American Journal of Clinical Dermatology最新文献

筛选
英文 中文
Adherence to Hidradenitis Suppurativa Treatment. 坚持化脓性扁桃体炎治疗。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-07-01 Epub Date: 2024-06-11 DOI: 10.1007/s40257-024-00871-2
Caitlyn B Dagenet, Swetha Atluri, Elaine Ma, Lauren Tong, Khiem A Tran, Joshua Hekmatajah, Rahul Masson, Jennifer L Hsiao, Vivian Y Shi
{"title":"Adherence to Hidradenitis Suppurativa Treatment.","authors":"Caitlyn B Dagenet, Swetha Atluri, Elaine Ma, Lauren Tong, Khiem A Tran, Joshua Hekmatajah, Rahul Masson, Jennifer L Hsiao, Vivian Y Shi","doi":"10.1007/s40257-024-00871-2","DOIUrl":"10.1007/s40257-024-00871-2","url":null,"abstract":"<p><p>Hidradenitis suppurativa (HS) is a chronic, debilitating skin condition that requires multimodal treatment. Adherence remains a significant challenge for many patients due to complex nature of treatment, thus presenting a barrier to management success. This review summarizes the current literature on the factors associated with adherence to medications, and lifestyle behaviors in patients with HS and proposes strategies to improve adherence. In February 2023, a systematic literature search was conducted by two independent authors on PubMed and EMBASE for articles from 2000 to 2023 on hidradenitis suppurativa adherence. A total of 21 articles met inclusion/exclusion criteria for this review. Of the studies, 11 addressed systemic medication adherence, 3 addressed topical medication adherence, 2 addressed both systemic and topical medication adherence, and 5 addressed lifestyle/behavioral modification adherence. The generalizability of results was limited by differences in study design, outcome measures, and sample size. English-only articles with full texts were used. The most reported reasons for non-adherence included presence of side effects, cost of medications, low efficacy, and unclear instructions. Proposed strategies to improve adherence in HS patients include management of side effects, use of reminder systems, improved patient education, patient support groups, aid of family and caregivers, personalization of the medication regimen, and regular follow-ups with patients. PROSPERO Registration Number: CRD42023488549.</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":8.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141299827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Switching to Interleukin-23 Inhibitors After Ineffectiveness of Ustekinumab: Evaluating Real-World Outcomes in Psoriasis Treatment. 乌司替库单抗无效后转用白细胞介素-23抑制剂:评估银屑病治疗的实际效果。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-07-01 Epub Date: 2024-05-27 DOI: 10.1007/s40257-024-00868-x
Sarah E Thomas, Marieke M B Seyger, Josje E Mangnus, Marisol E Otero, Antoni H Gostynski, Marcellus D Njoo, Paul M Ossenkoppele, Inge M Haeck, Judith H J Hendricksen-Roelofzen, John E M Körver, Sharon R P Dodemont, Ron A Tupker, Maartje A M Berends, Lizelotte M J T Weppner-Parren, Romy R M C Keijsers, Annet M Oostveen, Bas Peters, Roland Mommers, Martijn B A van Doorn, Milan Tjioe, Wendelien R Veldkamp, Astrid L A Kuijpers, Marloes M Kleinpenning, Elke M G J de Jong, Juul M P A van den Reek
{"title":"Switching to Interleukin-23 Inhibitors After Ineffectiveness of Ustekinumab: Evaluating Real-World Outcomes in Psoriasis Treatment.","authors":"Sarah E Thomas, Marieke M B Seyger, Josje E Mangnus, Marisol E Otero, Antoni H Gostynski, Marcellus D Njoo, Paul M Ossenkoppele, Inge M Haeck, Judith H J Hendricksen-Roelofzen, John E M Körver, Sharon R P Dodemont, Ron A Tupker, Maartje A M Berends, Lizelotte M J T Weppner-Parren, Romy R M C Keijsers, Annet M Oostveen, Bas Peters, Roland Mommers, Martijn B A van Doorn, Milan Tjioe, Wendelien R Veldkamp, Astrid L A Kuijpers, Marloes M Kleinpenning, Elke M G J de Jong, Juul M P A van den Reek","doi":"10.1007/s40257-024-00868-x","DOIUrl":"10.1007/s40257-024-00868-x","url":null,"abstract":"","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":8.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141157409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Integrated Safety Update of Abrocitinib in 3802 Patients with Moderate-to-Severe Atopic Dermatitis: Data from More than 5200 Patient-Years with Up to 4 Years of Exposure. 阿昔替尼治疗 3802 例中度至重度特应性皮炎患者的综合安全性更新:来自 5200 多名患者长达 4 年暴露期的数据。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-07-01 Epub Date: 2024-06-18 DOI: 10.1007/s40257-024-00869-w
Eric L Simpson, Jonathan I Silverberg, Audrey Nosbaum, Kevin Winthrop, Emma Guttman-Yassky, Karin M Hoffmeister, Alexander Egeberg, Hernan Valdez, Haiyun Fan, Saleem A Farooqui, Gary Chan, Justine Alderfer, William Romero, Kanti Chittuluru
{"title":"Integrated Safety Update of Abrocitinib in 3802 Patients with Moderate-to-Severe Atopic Dermatitis: Data from More than 5200 Patient-Years with Up to 4 Years of Exposure.","authors":"Eric L Simpson, Jonathan I Silverberg, Audrey Nosbaum, Kevin Winthrop, Emma Guttman-Yassky, Karin M Hoffmeister, Alexander Egeberg, Hernan Valdez, Haiyun Fan, Saleem A Farooqui, Gary Chan, Justine Alderfer, William Romero, Kanti Chittuluru","doi":"10.1007/s40257-024-00869-w","DOIUrl":"10.1007/s40257-024-00869-w","url":null,"abstract":"<p><strong>Background: </strong>Abrocitinib, an oral, once-daily, Janus kinase 1-selective inhibitor, is efficacious in moderate-to-severe atopic dermatitis with a manageable long-term safety profile.</p><p><strong>Objective: </strong>We aimed to provide updated integrated long-term safety results for abrocitinib from available data accrued up to a maximum of almost 4 years in patients with moderate-to-severe atopic dermatitis from the JADE clinical development program.</p><p><strong>Methods: </strong>Analysis included 3802 patients (exposure: 5213.9 patient-years) from the phase II monotherapy study (NCT02780167) and the phase III studies JADE MONO-1 (NCT03349060), JADE MONO-2 (NCT03575871), JADE TEEN (NCT03796676), JADE COMPARE (NCT03720470), JADE DARE (NCT04345367; 200 mg only), JADE REGIMEN (NCT03627767), and JADE EXTEND (NCT03422822; data cutoff 25 September, 2021). Data from patients receiving one or more doses of abrocitinib 200 mg or 100 mg were pooled in a consistent-dose cohort (patients were allocated to receive the same abrocitinib dose throughout exposure in the qualifying parent study and/or long-term study) or a variable-dose cohort (patients received open-label abrocitinib 200 mg; responders were randomized to abrocitinib 200 mg, 100 mg, or placebo, and could then receive abrocitinib 200 mg plus topical corticosteroids as rescue therapy). Incidence rates of adverse events of special interest were assessed. Cox regression analysis of risk factors for herpes zoster and serious infections was performed.</p><p><strong>Results: </strong>Overall, this safety analysis of long-term data up to a maximum of ~ 4 years of abrocitinib exposure does not indicate any changes from the previously reported risk profile. The most frequent serious infections (per Medical Dictionary for Regulatory Activities preferred term) with consistent-dose abrocitinib 200 mg and 100 mg were herpes zoster (0.5% and 0.2%), pneumonia (0.2% with either dose), and herpes simplex (0.1% with either dose). Risk factors for herpes zoster were a history of herpes zoster, abrocitinib 200-mg dose, age ≥ 65 years, absolute lymphocyte count < 1 × 10<sup>3</sup>/mm<sup>3</sup> before the event, and residing in Asia. For serious infections, > 100 kg body weight was a risk factor. Incidence rate/100 patient-years (95% confidence interval) with the consistent abrocitinib 200-mg and 100-mg dose combined was higher in older (aged ≥ 65 years) patients versus younger (aged 18 to < 65 years) patients for serious adverse events (17.6 [11.7‒25.4] vs 6.7 [5.8‒7.8]), malignancy excluding non-melanoma skin cancer (2.4 [0.6‒6.0] vs 0.1 [0.0‒0.4]), non-melanoma skin cancer (2.4 [0.6‒6.1] vs 0.2 [0.1‒0.4]), lymphopenia (3.5 [1.3‒7.6] vs 0.1 [0.0‒0.3]), and venous thromboembolism (1.7 [0.4‒5.1] vs 0.1 [0.0‒0.3]). Incident rate/100 patient-years (95% confidence interval) of non-melanoma skin cancer with the consistent abrocitinib 200-mg and 100-mg dose combined was higher in current/former smoke","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":8.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11193687/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141417287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Approach to the Atypical Wound. 处理非典型伤口的方法。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-07-01 Epub Date: 2024-05-14 DOI: 10.1007/s40257-024-00865-0
Sarah L Becker, Shannon Kody, Nicole M Fett, Alexander Hines, Afsaneh Alavi, Alex G Ortega-Loayza
{"title":"Approach to the Atypical Wound.","authors":"Sarah L Becker, Shannon Kody, Nicole M Fett, Alexander Hines, Afsaneh Alavi, Alex G Ortega-Loayza","doi":"10.1007/s40257-024-00865-0","DOIUrl":"10.1007/s40257-024-00865-0","url":null,"abstract":"<p><p>The heterogeneity of atypical wounds can present diagnostic and therapeutic challenges; however, as the prevalence of atypical wounds grows worldwide, prompt and accurate management is increasingly an essential skill for dermatologists. Addressing the underlying cause of an atypical wound is critical for successful outcomes. An integrated approach with a focus on pain management and patient engagement is recommended to facilitate enduring wound closure. Advances in treatment, in addition to further research and clinical training, are necessary to address the expanding burden of atypical wounds.</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":8.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140920737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Managing the Patient with Psoriasis and Metabolic Comorbidities. 管理银屑病和代谢并发症患者。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-07-01 Epub Date: 2024-05-15 DOI: 10.1007/s40257-024-00857-0
Francesco Bellinato, Martina Maurelli, Davide Geat, Giampiero Girolomoni, Paolo Gisondi
{"title":"Managing the Patient with Psoriasis and Metabolic Comorbidities.","authors":"Francesco Bellinato, Martina Maurelli, Davide Geat, Giampiero Girolomoni, Paolo Gisondi","doi":"10.1007/s40257-024-00857-0","DOIUrl":"10.1007/s40257-024-00857-0","url":null,"abstract":"<p><p>Epidemiological data demonstrate strong associations between psoriasis and metabolic comorbidities, including obesity, hypertension, diabetes mellitus, dyslipidemia, and non-alcoholic fatty liver disease. The presence of metabolic comorbidities significantly influences the selection and effectiveness of pharmacological treatments. Some drugs should be prescribed with caution in patients with metabolic comorbidities because of an increased risk of adverse events, while others could have a reduced effectiveness. The aim of this narrative review is to highlight the challenges that healthcare professionals may face regarding the management of psoriasis in patients with metabolic comorbidities. In the first part of the article, the epidemiological association between psoriasis and metabolic comorbidities and their pathogenetic mechanisms is summarized. The second part describes the efficacy and safety profile of conventional and biologic drugs in patients with selected metabolic comorbidities including obesity, non-alcoholic fatty liver disease/hepatic steatosis, and diabetes. Finally, the role of pharmacological and non-pharmacological interventions, such as diet, alcohol abstinence, physical activity, and smoking avoidance is discussed. In conclusion, the choice of the best approach to manage patients with psoriasis with metabolic comorbidities should encompass both tailored pharmacological and individualized non-pharmacological interventions.</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":8.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11193697/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140920743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Use of Biologic Agents for the Treatment of Cutaneous Immune-Related Adverse Events from Immune Checkpoint Inhibitors: A Review of Reported Cases. 使用生物制剂治疗免疫检查点抑制剂引起的皮肤免疫相关不良事件:报告病例回顾。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-07-01 Epub Date: 2024-05-20 DOI: 10.1007/s40257-024-00866-z
Jolanta Pach, Kailyn Valido, Annika Belzer, Jonathan S Leventhal
{"title":"The Use of Biologic Agents for the Treatment of Cutaneous Immune-Related Adverse Events from Immune Checkpoint Inhibitors: A Review of Reported Cases.","authors":"Jolanta Pach, Kailyn Valido, Annika Belzer, Jonathan S Leventhal","doi":"10.1007/s40257-024-00866-z","DOIUrl":"10.1007/s40257-024-00866-z","url":null,"abstract":"<p><p>Cutaneous immune-related adverse events encompass a spectrum of dermatological manifestations, including lichenoid reactions, psoriasiform eruptions, eczematous dermatitis, immunobullous disorders, granulomatous reactions, pruritus, vitiligo, and severe cutaneous adverse reactions such as Stevens-Johnson syndrome. The conventional approach to treating high-grade or refractory cutaneous immune-related adverse events has involved high-dose systemic corticosteroids. However, their use is limited owing to the potential disruption of antitumor responses and associated complications. To address this, corticosteroid-sparing targeted immunomodulators have been explored as therapeutic alternatives. Biologic agents, commonly employed for non-cutaneous immune-related adverse events such as colitis, are increasingly recognized for their efficacy in treating various patterns of cutaneous immune-related adverse events, including psoriasiform, immunobullous, and Stevens-Johnson syndrome-like reactions. This review consolidates findings from the English-language literature, highlighting the use of biologic agents in managing diverse cutaneous immune-related adverse event patterns, also encompassing maculopapular, eczematous, and lichenoid eruptions, pruritus, and transient acantholytic dermatosis (Grover disease). Despite the established efficacy of these agents, further research is necessary to explore their long-term effects on antitumor responses.</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":8.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141064256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy, Safety, and Long-Term Disease Control of Ruxolitinib Cream Among Adolescents with Atopic Dermatitis: Pooled Results from Two Randomized Phase 3 Studies. Ruxolitinib乳膏在青少年特应性皮炎患者中的疗效、安全性和长期疾病控制:两项随机 3 期研究的汇总结果。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-07-01 Epub Date: 2024-05-02 DOI: 10.1007/s40257-024-00855-2
Lawrence F Eichenfield, Eric L Simpson, Kim Papp, Jacek C Szepietowski, Andrew Blauvelt, Leon Kircik, Jonathan I Silverberg, Elaine C Siegfried, Michael E Kuligowski, May E Venturanza, Howard Kallender, Haobo Ren, Amy S Paller
{"title":"Efficacy, Safety, and Long-Term Disease Control of Ruxolitinib Cream Among Adolescents with Atopic Dermatitis: Pooled Results from Two Randomized Phase 3 Studies.","authors":"Lawrence F Eichenfield, Eric L Simpson, Kim Papp, Jacek C Szepietowski, Andrew Blauvelt, Leon Kircik, Jonathan I Silverberg, Elaine C Siegfried, Michael E Kuligowski, May E Venturanza, Howard Kallender, Haobo Ren, Amy S Paller","doi":"10.1007/s40257-024-00855-2","DOIUrl":"10.1007/s40257-024-00855-2","url":null,"abstract":"<p><strong>Background: </strong>Atopic dermatitis (AD), a highly pruritic, inflammatory skin disease, affects approximately 7% of adolescents globally. A topical formulation of ruxolitinib, a Janus kinase (JAK) 1/JAK2 inhibitor, demonstrated safety and efficacy among adolescents/adults in two phase 3 studies (TRuE-AD1/TRuE-AD2).</p><p><strong>Objective: </strong>To describe safety and efficacy of 1.5% ruxolitinib cream versus vehicle and long-term disease control of ruxolitinib cream among adolescents aged 12-17 years from pooled phase 3 study data.</p><p><strong>Methods: </strong>Patients [≥ 12 years old with AD for ≥ 2 years, Investigator's Global Assessment score (IGA) 2/3, and 3-20% affected body surface area (BSA) at baseline] were randomized 2:2:1 to ruxolitinib cream (0.75%/1.5%) or vehicle for 8 weeks of continuous use followed by a long-term safety (LTS) period up to 52 weeks with as-needed use. Patients originally applying vehicle were rerandomized 1:1 to 0.75%/1.5% ruxolitinib cream. Efficacy measures at week 8 included IGA treatment success (IGA-TS; i.e., score of 0/1 with ≥ 2 grade improvement from baseline), ≥ 75% improvement in Eczema Area and Severity Index (EASI-75), and ≥ 4-point improvement in itch numerical rating scale (NRS4). Measures of disease control during the LTS period included IGA score of 0 (clear) or 1 (almost clear) and percentage affected BSA. Safety was assessed throughout the study.</p><p><strong>Results: </strong>Of 1249 randomized patients, 245 (19.6%) were aged 12-17 years. Of these, 45 patients were randomized to vehicle and 92 patients to 1.5% ruxolitinib cream. A total of 104/137 (75.9%) patients continued on 1.5% ruxolitinib cream in the LTS period [82/92 (89.1%) continued on 1.5% ruxolitinib cream; 22/45 (48.9%) patients on vehicle were reassigned to 1.5% ruxolitinib cream], and 83/104 (79.8%) of these patients completed the LTS period. At week 8, substantially more patients who applied 1.5% ruxolitinib cream versus vehicle achieved IGA-TS (50.6% versus 14.0%), EASI-75 (60.9% versus 34.9%), and NRS4 (52.1% versus 17.4%; P = 0.009). The mean (SD) reduction in itch NRS scores was significantly greater in patients applying 1.5% ruxolitinib cream versus vehicle from day 2 [- 0.9 (1.9) versus -0.2 (1.4); P = 0.03]. During the LTS period, mean (SD) trough steady-state ruxolitinib plasma concentrations at weeks 12/52 were 27.2 (55.7)/15.5 (31.5) nM. The percentage of patients achieving IGA score of 0 or 1 was sustained or further increased with 1.5% ruxolitinib cream; mean affected BSA was generally low (< 3%; i.e., mild disease). Through 52 weeks, application site reactions occurred in 1.8% of adolescent patients applying 1.5% ruxolitinib cream at any time; no patients had serious adverse events. There were no serious infections, malignancies, major adverse cardiovascular events, or thromboembolic events.</p><p><strong>Conclusions: </strong>Meaningful anti-inflammatory and antipruritic effects were demonstrate","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":8.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11193693/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140851178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Dupilumab Safety and Efficacy up to 1 Year in Children Aged 6 Months to 5 Years with Atopic Dermatitis: Results from a Phase 3 Open-Label Extension Study. 杜匹单抗对 6 个月至 5 岁特应性皮炎患儿长达 1 年的安全性和有效性:3期开放标签扩展研究结果。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-07-01 Epub Date: 2024-05-14 DOI: 10.1007/s40257-024-00859-y
Amy S Paller, Elaine C Siegfried, Eric L Simpson, Michael J Cork, Robert Sidbury, Iris H Chen, Faisal A Khokhar, Jing Xiao, Ariane Dubost-Brama, Ashish Bansal
{"title":"Dupilumab Safety and Efficacy up to 1 Year in Children Aged 6 Months to 5 Years with Atopic Dermatitis: Results from a Phase 3 Open-Label Extension Study.","authors":"Amy S Paller, Elaine C Siegfried, Eric L Simpson, Michael J Cork, Robert Sidbury, Iris H Chen, Faisal A Khokhar, Jing Xiao, Ariane Dubost-Brama, Ashish Bansal","doi":"10.1007/s40257-024-00859-y","DOIUrl":"10.1007/s40257-024-00859-y","url":null,"abstract":"<p><strong>Background: </strong>Pediatric patients with moderate-to-severe atopic dermatitis (AD) often experience a high disease burden and have a high risk of persistent disease. Standard-of-care immunosuppressive systemic treatments have been used off-label for AD in pediatric patients despite concerns for suboptimal safety with continuous use and risk of relapse upon discontinuation. The biologic agent dupilumab is the first systemic treatment approved for moderate-to-severe AD in children as young as 6 months. Long-term safety and efficacy data in this patient population are needed to inform continuous AD management.</p><p><strong>Objectives: </strong>The purpose of this work was to determine the long-term safety and efficacy of dupilumab treatment up to 1 year in an open-label extension (OLE) study [LIBERTY AD PED-OLE (NCT02612454)] in children aged 6 months to 5 years with moderate-to-severe AD who previously participated in the 16-week, double-blind, phase 3 LIBERTY AD PRESCHOOL trial (NCT03346434 part B; parent study) and were subsequently enrolled in PED-OLE.</p><p><strong>Methods: </strong>In PED-OLE, patients received dupilumab every 4 weeks according to a weight-tiered regimen (body weight ≥ 5 kg to < 15 kg: 200 mg; ≥ 15 kg to < 30 kg: 300 mg).</p><p><strong>Results: </strong>Data for 142 patients were analyzed, 60 of whom had completed the 52-week visit at time of database lock. Mean age at baseline was 4.1 y [SD, 1.13; range, 1.0-5.9 years]. A majority (78.2%) of patients reported ≥ 1 treatment-emergent adverse event (TEAE), most of which were mild or moderate and transient. The most frequently reported TEAEs were nasopharyngitis (19.7%), cough (15.5%), and pyrexia (14.1%). One TEAE led to treatment discontinuation (severe urticaria, which resolved in 1 day). By week 52, 36.2% of patients had achieved an Investigator's Global Assessment score of 0/1 (clear/almost clear skin), and 96.6%, 79.3%, and 58.6% had at least 50%, 75%, or 90% improvement, respectively, in Eczema Area and Severity Index scores.</p><p><strong>Conclusions: </strong>Consistent with results seen in adults, adolescents, and older children (aged 6-11 years), treatment with dupilumab for up to 1 year in children aged 6 months to 5 years with inadequately controlled moderate-to-severe AD demonstrated an acceptable long-term safety profile and sustained efficacy. These results support the long-term continuous use of dupilumab in this patient population.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifiers: NCT02612454 and NCT03346434 (part B).</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":8.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11193700/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140920741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Expert Panel Review of Skin and Hair Dermatophytoses in an Era of Antifungal Resistance. 抗真菌抗药性时代的皮肤和毛发皮癣菌专家小组综述。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-05-01 Epub Date: 2024-03-18 DOI: 10.1007/s40257-024-00848-1
Rachel C Hill, Avrom S Caplan, Boni Elewski, Jeremy A W Gold, Shawn R Lockhart, Dallas J Smith, Shari R Lipner
{"title":"Expert Panel Review of Skin and Hair Dermatophytoses in an Era of Antifungal Resistance.","authors":"Rachel C Hill, Avrom S Caplan, Boni Elewski, Jeremy A W Gold, Shawn R Lockhart, Dallas J Smith, Shari R Lipner","doi":"10.1007/s40257-024-00848-1","DOIUrl":"10.1007/s40257-024-00848-1","url":null,"abstract":"<p><p>Dermatophytoses are fungal infections of the skin, hair, and nails that affect approximately 25% of the global population. Occlusive clothing, living in a hot humid environment, poor hygiene, proximity to animals, and crowded living conditions are important risk factors. Dermatophyte infections are named for the anatomic area they infect, and include tinea corporis, cruris, capitis, barbae, faciei, pedis, and manuum. Tinea incognito describes steroid-modified tinea. In some patients, especially those who are immunosuppressed or who have a history of corticosteroid use, dermatophyte infections may spread to involve extensive skin areas, and, in rare cases, may extend to the dermis and hair follicle. Over the past decade, dermatophytoses cases not responding to standard of care therapy have been increasingly reported. These cases are especially prevalent in the Indian subcontinent, and Trichophyton indotineae has been identified as the causative species, generating concern regarding resistance to available antifungal therapies. Antifungal-resistant dermatophyte infections have been recently recognized in the United States. Antifungal resistance is now a global health concern. When feasible, mycological confirmation before starting treatment is considered best practice. To curb antifungal-resistant infections, it is necessary for physicians to maintain a high index of suspicion for resistant dermatophyte infections coupled with antifungal stewardship efforts. Furthermore, by forging partnerships with federal agencies, state and local public health agencies, professional societies, and academic institutions, dermatologists can lead efforts to prevent the spread of antifungal-resistant dermatophytes.</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":8.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11201321/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140142625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Early and Sustained Improvements in Symptoms and Quality of Life with Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: 52-Week Results from Two Phase III Randomized Clinical Trials (Measure Up 1 and Measure Up 2). 中重度特应性皮炎成人和青少年使用乌达帕替尼后症状和生活质量的早期和持续改善:两项 III 期随机临床试验(Measure Up 1 和 Measure Up 2)的 52 周结果。
IF 7.3 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-05-01 Epub Date: 2024-03-25 DOI: 10.1007/s40257-024-00853-4
Jonathan I Silverberg, Melinda J Gooderham, Amy S Paller, Mette Deleuran, Christopher G Bunick, Linda F Stein Gold, DirkJan Hijnen, Brian M Calimlim, Wan-Ju Lee, Henrique D Teixeira, Xiaofei Hu, Shiyu Zhang, Yang Yang, Ayman Grada, Andrew M Platt, Diamant Thaçi
{"title":"Early and Sustained Improvements in Symptoms and Quality of Life with Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: 52-Week Results from Two Phase III Randomized Clinical Trials (Measure Up 1 and Measure Up 2).","authors":"Jonathan I Silverberg, Melinda J Gooderham, Amy S Paller, Mette Deleuran, Christopher G Bunick, Linda F Stein Gold, DirkJan Hijnen, Brian M Calimlim, Wan-Ju Lee, Henrique D Teixeira, Xiaofei Hu, Shiyu Zhang, Yang Yang, Ayman Grada, Andrew M Platt, Diamant Thaçi","doi":"10.1007/s40257-024-00853-4","DOIUrl":"10.1007/s40257-024-00853-4","url":null,"abstract":"<p><strong>Background: </strong>Atopic dermatitis is a chronic inflammatory disease characterized by increased itch, skin pain, poor sleep quality, and other symptoms that negatively affect patient quality of life. Upadacitinib, an oral selective Janus kinase (JAK) inhibitor with greater inhibitory potency for JAK1 than JAK2, JAK3, or tyrosine kinase 2, is approved to treat moderate-to-severe atopic dermatitis.</p><p><strong>Objective: </strong>We aimed to evaluate the effect of upadacitinib on patient-reported outcomes over 52 weeks in adults and adolescents with moderate-to-severe atopic dermatitis.</p><p><strong>Methods: </strong>Data from two phase III monotherapy trials of upadacitinib (Measure Up 1, NCT03569293; Measure Up 2, NCT03607422) were integrated. Changes in pruritus, pain, other skin symptoms, sleep, quality of life, mental health, and patient impression were evaluated. Patient-reported outcome assessments included the Worst Pruritus Numerical Rating Scale, Patient-Oriented Eczema Measure, Dermatology Life Quality Index, Atopic Dermatitis Symptom Scale, Atopic Dermatitis Impact Scale, Hospital Anxiety and Depression Scale, SCORing Atopic Dermatitis index, Patient Global Impression of Severity, Patient Global Impression of Change, and Patient Global Impression of Treatment. Minimal clinically important differences, achievement of scores representing minimal disease burden, and the change from baseline were evaluated in patients who received upadacitinib through week 52 and in patients who received placebo through week 16.</p><p><strong>Results: </strong>This analysis included 1609 patients (upadacitinib 15 mg, N = 557; upadacitinib 30 mg, N = 567; placebo, N = 485). Baseline demographics and disease characteristics were generally similar across all arms. The proportion of patients treated with upadacitinib reporting improvements in itch increased rapidly by week 1, increased steadily through week 8, and was sustained through week 52. Patients receiving upadacitinib also experienced improvements in pain and other skin symptoms by week 1, which continued through week 16; improvements were maintained through week 52. Patient reports of improved sleep increased rapidly from baseline to week 1, increased steadily through week 32, and were sustained through week 52. Patients experienced quality-of-life improvements through week 8, which were maintained through week 52. By week 1, patients in both upadacitinib groups experienced rapid improvements in emotional state, and by week 12, patients also achieved meaningful improvements in anxiety and depression. Improvements in mental health continued steadily through week 32 and were maintained through week 52. Patients treated with upadacitinib 30 mg generally experienced improvements in patient-reported outcomes earlier than those treated with upadacitinib 15 mg. Through week 16, patients receiving upadacitinib experienced greater improvements versus those receiving placebo in all assessed pat","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":7.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11070400/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140288060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信