Dermatology and Therapy最新文献

{"title":"Forensic Dermatology Expert Analytical Report: A New Frontier of Forensic Medicine.","authors":"Philip R Cohen, Lerah Sutton","doi":"10.1007/s13555-024-01322-w","DOIUrl":"10.1007/s13555-024-01322-w","url":null,"abstract":"<p><p>Specialists in forensic medicine assist in crime scene investigations. The forensic medicine experts include anthropologists, ballistic analysts, entomologists, odontologists, and osteologists. The experts are usually not at the crime scene; they provide an evaluation of evidence that is sent to them. After they complete their assessment of the evidence, they prepare a specialized presentation of their findings: a forensic expert analytical report. The format of the report is variable depending on which forensic expert is writing it; however, there are certain mandatory sections that are included: the chain of evidence, the methods of evidence evaluation, the results of the evaluation of the evidence, and the discussion (including the conclusion) of what the evidence demonstrates. Forensic dermatology is an emerging subfield of medicine. Dermatologists are experts in evaluating the skin, mucosa, hair, and nails. It is anticipated that the demand for forensic dermatology will increase as individuals who currently evaluate crime scenes become aware of the potential benefit of consulting a forensic dermatologist. An illustrative hypothetical forensic dermatology expert analytical report is presented. Like other forensic expert analytical reports, the forensic dermatology expert analytical report has four primary sections. The chain of evidence section is a chronologic documentation that not only identifies the protected care and control of the evidence but also the transfer of the evidence to another individual. The methods section is a comprehensive presentation of the analysis of the evidence; it comprises the majority of an analytical report. The results section provides the information obtained after the evidence has been evaluated; it should be written in plain language, so it is readily able to be understood by not only the other investigators but also the members of the legal profession (including the judge and the attorneys) and the members of the jury. The discussion section includes the opinion of the dermatologist and should be a summary of the investigation findings that puts the analysis of the evidence into context; it can include a conclusion section and should also be written in plain language. Depending on the specific circumstances of the case, the template of the illustrative forensic dermatology expert analytical report can be modified by the dermatologists who is preparing their analytical report. In conclusion, an excellent forensic dermatology expert report will aid both other investigators and the members of the legal system-such as the attorneys, judge, and jury-who are involved in the case. In addition, when the forensic dermatology expert testifies as an expert witness in court, the report will be an asset for the dermatologist.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1-13"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785840/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871724","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":"Effects of Retinol, Natural Pea Peptide and Antioxidant Blend in a Topical Formulation: In Vitro and Clinical Evidence.","authors":"Brian Cook, Melanie Riggs, K C Holley, Helen Knaggs, Ganesh Diwakar, Edwin D Lephart","doi":"10.1007/s13555-024-01332-8","DOIUrl":"10.1007/s13555-024-01332-8","url":null,"abstract":"<p><strong>Introduction: </strong>Retinol has a long history of treating skin conditions, including photoaging. However, skin irritation with repeated use of retinol is well documented. The present study assessed the effectiveness of a novel topical formulation, referred to as retinol topical formulation (RTF), to improve the quality of skin health. The RTF was composed of a low dose retinol, a synthetic retinoid ester, a pea peptide, and an antioxidant blend.</p><p><strong>Methods: </strong>In vitro assessment of RTF on human skin co-cultures (human keratinocytes, melanocytes, and dermal fibroblasts) identified gene expression levels and skin biomarkers after 24 h exposure. An 8-week clinical study was conducted to evaluate once-nightly application of the RTF for short-term and long-term benefits in 30 adult subjects between 35 and 70 years of age (21 female, 9 male). Skin evaluations were conducted via bioinstrumentation (for hydration, transepidermal water loss and elasticity) and at 0, 1-, 2-, 4-, and 8-week self-assessment questionnaires and photo-imaging analysis were performed.</p><p><strong>Results: </strong>RTF treatment of skin in vitro co-cultures upregulated aquaporin-3, PER1, collagen, and elastin, and downregulated expression of MMP1 and the pigmentation genes TYRP1 and MITF. The clinical assessment significantly improved hydration, transepidermal water loss, and elasticity along with incremental but significant increases in nine skin parameters (hydration, clarity, radiance/glow, smoothness, brightness, texture, appearance of pores, dark spots/hyperpigmentation, and skin tone evenness from baseline) with continuous use over 8 weeks compared to baseline values.</p><p><strong>Conclusions: </strong>The RTF in vitro analysis showed significant positive changes for several skin biomarkers, and the clinical assessment showed RTF significantly improved the visible signs of dermal aging, without irritation.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"189-200"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885256","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":"Italian Expert Opinion on Chronic Hand Eczema: from Guidelines to Clinical Practice.","authors":"Luca Stingeni, Maria Concetta Fargnoli, Fabrizio Guarneri, Anna Balato, Monica Corazza, Anna Belloni Fortina, Piergiacomo Calzavara Pinton, Antonio Costanzo, Silvia Mariel Ferrucci, Luigi Naldi, Giovanni Pellacani, Ketty Peris, Francesca Prignano, Giampiero Girolomoni","doi":"10.1007/s13555-024-01312-y","DOIUrl":"10.1007/s13555-024-01312-y","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic hand eczema (CHE) is an inflammatory skin condition characterized by different pathomechanisms, clinical presentations, and prognoses. Treatment is often challenging because of limited approved drugs, and severe CHE is associated with reduced quality of life (QoL) and poor overall health measures in terms of psychological, functional, and occupational challenges. This study aims to describe the real-life management practices of Italian dermatologists who frequently treat patients with CHE, compare these practices with existing guidelines, and propose practical clinical recommendations for the management of these patients.</p><p><strong>Methods: </strong>An 11-question survey was administered to 14 participating dermatologists to gather their insights on the diagnosis, treatment, and management of CHE. Moreover, a comprehensive literature search was conducted over the previous 10 years as a starting point for discussion among experts.</p><p><strong>Results: </strong>CHE was the reason for 6.9% of dermatological consultations by the 14 experts. Median time to CHE diagnosis was 12 (range: 2-24) months. Fissuring and itching (85.7% for both) were the most frequently reported signs and symptoms of CHE. The survey highlighted the need for long-term treatment that is effective and well tolerated, with experts emphasizing the importance of improving disease awareness among physicians and patients. Practical clinical approaches were proposed, emphasizing the significance of a thorough medical history and identification of symptoms in the management of CHE. Experts advocated for specifically developed CHE treatment approaches, concentrating on alleviating symptoms and signs, minimizing adverse events/safety issues, enhancing the QoL of patients, and long-term disease control. Findings from this survey were further discussed and compared to recommendations of the available guidelines for the management of CHE.</p><p><strong>Conclusions: </strong>Managing CHE requires a comprehensive approach that considers both objective clinical factors and subjective patient expectations. Experts emphasized the need for effective and well-tolerated long-term therapies, improved disease awareness, and communication among physicians and patients.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"75-93"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785867/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738671","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":"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":"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":"223-226"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785833/pdf/","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Circulating MicroRNAs in Patients with Psoriasis Treated with Anti-IL-23: A Cohort Study.","authors":"Federico Diotallevi, Giulia Matacchione, Anna Campanati, Elena Marinelli Busilacchi, Nadia Viola, Ilaria Pace, Beatrice Fontana, Roberta Roncarati, Massimiliano Bonafè, Manuela Ferracin, Jacopo Sabbatinelli, Fabiola Olivieri","doi":"10.1007/s13555-024-01331-9","DOIUrl":"10.1007/s13555-024-01331-9","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis is characterized by aberrant keratinocyte activity and immune cell infiltration, driven by immune-mediated pathways. MicroRNAs (miRNAs) play crucial roles in regulating these processes, offering insights into disease mechanisms and therapeutic targets.</p><p><strong>Objectives: </strong>This study aimed to investigate changes in circulating miRNAs in psoriasis patients undergoing risankizumab therapy, an anti-IL-23 monoclonal antibody, to understand its impact on disease pathogenesis and treatment response.</p><p><strong>Methods: </strong>Plasma samples from 12 psoriasis patients were collected before (T0) and after 1 year (T1) of risankizumab treatment and analyzed using small RNA sequencing. Findings were validated in a separate cohort of 23 patients using quantitative real-time PCR (qRT-PCR). T-regulatory cell (Treg) numbers and pro-inflammatory cytokine levels were also assessed.</p><p><strong>Results: </strong>Significant clinical improvement was observed in all patients after 1 year of treatment, accompanied by increased Treg counts and reduced levels of pro-inflammatory cytokines. Twenty-four miRNAs exhibited differential expression post-treatment; 9 were downregulated and 15 upregulated. Notably, miR-200a-3p showed a significant correlation with baseline Psoriasis Area Severity Index (PASI), indicating its potential as a severity marker. Risankizumab therapy also decreased peripheral blood levels of IL-23, IL-1β, and IL-8.</p><p><strong>Conclusions: </strong>This study identifies specific circulating miRNAs, including miR-200a-3p, as potential biomarkers for monitoring treatment responses in psoriasis patients. The findings underscore the therapeutic efficacy of risankizumab in modulating miRNA profiles and immune pathways associated with psoriasis pathogenesis. Overall, these results provide new insights into the mechanisms of risankizumab action and highlight miRNAs as promising candidates for personalized medicine approaches in psoriasis management.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"125-140"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142970091","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":"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":"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":"31-44"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785859/pdf/","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":"OA","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}