American Journal of Clinical Dermatology最新文献

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Rapidly Evolving Pre- and Post-surgical Systemic Treatment of Melanoma 快速发展的黑色素瘤术前和术后系统治疗。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-02-26 DOI: 10.1007/s40257-024-00852-5
Ryan C. Augustin, Jason J. Luke
{"title":"Rapidly Evolving Pre- and Post-surgical Systemic Treatment of Melanoma","authors":"Ryan C. Augustin,&nbsp;Jason J. Luke","doi":"10.1007/s40257-024-00852-5","DOIUrl":"10.1007/s40257-024-00852-5","url":null,"abstract":"<div><p>With the development of effective <i>BRAF</i>-targeted and immune-checkpoint immunotherapies for metastatic melanoma, clinical trials are moving these treatments into earlier adjuvant and perioperative settings. <i>BRAF</i>-targeted therapy is a standard of care in resected stage III–IV melanoma, while anti-programmed death-1 (PD1) immunotherapy is now a standard of care option in resected stage IIB through IV disease. With both modalities, recurrence-free survival and distant-metastasis-free survival are improved by a relative 35–50%, yet no improvement in overall survival has been demonstrated. Neoadjuvant anti-PD1 therapy improves event-free survival by approximately an absolute 23%, although improvements in overall survival have yet to be demonstrated. Understanding which patients are most likely to recur and which are most likely to benefit from treatment is now the highest priority question in the field. Biomarker analyses, such as gene expression profiling of the primary lesion and circulating DNA, are preliminarily exciting as potential biomarkers, though each has drawbacks. As in the setting of metastatic disease, markers that inform positive outcomes include interferon-<i>γ</i> gene expression, PD-L1, and high tumor mutational burden, while negative predictors of outcome include circulating factors such as lactate dehydrogenase, interleukin-8, and C-reactive protein. Integrating and validating these markers into clinically relevant models is thus a high priority. Melanoma therapeutics continues to advance with combination adjuvant approaches now investigating anti-PD1 with lymphocyte activation gene 3 (LAG3), T-cell immunoreceptor with Ig and ITIM domains (TIGIT), and individualized neoantigen therapies. How this progress will be integrated into the management of a unique patient to reduce recurrence, limit toxicity, and avoid over-treatment will dominate clinical research and patient care over the next decade.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 3","pages":"421 - 434"},"PeriodicalIF":8.6,"publicationDate":"2024-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139970715","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
The Impact of Dermatologic Adverse Events on the Quality of Life of Oncology Patients: A Review of the Literature 皮肤科不良事件对肿瘤患者生活质量的影响:文献综述
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-02-16 DOI: 10.1007/s40257-024-00847-2
Annika Belzer, Jolanta J. Pach, Kailyn Valido, Jonathan S. Leventhal
{"title":"The Impact of Dermatologic Adverse Events on the Quality of Life of Oncology Patients: A Review of the Literature","authors":"Annika Belzer,&nbsp;Jolanta J. Pach,&nbsp;Kailyn Valido,&nbsp;Jonathan S. Leventhal","doi":"10.1007/s40257-024-00847-2","DOIUrl":"10.1007/s40257-024-00847-2","url":null,"abstract":"<div><p>Dermatologic adverse events resulting from oncologic therapy are common and negatively impact patients’ quality of life. Dermatologic adverse events include toxicity of the skin, oral mucosa, nails, and hair and are seen with cytotoxic chemotherapy, targeted therapy, immunotherapy, and radiation therapy, with distinct patterns of dermatologic adverse events by drug class. Here, we review the literature on the impact of dermatologic adverse events on quality of life. Studies on quality of life in patients with cancer have relied on scales such as the Dermatologic Life Quality Index and Skindex to demonstrate the association between dermatologic adverse events and declining quality of life. This relationship is likely due to a variety of factors, including physical discomfort, changes to body image, decreased self-esteem, and an effect on social interactions. Addressing such quality-of-life concerns for patients with cancer is critical, not only for patients’ well-being but also because decreased satisfaction with treatment can lead to discontinuation of treatment or dose reduction. Prophylactic treatment and early management of dermatologic adverse events by experienced dermatologists can alleviate the negative effects on quality of life and allow continuation of life-prolonging treatment.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 3","pages":"435 - 445"},"PeriodicalIF":8.6,"publicationDate":"2024-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139745785","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
Field Cancerization Therapies for the Management of Actinic Keratosis: An Updated Review 治疗角化性皮炎的野战癌化疗法:最新综述。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-02-13 DOI: 10.1007/s40257-023-00839-8
Ishita Aggarwal, Carolina Puyana, Neha Chandan, Nathan Jetter, Maria Tsoukas
{"title":"Field Cancerization Therapies for the Management of Actinic Keratosis: An Updated Review","authors":"Ishita Aggarwal,&nbsp;Carolina Puyana,&nbsp;Neha Chandan,&nbsp;Nathan Jetter,&nbsp;Maria Tsoukas","doi":"10.1007/s40257-023-00839-8","DOIUrl":"10.1007/s40257-023-00839-8","url":null,"abstract":"<div><p>Field cancerization theory highlights that the skin surrounding actinic keratoses (AK) is also at increased risk for possible malignant transformation; thus, field-directed treatments may both reduce the risk of AK recurrence and potentially reduce the risk of development of cutaneous squamous cell carcinoma (cSCC). Photodynamic therapy (PDT) with either aminolevulinic acid (ALA) or methylaminolevulinate (MAL), as well as topical treatments such as 5-fluorouracil (5-FU), diclofenac gel, piroxicam, imiquimod, and ingenol mebutate, have all shown higher efficacy than vehicle treatments. PDT is widely recognized for its high efficacy; however, concerns for associated pain have driven new studies to begin using alternative illumination and pretreatment techniques, including lasers. Among topical treatments, a combination of 5-FU and salicylic acid (5-FU–SA) has shown to be the most effective but also causes the most adverse reactions. Tirbanibulin, a new topical agent approved for use in 2020, boasts a favorable safety profile in comparison with imiquimod, 5-FU, and diclofenac. Meanwhile, ingenol mebutate is no longer recommended for the treatment of AKs due to concerns for increased risk of cSCC development. Moving forward, an increasing number of studies push for standardization of outcome measures to better predict risk of future cSCC and use of more effective measures of cost to better guide patients. Here, we present an updated and comprehensive narrative review both confirming the efficacy of previously mentioned therapies as well as highlighting new approaches to PDT and discussing the use of lasers and novel topical treatments for treatment of AK.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 3","pages":"391 - 405"},"PeriodicalIF":8.6,"publicationDate":"2024-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139728802","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
Correction to: OX40 in the Pathogenesis of Atopic Dermatitis—A New Therapeutic Target 更正:特应性皮炎发病机制中的 OX40--新的治疗靶点。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-02-10 DOI: 10.1007/s40257-024-00850-7
Michael Croft, Ehsanollah Esfandiari, Camilla Chong, Hailing Hsu, Kenji Kabashima, Greg Kricorian, Richard B. Warren, Andreas Wollenberg, Emma Guttman-Yassky
{"title":"Correction to: OX40 in the Pathogenesis of Atopic Dermatitis—A New Therapeutic Target","authors":"Michael Croft,&nbsp;Ehsanollah Esfandiari,&nbsp;Camilla Chong,&nbsp;Hailing Hsu,&nbsp;Kenji Kabashima,&nbsp;Greg Kricorian,&nbsp;Richard B. Warren,&nbsp;Andreas Wollenberg,&nbsp;Emma Guttman-Yassky","doi":"10.1007/s40257-024-00850-7","DOIUrl":"10.1007/s40257-024-00850-7","url":null,"abstract":"","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 3","pages":"463 - 463"},"PeriodicalIF":8.6,"publicationDate":"2024-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11070392/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139715738","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
Autoimmune, Autoinflammatory Disease and Cutaneous Malignancy Associations with Hidradenitis Suppurativa: A Cross-Sectional Study 自身免疫性疾病、自身炎症性疾病和皮肤恶性肿瘤与扁平苔藓的关联:一项横断面研究
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-02-09 DOI: 10.1007/s40257-024-00844-5
Hilliard T. Brydges, Ogechukwu C. Onuh, Rebecca Friedman, Joy Barrett, Rebecca A. Betensky, Catherine P. Lu, Avrom S. Caplan, Afsaneh Alavi, Ernest S. Chiu
{"title":"Autoimmune, Autoinflammatory Disease and Cutaneous Malignancy Associations with Hidradenitis Suppurativa: A Cross-Sectional Study","authors":"Hilliard T. Brydges,&nbsp;Ogechukwu C. Onuh,&nbsp;Rebecca Friedman,&nbsp;Joy Barrett,&nbsp;Rebecca A. Betensky,&nbsp;Catherine P. Lu,&nbsp;Avrom S. Caplan,&nbsp;Afsaneh Alavi,&nbsp;Ernest S. Chiu","doi":"10.1007/s40257-024-00844-5","DOIUrl":"10.1007/s40257-024-00844-5","url":null,"abstract":"<div><h3>Background</h3><p>Hidradenitis suppurativa (HS) is a debilitating cutaneous disease characterized by severe painful inflammatory nodules/abscesses. At present, data regarding the epidemiology and pathophysiology of this disease are limited.</p><h3>Objective</h3><p>To define the prevalence and comorbidity associations of HS.</p><h3>Methods</h3><p>This was a cross-sectional study of EPIC<sup>TM</sup> Cosmos<sup>©</sup> examining over 180 million US patients. Prevalences were calculated by demographic and odds ratios (OR) and identified comorbidity correlations.</p><h3>Results</h3><p>All examined metabolism-related, psychological, and autoimmune/autoinflammatory (AI) diseases correlated with HS. The strongest associations were with pyoderma gangrenosum [OR 26.56; confidence interval (CI): 24.98–28.23], Down syndrome (OR 11.31; CI 10.93–11.70), and polycystic ovarian syndrome (OR 11.24; CI 11.09–11.38). Novel AI associations were found between HS and lupus (OR 6.60; CI 6.26–6.94) and multiple sclerosis (MS; OR 2.38; CI 2.29–2.48). Cutaneous malignancies were largely not associated in the unsegmented cohort; however, among Black patients, novel associations with melanoma (OR 2.39; CI 1.86–3.08) and basal cell carcinoma (OR 2.69; CI 2.15–3.36) were identified.</p><h3>Limitations</h3><p>International Classification of Diseases (ICD)-based disease identification relies on coding fidelity and diagnostic accuracy.</p><h3>Conclusion</h3><p>This is the first study to identify correlations between HS with melanoma and basal cell carcinoma (BCC) among Black patients as well as MS and lupus in all patients with HS.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 3","pages":"473 - 484"},"PeriodicalIF":8.6,"publicationDate":"2024-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139711229","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
Therapeutic Strategies in BRAF V600 Wild-Type Cutaneous Melanoma BRAF V600 野生型皮肤黑色素瘤的治疗策略
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-02-08 DOI: 10.1007/s40257-023-00841-0
Alexandra Haugh, Adil I. Daud
{"title":"Therapeutic Strategies in BRAF V600 Wild-Type Cutaneous Melanoma","authors":"Alexandra Haugh,&nbsp;Adil I. Daud","doi":"10.1007/s40257-023-00841-0","DOIUrl":"10.1007/s40257-023-00841-0","url":null,"abstract":"<div><p>There have been many recent advances in melanoma therapy. While 50% of melanomas have a BRAF mutation and are a target for BRAF inhibitors, the remaining 50% are BRAF wild-type. Immune checkpoint inhibitors targeting PD-1, cytotoxic T-lymphocyte-associated protein 4 (CTLA4) and lymphocyte activated gene-3 (Lag-3) are all approved for the treatment of patients with advanced BRAF wild-type melanoma; however, treatment of this patient population following initial immune checkpoint blockade is a current therapeutic challenge given the lack of other efficacious options. Here, we briefly review available US FDA-approved therapies for BRAF wild-type melanoma and focus on developing treatment avenues for this heterogeneous group of patients. We review the basics of genomic features of both BRAF mutant and BRAF wild-type melanoma as well as efforts underway to develop new targeted therapies involving the mitogen-activated protein kinase (MAPK) pathway for patients with BRAF wild-type tumors. We then focus on novel immunotherapies, including developing checkpoint inhibitors and agonists, cytokine therapies, oncolytic viruses and tumor-infiltrating lymphocytes, all of which represent potential therapeutic avenues for patients with BRAF wild-type melanoma who progress on currently approved immune checkpoint inhibitors.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 3","pages":"407 - 419"},"PeriodicalIF":8.6,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139701655","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
Autoimmune and Cutaneous Inflammatory Comorbidities in Adult-Onset Morphea in the All of Us Research Program 我们所有人研究计划》中成年发病型莫斐斯病的自身免疫和皮肤炎症并发症。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-02-02 DOI: 10.1007/s40257-024-00843-6
Jill T. Shah, William Mark Richardson, Lavanya Mittal, Emily Hejazi, Daniel R. Mazori, Alisa N. Femia
{"title":"Autoimmune and Cutaneous Inflammatory Comorbidities in Adult-Onset Morphea in the All of Us Research Program","authors":"Jill T. Shah,&nbsp;William Mark Richardson,&nbsp;Lavanya Mittal,&nbsp;Emily Hejazi,&nbsp;Daniel R. Mazori,&nbsp;Alisa N. Femia","doi":"10.1007/s40257-024-00843-6","DOIUrl":"10.1007/s40257-024-00843-6","url":null,"abstract":"","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 2","pages":"343 - 345"},"PeriodicalIF":8.6,"publicationDate":"2024-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139671092","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
Treatment of Psoriasis Patients with Latent Tuberculosis Using IL-17 and IL-23 Inhibitors: A Retrospective, Multinational, Multicentre Study 使用 IL-17 和 IL-23 抑制剂治疗患有潜伏肺结核的银屑病患者:一项回顾性、多国、多中心研究。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-01-24 DOI: 10.1007/s40257-024-00845-4
Tiago Torres, Andrea Chiricozzi, Luis Puig, Ana Maria Lé, Angelo Valerio Marzano, Paolo Dapavo, Esteban Dauden, Jόse-Manuel Carrascosa, Elizabeth Lazaridou, Gleison Duarte, André V. E. Carvalho, Ricardo Romiti, Natalia Rompoti, Laetitia Teixeira, Miguel Abreu, Elena Ippoliti, Carlo Alberto Maronese, Mar Llamas-Velasco, Eva Vilarrasa, Elena del Alcázar, Athina-Ioanna Daponte, Marina Papoutsaki, Andrea Carugno, Francesco Bellinato, Paolo Gisondi
{"title":"Treatment of Psoriasis Patients with Latent Tuberculosis Using IL-17 and IL-23 Inhibitors: A Retrospective, Multinational, Multicentre Study","authors":"Tiago Torres,&nbsp;Andrea Chiricozzi,&nbsp;Luis Puig,&nbsp;Ana Maria Lé,&nbsp;Angelo Valerio Marzano,&nbsp;Paolo Dapavo,&nbsp;Esteban Dauden,&nbsp;Jόse-Manuel Carrascosa,&nbsp;Elizabeth Lazaridou,&nbsp;Gleison Duarte,&nbsp;André V. E. Carvalho,&nbsp;Ricardo Romiti,&nbsp;Natalia Rompoti,&nbsp;Laetitia Teixeira,&nbsp;Miguel Abreu,&nbsp;Elena Ippoliti,&nbsp;Carlo Alberto Maronese,&nbsp;Mar Llamas-Velasco,&nbsp;Eva Vilarrasa,&nbsp;Elena del Alcázar,&nbsp;Athina-Ioanna Daponte,&nbsp;Marina Papoutsaki,&nbsp;Andrea Carugno,&nbsp;Francesco Bellinato,&nbsp;Paolo Gisondi","doi":"10.1007/s40257-024-00845-4","DOIUrl":"10.1007/s40257-024-00845-4","url":null,"abstract":"<div><h3>Background</h3><p>Tuberculosis has a major global impact. Immunocompetent hosts usually control this disease, resulting in an asymptomatic latent tuberculosis infection (LTBI). Because TNF inhibitors increase the risk of tuberculosis reactivation, current guidelines recommend tuberculosis screening before starting any biologic drug, and chemoprophylaxis if LTBI is diagnosed. Available evidence from clinical trials and real-world studies suggests that IL-17 and IL-23 inhibitors do not increase the risk of tuberculosis reactivation.</p><h3>Objective</h3><p>To evaluate psoriasis patients with treated or untreated newly diagnosed LTBI who received IL-17 and IL-23 inhibitors and the tolerability/safety of tuberculosis chemoprophylaxis.</p><h3>Methods</h3><p>This is a retrospective, observational, multinational study from a series of 14 dermatology centres based in Portugal, Spain, Italy, Greece and Brazil, which included adult patients with moderate-to-severe chronic plaque psoriasis and newly diagnosed LTBI who were treated with IL-23 or IL-17 inhibitors between January 2015 and March 2022. LTBI was diagnosed in the case of tuberculin skin test and/or interferon gamma release assay positivity, according to local guideline, prior to initiating IL-23 or IL-17 inhibitor. Patients with prior diagnosis of LTBI (treated or untreated) or treated active infection were excluded.</p><h3>Results</h3><p>A total of 405 patients were included; complete/incomplete/no chemoprophylaxis was administered in 62.2, 10.1 and 27.7% of patients, respectively. The main reason for not receiving or interrupting chemoprophylaxis was perceived heightened risk of liver toxicity and hepatotoxicity, respectively. The mean duration of biological treatment was 32.87 ± 20.95 months, and only one case of active tuberculosis infection (ATBI) was observed, after 14 months of treatment with ixekizumab. The proportion of ATBI associated with ixekizumab was 1.64% [95% confidence interval (CI): 0–5.43%] and 0% for all other agents and 0.46% (95% CI 0–1.06%) and 0% for IL-17 and IL-23 inhibitors, respectively (not statistically significant).</p><h3>Conclusions</h3><p>The risk of tuberculosis reactivation in patients with psoriasis and LTBI does not seem to increase with IL-17 or IL-23 inhibitors. IL-17 or IL-23 inhibitors should be preferred over TNF antagonists when concerns regarding tuberculosis reactivation exists. In patients with LTBI considered at high risk for developing complications related to chemoprophylaxis, this preventive strategy may be waived before initiating treatment with IL-17 inhibitors and especially IL-23 inhibitors.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 2","pages":"333 - 342"},"PeriodicalIF":8.6,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10867072/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139541156","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
Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program 口服 JAK3/TEC 家族激酶抑制剂 Ritlecitinib 治疗脱发症的综合安全性分析(来自 ALLEGRO 临床试验项目)。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-01-23 DOI: 10.1007/s40257-024-00846-3
Brett King, Jennifer Soung, Christos Tziotzios, Lidia Rudnicka, Pascal Joly, Melinda Gooderham, Rodney Sinclair, Natasha A. Mesinkovska, Carle Paul, Yankun Gong, Susan D. Anway, Helen Tran, Robert Wolk, Samuel H. Zwillich, Alexandre Lejeune
{"title":"Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program","authors":"Brett King,&nbsp;Jennifer Soung,&nbsp;Christos Tziotzios,&nbsp;Lidia Rudnicka,&nbsp;Pascal Joly,&nbsp;Melinda Gooderham,&nbsp;Rodney Sinclair,&nbsp;Natasha A. Mesinkovska,&nbsp;Carle Paul,&nbsp;Yankun Gong,&nbsp;Susan D. Anway,&nbsp;Helen Tran,&nbsp;Robert Wolk,&nbsp;Samuel H. Zwillich,&nbsp;Alexandre Lejeune","doi":"10.1007/s40257-024-00846-3","DOIUrl":"10.1007/s40257-024-00846-3","url":null,"abstract":"<div><h3>Background</h3><p>The ALLEGRO phase 2a and 2b/3 studies demonstrated that ritlecitinib, an oral JAK3/TEC family kinase inhibitor, is efficacious at doses of ≥ 30 mg in patients aged ≥ 12 years with alopecia areata (AA).</p><h3>Objective</h3><p>The objective of this study was to evaluate the safety of ritlecitinib in an integrated analysis of four studies in AA.</p><h3>Methods</h3><p>Two cohorts were analyzed: a placebo-controlled and an all-exposure cohort. Proportions and study size–adjusted incidence rates (IRs) of adverse events (AEs) of interest and laboratory abnormalities are reported.</p><h3>Results</h3><p>In the placebo-controlled cohort (<i>n</i> = 881; median exposure: 169 days), the proportion of ritlecitinib-treated patients with AEs was 70.2–75.4% across doses versus 69.5% in the placebo group; serious AEs occurred in 0-3.2% versus 1.9% for the placebo. A total of 19 patients permanently discontinued due to AEs (5 while receiving the placebo). In the all-exposure cohort (<i>n</i> = 1294), median ritlecitinib exposure was 624 days [2091.7 total patient-years (PY)]. AEs were reported in 1094 patients (84.5%) and serious AEs in 57 (4.4%); 78 (6.0%) permanently discontinued due to AEs. The most common AEs were headache (17.7%; 11.9/100 PY), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test (15.5%; 9.8/100 PY), and nasopharyngitis (12.4%; 8.2/100 PY). There were two deaths (breast cancer and acute respiratory failure/cardiorespiratory arrest). Proportions (IRs) were &lt; 0.1% (0.05/100 PY) for opportunistic infections, 1.5% (0.9/100 PY) for herpes zoster, 0.5% (0.3/100 PY) for malignancies (excluding nonmelanoma skin cancer), and 0.2% (0.1/100 PY) for major adverse cardiovascular events.</p><h3>Conclusions</h3><p>Ritlecitinib is well tolerated with an acceptable safety profile up to 24 months in patients aged ≥ 12 years with AA (video abstract and graphical plain language summary available).</p><h3>Trial Registries</h3><p>ClinicalTrials.gov: NCT02974868 (date of registration: 11/29/2016), NCT04517864 (08/18/2020), NCT03732807 (11/07/2018), and NCT04006457 (07/05/2019).</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 2","pages":"299 - 314"},"PeriodicalIF":8.6,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10867086/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139541153","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 Skin Microbiome and its Significance for Dermatologists 皮肤微生物组及其对皮肤科医生的意义。
IF 8.6 1区 医学
American Journal of Clinical Dermatology Pub Date : 2024-01-22 DOI: 10.1007/s40257-023-00842-z
Cleo Whiting, Sara Abdel Azim, Adam Friedman
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