Ramez M Odat, Abdullah Yousef Aldalati, Bara M Hammadeh, Ayham Mohammad Hussein, Muhammad Idrees, Hamza Marzouk, Sakhr Alshwayyat, Hamdah Hanifa
{"title":"Efficacy and safety of sofpironium in treatment of primary hyperhidrosis: a systematic review.","authors":"Ramez M Odat, Abdullah Yousef Aldalati, Bara M Hammadeh, Ayham Mohammad Hussein, Muhammad Idrees, Hamza Marzouk, Sakhr Alshwayyat, Hamdah Hanifa","doi":"10.1080/09546634.2024.2441258","DOIUrl":"https://doi.org/10.1080/09546634.2024.2441258","url":null,"abstract":"<p><strong>Background: </strong>Primary axillary hyperhidrosis has limited noninvasive and effective treatment, and we present the use of sofpironium bromide as a promising treatment option. We aimed to assess the efficacy and safety of sofpironium in patients with primary hyperhidrosis.</p><p><strong>Methods: </strong>We systematically searched the databases for Studies that assessed sofpironium bromide in patients with primary axillary hyperhidrosis. Methodological quality was determined using the Cochrane Risk of Bias Assessment tool and Newcastle-Ottowa scale.</p><p><strong>Results: </strong>Five studies were included (752 patients). They used 5% sofpironium, except for one study that used 5%, 10%, and 15% sofpironium. Studies have shown a significant difference in the incidence of patients with an HDSS score of 1 or 2 ranging from 53.9% to 86.7% and reported a greater reduction in the mean change in the DLQI score in the sofpironium group. They also noted a more significant reduction in the total gravimetric weight of sweat in the sofpironium group. A 1.5 point or greater improvement in HDSM-Ax score ranged from 48.2% to 69.1%. Serious adverse events were not observed in the intervention group.</p><p><strong>Conclusion: </strong>Sofpironium gel provides notable improvements in symptom severity, sweat reduction, and quality of life, with mostly mild localized adverse events.Hyperhidrosis is relatively common, affecting 4.8% of the US population and negatively affects physical, social, and psychological well-being.Sofpironium bromide is recently approved by the FDA for the treatment of primary axillary hyperhidrosisSofpironium bromide showed promising results in terms of safety and efficacy for treating hyperhidrosisWe systematically assessed the use of sofpironium gel reported in five studies (752 patients)Sofpironium gel provides notable improvements in symptom severity, sweat reduction and quality of life, with mostly mild localized adverse events.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"36 1","pages":"2441258"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142820524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Bibliometric analysis and description of research trends in the treatment of psoriasis with biologic agents in the past two decades (2004-2023).","authors":"Yingdong Wang, Junchen Li, Chenqi Guo, Guojing Yang, Haiyue Lin, Yu Zhang","doi":"10.1080/09546634.2024.2346282","DOIUrl":"10.1080/09546634.2024.2346282","url":null,"abstract":"<p><strong>Background: </strong>Biologics are essential in treating psoriasis. In recent years, the pathogenesis exploration and development of new target drugs have provided a more complete evidence-based foundation for the biological treatment of psoriasis. This study aims to use bibliometrics to analyze the research status and development trends of biologics in psoriasis.</p><p><strong>Methods: </strong>The bibliometric analysis of publications related to biologics in psoriasis from 2004 to 2023 was conducted using the Web of Science Core Collection (WoSCC) database as the search data source. To perform the bibliometric analysis and create visual knowledge graphs, CiteSpace, the Bibliometrix R package, and VOSviewers were utilized.</p><p><strong>Results: </strong>The study included a total of 3800 articles. The United States had the highest number of publications. The leading authors and institutions were Steven R. Feldman and the University of Manchester, respectively, in the global partnership. The cluster plot divided all keywords into 11 categories. Currently, Secukinumab and Guselkumab are representative biological agents being studied due to their considerable efficacy and long-term safety.</p><p><strong>Conclusions: </strong>Targeted therapy has emerged as a significant trend in the current treatment of psoriasis. Early and active use of biologics can effectively control disease progression, prevent or delay the occurrence of comorbidities, and may even alter the natural course of psoriasis. However, further investigation is required to fully understand the specific mechanisms of psoriasis and the use of biological agents.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2346282"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141332800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Miranda K Branyiczky, Shahnawaz Towheed, Tiago Torres, Ronald Vender
{"title":"A systematic review of recent randomized controlled trials for palmoplantar pustulosis.","authors":"Miranda K Branyiczky, Shahnawaz Towheed, Tiago Torres, Ronald Vender","doi":"10.1080/09546634.2024.2414048","DOIUrl":"10.1080/09546634.2024.2414048","url":null,"abstract":"<p><p><b>Background:</b> Palmoplantar pustulosis (PPP) is a chronic inflammatory condition, that leads to significant functional impairment and reduced quality of life. Despite its low incidence, treatment options are diverse and often ineffective, necessitating a review of recent therapeutic advances.</p><p><p><b>Objective:</b> This review aims to evaluate the efficacy and safety of recent therapeutic options for the treatment of PPP, focusing on phototherapy, systemic therapies, and biologics.</p><p><p><b>Materials and methods:</b> A systematic literature search identified 13 studies evaluating phototherapy and systemic therapies, including biologics. Inclusion criteria focused on randomized controlled trials with participants diagnosed with PPP.</p><p><p><b>Results:</b> Phototherapy showed success: excimer laser demonstrated high efficacy for severe disease [PPP Area and Severity Index (PPPASI)-75 of 95.0%], while psoralen plus ultraviolet A therapy with retinoids or fumaric acid esters worked well in milder disease (PPPASI-90 of 90.0 and 81.8%, respectively). Evidence supports the efficacy and safety of guselkumab, brodalumab, and apremilast over a range of disease severity (PPPASI-50 ranged from 57.4 to 78.3% at week 16). Agents including anakinra, secukinumab, spesolimab, and RIST4721 (primary outcomes not achieved) may not be first-line treatments. By targeting multiple inflammatory pathways in PPP, JAK inhibitors may be more effective than biologics in treating PPP; however, more research is needed to confirm their safety and appropriate use.</p><p><p><b>Conclusions:</b> Multiple new treatments exist for PPP with promising results, however longer-term studies with standardized outcome reporting are needed to determine optimal treatment strategies and their comparative efficacy.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2414048"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142402546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comparative efficacy of targeted systemic therapies for pruritus in moderate-to-severe atopic dermatitis without topical treatment: a network meta-analysis.","authors":"Mei Xiong, Qiaoli Gao, Hu Ren, Tingting Zhong","doi":"10.1080/09546634.2024.2432930","DOIUrl":"10.1080/09546634.2024.2432930","url":null,"abstract":"<p><strong>Background: </strong>Chronic pruritus is the most prevalent and severe symptom of atopic dermatitis (AD).</p><p><strong>Objective: </strong>This network meta-analysis aims to assess the comparative efficacy of systemic targeted monotherapies in alleviating pruritus among adults and adolescents with moderate-to-severe AD.</p><p><strong>Methods: </strong>Data were collected from phase 3/4 randomized controlled trials (RCTs) published until 24 August 2024, focusing on targeted therapies for moderate-to-severe AD. The outcome measure was the proportion of patients achieving <i>a</i> ≥ 4-point improvement from baseline on the Pruritus Numerical Rating Scale (NRS). This analysis included both primary endpoints (week 12 or week 16) and secondary endpoints (weeks 2, 4, and 8).</p><p><strong>Results: </strong>Eleven reports comprising 16 studies with 8,462 participants were included. At all time points examined, targeted therapies demonstrated statistically significant efficacy over placebo, with upadacitinib 30 mg showing the highest response rate. The next most effective treatments at the primary endpoint were abrocitinib 200 mg, upadacitinib 15 mg, dupilumab 300 mg, and lebrikizumab 250 mg. Cumulative ranking probabilities at secondary endpoints varied based on time points.</p><p><strong>Conclusion: </strong>Targeted therapies, particularly upadacitinib 30 mg, showed significant advantages in managing moderate-to-severe AD pruritus. Further direct comparative trials are needed for conclusive evidence.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2432930"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142735488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Petra Staubach, Benedikt Bilo, Joachim W Fluhr, Karoline Krause, Kanokvalai Kulthanan, Andac Salman, Connie Katelaris, Jonathan A Bernstein, Marcus Maurer, Caroline Mann
{"title":"UCOMB-real life data: treatment strategies for chronic urticaria patients with comorbidities.","authors":"Petra Staubach, Benedikt Bilo, Joachim W Fluhr, Karoline Krause, Kanokvalai Kulthanan, Andac Salman, Connie Katelaris, Jonathan A Bernstein, Marcus Maurer, Caroline Mann","doi":"10.1080/09546634.2024.2329784","DOIUrl":"10.1080/09546634.2024.2329784","url":null,"abstract":"<p><strong>Background: </strong>There is a lack of real-life safety data on treatment options for chronic urticaria in the presence of comedication and comorbidities.</p><p><strong>Methods: </strong>We present a single-center UCARE pilot study of 212 outpatients with chronic urticaria. Patients were divided into three groups according to different CU therapies according to international guidelines.</p><p><strong>Results: </strong>Of 212 patients, 108 (mean age 48.9 years, 71.3% female) had 59 comorbidities, including cardiovascular, autoimmune and malignant diseases. Patients were followed for a mean of 24.6 months (SD ± 21.3). Urticaria therapies were divided into three groups: A: 105 (97.2%) with omalizumab and 2nd generation antihistamines), B: 16 patients (14.8%): dual therapy with antihistamines and cyclosporine in 10 (9.3%), montelukast in five (4. 6%), dapsone in four (3.7%), hydroxychloroquine in one patient (0.9%), C: 12 (11.1%) patients received a third drug for 4.9 months (SD ± 3.2) and one quadruple therapy (2.1 months). 10 out of 12 (83.3%) patients received montelukast, two (16.7%) cyclosporine, two (16.7%) dapsone and one (8.3%) hydroxychloroquine as a third drug for chronic urticaria.</p><p><strong>Conclusions: </strong>Combining treatment modalities for chronic urticaria and comorbidities are available and feasible with a good safety profile.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2329784"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140178556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yizhang Liu, Kun Hu, Lu Jian, Yongfang Duan, Mi Zhang, Yehong Kuang
{"title":"Comparison between super-responders and non-super-responders in psoriasis under adalimumab treatment: a real-life cohort study on the effectiveness and drug survival over one-year.","authors":"Yizhang Liu, Kun Hu, Lu Jian, Yongfang Duan, Mi Zhang, Yehong Kuang","doi":"10.1080/09546634.2024.2331782","DOIUrl":"10.1080/09546634.2024.2331782","url":null,"abstract":"<p><strong>Background: </strong>Data on the characteristics and treatment outcomes of super-responders and non-super-responders in psoriasis under adalimumab treatment are limited.</p><p><strong>Methods: </strong>A retrospective analysis from psoriatic patients treated with adalimumab was compared to characterize super-responders vs non-super-responders' groups, identify factors associated with super response, and assess treatment outcomes after switching.</p><p><strong>Results: </strong>15 out of 70 (21.4%) patients were categorized as super-responder. The proportion of patients achieving a PASI 100 response was significantly higher in super-responders than non-super-responders at weeks 12, 24, and 52. Female sex and Charlson Co-morbidity Index were significantly associated with super-responders. A high level of high-density lipoprotein was independently associated with PASI 90 response at weeks 24 and 52. Additionally, nearly 35%-43% of non-super-responders switching to interleukin-17A (IL-17A) inhibitors may achieve a PASI 100 response at week 12. In contrast, all super-responders switching to IL-17A inhibitors achieved a PASI 100 response at week 4.</p><p><strong>Conclusions: </strong>Super-responders treated with adalimumab have a higher rate of being female and fewer comorbidities. And super-responders have better PASI responses than non-super-responders, whether the patients were treated with adalimumab or switched to IL-17A inhibitors.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2331782"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140186793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jundong Huang, Jia Jian, Tingting Li, Min Li, Kaifu Luo, Sihan Deng, Yan Tang, Fangfen Liu, Zhixiang Zhao, Wei Shi, Ji Li
{"title":"Dupliumab therapy for alopecia areata: a case series and review of the literature.","authors":"Jundong Huang, Jia Jian, Tingting Li, Min Li, Kaifu Luo, Sihan Deng, Yan Tang, Fangfen Liu, Zhixiang Zhao, Wei Shi, Ji Li","doi":"10.1080/09546634.2024.2312245","DOIUrl":"10.1080/09546634.2024.2312245","url":null,"abstract":"<p><strong>Background: </strong>A growing body of research supports the important role of the TH2 axis in alopecia areata (AA). Dupilumab is a humanized monoclonal antibody against IL-4Rα that downregulates TH2 response. Although efficacy has been shown in clinical trials, real-world data on the use of dupilumab in AA patients is limited.</p><p><strong>Objectives: </strong>To report on a case series of 10 patients with AA who were treated with dupilumab and provide real-world evidence regarding its efficacy in treating severe AA.</p><p><strong>Methods: </strong>In this retrospective single-center study, all AA patients treated with dupilumab treatment were included between May 2022 and October 2023. Clinical outcome measures (Severity of Alopecia Tool, SALT) and adverse events (AEs) were analyzed. In addition, a literature review was conducted to summarize the efficacy of AA with dupilumab and the characteristics of patients previously reported in the literature.</p><p><strong>Results: </strong>We identified 10 patients with AA who were or are being treated with dupilumab, with a median (range) treatment duration of 8 (3-15) months. Of these, four patients have high serum immunoglobulin E (IgE) levels (≥200IU/ml). The mean (IQR) pretreatment SALT score was 79% (52-100). Seven of 10 patients achieved at least 50% re-growth. Of those who improved, the mean (IQR) percentage change in SALT score at 3 months and the end of follow-up was 57% (29%-89%) and 95% (68-100), respectively. Notably, seven patients (70%) had white hair regrowth, with the white hair slowly decreasing over time and the proportion of pigmented black hair increasing. Dupilumab was well tolerated by all patients. No adverse events were reported.</p><p><strong>Conclusions: </strong>Overall, our research supports dupilumab as another candidate that possesses potential benefits for AA. High levels of IgE may be not prerequisites for dupilumab's successful treatment response.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2312245"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139718195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Amy S Paller, Shireen V Guide, Diego Ayala, Mercedes E Gonzalez, Anne W Lucky, Isin Sinem Bagci, M Peter Marinkovich
{"title":"Practical considerations relevant to treatment with the gene therapy beremagene geperpavec-svdt for dystrophic epidermolysis bullosa.","authors":"Amy S Paller, Shireen V Guide, Diego Ayala, Mercedes E Gonzalez, Anne W Lucky, Isin Sinem Bagci, M Peter Marinkovich","doi":"10.1080/09546634.2024.2350232","DOIUrl":"10.1080/09546634.2024.2350232","url":null,"abstract":"<p><strong>Background/purpose: </strong>Dystrophic epidermolysis bullosa (DEB), a rare genetic skin disease caused by loss-of-function mutations in <i>COL7A1</i>, the gene encoding type VII collagen (COL7), is characterized by skin blistering, scarring, and extracutaneous manifestations that markedly reduce patient quality-of-life. Beremagene geperpavec-svdt ('B-VEC') is a gene therapy employing a non-integrating, replication-defective herpes simplex virus type 1 (HSV-1)-based vector encoding two copies of full-length human <i>COL7A1</i> to restore COL7 protein after topical administration to DEB wounds. B-VEC was approved in the United States in 2023 as the first topical gene therapy and the first approved treatment for DEB. However, few providers have experience with use of this gene therapy.</p><p><strong>Methods: </strong>Data was obtained through literature review and the experience of providers who participated in the B-VEC clinical study or initiated treatment after B-VEC approval.</p><p><strong>Results: </strong>This review discusses the burden of disease, describes the clinical trial outcomes of B-VEC, and provides physician and patient/caregiver recommendations as a practical guide for the real-world use of B-VEC, which can be administered in-office or at the patient's home.</p><p><strong>Conclusions: </strong>By continuing to optimize the practical aspects of B-VEC administration, the focus will continue to shift to patient-centric considerations and improved patient outcomes.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2350232"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140900052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yuge Gao, Chao Li, Meng Tong, Yizhou Hu, Yuzhen Li
{"title":"Characterization of psoriasis patients in special body areas: real-world evidence from the Chinese Psoriasis Standardized Diagnosis and Treatment Center.","authors":"Yuge Gao, Chao Li, Meng Tong, Yizhou Hu, Yuzhen Li","doi":"10.1080/09546634.2024.2337264","DOIUrl":"10.1080/09546634.2024.2337264","url":null,"abstract":"<p><strong>Background: </strong>While extensive research has provided a wealth of information on psoriasis in general, there remains a critical gap in understanding the unique characteristics of psoriasis in special body areas, such as the scalp, nails, palms, and genitals.</p><p><strong>Objective: </strong>To investigate the characterization and treatment of psoriasis patients in special body areas.</p><p><strong>Methods: </strong>The study was a retrospective analysis of patients with psoriasis enrolled in the Psoriasis Standardized Diagnosis and Treatment Center Project between January 2020 and September 2021.</p><p><strong>Results: </strong>The study encompassed 346 patients, 81% of them had psoriasis in at least two special body areas, with the nails as the most common area. Patients with genital psoriasis reported higher Dermatology Life Quality Index (DLQI) scores. A higher propensity for scalp and palmoplantar psoriasis was noted in patients with genital psoriasis. The proportion of patients treated with biologics rose, as the number of specific areas involved increased.</p><p><strong>Conclusions: </strong>Patients with genital psoriasis are more likely to have scalp and palmoplantar psoriasis. This study highlights the significant escalation in the proportion of biologics when the involvement of special body areas was ≥2.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2337264"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141592532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Adelaide A Hebert, Carsten Flohr, H Chih-Ho Hong, Alan D Irvine, Evangeline Pierce, Hany Elmaraghy, Sreekumar Pillai, Zach Dawson, Sherry Chen, Clara Armengol, Elaine Siegfried, Stephan Weidinger
{"title":"Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials.","authors":"Adelaide A Hebert, Carsten Flohr, H Chih-Ho Hong, Alan D Irvine, Evangeline Pierce, Hany Elmaraghy, Sreekumar Pillai, Zach Dawson, Sherry Chen, Clara Armengol, Elaine Siegfried, Stephan Weidinger","doi":"10.1080/09546634.2024.2324833","DOIUrl":"10.1080/09546634.2024.2324833","url":null,"abstract":"<p><strong>Background: </strong>Lebrikizumab, a high-affinity monoclonal antibody targeting IL-13, previously demonstrated clinical efficacy in three randomized, double-blind, placebo-controlled Phase 3 trials that included adults and adolescents with moderate-to-severe atopic dermatitis (AD): ADvocate1, ADvocate2, and ADhere.</p><p><strong>Aim: </strong>This subset analysis evaluated 16-week physician- and patient-reported outcomes of lebrikizumab in the adolescent patients enrolled in these three trials.</p><p><strong>Methods: </strong>Eligible adolescents (≥12 to <18 years weighing ≥40kg) were randomized 2:1 to subcutaneous lebrikizumab (500 mg loading doses at baseline and Week 2 followed by 250 mg every 2 weeks) or placebo as monotherapy in ADvocate1&2, and in combination with topical corticosteroids (TCS) in the ADhere study. Week 16 analyses included clinical efficacy outcomes (IGA (0,1) with ≥2-point improvement, EASI 75, EASI 90), patient-reported Pruritus NRS ≥4-point improvement and Sleep-Loss Scale ≥2-point improvement.</p><p><strong>Results: </strong>Pooled ADvocate1&2 16-week results in lebrikizumab (<i>N</i> = 67) vs placebo (<i>N</i> = 35) were: IGA (0,1) 46.6% vs 14.3% (<i>p</i> < 0.01), EASI 75 62.0% vs 17.3% (<i>p</i> < 0.001), EASI 90 40.7% vs 11.5% (<i>p</i> < 0.01), Pruritus NRS 48.9% vs 13.1% (<i>p</i> < 0.01), and Sleep-Loss Scale 26.9% vs 6.9% (<i>p</i> = 0.137). Corresponding results for ADhere, (lebrikizumab + TCS, <i>N</i> = 32; placebo + TCS, <i>N</i> = 14), were consistent.</p><p><strong>Conclusions: </strong>Lebrikizumab treatment demonstrated efficacy in improving the signs and symptoms of AD in adolescent patients, consistent with the ADvocate and ADhere overall population results.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2324833"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140913615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}