies.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2967-2981"},"PeriodicalIF":4.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454719/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144854895","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}

{"title":"Skin-Directed Therapies in Mycosis Fungoides: An Update.","authors":"Maciej Tota, Magdalena Łyko, Piotr Misiąg, Julia Łacwik, Julia Laska, Karol Biliński, Julita Kulbacka, Alina Jankowska-Konsur","doi":"10.1007/s13555-025-01511-1","DOIUrl":"10.1007/s13555-025-01511-1","url":null,"abstract":"<p><p>Mycosis fungoides (MF) is the most common subtype of cutaneous T cell lymphoma (CTCL), characterized by monoclonal proliferation of malignant T cells primarily involving the skin. The management of MF, especially in the early stages, involves skin-directed therapies (SDTs) to achieve disease control, alleviate symptoms, and enhance the quality of life (QoL). This review provides an updated overview of SDTs in MF treatment, including topical agents such as corticosteroids, retinoids, mechlorethamine, carmustine, imiquimod, as well as photodynamic therapy (PDT); phototherapy modalities including narrowband UVB (nb-UVB) and psoralen-UVA (PUVA); local radiotherapy; total skin electron beam radiotherapy (TSEBT) and total skin helical tomotherapy (TSHT). We review the indications, mechanisms of action, efficacy data, and adverse effect profiles associated with both established and emerging SDTs. Additionally, we present ongoing clinical trials evaluating emerging SDTs in the treatment of MF.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2765-2801"},"PeriodicalIF":4.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454724/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144854894","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}

{"title":"Comparative Effectiveness and Durability of Biologics Through 24 Months for Patients with Moderate-to-Severe Psoriasis: Results from the International, Observational Psoriasis Study of Health Outcomes (PSoHO).","authors":"Andreas Pinter, Alan Brnabic, Emanuele Trovato, Lluís Puig, Jose-Manuel Carrascosa, Thierry Boyé, Matteo Megna, Silvia Sabatino, Inmaculada De La Torre, Julia-Tatjana Maul","doi":"10.1007/s13555-025-01494-z","DOIUrl":"10.1007/s13555-025-01494-z","url":null,"abstract":"<p><strong>Introduction: </strong>The Psoriasis Study of Health Outcomes (PSoHO) is an international, prospective, non-interventional study investigating the comparative effectiveness and durability of biologic treatments for patients with moderate-to-severe psoriasis (PsO) over 36 months. Patients were grouped into cohorts based on biologic class: anti-interleukin (IL)-17A/receptor A (anti-IL-17A), anti-IL-12/23, anti-IL-23 and anti-tumor necrosis factor (TNF)-α for the purpose of comparison. Additionally, the durability and effectiveness of individual biologic treatments were compared to ixekizumab (IXE).</p><p><strong>Methods: </strong>Effectiveness was assessed using Psoriasis Area and Severity Index (PASI) 90 and PASI100 response rates and durability, defined as achieving therapeutic response (PASI90/100) at week 12 and its maintenance at months 6, 12, 18 and 24. Statistical analysis included unadjusted descriptive summaries and model-based comparisons that accounted for baseline confounders using the frequentist model averaging (FMA) framework and marginal structural models (MSM) that accounted for both baseline and time-varying confounders.</p><p><strong>Results: </strong>Results demonstrated that patients treated with anti-IL-17A biologics had significantly higher odds of achieving PASI100 and PASI90 compared to those treated with anti-IL-12/23 and anti-TNFα biologics. Specifically, at 24 months, IXE showed greater PASI100 and PASI90 response rates compared to adalimumab (ADA) and ustekinumab (UST), with adjusted odds ratios of 1.9 and 2.3 for PASI100 and 2.0 and 2.5 for PASI90, respectively. IXE-treated patients also exhibited higher durability rates for PASI100 and PASI90 compared to ADA, UST, secukinumab (SEC), tildrakizumab (TILD) and guselkumab (GUS), with adjusted odds ratios (non-responder imputation [NRI]) between 1.7 and 4.3 (PASI100) and 1.6 and 4.2 (PASI90), while being similar to risankizumab (RIS).</p><p><strong>Conclusion: </strong>This study provides valuable real-world data on the long-term effectiveness and durability of biologic treatments for PsO, emphasizing the advantages of anti-IL-17A biologics, particularly IXE, in achieving and maintaining therapeutic responses. These findings support dermatologists in making informed decisions regarding PsO treatment strategies.</p><p><strong>Trial number: </strong>The study was registered at the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCEPP24207).</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2819-2832"},"PeriodicalIF":4.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454241/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144689488","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}

{"title":"A Global Assessment of Patient Experience and Quality of Life in Generalized Pustular Psoriasis: Results from Interviews and Online Surveys.","authors":"Lauren C S Kole, Yayoi Tada, Sascha Gerdes, Alice B Gottlieb, Matthias Augustin, Min Zheng, Hideaki Miyachi, Iris Chen-Yin Lai, S Renée Marshall, Smita Jha, Ferhal Küçükosman, Gang Wang","doi":"10.1007/s13555-025-01483-2","DOIUrl":"10.1007/s13555-025-01483-2","url":null,"abstract":"<p><strong>Introduction: </strong>Generalized pustular psoriasis (GPP) is a chronic, systemic, neutrophilic inflammatory disease that significantly impacts patients' quality of life (QoL). A multinational panel of patients with GPP participated in surveys and interviews, with the aim to assess the impact of chronic symptoms and GPP flares on QoL and well-being, and to better understand the resources and support that patients need.</p><p><strong>Methods: </strong>Patients (aged 18-65 years) with a confirmed diagnosis of GPP (> 1 month), who had experienced ≥ 1 flare in the past year and were receiving active treatment for GPP were recruited through databases and healthcare professionals (HCPs).</p><p><strong>Results: </strong>A total of 18 patients (female, n = 15) participated in the study (USA, n = 7; Germany, n = 4; China, n = 4; and Japan, n = 3). Comorbidities included plaque psoriasis (n = 5), psoriatic arthritis (n = 3), and palmoplantar pustulosis (n = 1). Most patients (94%) were receiving active treatment for GPP, including biologics, immunosuppressants (non-biologic), retinoids, and steroids. Itchiness was the most prevalent symptom (82%), followed by dryness (75%), erythema (70%), and fatigue (65%). The scalp, arms, and palms of hands were the most affected areas. Most patients interviewed (80%) reported chronic symptoms, with itchy and dry skin and joint pain being the most frequent. Dermatology Life Quality Index scores indicated a moderate to extremely large impact on QoL in nine patients (50%). Chronic symptoms significantly impacted activities of daily life in 60% of patients. Chronic symptoms and flares negatively affected the psychological well-being of patients (mean General Health Questionnaire-12 score: 15 and 17, respectively). Patients employed self-care strategies, painkillers, and dietary modifications to manage symptoms, sometimes under the guidance of HCPs.</p><p><strong>Conclusion: </strong>This study highlights the impact of GPP on patients' QoL and physical and psychological well-being, due to chronic symptoms that persist despite current treatments. It emphasizes the need for continuous treatment of GPP and the importance of additional resources and support networks for patients.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3037-3053"},"PeriodicalIF":4.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454240/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798445","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}

{"title":"Clinical Characteristics of Super Responders to Anti-IL-4Rα Biologic Therapy in Atopic Dermatitis.","authors":"Litian Zhang, Linglu Fang, Kun Zhong, Ying Zhou","doi":"10.1007/s13555-025-01514-y","DOIUrl":"10.1007/s13555-025-01514-y","url":null,"abstract":"<p><strong>Introduction: </strong>Biologics have revolutionized the treatment of moderate-to-severe atopic dermatitis (AD), with dupilumab, an anti-interleukin-4Rα monoclonal antibody, showing notable clinical efficacy. However, some patients achieve rapid and profound improvement-termed super responders (SRs), while others respond poorly. This study aimed to identify SRs to dupilumab in patients with AD and analyze their clinical characteristics to inform personalized treatment strategies.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on patients with moderate-to-severe AD treated with dupilumab, sourced from the National Clinical Research Center for Skin and Immune Diseases in China. Clinical and follow-up data were reviewed. Categorical variables were compared using Chi-square or Fisher's exact tests, while continuous variables were compared via t-tests or Mann-Whitney U tests. Furthermore, a logistic regression model was employed to evaluate the predictive ability of clinical and demographic variables collected at baseline on the probability of becoming SRs.</p><p><strong>Results: </strong>Among 1,034 patients with AD, 125 (12.09%) were identified as SRs, achieving significant clinical improvement within 16 weeks. Further univariate analysis indicated that factors closely associated with SRs included: older age, higher body mass index, later disease onset, higher baseline scores of pruritus intensity (Peak pruritus Numerical Rating Scale, PP-NRS)/disease severity (Eczema Area and Severity Index, EASI)/quality of life (Dermatology Life Quality Index, DLQI), prior systemic therapy use, no prior biologics, elevated eosinophil count, high-dose dupilumab, shorter dosing intervals of dupilumab, and absence of concomitant therapies. Logistic regression identified moderate baseline pruritus (PP-NRS) and higher baseline DLQI scores (moderate-to-severe impact) as strong predictors of SRs (moderate pruritus Adj odds ratio (OR): 8.38, 95% confidence interval (CI) 2.56-27.42; moderate DLQI Adj OR: 11.01, 95% CI 3.34-36.29; severe DLQI Adj OR: 14.52, 95% CI 4.70-44.91; all p < 0.001).</p><p><strong>Conclusions: </strong>Baseline pruritus and quality of life impairment are key predictors of super response to dupilumab in AD. Early identification may guide more tailored, effective treatment strategies.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2983-2996"},"PeriodicalIF":4.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454842/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144859043","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}

{"title":"Investigation of the Efficacy and Safety of Xeligekimab (GR1501) in Patients with Moderate-to-Severe Plaque Psoriasis: A Multicenter, Randomized, Double-Blind Phase II Clinical trial.","authors":"Lin Cai, Chengxin Li, Shanshan Li, Xiaodong Zhang, Gang Wang, Jianbin Yu, Kun Huang, Hong Fang, Yangfeng Ding, Jinyan Wang, Congjun Jiang, Qianjin Lu, Juan Tao, Jianzhong Zhang","doi":"10.1007/s13555-025-01450-x","DOIUrl":"10.1007/s13555-025-01450-x","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis is a chronic inflammatory skin disease. This study evaluated the efficacy and safety of xeligekimab (GR1501), a novel anti-interleukin-17A (anti-IL-17A) monoclonal antibody, in Chinese patients with moderate-to-severe plaque psoriasis.</p><p><strong>Methods: </strong>In this multicenter, randomized, double-blind, phase II trial, 199 patients were assigned (1:1:1:1) to receive placebo (n = 49) or xeligekimab 100 mg (n = 50), 150 mg (n = 49), or 200 mg (n = 51) every 4 weeks for 12 weeks. All participants then entered a 40-week extension receiving xeligekimab 200 mg every 4 or 8 weeks. The primary endpoint was a 75% reduction in the Psoriasis Area and Severity Index (PASI 75) at week 12. Secondary endpoints included PASI 75, PASI 90 (≥ 90% improvement), and a static Physician's Global Assessment (sPGA) score of 0/1 (clear/almost clear) at week 52. Safety, pharmacokinetics (PK), and anti-drug antibodies (ADA) were also assessed.</p><p><strong>Results: </strong>At week 12, PASI 75 response rates for the 100, 150, and 200 mg groups were 86.0%, 89.8%, and 88.2%, respectively, versus 2.0% for placebo (P < 0.05). At week 52, PASI 75, PASI 90, and sPGA 0/1 response rates remained high in both 4-week (98.8%, 83.3%, 77.4%) and 8-week (92.9%, 83.3%, 78.6%) groups. No dose-dependent safety issues or ADA positivity were observed.</p><p><strong>Conclusion: </strong>Xeligekimab demonstrated strong efficacy, sustained response, and favorable safety in patients with moderate-to-severe plaque psoriasis.</p><p><strong>Trial registration number: </strong>ChiCTR1800017956.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2803-2816"},"PeriodicalIF":4.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454832/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301337","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}

{"title":"The Urticaria Voices Study: Physicians' Perspectives on the Real-World Patient Burden, Treatments, and Outcomes in Chronic Spontaneous Urticaria.","authors":"Karsten Weller, Tonya A Winders, Jessica McCarthy, Pallavi Saraswat, Nadine Chapman-Rothe, Tara Raftery, Jonathan A Bernstein","doi":"10.1007/s13555-025-01498-9","DOIUrl":"10.1007/s13555-025-01498-9","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic spontaneous urticaria (CSU) significantly impacts patients' quality of life (QOL). Understanding physicians' perspectives and treatment approaches for CSU is crucial for optimizing the outcomes. We describe the CSU management challenges and treatment perceptions reported by physicians in the Urticaria Voices study.</p><p><strong>Methods: </strong>This is a multinational cross-sectional online survey involving patients with CSU and CSU-treating physicians from seven countries (USA, Canada, UK, Germany, France, Italy, and Japan). The reported analyses assessed prescribing patterns, treatment satisfaction, and disease management challenges for physicians. Data were analyzed descriptively.</p><p><strong>Results: </strong>Overall, 862 physicians (517 dermatologists; 345 allergists) participated in the study. Fifty-two percent perceived CSU as serious and 65% reported that CSU negatively impacts patients' life, particularly mental well-being (mean [SD], 8.2 [1.7]; 10-point scale). Key challenges included treatment-related issues (approx. 66%) and diagnosis (39%). Globally, 56% of physicians adhered to guidelines, 19% followed therapeutic protocols, and approximately 30% did not adhere to any guideline. Physicians reported that 80% of patients were on H₁-antihistamines (H1-AH; second-generation H1-AH [sgH1-AH], 57%; first-generation H1-AH, 23%), 29% on steroids, and 21% on omalizumab. Overall, 67% of physicians were satisfied with omalizumab and 33% with sgH1-AH. For patients inadequately controlled on H1-AH, physicians doubled (21%) or quadrupled (32%) H1-AH dose or added omalizumab (11%) or another sgH1-AH (10%). Key treatment goals were improving patients' QOL (81%) and being free of itch and hives (75%); approximately, half of the physicians (51%) reported success in achieving complete symptom control. Unmet needs included better understanding of CSU etiology (48%), better access to treatments (47%), and reduced administrative barriers for prescribing biologics (45%).</p><p><strong>Conclusion: </strong>Improving patients' QOL and diagnosis- and treatment-related challenges is critical in CSU management from physicians' perspective. Despite higher satisfaction with omalizumab, predominant use of sgH1-AH and reluctance to escalate to omalizumab indicate areas for improving treatment strategies in CSU care. Notably, reluctance to escalate to biologics may be partly due to limited availability and barriers to access in certain countries, which must be addressed to optimize care globally.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2925-2946"},"PeriodicalIF":4.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454223/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798447","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}