DermatologyPub Date : 2025-01-01Epub Date: 2025-01-10DOI: 10.1159/000543455
Jørgen Serup, Bjørn Christian Severin, Esben Hammershøy
{"title":"Tattoo Ink Products and Pigments 2018-2019 Upfront the New EU-REACH Regulation: Danish Golden Benchmark Study of 108 Studios and 39,687 Clients Tattooed with Inks from 109,720 Ink Bottles.","authors":"Jørgen Serup, Bjørn Christian Severin, Esben Hammershøy","doi":"10.1159/000543455","DOIUrl":"10.1159/000543455","url":null,"abstract":"<p><strong>Introduction: </strong>The new EU regulation on tattoo inks in force January 2022 in a hitherto unregulated market marks a historical change. The study aim was to register tattoo inks de facto used in studios before the new EU regulation and establish a historical reference to tattoo customer exposure, ink toxicology assessment, clinical complications, and the impact on tattooing businesses.</p><p><strong>Method: </strong>A tattooist-operated electronic system (InkBase) for ink registration required by law is used in Denmark since 2018. A local database in studios refers to a central database. Clients, sessions, ink bottles, brand name, and pigment color index (CI) are registered. Person's data protection is respected. Tracing harmful inks is possible, with public warning.</p><p><strong>Results: </strong>Registrations from 108 studios employing about 700 tattooists were collected from March 2018 to 2019. 39,687 clients were tattooed in 50,604 sessions, using colors from 109,720 ink bottles. 10,833 were CI-labelled identifying the pigment. 98.1% of inks originated from USA. Detailed statistics on inks and pigments used are provided as a benchmark showing the spontaneous use and preference of \"old\" tattoo inks before the EU regulation compulsory to member states introduced dramatic restrictions difficult to follow.</p><p><strong>Conclusions: </strong>Denmark can, having detailed ink registration enforced by law and having a commonly used electronic registration system reporting to a central server, function as an index country in future surveillance of use of tattoo inks in studios, toxicology aspects and the impact of regulatory intervention on the tattooing industry, with a large sample of data collected in 2018-2019.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":" ","pages":"259-271"},"PeriodicalIF":2.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12324700/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142970090","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}
DermatologyPub Date : 2025-01-01Epub Date: 2025-07-07DOI: 10.1159/000538422
Johanna C van Huijstee, Nadja E Zorge, Johanna C van Huijstee, Jasper S Dijkema, Dorra Bouazzi, Cecilia E Medianfar, Robin Christensen, Gregor B E Jemec, Errol P Prens, Hessel H van der Zee
{"title":"Prevalence of Hidradenitis Suppurativa in the Gulf Province of Papua New Guinea.","authors":"Johanna C van Huijstee, Nadja E Zorge, Johanna C van Huijstee, Jasper S Dijkema, Dorra Bouazzi, Cecilia E Medianfar, Robin Christensen, Gregor B E Jemec, Errol P Prens, Hessel H van der Zee","doi":"10.1159/000538422","DOIUrl":"10.1159/000538422","url":null,"abstract":"<p><p><p>Introduction: Hidradenitis suppurativa (HS) is a chronic and debilitating inflammatory skin disease, which mostly occurs in the skinfolds. The global prevalence of HS is currently unknown. Depending on the type of research and studied population, the reported prevalence varies between 0.03% and 4.1%. It is important to investigate the prevalence of HS worldwide using the same study design, in order to recognize, diagnose, and treat patients at an earlier stage. Consequently, a worldwide initiative, the Global Hidradenitis Suppurativa Atlas (GHiSA) has developed a study design to investigate the worldwide prevalence of HS in a comparable manner. The prevalence of HS in a Pacific Islander population has not been reported. The aim of this study was to estimate the prevalence of HS in Kapuna, Papua New Guinea.</p><p><strong>Methods: </strong>An explorative, descriptive, cross-sectional mono-center study in a secondary care center, the Kapuna Hospital, Papua New Guinea. Participants were healthy persons accompanying patients who were admitted to Kapuna Hospital or attending its Outpatient Department, and healthy hospital staff. The primary outcome of this study was the point prevalence of HS in Papua New Guinea using a validated questionnaire and physical examination.</p><p><strong>Results: </strong>A total of 520 participants were included in this study. The prevalence of HS in these 520 participants was 0.38% (2/520, 95% confidence interval 0.1-1.4%).</p><p><strong>Conclusion: </strong>The point prevalence of HS in Papua New Guinea was 0.38%. The findings of this study contribute to fill a gap in the current insights into global HS prevalence. </p>.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":" ","pages":"92-97"},"PeriodicalIF":2.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12233960/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144583307","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}
DermatologyPub Date : 2025-01-01Epub Date: 2025-07-07DOI: 10.1159/000539758
Theodora Kanni, Theodora Kanni, Sofia Ktena, Konstantinos Leventogiannis, Christina Damoulari, Dorra Bouazzi, Cecilia E Medianfar, Robin Christensen, Gregor B E Jemec, Evangelos J Giamarellos-Bourboulis
{"title":"Prevalence of Hidradenitis Suppurativa in Athens, Greece: A Cross-Sectional Study Based on a Validated Questionnaire.","authors":"Theodora Kanni, Theodora Kanni, Sofia Ktena, Konstantinos Leventogiannis, Christina Damoulari, Dorra Bouazzi, Cecilia E Medianfar, Robin Christensen, Gregor B E Jemec, Evangelos J Giamarellos-Bourboulis","doi":"10.1159/000539758","DOIUrl":"10.1159/000539758","url":null,"abstract":"<p><p><p>Introduction: Prevalence of hidradenitis suppurativa (HS) differs between countries and the worldwide prevalence of the disease remains unknown. Prevalence of HS has never been studied in Greece. The aim of this study was to estimate the HS prevalence in Athens, the capital of Greece.</p><p><strong>Method: </strong>Healthy adults accompanying patients to the outpatient department of internal medicine of ATTIKON University Hospital were approached by physicians familiar with HS. All eligible persons signed an informed consent form and answered the questionnaire. This study was a part of the Global Hidradenitis Suppurativa Atlas (GHiSA) initiative and therefore followed the objective and approach previously published by Bouazzi et al. [Dermatology. 2024 Feb;240(3):369-75].</p><p><strong>Results: </strong>Out of 553 participants, 20 screened positive for HS. Of these, only one was diagnosed with HS, resulting in a prevalence of 0.18% (95% CI, 0.03%-1.02%). The sensitivity of the HS questionnaire was 100%, specificity 75.9%, positive predictive value 5.0%, and negative predictive value 100%.</p><p><strong>Conclusion: </strong>The prevalence of HS in our study was relatively low. A further study with a larger number of participants is needed to confirm the findings. </p>.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":" ","pages":"52-56"},"PeriodicalIF":2.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12233989/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144583355","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}
DermatologyPub Date : 2025-01-01Epub Date: 2025-07-07DOI: 10.1159/000539706
Anja Pahlow Mose, Anja Pahlow Mose, Karin Arvidsson, Karin Nyberg, Dorra Bouazzi, Robin Christensen, Gregor B E Jemec, Victoria Marmgren
{"title":"Prevalence of Hidradenitis Suppurativa in Lund and Gothenburg, Sweden: An Analysis from the Global Hidradenitis Suppurativa Atlas Initiative.","authors":"Anja Pahlow Mose, Anja Pahlow Mose, Karin Arvidsson, Karin Nyberg, Dorra Bouazzi, Robin Christensen, Gregor B E Jemec, Victoria Marmgren","doi":"10.1159/000539706","DOIUrl":"10.1159/000539706","url":null,"abstract":"<p><p><p>Introduction: Epidemiologic studies of hidradenitis suppurativa (HS) from Sweden are limited. The aim of this study was to investigate the prevalence of HS in Lund and Gothenburg, Sweden.</p><p><strong>Methods: </strong>This study was a part of the Global Hidradenitis Suppurativa Atlas (GHiSA) initiative. The study was multicentered and included apparently healthy adults accompanying a patient to the Department of either Endocrinology or Ophthalmology in a Swedish University Hospital from February 1 to November 30, 2023. Recruitment occurred in the waiting rooms where the study participants were consecutively invited to answer a validated screening questionnaire which had been translated into Swedish. In the questionnaire, the key screening questions asked were whether the study participant had had 2 or more boils/abscesses in the past 6 months and if these were in any of the typical skin sites for HS. Screen-positive and randomly selected screen-negative participants were clinically examined for HS by a dermatologist to verify the results.</p><p><strong>Results: </strong>A total of 551 accompanying adults were approached of which 505 answered the questionnaire. The prevalence of HS in this sample was 0.99% (95% confidence interval [0.43%-2.30%]). There was a statistically significant difference in BMI between the HS and control group, but not in relation to age or sex.</p><p><strong>Conclusion: </strong>HS appears to be a common chronic disease in Sweden. Also, there is a strong association between overweight/obesity and HS. </p>.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":" ","pages":"134-138"},"PeriodicalIF":2.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12233967/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144583364","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}
DermatologyPub Date : 2025-01-01Epub Date: 2025-03-11DOI: 10.1159/000545022
Fanny Carolina López Jiménez, Jorge Alberto González Torres, Sirenia Castro Molina, Andrea Malagón Liceaga, Linda García Hidalgo
{"title":"Kaposi's Sarcoma, Epidemiology and Clinical Characteristics in a Tertiary Hospital: A Cross-Sectional Study.","authors":"Fanny Carolina López Jiménez, Jorge Alberto González Torres, Sirenia Castro Molina, Andrea Malagón Liceaga, Linda García Hidalgo","doi":"10.1159/000545022","DOIUrl":"10.1159/000545022","url":null,"abstract":"<p><strong>Introduction: </strong>Kaposi's sarcoma (KS) is a rare soft tissue tumor linked to human herpesvirus 8, a recognized oncogenic virus. Five distinct clinical presentations have been identified, with the epidemic type being the most prevalent and notably associated with human immunodeficiency virus (HIV). A delayed diagnosis significantly compromises patient prognosis and survival rates.</p><p><strong>Methods: </strong>This article aimed to describe the epidemiological and clinical characteristics of KS cases diagnosed through histological examination between 2007 and 2023 in our dermatology department, after a comprehensive review of electronic medical records.</p><p><strong>Results: </strong>A total of 52 cases were identified, with 51 cases corresponding to the epidemic type (associated with HIV infection) and only one to the classic type. Men were predominantly affected, all cases being of the epidemic type. The most prevalent topography was the lower extremities, with nodular lesions being the most frequent morphology. Half of the cases presented as a disseminated form, while the remaining half exhibited localized manifestations. In both groups, 50% had previously undergone combined antiretroviral therapy. Gastrointestinal involvement occurred in 8 cases. No deaths were associated with KS.</p><p><strong>Conclusions: </strong>Due to its often asymptomatic nature, KS can easily go unnoticed. Recognizing the significance of early detection is crucial, emphasizing the necessity for prompt intervention, accurate staging, and vigilant follow-up protocols.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":" ","pages":"254-258"},"PeriodicalIF":2.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604141","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}
DermatologyPub Date : 2025-01-01Epub Date: 2025-04-29DOI: 10.1159/000546035
Vanya Rossel, S Vanya J Rossel, Jason Shourick, Maria C Bolling, Anna M G Pasmooij, Karin Veldman, Jamie J Kirkham, Juliette Mazereeuw-Hautier, Antoni H Gostyński
{"title":"Protocol for the Development of a Core Outcome Set for Inherited Ichthyosis.","authors":"Vanya Rossel, S Vanya J Rossel, Jason Shourick, Maria C Bolling, Anna M G Pasmooij, Karin Veldman, Jamie J Kirkham, Juliette Mazereeuw-Hautier, Antoni H Gostyński","doi":"10.1159/000546035","DOIUrl":"10.1159/000546035","url":null,"abstract":"<p><p><p>Introduction: Inherited ichthyosis comprises a group of rare keratinization disorders caused by abnormal epidermal barrier function. Ichthyosis is yet incurable and current treatments mainly focus on alleviating symptoms such as scaling, erythema and pruritus. Recent developments show promising results for interventions based on the immune-phenotype like biologicals or pathogenesis-based therapies such as gene therapy. However, the lack of uniform reporting and variety of treatment outcomes may complicate performing and comparing efficacy studies. The core outcome set for inherited ichthyosis (COSII) aims to develop a core outcome set (COS), i.e., the minimum of outcomes that should be measured and reported in observational and interventional studies, including a minimum set of baseline characteristics. Methods: The COSII project will follow the guidelines from the Core Outcome Measures in Effectiveness Trials (COMET) initiative, including the Core Outcome Set-Standards for Development (COS-STAD) recommendations and the Core Outcome Set Standardised Protocol (COS-STAP) checklist. The COS development methodology, including this protocol, follows the guidance of the CHORD COUSIN Collaboration 'C3'. The first stage of this project involves identifying a possible list of outcomes through performing a scoping literature review and conducting interviews with patient(s) (representatives). This list will be presented to five different stakeholder groups: healthcare professionals, researchers, patient(s) (representatives), industry representatives, and regulators. All stakeholders will rate the importance of each outcome in a three-round eDelphi survey. Ultimately, a virtual consensus meeting will be convened to finalize the COS. Ethical approval was obtained prior to the start of this project from the Medical Ethics Committee Board at Maastricht University Medical Centre (METC 2022-3192). Informed consent will be asked prior to enrolment in the eDelphi. This study is registered with the COMET. The results will be distributed via a peer-reviewed journal, communicated to all relevant parties and showcased at national and international conferences. Conclusion: This will be the first COS for inherited ichthyosis research in accordance with the Core Outcome Measures in Effectiveness Trials initiative. The development of a COS aims to improve the consistency of reporting and the heterogeneity of outcomes in ichthyosis research. </p>.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":" ","pages":"348-355"},"PeriodicalIF":2.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12201926/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143957493","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":"Value of Diagnosis and Management for Skin Lesions by Integration of High-Frequency Ultrasound in Daily Practices: A Prospective Study.","authors":"An-Qi Zhu, Xue-Wen Chen, Wei-Chen Xu, Yin-Cheng Gao, Jia Liu, Ruo-Yi Lin, Yu-Jing Zhao, Hui-Jun Fu, Hui-Xiong Xu, Li-Ping Sun, Qiao Wang, Le-Hang Guo","doi":"10.1159/000546224","DOIUrl":"10.1159/000546224","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to identify whether high-frequency ultrasound (HFUS) could correct the misdiagnosis, confirm equivocal skin lesions, and improve the management after clinical examination.</p><p><strong>Methods: </strong>In this study, a total of 574 skin lesions from 552 patients were prospectively enrolled. The specific diagnosis and management decisions (treatment/excision, observation) determined by HFUS after clinical examination were recorded during the clinical practice. The area under the receiver operating characteristic curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and the number needed to excise (NNE) before and after HFUS were also evaluated. The pathological results were conducted as golden standards to compare the performance.</p><p><strong>Results: </strong>Among the 574 skin lesions, 290 (50.5%) were malignancies and 284 (49.5%) were benign. The diagnostic accuracy was improved from 77.5% to 90.8% after the HFUS examination. There were 44 lesions wrongfully diagnosed by the initial clinical diagnosis, whereas 28 of 44 (63.6%) lesions were correctly identified by HFUS examination. Of 85 lesions categorized as equivocal skin lesions by clinical examination, 65 (76.5%) were diagnosed correctly after HFUS. Lesion management changed in 72 of 574 (12.5%) after HFUS. Among these lesions, HFUS saved 22 unnecessary excisions and prompted the treatment of 30 malignancies that would be observed based on clinical examination alone. Additionally, the NNE was reduced by 15.4% (NNE, 0.828) after HFUS and 4.6% (NNE, 0.933) before HFUS.</p><p><strong>Conclusions: </strong>HFUS could be a valuable tool in diagnosing equivocal skin lesions, identifying skin cancers missed by clinical examination, and reducing unnecessary excision of benign lesions while improving NNE.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":" ","pages":"336-343"},"PeriodicalIF":2.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144282830","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}
DermatologyPub Date : 2025-01-01Epub Date: 2024-10-14DOI: 10.1159/000541943
Lorena Gantenbein, Sara Elisa Cerminara, Julia-Tatjana Maul, Alexander A Navarini, Lara Valeska Maul
{"title":"Artificial Intelligence-Driven Skin Aging Simulation as a Novel Skin Cancer Prevention.","authors":"Lorena Gantenbein, Sara Elisa Cerminara, Julia-Tatjana Maul, Alexander A Navarini, Lara Valeska Maul","doi":"10.1159/000541943","DOIUrl":"10.1159/000541943","url":null,"abstract":"<p><strong>Introduction: </strong>Skin cancer, a prevalent cancer type among fair-skinned patients globally, poses a relevant public health concern due to rising incidence rates. Ultraviolet (UV) radiation poses a major risk factor for skin cancer. However, intentional tanning associated with sunburns remains a common practice, notably among female adults. Appropriate prevention campaigns targeting children and adolescents are needed to improve sun protection behavior particularly in these age groups. The aim of our study was to investigate if an AI-based simulation of facial skin aging can enhance sun protection behavior in female adults.</p><p><strong>Methods: </strong>In this single-center, prospective, observational pilot study at Department of Dermatology at the University Hospital of Basel, we took photographs of healthy young females' faces with a VISIA-CR camera (Version 8.2; Canfield Scientific Inc., Parsippany, NJ, USA) between February and March 2021. Digital images were performed in three angles (straight, left 45°, and right 45°). All participants received an AI-based simulation of their facial skin with continuous aging to 80 years. A newly created anonymous questionnaire capturing participants' sociodemographic data and also tanning and sun protection behavior was completed in pre- and post-aging simulation. To observe long-term effects, a 2-year follow-up was conducted between March and April 2023.</p><p><strong>Results: </strong>The 60 participants (mean age 23.6 ± 2.5 years) evaluated the importance of sun protection significantly higher after skin aging simulation with VISIA-CR camera (p < 0.0001; 95% CI: 8.2-8.8). Post-intervention, 91.7% (55/60) of the females were motivated to reduce UV exposure and to intensify UV protection in the future since the individual UV-dependent risk was perceived significantly higher (p < 0.001; 95% CI: 5.9-6.7). At 2-year follow-up, 96% (24/25) indicated persistent effort reducing UV exposure. The preference for SPF 50+ sunscreen increased to 46.7% (28/65) directly after the skin aging simulation and continued to rise up to 60.0% (15/25) after 2 years.</p><p><strong>Conclusions: </strong>Our data emphasize the potential of AI-assisted photoaging interventions to enhance motivation for UV protection in the short and the long term. We encourage that different age and gender groups are addressed in a personalized, generation-specific manner with the appropriate media and by considering the Hawthorne effect. Campaigns with visual AI support can improve the intent of cancer-preventative behavior.</p><p><strong>Introduction: </strong>Skin cancer, a prevalent cancer type among fair-skinned patients globally, poses a relevant public health concern due to rising incidence rates. Ultraviolet (UV) radiation poses a major risk factor for skin cancer. However, intentional tanning associated with sunburns remains a common practice, notably among female adults. Appropriate prevention campaigns targeting childr","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":" ","pages":"59-71"},"PeriodicalIF":3.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11793091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460186","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}
DermatologyPub Date : 2025-01-01Epub Date: 2025-07-02DOI: 10.1159/000547142
Gil Yosipovitch, Peter A Lio, David Rosmarin, Franz J Legat, Esther Serra-Baldrich, Jose-Manuel Carrascosa, Laia Bardolet, Heidi Crane, Marta Casillas, Evangeline Pierce, Jinglin Zhong, Hany ElMaraghy, Sonja Ständer
{"title":"Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials.","authors":"Gil Yosipovitch, Peter A Lio, David Rosmarin, Franz J Legat, Esther Serra-Baldrich, Jose-Manuel Carrascosa, Laia Bardolet, Heidi Crane, Marta Casillas, Evangeline Pierce, Jinglin Zhong, Hany ElMaraghy, Sonja Ständer","doi":"10.1159/000547142","DOIUrl":"10.1159/000547142","url":null,"abstract":"<p><strong>Introduction: </strong>Lebrikizumab significantly reduced itch and itch interference on sleep in patients with moderate-to-severe atopic dermatitis (AD) at week 16 in two phase 3 trials. We investigated itch reduction and the efficacy of improving itch interference on sleep in lebrikizumab-treated patients over 52 weeks.</p><p><strong>Methods: </strong>At week 16 in ADvocate1 and ADvocate2, patients who met protocol-defined response criteria to lebrikizumab 250 mg every 2 weeks (Q2W) were re-randomized 2:2:1 to lebrikizumab Q2W, lebrikizumab 250 mg every 4 weeks (Q4W), or placebo Q2W to week 52; patients who did not achieve protocol-defined response continued open-label lebrikizumab Q2W. The Pruritus Numeric Rating Scale (NRS) evaluated the worst itch intensity over the previous 24 h in daily electronic diaries; the Sleep-Loss Scale measured the interference of itch on sleep over the last night. For week 16 responders, data after systemic rescue medication or discontinuation due to lack of efficacy were imputed with non-responder imputation; data after topical corticosteroid usage and discontinuation due to other reasons were set as missing; all missing data were imputed with multiple imputation. Descriptive statistics using observed data are reported for week 16 by non-responders.</p><p><strong>Results: </strong>At week 52 among patients who met week-16 protocol-defined response criteria, 73.4% and 71.8% receiving lebrikizumab Q4W and Q2W, respectively, reported ≥3-point improvement in the Pruritus NRS. Mean percent improvement from baseline to week 52 in the Pruritus NRS was 59.9% and 59.6% with lebrikizumab Q4W and Q2W, respectively. For patients who did not achieve a week-16 protocol-defined response, 73.3% achieved ≥3-point improvement on the Pruritus NRS at week 52, with mean percent improvement from baseline to week 52 of 59.2%. At week 52 in responders, ≥1-point improvement in the Sleep-Loss Scale was achieved by 77.9% and 78.9% of patients receiving lebrikizumab Q4W and Q2W, respectively, with a mean percent improvement from baseline to week 52 of 64.4% and 65.9%. For week-16 non-responders, 86.1% of patients achieved ≥1-point improvement in the Sleep-Loss Scale at week 52, with a mean percent improvement of 74.9%.</p><p><strong>Conclusion: </strong>These findings indicate that lebrikizumab is an effective AD treatment to reduce itch and improve sleep loss due to itch over the long term for both patients who did and did not meet protocol-defined response criteria at week 16.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":" ","pages":"325-335"},"PeriodicalIF":2.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12500264/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144552591","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}