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The Tralokinumab Pre-Filled Pen Improved Atopic Dermatitis Signs and Symptoms and Was Well Tolerated in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A 16-Week, Open-Label, Single-Arm Phase 3 Study (INJECZTRA). Tralokinumab预填充笔改善了特应性皮炎的体征和症状,并且在中度至重度特应性皮炎的成人和青少年中具有良好的耐受性:一项为期16周,开放标签,单组3期研究(INJECZTRA)。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-07-18 DOI: 10.1007/s13555-025-01490-3
Jennifer Soung, Vivian Laquer, Matthew Zirwas, Peter van Iperen, John C Stinson, Katrine Lykke Albertsen, Linda Stein Gold
{"title":"The Tralokinumab Pre-Filled Pen Improved Atopic Dermatitis Signs and Symptoms and Was Well Tolerated in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A 16-Week, Open-Label, Single-Arm Phase 3 Study (INJECZTRA).","authors":"Jennifer Soung, Vivian Laquer, Matthew Zirwas, Peter van Iperen, John C Stinson, Katrine Lykke Albertsen, Linda Stein Gold","doi":"10.1007/s13555-025-01490-3","DOIUrl":"https://doi.org/10.1007/s13555-025-01490-3","url":null,"abstract":"<p><strong>Introduction: </strong>The tralokinumab pre-filled pen was developed to improve patient convenience and deliver 300 mg tralokinumab (the recommended dose for most patients) with one injection. This study evaluated the efficacy, safety, and usability of the tralokinumab pre-filled pen autoinjector in patients with moderate-to-severe atopic dermatitis.</p><p><strong>Methods: </strong>This 16-week, open-label, single-arm phase 3 study enrolled patients ≥ 12 years with Investigator's Global Assessment (IGA) score ≥ 3 and Eczema Area and Severity Index (EASI) ≥ 12. Patients received tralokinumab 300 mg via self-administered pre-filled pen every 2 weeks for 16 weeks. The primary endpoints were IGA 0/1 and ≥ 75% improvement in EASI (EASI-75) at week 16. Safety was assessed as the number of adverse events from baseline to week 16.</p><p><strong>Results: </strong>At week 16, 28.7% (39/136) of patients achieved IGA 0/1 (28.6% [30/105] adults; 29.0% [9/31] adolescents) and 43.4% (59/136) of patients achieved EASI-75 (44.8% [47/105] adults; 38.7% [12/31] adolescents). The tralokinumab pre-filled pen was well tolerated, and the observed safety profile was comparable to the safety profile with the tralokinumab pre-filled syringe.</p><p><strong>Conclusions: </strong>Tralokinumab formulated as a pre-filled pen was effective, well tolerated, and easy to use. The tralokinumab pre-filled pen may offer a more convenient method of tralokinumab administration with fewer injections per dose.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05194540.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667414","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
Well-Being in Psoriasis: Weighting its Components Using Best-worst Scaling Methodology. 牛皮癣的健康:使用最佳-最差缩放方法加权其组成部分。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-07-18 DOI: 10.1007/s13555-025-01499-8
Esteban Daudén, Isabel Belinchón, Elena Colominas-González, Pablo Coto, Pablo de la Cueva, Fernando Gallardo, Jose Luis Poveda, Esther Ramírez, Sandra Ros, Ricardo Ruíz-Villaverde, Isabel Cabezas, Luis Lizán
{"title":"Well-Being in Psoriasis: Weighting its Components Using Best-worst Scaling Methodology.","authors":"Esteban Daudén, Isabel Belinchón, Elena Colominas-González, Pablo Coto, Pablo de la Cueva, Fernando Gallardo, Jose Luis Poveda, Esther Ramírez, Sandra Ros, Ricardo Ruíz-Villaverde, Isabel Cabezas, Luis Lizán","doi":"10.1007/s13555-025-01499-8","DOIUrl":"https://doi.org/10.1007/s13555-025-01499-8","url":null,"abstract":"<p><strong>Introduction: </strong>The Inpsight Project, established in 2021, aimed to define the concept of well-being in patients with psoriasis from a holistic perspective. Well-being was defined as a multi-dimensional concept that includes achieving emotional balance, having adequate overall health and control of the disease, enjoying positive social relationships, and being satisfied with disease care. However, while these components are recognized as integral to the concept, their relative contribution to achieving optimal well-being remains unclear. To address this gap, the present study aimed to determine the relative weight of each component in contributing to optimal well-being, focusing on a Spanish population.</p><p><strong>Methods: </strong>An observational, descriptive, cross-sectional study was conducted in Spain using best-worst scaling (BWS). Two questionnaires were developed: one addressed to patients (33 item) and the other to healthcare professionals (HCPs) (18 item). The questionnaires collected sociodemographic and clinical (patients)/occupational (HCP) characteristics of the participants and the BWS scenarios. The 20 components of well-being were randomly distributed across 76 scenarios, with each component paired with others four times to ensure a comprehensive evaluation of all possible combinations. Participants assessed 9-10 randomly selected scenarios and identified the components they considered most (best) and least (worst) important for achieving optimal well-being.</p><p><strong>Results: </strong>A total of 87 HCPs and 152 patients with psoriasis participated in the study. The five key components for patients were pain (P: 100.00), stress (P: 98.74), treatment satisfaction (92.21), itching (72.05), and lesions in functional locations (P: 69.09). From a HCP perspective, the most important components were mood disorders (100.00), pain (69.39), lesions in functional locations (49.34), self-esteem (49.24), and stigmatization/shame (45.22).</p><p><strong>Conclusions: </strong>This study highlights the differences between patients and HCPs in their perception of the relative importance and relevance of the components contributing to the well-being of patients with psoriasis. Future research should focus on understanding the cumulative impact of psoriasis on patient well-being.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658670","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
Current Treatments and Future Directions for Hidradenitis Suppurativa: a Narrative Review of Completed and Ongoing Phase 3 Clinical Trials of Biologic Therapies. 化脓性汗腺炎的当前治疗方法和未来发展方向:对已完成和正在进行的生物疗法3期临床试验的叙述性回顾。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-07-18 DOI: 10.1007/s13555-025-01487-y
Amit Garg, Jennifer Hsiao, Martina L Porter, Vivian Shi
{"title":"Current Treatments and Future Directions for Hidradenitis Suppurativa: a Narrative Review of Completed and Ongoing Phase 3 Clinical Trials of Biologic Therapies.","authors":"Amit Garg, Jennifer Hsiao, Martina L Porter, Vivian Shi","doi":"10.1007/s13555-025-01487-y","DOIUrl":"https://doi.org/10.1007/s13555-025-01487-y","url":null,"abstract":"<p><p>Hidradenitis suppurativa (HS) is a chronic, progressive inflammatory disease characterized by recurrent nodules, abscesses, draining tunnels, and scarring. Current treatment strategies for patients with HS typically involve a combination of therapeutic and surgical interventions that are tailored to the severity and extent of the disease. Treatment of patients with mild disease often includes topical or systemic antibiotics followed by anti-androgen therapies; however, these treatments are off-label and are generally only modestly effective for patients with moderate-to-severe disease. The lack of dedicated therapies targeting pathogenic mechanisms of HS has historically contributed to the unmet needs for disease management. These needs have been addressed recently by the emergence of biologic therapies, which can provide rapid and sustained symptom and disease control for patients who have poor treatment responses to initial therapies and progressive disease. Biologics have become an integral component in treatment strategies for patients with HS, but the unique clinical benefits and safety profile of each biologic can impact treatment decisions for individual patients. Recent elucidation of unique immunological pathways that contribute to HS pathophysiology may lead to the development of novel therapeutics that would expand the current therapeutic options, especially for patients with advanced disease. The purpose of this review is to provide an overview of the present therapeutic landscape for HS, with a particular focus on the mechanism of action, efficacy, and safety of biologic therapies either approved or under clinical investigation for the treatment of patients with HS. We also provide expert commentary on future directions of HS therapies as they pertain to recent research on the immunopathology of HS.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667412","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
Biologic Sequence for the Treatment of Psoriatic Arthritis Following Nonresponse: A Narrative Review. 治疗银屑病关节炎后无反应的生物序列:叙述性回顾。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-07-18 DOI: 10.1007/s13555-025-01482-3
Nicole D Boswell, Alexa Ries, Kenneth B Gordon, Shikha Singla
{"title":"Biologic Sequence for the Treatment of Psoriatic Arthritis Following Nonresponse: A Narrative Review.","authors":"Nicole D Boswell, Alexa Ries, Kenneth B Gordon, Shikha Singla","doi":"10.1007/s13555-025-01482-3","DOIUrl":"https://doi.org/10.1007/s13555-025-01482-3","url":null,"abstract":"<p><p>Psoriatic arthritis (PsA) is a complex, heterogeneous disease affecting multiple domains which necessitates a nuanced approach to treatment. While tumor necrosis factor (TNF) inhibitors have historically been the preferred first line therapy, increasing evidence highlights the efficacy of interleukin (IL) 17 and IL-23 inhibitors, particularly in cases of nonresponse to TNF inhibitors. These targeted biologics offer additional therapeutic options, especially for those with concomitant psoriasis (PsO) and axial disease. The proposed biologic sequence derived from clinical trial data and expert opinion incorporates PsA disease severity as well as concomitant PsO and axial disease in the setting of biologic nonresponse. This approach aims to guide clinicians in selecting the most effective therapy while conserving future treatment options. However, gaps remain in understanding the sequential use of IL-17 and IL-23 inhibitors, particularly in axial disease, emphasizing the need for further research and real-world clinical data.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658668","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
Time to Onset of Action for Biologics and Targeted Treatments in Psoriasis: Systematic Targeted Literature Review and Network Meta-Analysis. 银屑病生物制剂和靶向治疗的起效时间:系统的靶向文献综述和网络荟萃分析。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-07-17 DOI: 10.1007/s13555-025-01463-6
Kim A Papp, Ron Vender, Kerri Purdy, Fiona Lovegrove, Irina Oroz, Parbeer Grewal, Perla Lansang, Laura Park-Wyllie, Nastaran Abbarin, Ya-Wen Yang, Becky Hooper, Sandra Vigelis, Tim Disher, Richard G Langley
{"title":"Time to Onset of Action for Biologics and Targeted Treatments in Psoriasis: Systematic Targeted Literature Review and Network Meta-Analysis.","authors":"Kim A Papp, Ron Vender, Kerri Purdy, Fiona Lovegrove, Irina Oroz, Parbeer Grewal, Perla Lansang, Laura Park-Wyllie, Nastaran Abbarin, Ya-Wen Yang, Becky Hooper, Sandra Vigelis, Tim Disher, Richard G Langley","doi":"10.1007/s13555-025-01463-6","DOIUrl":"https://doi.org/10.1007/s13555-025-01463-6","url":null,"abstract":"<p><strong>Introduction: </strong>For some patients with plaque psoriasis (PsO), a rapid response (i.e. short interval to time to onset of action [TOA]) is desired. The primary objective was to determine average time to achieve a Psoriasis Area and Severity Index (PASI) 90 response (50% of patients) for individual biologics or targeted therapies. Secondary outcomes included the average time to achieve a PASI 75 response (50% of patients), as well as PASI 90 and PASI 75 responses over the first 16 weeks of therapy.</p><p><strong>Methods: </strong>A systematic targeted literature review was conducted to identify phase III and IV randomised, double-blinded trials according to pre-specified eligibility criteria that investigated interleukin (IL)-12/23 inhibitors, IL-17 inhibitors, IL-23 inhibitors, Janus kinase (JAK) inhibitors, and phosphodiesterase (PDE) inhibitors. Using proportions of patients achieving PASI 90 or 75 responses over 16 weeks, network meta-analyses were conducted to estimate response over time. This was presented as curves, and TOA was summarized as median time to reach the 50th percentile.</p><p><strong>Results: </strong>Forty-five trials were included in the main analyses. The IL-17 inhibitors bimekizumab, ixekizumab, brodalumab, and secukinumab 300 mg were estimated to provide the earliest onset of PASI 90 response at approximately 6 to 8 weeks. This was followed by the IL-23 inhibitors risankizumab and guselkumab at approximately 9-10 weeks, and the IL-12/23 inhibitor at 11-12 weeks. Although wide and overlapping credible intervals and similar point estimates were observed, these results suggest onset of action does not vary greatly across biologics in these classes. Onset of PASI 90 response could not be estimated by the model for tildrakizumab, and JAK and PDE4 inhibitors. Onset of PASI 75 response showed similar trends to PASI 90 response.</p><p><strong>Conclusions: </strong>IL-17 inhibitors, followed by IL-23 inhibitors, have the most rapid TOA among PsO biologics evaluated; any differences in onset of action between specific agents within the same drug class are not statistically or clinically significant. These analyses will allow clinicians to make more informed treatment decisions for their patients.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658669","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
Lebrikizumab Rapidly Lowers Inflammatory Biomarkers with Clinical Correlations in Moderate-to-Severe Atopic Dermatitis. Lebrikizumab快速降低中重度特应性皮炎的炎症生物标志物与临床相关性
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-07-15 DOI: 10.1007/s13555-025-01481-4
Emma Guttman-Yassky, Zhe Sun, Laura Rebeca Mena, Nathan Hahn, Brian J Nickoloff, Christoph Preuss, Kimberly Siu, Chitra R Natalie, Gaia Gallo, Eric Wolf, Kilian Eyerich, Mònica Aparici, Robert J Benschop, Angela Okragly
{"title":"Lebrikizumab Rapidly Lowers Inflammatory Biomarkers with Clinical Correlations in Moderate-to-Severe Atopic Dermatitis.","authors":"Emma Guttman-Yassky, Zhe Sun, Laura Rebeca Mena, Nathan Hahn, Brian J Nickoloff, Christoph Preuss, Kimberly Siu, Chitra R Natalie, Gaia Gallo, Eric Wolf, Kilian Eyerich, Mònica Aparici, Robert J Benschop, Angela Okragly","doi":"10.1007/s13555-025-01481-4","DOIUrl":"https://doi.org/10.1007/s13555-025-01481-4","url":null,"abstract":"<p><strong>Introduction: </strong>Lebrikizumab is a novel monoclonal antibody that selectively binds to interleukin (IL)-13 with high affinity and a slow dissociation rate.</p><p><strong>Methods: </strong>We assayed serum from select patients enrolled in ADvocate1 and ADvocate2 to determine the impact of lebrikizumab on circulating biomarkers and pathways relevant to atopic dermatitis (AD) and to assess the correlation between key biomarkers and clinical measures of improvement.</p><p><strong>Results: </strong>At baseline, IL-13, CC motif chemokine ligand (CCL)13, CCL17, CCL22, total immunoglobulin (Ig)E, IL-5, and periostin were elevated in patients with moderate-to-severe AD versus healthy controls (p < 0.001). Baseline Eczema and Area Severity Index (EASI) and Investigator's Global Assessment (IGA) scores were significantly correlated with IL-13, IL-5, CCL13, CCL22, and CCL26. Lebrikizumab induced rapid and progressive reductions in CCL13, CCL17, CCL22, and periostin at weeks 4, 16, and 52 compared with baseline (p < 0.05). AD-associated pathways linked to cytokine signaling were significantly improved at weeks 4 and 16. Improvements in EASI, IGA, and the Pruritus Numeric Rating Scale were correlated with reductions in CCL13, CCL17, CCL22, CCL26, and periostin across all time points. After multiple testing correction and adjusting for sex and race as covariates, we identified the chemokine CCL26 as a pharmacodynamic marker for lebrikizumab response at weeks 4 and 16.</p><p><strong>Conclusions: </strong>Selective inhibition of IL-13 with lebrikizumab monotherapy induced progressive inhibition of systemic biomarkers and pathways of type 2 inflammation, which correlated with clinical measures of improvement in patients with moderate-to-severe AD.</p><p><strong>Clinical trial registrations: </strong>NCT04146363 and NCT04178967.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636521","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
Achieving Optimal Treatment Targets and Minimal Disease Activity with Upadacitinib for Moderate-to-Severe Atopic Dermatitis: Integrated Analysis of Phase 3 Studies (Measure Up 1 and 2). Upadacitinib治疗中重度特应性皮炎达到最佳治疗目标和最小疾病活动性:3期研究的综合分析(Measure Up 1和2)
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-07-14 DOI: 10.1007/s13555-025-01485-0
Jonathan I Silverberg, Melinda Gooderham, Norito Katoh, Valeria Aoki, Andrew E Pink, Yousef Binamer, Brad Glick, Petra Staubach, Brian Calimlim, Chao Li, Ayman Grada, Alvaro Moreira, Wan-Ju Lee, Andreas Wollenberg
{"title":"Achieving Optimal Treatment Targets and Minimal Disease Activity with Upadacitinib for Moderate-to-Severe Atopic Dermatitis: Integrated Analysis of Phase 3 Studies (Measure Up 1 and 2).","authors":"Jonathan I Silverberg, Melinda Gooderham, Norito Katoh, Valeria Aoki, Andrew E Pink, Yousef Binamer, Brad Glick, Petra Staubach, Brian Calimlim, Chao Li, Ayman Grada, Alvaro Moreira, Wan-Ju Lee, Andreas Wollenberg","doi":"10.1007/s13555-025-01485-0","DOIUrl":"https://doi.org/10.1007/s13555-025-01485-0","url":null,"abstract":"<p><strong>Introduction: </strong>The Aiming High in Eczema/Atopic Dermatitis (AHEAD) guidelines recommend achieving minimal disease activity (MDA) in atopic dermatitis (AD), defined as simultaneous achievement of optimal treatment targets for at least one clinician- and one patient-reported outcome (ClinRO + PRO). We assessed the effect of upadacitinib on achieving optimal ClinROs, optimal PROs, and MDA in Measure Up 1 (NCT03569293) and Measure Up 2 (NCT3607422) studies for patients with moderate to severe AD.</p><p><strong>Methods: </strong>Patients were randomized to receive upadacitinib (15 mg or 30 mg) or placebo. Achievement of ≥ 1 optimal target in ClinROs, ≥ 1 optimal target in PROs, and MDA (≥ 1 optimal ClinROs and ≥ 1 optimal PROs) were reported at weeks 16 (upadacitinib vs placebo) and 52 (upadacitinib only). MDAs in selected combinations were also assessed at weeks 16 and 52. A total of 1683 and 1124 patients were included in the week 16 and 52 analysis, respectively.</p><p><strong>Results: </strong>At week 16, a significantly higher proportion of patients receiving upadacitinib (15 mg: 42.5%, 30 mg: 55.9%) compared with placebo (6.4%) achieved MDA. At week 52, 57.4% and 69.9% of patients receiving 15 mg and 30 mg of upadacitinib achieved MDA, respectively. Specifically, patients receiving upadacitinib attained higher rates of ≥ 90% reduction from baseline in Eczema Area and Severity Index (EASI 90) + Worst Pruritus-Numerical Rating Scale (WP-NRS) 0/1 at week 16 (15 mg: 25.3%, 30 mg: 39.4% vs placebo: 1.8%) and maintained at week 52 (15 mg: 38.1%, 30 mg: 46.9%).</p><p><strong>Conclusion: </strong>Treatment with upadacitinib achieved both ClinRO and PRO optimal treatment targets as well as MDA and may optimize overall disease management in patients with moderate-to-severe AD.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144625593","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
Bimekizumab Impact on Patient-Reported Outcomes in Patients with Moderate to Severe Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II. 比美珠单抗对中重度化脓性汗腺炎患者报告结果的影响:来自BE HEARD i和ii的48周汇总结果
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-07-13 DOI: 10.1007/s13555-025-01465-4
Vivian Y Shi, John R Ingram, Hadar Lev-Tov, Sylke Schneider-Burrus, Seth Forman, Martina L Porter, Koremasa Hayama, Linnea Thorlacius, Jérémy Lambert, Tom Vaux, Bartosz Lukowski, Robert L Rolleri, Jacek C Szepietowski
{"title":"Bimekizumab Impact on Patient-Reported Outcomes in Patients with Moderate to Severe Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II.","authors":"Vivian Y Shi, John R Ingram, Hadar Lev-Tov, Sylke Schneider-Burrus, Seth Forman, Martina L Porter, Koremasa Hayama, Linnea Thorlacius, Jérémy Lambert, Tom Vaux, Bartosz Lukowski, Robert L Rolleri, Jacek C Szepietowski","doi":"10.1007/s13555-025-01465-4","DOIUrl":"https://doi.org/10.1007/s13555-025-01465-4","url":null,"abstract":"<p><strong>Introduction: </strong>Hidradenitis suppurativa (HS) symptoms (pain, itch, odour and drainage) impair quality of life (QoL). Bimekizumab, a humanised IgG1 monoclonal antibody, selectively inhibits interleukin (IL)-17A and IL-17F. The impact of bimekizumab on patient-reported outcomes (PROs) was assessed using pooled 48-week data from BE HEARD I&II (BHI&II) studies in moderate to severe HS.</p><p><strong>Methods: </strong>Patients received (initial/maintenance) bimekizumab 320 mg every 2 weeks (Q2W)/Q2W, bimekizumab Q2W/Q4W, bimekizumab Q4W/Q4W or placebo/bimekizumab Q2W. HS Symptom Daily Diary (HSSDD) and HS Symptom Questionnaire (HSSQ) captured HS-specific patient-reported symptoms; HS Quality of Life questionnaire (HiSQOL<sup>©</sup>) and Dermatology Life Quality Index (DLQI) captured health-related QoL (HRQoL). Change from baseline (CfB) and proportions of patients achieving clinically meaningful improvement thresholds or low disease impact are reported to Week 48 (observed case).</p><p><strong>Results: </strong>Of 1014 randomised patients, 868 received bimekizumab and 146 placebo. Greater numerical reductions at Week 16 were observed across HSSDD/HSSQ scores with bimekizumab vs placebo. From Week 16 to 48, HSSQ scores further numerically reduced with continuous bimekizumab and substantially reduced for placebo/bimekizumab switchers. At Week 16, bimekizumab showed numerically greater improvement in HRQoL vs placebo (HiSQOL total score mean CfB: - 11.7 to - 10.3 vs - 5.5). HiSQOL response rate (21-point total score reduction) was numerically higher by Week 4 in bimekizumab-treated patients (17.2-21.4%) vs placebo (9.2%); rates increased to Week 48 with continuous bimekizumab (42.0-47.4%) and in switchers (55.0%). Patients with very severe disease impact (HiSQOL total score ≥ 24) decreased over time with bimekizumab. At Week 16, DLQI minimal clinically important difference (4-point decrease) achievement was numerically greater with bimekizumab vs placebo (54.9-64.6% vs 49.1%). Achievement increased to Week 48 and switchers attained similar proportions (63.5-74.5% vs 76.5%). Comparable trends were observed for DLQI score of 0/1 (no HRQoL impact) achievement rates.</p><p><strong>Conclusion: </strong>Bimekizumab demonstrated clinically meaningful improvements by Week 4 in HRQoL, which were maintained over 1 year across PROs in patients with moderate to severe HS. Graphical Abstract available for this article.</p><p><strong>Trial registration: </strong>NCT04242446; NCT04242498.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616665","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
Prognostic Factors Associated with Clinical Improvement Following Energy-Based Device Treatment in Thai Patients with Atrophic Acne Scars: A Retrospective Study. 泰国萎缩性痤疮疤痕患者能量装置治疗后与临床改善相关的预后因素:一项回顾性研究。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-07-13 DOI: 10.1007/s13555-025-01486-z
Chadakan Yan, Phichayut Phinyo, Yuri Yogya, Mati Chuamanochan, Rungsima Wanitphakdeedecha
{"title":"Prognostic Factors Associated with Clinical Improvement Following Energy-Based Device Treatment in Thai Patients with Atrophic Acne Scars: A Retrospective Study.","authors":"Chadakan Yan, Phichayut Phinyo, Yuri Yogya, Mati Chuamanochan, Rungsima Wanitphakdeedecha","doi":"10.1007/s13555-025-01486-z","DOIUrl":"https://doi.org/10.1007/s13555-025-01486-z","url":null,"abstract":"<p><strong>Introduction: </strong>Acne scarring is a prevalent complication of acne vulgaris, often resulting in significant psychosocial distress. While energy-based devices (EBDs), including fractional laser (FL) and fractional radiofrequency (FRF), are increasingly used for atrophic acne scars, limited data exist on prognostic factors predicting treatment outcomes, particularly in Asian populations. The study aims to identify clinical predictors of graded clinical improvement in patients with atrophic acne scars treated with FL and FRF.</p><p><strong>Methods: </strong>This retrospective cohort study was conducted at a university hospital in Bangkok, Thailand, from 2012 to 2023. Clinical improvement was assessed using standardized photographic evaluations and categorized into four levels: < 25%, 25-50%, 51-75%, and > 75% improvement. Univariable and multivariable ordinal logistic regression models were used to determine prognostic factors. Sensitivity analyses were performed to confirm the robustness of the findings.</p><p><strong>Results: </strong>A total of 397 patients were included, of whom 254 received FL and 143 received FRF treatments. Older age (per 5-year increase) (mOR: 1.24; 95% CI: 1.07-1.43), male sex (mOR: 1.29; 95% CI: 1.06-1.57), shorter scar duration (per 5 years) (mOR: 0.73; 95% CI: 0.56-0.97), lower Fitzpatrick skin phototypes, and completion of at least three treatment sessions (mOR: 1.33; 95% CI: 1.16-1.53) were independently associated with greater clinical improvement. Sensitivity analyses confirmed the robustness of these associations.</p><p><strong>Conclusions: </strong>Key clinical factors, including patient age, sex, scar duration, skin phototype, and completion of at least three treatment sessions, significantly influence treatment outcomes with EBDs. These findings support the development of personalized treatment strategies to optimize outcomes, particularly in patients with severe scarring.</p><p><strong>The trial registration number: </strong>TCTR20240512006.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616667","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
Dupilumab versus Lebrikizumab Demonstrates Greater Likelihood of Achieving and Maintaining Improvements in Efficacy Outcomes Using a Placebo-Adjusted Indirect Treatment Comparison. 使用安慰剂调整间接治疗比较,Dupilumab与Lebrikizumab显示更有可能实现和维持疗效结果的改善。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-07-11 DOI: 10.1007/s13555-025-01479-y
Sonja Ständer, Andreas Pinter, Firas G Hougeir, Patricia Guyot, Yingxin Xu, Amy H Praestgaard, Nick Freemantle, Ana B Rossi, Gaëlle Bégo-Le-Bagousse, Zhixiao Wang, Kerry Noonan, Mike Bastian
{"title":"Dupilumab versus Lebrikizumab Demonstrates Greater Likelihood of Achieving and Maintaining Improvements in Efficacy Outcomes Using a Placebo-Adjusted Indirect Treatment Comparison.","authors":"Sonja Ständer, Andreas Pinter, Firas G Hougeir, Patricia Guyot, Yingxin Xu, Amy H Praestgaard, Nick Freemantle, Ana B Rossi, Gaëlle Bégo-Le-Bagousse, Zhixiao Wang, Kerry Noonan, Mike Bastian","doi":"10.1007/s13555-025-01479-y","DOIUrl":"https://doi.org/10.1007/s13555-025-01479-y","url":null,"abstract":"<p><strong>Introduction: </strong>Dupilumab and lebrikizumab have demonstrated efficacy in atopic dermatitis (AD) clinical trials; however, no direct comparisons exist.</p><p><strong>Methods: </strong>Efficacy outcome achievement (dupilumab and lebrikizumab with topical corticosteroids [TCS]) at 16 weeks and efficacy outcomes maintenance (dupilumab and lebrikizumab monotherapy without TCS) at 52 weeks were assessed using a placebo-adjusted Bucher indirect treatment comparison (ITC). Week 16 data were sourced from LIBERTY AD CHRONOS (dupilumab, n = 106; placebo, n = 315) and ADhere (lebrikizumab, n = 145; placebo, n = 66) trials. Week 52 data were sourced from SOLO-CONTINUE (dupilumab, n = 80; placebo, n = 39) and ADvocate 1 and 2 (lebrikizumab, n = 231; placebo, n = 60) trials, including patients who had achieved ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI)-75 or Investigator's Global Assessment (IGA) score 0/1 (clear/almost clear) at week 16. Results are presented as odds ratios (ORs) with 95% confidence intervals (CIs).</p><p><strong>Results: </strong>At week 16, patients receiving dupilumab every 2 weeks (q2w) + TCS had a significantly higher likelihood of achieving EASI-75 (OR 2.4; 95% CI 1.1-5.1) and a ≥ 4-point improvement in Peak Pruritus Numeric Rating Scale (PP-NRS; OR 2.7; 95% CI 1.2-6.0) versus those receiving lebrikizumab q2w + TCS. ORs for other endpoints (IGA-0/1 and ≥ 4-point improvement in Dermatology Life Quality Index) numerically favored dupilumab. At week 52, dupilumab q2w maintained a significantly higher OR for EASI-75 (OR 3.5; 95% CI 1.2-10.5) versus lebrikizumab every 4 weeks. ORs for EASI-90 (OR 3.3; 95% CI 1.0-11.3), IGA 0/1 (OR 3.3; 95% CI 0.7-15.1), and PP-NRS (OR 8.8; 95% CI 0.9-84.8) numerically favored dupilumab.</p><p><strong>Conclusions: </strong>Placebo-adjusted Bucher ITC analyses showed that the likelihood of achieving efficacy outcomes at 16 weeks and maintaining efficacy outcomes at 52 weeks was higher for dupilumab versus lebrikizumab recipients.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616666","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
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