Dermatology and Therapy最新文献

{"title":"STRIAA (Severity TRichoscopy Index Alopecia Areata): Validation of a Novel Trichoscopic Tool for Evaluation of Alopecia Areata.","authors":"Michela Starace, Francesca Pampaloni, Federico Quadrelli, Stephano Cedirian, Luca Rapparini, Francesca Bruni, Bianca Maria Piraccini","doi":"10.1007/s13555-024-01313-x","DOIUrl":"https://doi.org/10.1007/s13555-024-01313-x","url":null,"abstract":"<p><strong>Introduction: </strong>Alopecia areata (AA) is a non-scarring autoimmune disease characterized by patchy hair loss. The aim of this study was to validate a novel trichoscopic scoring tool, the Severity TRichoscopy Index for Alopecia Areata (STRIAA), for rapid assessment of AA severity.</p><p><strong>Methods: </strong>Anonymized images from 340 patients were scored by two independent raters who analyzed four scalp areas (vertex, occipital, and left and right parietal) for trichoscopic signs: black dots, yellow dots, exclamation mark hairs, broken hairs, and short vellus hairs. Scores (0-3) were assigned according to the number of trichoscopic signs per area, resulting in a total STRIAA score out of 60.</p><p><strong>Results: </strong>STRIAA showed high interrater reliability (Cronbach's alpha 0.99) and significant correlation with the Severity of Alopecia Tool (SALT) score (p < 0.001). Yellow and black dots were significantly associated with the SALT score.</p><p><strong>Conclusions: </strong>The STRIAA provides a rapid and comprehensive assessment of AA severity, complementing current assessment tools in clinical practice.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846044","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}

{"title":"Sexual Dysfunction in Chronic Urticaria: A Systematic Review.","authors":"Sarah E Park, Elaine Ma, Caitlyn Dagenet, Maria A Aleshin, Heather M Holahan, Vivian Y Shi, Jennifer L Hsiao","doi":"10.1007/s13555-024-01319-5","DOIUrl":"https://doi.org/10.1007/s13555-024-01319-5","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic urticaria (CU) is frequently a debilitating skin condition characterized by recurrent and spontaneous wheal and flares with significant impact on quality of life. This systematic review examines the impact of CU on sexual health.</p><p><strong>Methods: </strong>A systematic review using PubMed, Embase, Web of Science, and Cochrane library databases was conducted for articles on sexual health in chronic urticaria.</p><p><strong>Results: </strong>The database search produced 741 articles, of which 14 articles met inclusion criteria. Study design, patient demographics, disease characteristics, measures used to assess sexuality or sexual function, and study results were independently extracted for each article by two researchers. Any discrepancies were resolved to consensus by a third reviewer. Sexual dysfunction was common in patients with CU and its severity is associated with increased disease activity and poor disease control.</p><p><strong>Conclusion: </strong>Sexual dysfunction is common in patients with CU, and it negatively affects their quality of life (QoL), body image, sleep quality, and mental health. Incorporating sexual health assessments into CU trials will allow for valuable insights into efficacy of study medications on this important QoL domain. Increased awareness of sexual impairment in CU is needed to provide comprehensive care.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142806474","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}

{"title":"Real-Life Data of Secukinumab in Patients with Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, and Ankylosing Spondylitis: Patient Baseline Characteristics Data from the PROMPT Study.","authors":"Ploysyne Rattanakaemakorn, Parawee Chevaisrakul, Chanisada Wongpraparut, Praveena Chiowchanwisawakit, Napatra Tovanabutra, Pimchanok Tantiwong, Warayuwadee Amornpinyo, Panlop Chakkavittumrong, Punchong Hanvivadhanakul, Sumapa Chaiamnuay, Supapat Laodheerasiri, Bensachee Pattamadilok, Charoen Choonhakarn, Ajanee Mahakkanukrauh, Duangkamol Aiewruengsurat, Siripan Sangmala, Nisa Pretikul, Kittiwan Sumethkul, Panchalee Satpanich, Metavee Boonsiri, Naruemon Sangob, Pravit Asawanonda","doi":"10.1007/s13555-024-01299-6","DOIUrl":"10.1007/s13555-024-01299-6","url":null,"abstract":"<p><strong>Introduction: </strong>Secukinumab has proven to be effective and safe in psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in the phase 3 studies. However, data on real-world practice is limited.</p><p><strong>Methods: </strong>This study is an ongoing, multicenter, 2-year observational study that focuses on patients with moderate to severe plaque PsO, active PsA, or AS receiving secukinumab. The aim of this study is to present baseline data for the entire study population.</p><p><strong>Results: </strong>A total of 127 patients were enrolled, with 101 having PsO, 12 with PsA, and 14 with AS. Among the patients, approximately 54.0% were male. The mean body mass index ranged from 25.0 to 27.4 kg/m² across all groups. Patients with PsO had the longest disease duration with an average of 11.0 years, followed by AS (3.0 years) and PsA (1.0 year). Previous biologic therapy was observed in 6.9-8.1% of patients. Baseline disease severity scores revealed moderate to severe disease. In the PsO group, the mean Psoriasis Area and Severity Index score was 16.1. For patients with PsA, the mean Tender Joint Count was 9.1, and the mean Swollen Joint Count was 6.7. In the AS group, the mean Bath Ankylosing Spondylitis Disease Activity Index score was 4.6, and the mean Ankylosing Spondylitis Disease Activity Score was 3.7.</p><p><strong>Conclusion: </strong>The study demonstrates disease durations, disease activity, and treatment history in Thai patients that were generally consistent with previous randomized controlled studies. Long-term data on the efficacy and safety of the treatment will be presented in future publications.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3229-3241"},"PeriodicalIF":3.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604867/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142589735","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 Narrative Review of the OX40-OX40L Pathway as a Potential Therapeutic Target in Atopic Dermatitis: Focus on Rocatinlimab and Amlitelimab.","authors":"Asaad Abdelhalim, Orhan Yilmaz, Mohamed Elshaikh Berair, Tiago Torres","doi":"10.1007/s13555-024-01308-8","DOIUrl":"10.1007/s13555-024-01308-8","url":null,"abstract":"<p><p>Atopic dermatitis (AD) is a common chronic inflammatory skin disease involving complex immune dysregulation, including the OX40-OX40L pathway. Rocatinlimab and amlitelimab, monoclonal antibodies targeting OX40 and OX40L, respectively, have shown promise in treating moderate-to-severe AD. Both therapies have demonstrated significant efficacy in reducing disease severity, with favorable safety profiles and no serious treatment-related adverse events. Both treatments outperformed placebo across key clinical endpoints, including skin clearance and symptom reduction, highlighting their potential as effective AD therapies. Although initial results are promising, further research is needed to evaluate the long-term effects, durability of response, and safety of these treatments. These findings support the therapeutic potential of targeting the OX40-OX40L pathway in AD, providing new options for patients with moderate-to-severe disease, with ongoing trials necessary to confirm their sustained benefits.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3197-3210"},"PeriodicalIF":3.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604912/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675430","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 Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Phase 2 Study Evaluating the Efficacy and Safety of GN-037 Cream in Patients with Mild-to-Moderate Plaque Psoriasis.","authors":"Burhan Engin, Müge Güler Özden, Özge Sevil Karstarlı Bakay, Selda Pelin Kartal, İlkin Zindancı, Salih Levent Çınar, Recep Dursun, Gizem Pehlivan Ulutaş, Tuğba Özkök Özkök Akbulut, Fatma Aslı Hapa, Emel Bülbül Başkan, Mehmet Melikoğlu, Algün Polat Ekinci, Neslihan Demirel Öğüt, Pelin Hızlı, Zafer Türkoğlu, Özlem Su Küçük, Zeynep Topkarcı, Ümit Türsen, Filiz Canpolat, Hanife Uçgun, Şirin Yaşar, Selami Aykut Temiz, Asena Çiğdem Doğramacı, Sedat Altuğ, Serhat Kozlu, Nadir Ulu, Server Serdaroğlu","doi":"10.1007/s13555-024-01301-1","DOIUrl":"10.1007/s13555-024-01301-1","url":null,"abstract":"<p><strong>Introduction: </strong>Topical therapies are used in almost all patients with psoriasis. A novel fixed topical combination cream (GN-037) with a lower concentration (0.0356%) of clobetasol 17-propionate (CP) was developed together with urea, salicylic acid, and retinoic acid to provide a better benefit-risk ratio. The present multicenter randomized double-blind vehicle-controlled parallel group phase 2 study aimed to investigate the efficacy and safety of GN-037 in patients with mild-to-moderate plaque psoriasis (MMPP).</p><p><strong>Methods: </strong>Patients (n = 190) were randomized (2:2:1) to receive GN-037 or CP or vehicle (V) cream twice daily to a selected target body lesion for 4 weeks. The primary endpoint was treatment success defined as percentage of patients with at least two-grade improvement in Investigator's Global Assessment Score (IGA) and IGA score equal to 0 or 1 evaluated at weeks 2, 4, 6, and 8 in each arm compared with baseline. Treatment-emergent adverse events (TEAEs) and safety were evaluated throughout the study.</p><p><strong>Results: </strong>GN-037 demonstrated statistically significant superiority over V throughout the study. At week 4, treatment success was achieved in 37.9% of patients in the GN-037 arm compared with 29.2% and 9.1% in the CP and V arms, respectively. At least two-grade improvement compared with baseline was achieved by 57.6%, 72.7%, and 80.3% of the patients in the GN-037 arm for erythema, plaque elevation, and scaling, respectively. The mean changes in affected BSA were -2.1 ± 2.9, -1.8 ± 2.4, and -0.5 ± 1.6 in the GN-037, CP, and V arms, respectively. The TEAEs were similar among the arms and the most frequently observed TEAEs were Psoriasis Area and Severity Index (PASI) increase in all arms.</p><p><strong>Conclusions: </strong>GN-037 was more effective than V in achieving primary and all secondary endpoints throughout the study. Safety data did not reveal any new safety concerns with the combination cream product. Therefore, 4 weeks of GN-037 treatment demonstrated an excellent efficacy and safety profile in patients with MMPP.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov identifier, NCT05706870.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3337-3350"},"PeriodicalIF":3.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604858/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692429","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":"Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study.","authors":"Richard B Warren, Lev Pavlovsky, Antonio Costanzo, Michael Bukhalo, Neil J Korman, Yu-Huei Huang, Georgios Kokolakis, Andreas Pinter, Nadia Ibrahim, Yanbing Zheng, Leonidas Drogaris, Vassilis Stakias, Ahmed M Soliman, Simone Rubant, Diamant Thaçi","doi":"10.1007/s13555-024-01292-z","DOIUrl":"10.1007/s13555-024-01292-z","url":null,"abstract":"<p><strong>Introduction: </strong>Risankizumab has demonstrated superior efficacy compared to other psoriasis treatments, including secukinumab, adalimumab, and ustekinumab; switching to risankizumab from other psoriasis treatments has shown superior clinical and quality of life (QoL) outcomes. We evaluated the efficacy and safety of directly switching patients with moderate-to-severe plaque psoriasis and a suboptimal response to interleukin (IL)-17 inhibitors (secukinumab or ixekizumab) to risankizumab.</p><p><strong>Methods: </strong>This 52-week, phase 3b study enrolled patients (≥ 18 years) with moderate-to-severe plaque psoriasis who had previously been treated with the recommended dose of secukinumab or ixekizumab for ≥ 6 months but did not achieve an optimal response (static Physician's Global Assessment [sPGA] 2/3; body surface are [BSA] 3- < 10%). Patients received subcutaneous risankizumab (150 mg) without washout. The primary endpoint was the proportion of patients achieving sPGA of 0/1 at week 16. Secondary endpoints included sPGA 0/1 at week 52, sPGA 0, Dermatology Life Quality Index (DLQI) 0/1, and Psoriasis Symptoms Scale (PSS) 0 at weeks 16 and 52. Safety was monitored throughout the study.</p><p><strong>Results: </strong>The study included 244 patients. sPGA 0/1 was achieved by 57.4% and 62.3% at week 16 and 52. At week 16, sPGA 0, DLQI 0/1, and PSS 0 were achieved by 20.5%, 40.2%, and 20.9%, respectively. At week 52, these proportions increased to 27.1% for sPGA 0, 47.2% for DLQI 0/1, and 27.5% for PSS 0. Most frequently reported adverse events (reported in ≥ 5% of patients) in risankizumab-treated patients were COVID-19 infection (8.6%) and nasopharyngitis (5.7%). No new safety signals were observed.</p><p><strong>Conclusions: </strong>Directly switching to risankizumab improved outcomes and QoL in patients with moderate-to-severe psoriasis who had suboptimal responses to anti-IL-17 inhibitors (secukinumab or ixekizumab). The safety results are consistent with previously reported safety of risankizumab. This study supports the efficacy of risankizumab in patients previously treated with biologics, including IL-17 inhibitors, and suggests a direct switch to risankizumab for improved clinical outcomes and QoL.</p><p><strong>Clinical trials: </strong>ClinicalTrials.gov identifier: NCT04102007.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3273-3290"},"PeriodicalIF":3.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604970/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616523","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":"Intelligent Diagnosis of Hypopigmented Dermatoses and Intelligent Evaluation of Vitiligo Severity on the Basis of Deep Learning.","authors":"Hequn Huang, Changqing Wang, Geng Gao, Zhuangzhuang Fan, Lulu Ren, Rui Wang, Zhu Chen, Maoxin Huang, Mei Li, Fei Yang, Fengli Xiao","doi":"10.1007/s13555-024-01296-9","DOIUrl":"10.1007/s13555-024-01296-9","url":null,"abstract":"<p><strong>Introduction: </strong>There is a lack of objective, accurate, and convenient methods for classification diagnostic hypopigmented dermatoses (HD) and severity evaluation of vitiligo. To achieve an accurate and intelligent classification diagnostic model of HD and severity evaluation model of vitiligo using a deep learning-based method.</p><p><strong>Methods: </strong>A total of 11,483 images from 4744 patients with HD were included in this study. An optimal diagnostic model was constructed by merging the squeeze-and-excitation (SE) module with the candidate model, its diagnostic efficiency was compared with that of 98 dermatologists. An objective severity evaluation indicator was proposed through weighting method and combined with a segmentation model to form a severity evaluation model, which was then compared with the assessments conducted by three experienced dermatologists using the naked eye.</p><p><strong>Results: </strong>The improved diagnosis model SE_ResNet-18 outperformed the other 11 classic models with an accuracy of 0.9389, macro-specificity of 0.9878, and macro-f1 score of 0.9395, and outperformed the different categories of 98 dermatologists (P < 0.001). The weighted Kappa test indicated medium consistency between the Indicator_v and the VASI_change (K = 0.567, P < 0.05). The optimal segmented model, HR-Net, had 0.8421 mIOU. The model-based severity evaluation results were not significantly different among the three experienced dermatologists.</p><p><strong>Conclusions: </strong>This study proposes an objective, accurate, and convenient hybrid model for diagnosing HD and evaluating the severity of vitiligo, providing a method for dermatologists especially in grassroots hospitals, and provides a foundation for telemedicine.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3307-3320"},"PeriodicalIF":3.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142603408","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":"Alopecia Areata Treatment Patterns and Satisfaction: Results of a Real-World Cross-Sectional Survey in Europe.","authors":"Peter Anderson, James Piercy, Jenny Austin, Simran Marwaha, Kent A Hanson, Ernest H Law, Gregor Schaefer, Samantha K Kurosky, Sergio Vañó-Galván","doi":"10.1007/s13555-024-01280-3","DOIUrl":"10.1007/s13555-024-01280-3","url":null,"abstract":"<p><strong>Introduction: </strong>Alopecia areata (AA) is an autoimmune disease that causes scalp, face, and/or body hair loss. Recently, oral treatments with kinases inhibition became the first approved therapies for severe AA. An understanding of the use and effectiveness of traditional therapies in real-world treatment settings is needed to guide integration of novel therapies into the treatment paradigm. This study aimed to describe traditional treatment patterns, dermatologists' reasons for therapy choice, and dermatologists' satisfaction with disease control among patients with AA.</p><p><strong>Methods: </strong>Data were drawn from the 2021-2022 Adelphi Real World AA Disease Specific Programme™, a cross-sectional survey of dermatologists and adult patients with AA, conducted in France, Germany, Italy, Spain, and the UK. For each patient, using data from patient consultation and medical records, dermatologists reported % scalp hair loss (SHL), characteristics of current and prior AA therapies, and satisfaction with disease control.</p><p><strong>Results: </strong>Overall, 239 dermatologists provided data for 1720 patients with AA. Mean (SD) patient age was 35.8 (11.6) years, and 51% were male. Based on dermatologist perception, among patients with ≤ 10% SHL, 74% were experiencing mild AA, while ≥ 95% of patients with ≥ 50% SHL were experiencing severe/very severe AA. In patients with ≥ 50% SHL, the most common therapies received included systemic immunosuppressants (31%), topical corticosteroids (24%), and oral corticosteroids (24%). Among all patients who had switched therapies, 49%, 26%, and 24% switched because of worsening AA, lack of initial efficacy with prior treatment, and loss of response over time, respectively. Among those with SHL ≥ 50%, dermatologists reported satisfaction with current therapy in < 30% of patients.</p><p><strong>Conclusion: </strong>Dermatologists reported low satisfaction with traditional AA therapies used in patients with extensive SHL, with some patients discontinuing treatment because of worsening disease. This suggests more effective treatments are needed for patients with severe AA.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3243-3258"},"PeriodicalIF":3.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460193","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 Atopic Dermatitis Control Tool: Adaptation and Content Validation for Children and Caregivers of Children with Atopic Dermatitis.","authors":"Chien-Chia Chuang, David M Pariser, Eric Simpson, Jennifer Dine, Michelle Brown, Sheri Fehnel, Zhixiao Wang","doi":"10.1007/s13555-024-01289-8","DOIUrl":"10.1007/s13555-024-01289-8","url":null,"abstract":"<p><strong>Introduction: </strong>The Atopic Dermatitis Control Tool (ADCT) assesses six concepts regarding patient-perceived control of atopic dermatitis (AD) in adults and adolescents with AD. This study aimed to develop two modified ADCT versions, one for children with AD aged 8-11 years and another for caregivers of children with AD aged 6 months to 11 years.</p><p><strong>Methods: </strong>Following the US Food and Drug Administration patient-reported outcomes guidance, the ADCT was modified to produce draft Child and Caregiver ADCT versions, maintaining the original six concepts. The instruments were refined and finalized through an iterative process using input from children with AD and caregivers of children with AD via qualitative interviews. Inclusion criteria were clinician diagnosis of AD, prescription treatment use in the past 3 months, and itching/scratching or rash in the past month. Interviews consisted of concept elicitation to identify perceptions of AD control and cognitive debriefing to test and refine the ADCT items.</p><p><strong>Results: </strong>In total, 19 children (mean age 9.2 years, 74% male) and 17 caregivers (mean age 36.3 years, 100% female) were interviewed. During concept elicitation, children and caregivers reported similar symptoms and described the cycling and unpredictability of AD. Most participants reported that daily activities were impacted negatively by AD symptoms. The concept of AD control resonated with children and caregivers, and respondents were able to describe their experiences related to AD symptom severity. Children were unfamiliar with the term AD, so the Child ADCT version was named the Child Eczema Control Tool (ECT). Children and caregivers both reported that the instruments assessed relevant concepts, comprehensively measured AD control, and demonstrated content and face validity.</p><p><strong>Conclusions: </strong>The Child ECT and Caregiver ADCT were developed and qualitatively validated for assessing AD control in patients aged 6 months to 11 years and may offer simple ways to assess disease control and optimize treatment decisions. Video Abstract.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3261-3271"},"PeriodicalIF":3.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604878/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142681078","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":"Rocatinlimab Improves Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Double-Blind Placebo-Controlled Phase 2b Study.","authors":"Melinda Gooderham, Emma Guttman-Yassky, Ken Igawa, Kenji Kabashima, Ehsanollah Esfandiari, Angela J Rylands, Angela Williams, Annabel Nixon, Jennifer E Dent, Eric Simpson","doi":"10.1007/s13555-024-01303-z","DOIUrl":"10.1007/s13555-024-01303-z","url":null,"abstract":"<p><strong>Introduction: </strong>In adults with moderate-to-severe atopic dermatitis (AD), rocatinlimab demonstrated significant and progressive improvement in clinical measures of disease severity compared with placebo. This post hoc analysis of a phase 2b study was undertaken to understand the disease burden and to assess the impact of rocatinlimab on patient-reported outcomes (PROs).</p><p><strong>Methods: </strong>This analysis used baseline data from a multicenter, randomized, double-blind study of adults with moderate-to-severe AD, who completed a Worst Pruritus numerical rating scale (NRS), Sleep Disturbance NRS, and the Dermatology Life Quality Index (DLQI). A mixed model for repeated measures was used to estimate changes in PRO scores from baseline; scores were also compared with clinically meaningful change benchmarks.</p><p><strong>Results: </strong>The analysis included 267 subjects, mean (SD) age 37.9 (14.7) years, 40.8% female; 55.1% grade 3 and 44.9% grade 4 Investigator Global Assessment for AD. Mean (SD) scores were: Worst Pruritus NRS 7.5 (1.9), Sleep Disturbance NRS 5.5 (2.9), DLQI total score 12.6 (7.1). Worst Pruritus and Sleep NRS scores had low positive correlations with SCORing AD (SCORAD) score (r = 0.44, r = 0.45 respectively) and negligible correlations with Eczema Area and Severity Index (EASI) score and area affected (r < 0.30). DLQI score varied by sex, study country, race, age, longer disease duration, disease severity (EASI and SCORAD), presence of asthma, and Worst Pruritus NRS, Sleep disturbance NRS, and DLQI scores. Rocatinlimab showed benefit on all three PROs, with significant improvements from baseline at the end of the double-blind period (week 18) and active treatment extension (week 36). Benefits were maintained over 20 weeks' post-treatment follow-up. The benefit of rocatinlimab treatment on PROs is rapid and maintained for at least 20 weeks following treatment completion.</p><p><strong>Conclusion: </strong>This analysis demonstrates the importance of characterizing the burden of moderate-to-severe AD from the patient's perspective, alongside clinical disease measures, to develop a fuller picture of treatment benefit.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT03703102.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"3351-3366"},"PeriodicalIF":3.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604902/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616525","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}