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Comorbid Conditions Associated with Alopecia Areata: A Systematic Review and Meta-analysis 与斑秃相关的合并症:系统综述和荟萃分析。
IF 7.3 1区 医学 Q1 Medicine Pub Date : 2023-07-18 DOI: 10.1007/s40257-023-00805-4
Sophia Ly, Priya Manjaly, Kanika Kamal, Ali Shields, Bruna Wafae, Najiba Afzal, Lara Drake, Katherine Sanchez, Samantha Gregoire, Guohai Zhou, Carol Mita, Arash Mostaghimi

Background

Alopecia areata (AA) is a complex autoimmune condition resulting in nonscarring hair loss. In recent years, many studies have provided new evidence on comorbid diseases present in patients with AA. However, some studies have conflicting results, and analyses conducting a comprehensive approach are lacking.

Objective

The aim of our study was to provide an updated systematic review and meta-analysis of medical comorbidities associated with AA.

Methods

We searched PubMed, Embase, and Web of Science for case-control, cross-sectional, and cohort studies investigating medical comorbidities in AA published from inception through 1 February 2023.

Results

We screened 3428 abstracts and titles and reviewed 345 full text articles for eligibility. Ultimately, 102 studies were analyzed, comprising 680,823 patients with AA and 72,011,041 healthy controls. Almost all included studies (100 of 102 studies) were of satisfactory to high quality (Newcastle–Ottawa scale score ≥ 4). Among patients with AA, comorbidities with the highest odds ratios (OR) compared with healthy controls and data available from more than one study included vitamin D deficiency (OR 10.13, 95% CI 4.24–24.20), systemic lupus erythematous (OR 5.53, 95% CI 3.31–9.23), vitiligo (OR 5.30, 95% CI 1.86–15.10), metabolic syndrome (OR 5.03, 95% CI 4.18–6.06), and Hashimoto’s thyroiditis (OR 4.31, 95% CI 2.51–7.40). AA may be a protective factor for certain disorders, for which the AA group had lower odds compared with healthy controls, such as irritable bowel syndrome (OR 0.38, 95% CI 0.14–0.99) and colorectal cancer (OR 0.61, 95% CI 0.42–0.89).

Conclusion

These findings corroborate and contextualize the risks across comorbidities for patients with AA. Further work should be done to identify the underlying pathophysiology and understand appropriate screening criteria.

背景:斑秃(AA)是一种复杂的自身免疫性疾病,导致非持续性脱发。近年来,许多研究为AA患者存在的共病提供了新的证据。然而,一些研究的结果相互矛盾,缺乏全面的分析方法。目的:我们研究的目的是提供与AA相关的医学合并症的最新系统综述和荟萃分析。方法:我们在PubMed、Embase和Web of Science中搜索病例对照、横断面、,以及从开始到2023年2月1日发表的调查AA医学合并症的队列研究。结果:我们筛选了3428篇摘要和标题,并审查了345篇全文文章的资格。最终,分析了102项研究,包括680823名AA患者和72011041名健康对照。几乎所有纳入的研究(102项研究中的100项)都具有令人满意的高质量(纽卡斯尔-渥太华量表得分≥4)。在AA患者中,与健康对照组和一项以上研究的数据相比,优势比(OR)最高的合并症包括维生素D缺乏症(OR 10.13,95%CI 4.24-24.20)、系统性红斑狼疮(OR 5.53,95%CI3.31-9.23)、白癜风(OR 5.30,95%CI 1.86-15.10)、代谢综合征(OR 5.03,95%CI4.18-6.06),和桥本甲状腺炎(OR 4.31,95%CI 2.51-7.40)。AA可能是某些疾病的保护因素,与健康对照组相比,AA组的发病率较低,如肠易激综合征(OR 0.38,95%CI 0.14-0.99)和结直肠癌癌症(OR 0.61,95%CI 0.42-0.89)。
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引用次数: 0
Diagnosis and Management of Dermatologic Adverse Events from Systemic Melanoma Therapies 系统性黑色素瘤治疗皮肤病不良事件的诊断和处理
IF 7.3 1区 医学 Q1 Medicine Pub Date : 2023-07-03 DOI: 10.1007/s40257-023-00790-8
Christopher J. Fay, Samantha Jakuboski, Beth Mclellan, Blair S. Allais, Yevgeniy Semenov, Cecilia A. Larocca, Nicole R. LeBoeuf

The advent of protein kinase inhibitors and immunotherapy has profoundly improved the management of advanced melanoma. However, with these therapeutic advancements also come drug-related toxicities that have the potential to affect various organ systems. We review dermatologic adverse events from targeted (including BRAF and MEK inhibitor-related) and less commonly used melanoma treatments, with a focus on diagnosis and management. As immunotherapy-related toxicities have been extensively reviewed, herein, we discuss injectable talimogene laherparepvec and touch on recent breakthroughs in the immunotherapy space. Dermatologic adverse events may severely impact quality of life and are associated with response and survival. It is therefore essential that clinicians are aware of their diverse presentations and management strategies.

蛋白激酶抑制剂和免疫疗法的出现极大地改善了晚期黑色素瘤的治疗。然而,随着这些治疗进展,药物相关的毒性也有可能影响各种器官系统。我们回顾了靶向(包括BRAF和MEK抑制剂相关)和不太常用的黑色素瘤治疗的皮肤病不良事件,重点是诊断和管理。随着免疫疗法相关毒性的广泛综述,在此,我们讨论了注射用talimogene laherparepvec,并谈到了免疫疗法领域的最新突破。皮肤病不良事件可能严重影响生活质量,并与反应和生存率有关。因此,临床医生必须了解他们的不同表现和管理策略。
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引用次数: 0
Characteristics and Burdens of Disease in Patients from Beijing with Generalized Pustular Psoriasis and Palmoplantar Pustulosis: Multicenter Retrospective Cohort Study Using a Regional Database 北京地区广泛性脓疱性银屑病和掌跖脓疱病患者的疾病特征和负担:使用区域数据库的多中心回顾性队列研究。
IF 7.3 1区 医学 Q1 Medicine Pub Date : 2023-06-29 DOI: 10.1007/s40257-023-00807-2
Hai-Meng Wang, Jia-Ming Xu, Hong-Zhong Jin

Background and Objective

Pustular psoriasis is a chronic and recurrent autoimmune disease, although little is known about the disease burden of pustular psoriasis in China. We analyzed the characteristics and disease burdens of patients from Beijing who had generalized pustular psoriasis (GPP) or palmoplantar pustulosis (PPP).

Methods

This multicenter retrospective cohort study used a regional electronic health database that covered 30 public hospitals in Beijing. From June 2016 to June 2021, all patients with a diagnosis of GPP, PPP, or psoriasis vulgaris (PV) were identified by International Statistical Classification of Diseases and Related Health Problems, 10th Revision codes. The GPP and PPP cohorts were separately matched with patients with PV in a 3:1 ratio for comparisons. Demographic data, clinical characteristics, healthcare resource utilization, and costs were collected. Descriptive and comparative analyses were used to compare the cohorts.

Results

There were 744 patients with GPP (46.8% men; age 42.14 ± 21.47 years) and 4808 patients with PPP (35.5% men; age 51.65 ± 16.12 years); 14.5% of patients with GPP had concomitant PV and 7.5% of patients with PPP had concomitant PV. Relative to matched patients with PV, patients with GPP had a higher prevalence of erythrodermic psoriasis (5.9% vs 0.4%, p < 0.0001), psoriatic arthritis (3.1% vs 1.5%, p = 0.007), and organ failure (1.1% vs 0.2%, p = 0.002). Relative to matched patients with PV, patients with PPP had a higher prevalence of cerebrovascular disease (4.7% vs 1.2%, p < 0.0001), thyroid dysfunction (3.9% vs 3.3%, p = 0.035), and type 2 diabetes mellitus (6.8% vs 5.9%, p = 0.030). More patients with GPP than patients with PV received systemic non-biological agents (27.9% vs 3.3%, p < 0.0001) and biologic agents (4.8% vs 2.0%, p = 0.010). More patients with PPP than patients with PV received topical agents (50.9% vs 34.7%, p < 0.0001) and systemic non-biological agents (17.8% vs 2.7%, p < 0.0001). More patients with GPP than patients with PV required inpatient hospitalization (22.0% vs 7.8%, p < 0.0001). Hospitalization stay was longer in patients with GPP than patients with PV (11.72 ± 0.45 vs 10.38 ± 0.45 days, p = 0.022). More patients with PPP than patients with PV had emergency visits (16.3% vs 12.8%, p < 0.0001). The GPP and PPP cohorts and their matched PV cohorts had no significant differences in costs. However, patients with PPP had lower outpatient costs than patients with PV (368.20 ± 8.19 vs 445.38 ± 5.90 Chinese Yuan per patient per month, p < 0.0001).

Conclusions

Patients from Beijing with GPP and PPP had higher disease burdens than matched PV cohorts, including the prevalence of comorbidities, healthcare resource utilization, and medication burden. However, the economic burden of pustular psoria

背景与目的:脓疱性银屑病是一种慢性复发性自身免疫性疾病,但对我国脓疱性牛皮癣的疾病负担知之甚少。我们分析了北京地区全身性脓疱性银屑病(GPP)或掌跖脓疱病(PPP)患者的特征和疾病负担。方法:这项多中心回顾性队列研究使用了一个覆盖北京30家公立医院的区域电子健康数据库。从2016年6月到2021年6月,所有诊断为GPP、PPP或寻常型银屑病(PV)的患者均通过《国际疾病和相关健康问题统计分类》第10版代码进行识别。GPP和PPP队列分别与PV患者以3:1的比例进行比较。收集人口统计学数据、临床特征、医疗资源利用率和成本。使用描述性和比较分析来比较队列。结果:GPP患者744例(男性46.8%,年龄42.14±21.47岁),PPP患者4808例(男性35.5%,年龄51.65±16.12岁);14.5%的GPP患者伴有PV,7.5%的PPP患者伴有PV。与匹配的PV患者相比,GPP患者的红皮病银屑病(5.9%vs 0.4%,p<0.0001)、银屑病关节炎(3.1%vs 1.5%,p=0.007)和器官衰竭(1.1%vs 0.2%,p=0.002)的患病率更高,甲状腺功能障碍(3.9%vs3.3%,p=0.035),和2型糖尿病(6.8%vs 5.9%,p=0.030)。接受全身非生物制剂治疗的GPP患者比PV患者多(27.9%vs 3.3%,p=0.001)和生物制剂治疗(4.8%vs 2.0%,p=0.010)。接受局部制剂治疗的PPP患者比PV病人多(50.9%vs 34.7%,p<0.001)和全身非生物剂治疗(17.8%vs 2.7%,p<0.0001)GPP患者比PV患者需要住院治疗(22.0%vs 7.8%,p<0.0001)。GPP患者的住院时间比PV患者更长(11.72±0.45 vs 10.38±0.45天,p=0.022)。PPP患者多于PV患者急诊就诊(16.3%vs 12.8%,p>0.0001)成本。然而,PPP患者的门诊费用低于PV患者(368.20±8.19 vs 445.38±5.90元/月,p<0.0001)。结论:来自北京的GPP和PPP患者的疾病负担高于匹配的PV队列,包括合并症的患病率、医疗资源利用率和药物负担。然而,脓疱性银屑病的经济负担与PV相似。需要实用和特异的治疗方法来减轻脓疱性银屑病的负担。
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引用次数: 3
Disease Burden and Treatment Patterns Among US Patients with Hidradenitis Suppurativa: A Retrospective Cohort Study 美国先天性巨结肠炎患者的疾病负担和治疗模式:一项回顾性队列研究。
IF 7.3 1区 医学 Q1 Medicine Pub Date : 2023-06-28 DOI: 10.1007/s40257-023-00796-2
Amit Garg, Yvonne Geissbühler, Emma Houchen, Nilesh Choudhary, Disha Arora, Varun Vellanki, Abhishek Srivastava,  Priyanka, John Darcy II, Craig Richardson, Alexa B. Kimball

Introduction

Hidradenitis suppurativa (HS) is a chronic, autoinflammatory skin disease associated with many comorbidities. One biologic (adalimumab) is approved for HS. This study assessed the sociodemographic characteristics, comorbidities, treatment patterns, healthcare resource utilization (HCRU) and associated costs of patients with HS following biologic approval.

Methods

This non-interventional, retrospective cohort study involved adult (≥ 18 years) and adolescent (12–17 years) patients diagnosed with HS in the United States (US) using Optum’s de-identified Clinformatics® Data Mart Database during the period 1 January 2016 to 31 December 2018.

Results

Of 42,843 identified patients, 10,909 met the incident HS patient criteria (10,230 adults, 628 adolescents, 51 patients aged <12 years). Patients were mostly diagnosed by a general practitioner/pediatrician (adults: 41.6%; adolescents: 39.6%) or dermatologist (adults: 22.1%; adolescents: 30.6%). Commonly reported Charlson comorbidities at pre-index in adult patients were diabetes without complications (20.4%), chronic pulmonary disease (16.4%) and diabetes with complications (9.0%), and the most frequent Elixhauser comorbidities were uncomplicated hypertension (38.3%), obesity (22.5%), uncomplicated diabetes (19.0%) and depression (17.4%). The burden of comorbidities generally increased over time after diagnosis in both adults and adolescents. HS-related surgical procedures were uncommon in the 2-years post-index period: an incision and drainage procedure was reported in 7.6% of adults and 6.4% of adolescents. Patients were predominantly treated with both topical and systemic antibiotic treatments (adults: 25.0% and 65.1%, respectively; adolescents: 41.7% and 74.5%, respectively). Biologic prescription was higher in adults than adolescents (3.5% vs. 1.8%). Total healthcare costs for adult and adolescent patients in the 2-years post-index period were US$42,143 and US$16,057, respectively, with outpatient costs accounting for the majority of these costs (US$20,980 and US$8408, respectively).

Conclusion

In adult and adolescent patients with HS, comorbidity burden continues to increase after diagnosis. All-cause and HS-specific HCRU and costs are high in adults and adolescents with HS. These findings support the need for a multidisciplinary comprehensive care strategy for patients with HS.

简介:化脓性手足口炎(HS)是一种慢性、自身炎症性皮肤病,伴有多种合并症。一种生物制剂(阿达木单抗)被批准用于HS。本研究评估了HS患者在生物批准后的社会人口学特征、合并症、治疗模式、医疗资源利用率(HCRU)和相关成本。方法:这项非介入性回顾性队列研究涉及2016年1月1日至2018年12月31日期间在美国诊断为HS的成人(≥18岁)和青少年(12-17岁)患者,使用Optum的去识别Clinformatics®Data Mart数据库。结果:在42843名已识别患者中,10909例符合事件HS患者标准(10230名成人,628名青少年,51名年龄段患者)结论:在成年和青少年HS患者中,诊断后合并症负担继续增加。成人和青少年HS的全因和HS特异性HCRU和费用很高。这些发现支持对HS患者采取多学科综合护理策略的必要性。
{"title":"Disease Burden and Treatment Patterns Among US Patients with Hidradenitis Suppurativa: A Retrospective Cohort Study","authors":"Amit Garg,&nbsp;Yvonne Geissbühler,&nbsp;Emma Houchen,&nbsp;Nilesh Choudhary,&nbsp;Disha Arora,&nbsp;Varun Vellanki,&nbsp;Abhishek Srivastava,&nbsp; Priyanka,&nbsp;John Darcy II,&nbsp;Craig Richardson,&nbsp;Alexa B. Kimball","doi":"10.1007/s40257-023-00796-2","DOIUrl":"10.1007/s40257-023-00796-2","url":null,"abstract":"<div><h3>Introduction</h3><p>Hidradenitis suppurativa (HS) is a chronic, autoinflammatory skin disease associated with many comorbidities. One biologic (adalimumab) is approved for HS. This study assessed the sociodemographic characteristics, comorbidities, treatment patterns, healthcare resource utilization (HCRU) and associated costs of patients with HS following biologic approval.</p><h3>Methods</h3><p>This non-interventional, retrospective cohort study involved adult (≥ 18 years) and adolescent (12–17 years) patients diagnosed with HS in the United States (US) using Optum’s de-identified Clinformatics<sup>®</sup> Data Mart Database during the period 1 January 2016 to 31 December 2018.</p><h3>Results</h3><p>Of 42,843 identified patients, 10,909 met the incident HS patient criteria (10,230 adults, 628 adolescents, 51 patients aged &lt;12 years). Patients were mostly diagnosed by a general practitioner/pediatrician (adults: 41.6%; adolescents: 39.6%) or dermatologist (adults: 22.1%; adolescents: 30.6%). Commonly reported Charlson comorbidities at pre-index in adult patients were diabetes without complications (20.4%), chronic pulmonary disease (16.4%) and diabetes with complications (9.0%), and the most frequent Elixhauser comorbidities were uncomplicated hypertension (38.3%), obesity (22.5%), uncomplicated diabetes (19.0%) and depression (17.4%). The burden of comorbidities generally increased over time after diagnosis in both adults and adolescents. HS-related surgical procedures were uncommon in the 2-years post-index period: an incision and drainage procedure was reported in 7.6% of adults and 6.4% of adolescents. Patients were predominantly treated with both topical and systemic antibiotic treatments (adults: 25.0% and 65.1%, respectively; adolescents: 41.7% and 74.5%, respectively). Biologic prescription was higher in adults than adolescents (3.5% vs. 1.8%). Total healthcare costs for adult and adolescent patients in the 2-years post-index period were US$42,143 and US$16,057, respectively, with outpatient costs accounting for the majority of these costs (US$20,980 and US$8408, respectively).</p><h3>Conclusion</h3><p>In adult and adolescent patients with HS, comorbidity burden continues to increase after diagnosis. All-cause and HS-specific HCRU and costs are high in adults and adolescents with HS. These findings support the need for a multidisciplinary comprehensive care strategy for patients with HS.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":7.3,"publicationDate":"2023-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4d/f0/40257_2023_Article_796.PMC10570206.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9692623","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
Authors’ Reply to Chen and Chen: Comment on: “Isotretinoin Exposure and Risk of Inflammatory Bowel Disease: A Systematic Review with Meta-Analysis and Trial Sequential Analysis” 作者对Chen和Chen的回复:评论:“异维甲酸暴露与炎症性肠病的风险:荟萃分析和试验序贯分析的系统评价”
IF 7.3 1区 医学 Q1 Medicine Pub Date : 2023-06-27 DOI: 10.1007/s40257-023-00803-6
Chia-Ling Yu, Po-Yi Chou, Chih-Sung Liang, Li-Huei Chiang, Tzu-Yu Wang, Yu-Kang Tu, Ching-Chi Chi
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引用次数: 0
Comment on: “Isotretinoin Exposure and Risk of Inflammatory Bowel Disease: A Systematic Review with Meta-Analysis and Trial Sequential Analysis” 评论:“异维甲酸暴露与炎症性肠病风险:荟萃分析和试验序贯分析的系统综述”
IF 7.3 1区 医学 Q1 Medicine Pub Date : 2023-06-27 DOI: 10.1007/s40257-023-00802-7
Shurong Chen, Yi Chen
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引用次数: 1
Dupilumab-Associated Arthritis: A Dermatology-Rheumatology Perspective Dupilumab相关关节炎:皮肤病学-风湿病的观点。
IF 7.3 1区 医学 Q1 Medicine Pub Date : 2023-06-22 DOI: 10.1007/s40257-023-00804-5
Michael J. Woodbury, Jeffrey S. Smith, Joseph F. Merola

Dupilumab is an interleukin (IL)-4/13 inhibitor approved by the US FDA for multiple atopic indications. It is well-known to have favorable efficacy and safety profiles; however, emerging reports of dupilumab-associated arthritis suggest an underrecognized potential adverse effect. In this article, we summarize the literature to date to better characterize this clinical phenomenon. Arthritic symptoms were most commonly peripheral, generalized, and symmetric. Onset was generally within 4 months following initiation of dupilumab, and most patients resolved fully after a matter of weeks following discontinuation. Mechanistic insights suggest that suppression of IL-4 may lead to increased activity of IL-17, a prominent cytokine in inflammatory arthritis. We propose a treatment algorithm that stratifies patients by severity, recommending that patients with more mild disease continue dupilumab and treat through symptoms, while patients with more severe disease discontinue dupilumab and consider switching to another class (e.g., Janus kinase inhibitors). Lastly, we discuss important ongoing questions that should be addressed in future studies.

Dupilumab是一种白细胞介素(IL)-4/13抑制剂,经美国食品药品监督管理局批准用于多种特应性适应症。众所周知,它具有良好的疗效和安全性;然而,新出现的dupilumab相关关节炎的报告表明,潜在的不良反应尚未得到充分认识。在这篇文章中,我们总结了迄今为止的文献,以更好地描述这种临床现象。关节炎症状最常见的是周围性、全身性和对称性。发病时间通常在开始使用杜匹单抗后4个月内,大多数患者在停药后几周内完全缓解。机制研究表明,IL-4的抑制可能导致IL-17的活性增加,IL-17是炎症性关节炎中的一种重要细胞因子。我们提出了一种按严重程度对患者进行分层的治疗算法,建议病情较轻的患者继续使用dupilumab并通过症状进行治疗,而病情较重的患者停用dupilumb并考虑改用另一类药物(例如Janus激酶抑制剂)。最后,我们讨论了在未来研究中应该解决的重要的持续问题。
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引用次数: 0
Do Biologic Treatments for Psoriasis Lower the Risk of Psoriatic Arthritis? A Systematic Review 银屑病的生物治疗能降低银屑病关节炎的风险吗?系统回顾。
IF 7.3 1区 医学 Q1 Medicine Pub Date : 2023-06-21 DOI: 10.1007/s40257-023-00801-8
Anna Aronovich, Ilya Novikov, Lev Pavlovsky

Background and Objective

The effectiveness of biologic treatments in slowing the progression of psoriatic arthritis is well established, but there is limited and conflicting evidence on their ability to prevent the development of psoriatic arthritis in patients with psoriasis. The objective of this review was to evaluate the role of biologic treatment for psoriasis in preventing or delaying subsequent psoriatic arthritis.

Methods

A literature search was performed using MEDLINE (PubMed), Embase, Web of Science, and the Cochrane Library for studies published in English from database inception to March 2022 that statistically compared the risk of psoriatic arthritis in patients aged > 16 years who were previously treated with biologic disease-modifying antirheumatic drugs or with other drugs for skin psoriasis.

Results

Four articles were eligible for analysis, all retrospective cohort studies. Three were conducted in preselected patients attending dermatology or dermatology–rheumatology collaboration centers and one was a large population-based study. In three studies, a primary two-step statistical analysis yielded a significantly lower risk of psoriatic arthritis in patients treated with biologic agents. These findings were not supported by the large retrospective electronic health record-based study.

Conclusions

Biologic treatments may be effective in preventing the development of psoriatic arthritis in patients with psoriasis. More research is needed given the retrospective cohort design of all studies included in the review limiting the generalizability of the results, and the conflicting results from the registry study. At present, biologic agents should not be prescribed to unselected patients with psoriasis for the sole purpose of preventing psoriatic arthritis.

背景和目的:生物治疗在减缓银屑病关节炎进展方面的有效性已得到充分证实,但关于其预防银屑病患者银屑病关节炎发展的能力,证据有限且相互矛盾。本综述的目的是评估银屑病的生物治疗在预防或延缓随后的银屑病关节炎中的作用。方法:使用MEDLINE(PubMed)、Embase、Web of Science和Cochrane Library进行文献检索,检索从数据库创建到2022年3月以英文发表的研究,这些研究对年龄>16岁的患者患银屑病关节炎的风险进行了统计比较,这些患者以前曾接受过生物疾病改良抗风湿药物或其他治疗皮肤银屑病的药物治疗。结果:4篇文章符合分析条件,均为回顾性队列研究。其中三项是在皮肤科或皮肤风湿病协作中心的预选患者中进行的,一项是基于人群的大型研究。在三项研究中,主要的两步统计分析显示,接受生物制剂治疗的患者患银屑病关节炎的风险显著降低。这些发现没有得到基于电子健康记录的大型回顾性研究的支持。结论:生物治疗可有效预防银屑病患者银屑病关节炎的发展。考虑到综述中所有研究的回顾性队列设计限制了结果的可推广性,以及注册研究的相互矛盾的结果,还需要更多的研究。目前,不应仅为了预防银屑病关节炎而给未经选择的银屑病患者开生物制剂。
{"title":"Do Biologic Treatments for Psoriasis Lower the Risk of Psoriatic Arthritis? A Systematic Review","authors":"Anna Aronovich,&nbsp;Ilya Novikov,&nbsp;Lev Pavlovsky","doi":"10.1007/s40257-023-00801-8","DOIUrl":"10.1007/s40257-023-00801-8","url":null,"abstract":"<div><h3>Background and Objective</h3><p>The effectiveness of biologic treatments in slowing the progression of psoriatic arthritis is well established, but there is limited and conflicting evidence on their ability to prevent the development of psoriatic arthritis in patients with psoriasis. The objective of this review was to evaluate the role of biologic treatment for psoriasis in preventing or delaying subsequent psoriatic arthritis.</p><h3>Methods</h3><p>A literature search was performed using MEDLINE (PubMed), Embase, Web of Science, and the Cochrane Library for studies published in English from database inception to March 2022 that statistically compared the risk of psoriatic arthritis in patients aged &gt; 16 years who were previously treated with biologic disease-modifying antirheumatic drugs or with other drugs for skin psoriasis.</p><h3>Results</h3><p>Four articles were eligible for analysis, all retrospective cohort studies. Three were conducted in preselected patients attending dermatology or dermatology–rheumatology collaboration centers and one was a large population-based study. In three studies, a primary two-step statistical analysis yielded a significantly lower risk of psoriatic arthritis in patients treated with biologic agents. These findings were not supported by the large retrospective electronic health record-based study.</p><h3>Conclusions</h3><p>Biologic treatments may be effective in preventing the development of psoriatic arthritis in patients with psoriasis. More research is needed given the retrospective cohort design of all studies included in the review limiting the generalizability of the results, and the conflicting results from the registry study. At present, biologic agents should not be prescribed to unselected patients with psoriasis for the sole purpose of preventing psoriatic arthritis.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":7.3,"publicationDate":"2023-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9661425","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: 1
Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials Secukinumab治疗儿童斑块型银屑病:两项3期随机临床试验的综合安全性分析
IF 7.3 1区 医学 Q1 Medicine Pub Date : 2023-06-21 DOI: 10.1007/s40257-023-00782-8
Michael Sticherling, Arjen F. Nikkels, Ashraf M. Hamza, Pearl Kwong, Jacek C. Szepietowski, Mahira El Sayed, Pierre-Dominique Ghislain, Alkes A. Khotko, Manmath Patekar, Christine-Elke Ortmann, Pascal Forrer, Philemon Papanastasiou, Deborah Keefe

Background

Plaque psoriasis affects ~ 1% of the pediatric population, negatively impacting quality of life. The efficacy and safety of secukinumab in pediatric patients with moderate to severe or severe chronic plaque psoriasis have been established in two pivotal phase 3 trials (open-label, NCT03668613; double-blind, NCT02471144).

Objectives

The aims were to report the pooled safety of secukinumab up to 52 weeks from two studies in subgroups of pediatric patients stratified by age and bodyweight, and to present, alongside the pediatric data, the pooled safety data from four pivotal adult secukinumab trials.

Methods

The safety of secukinumab was evaluated in subgroups of pediatric patients defined by age (6 to < 12 and 12 to < 18 years) and bodyweight (< 25 kg, 25 to < 50 kg, and ≥ 50 kg) in the pooled population. Patients received secukinumab low dose (LD; 75/75/150 mg), secukinumab high dose (HD; 75/150/300 mg), placebo, or etanercept (0.8 mg/kg). For safety analyses, data were pooled from the pediatric studies NCT03668613 and NCT02471144, and presented alongside the pooled data from four adult pivotal studies (NCT01365455, NCT01636687, NCT01358578, NCT01555125).

Results

A total of 198 pediatric patients (overall exposure: 184.6 patient-years [PY]) and 1989 adult patients (1749.5 PY) receiving secukinumab up to week 52 were included in this analysis. At week 52, the incidence of adverse events (AEs) was lower in the lower age and bodyweight subgroups. The AEs reported within these subgroups were consistent with the overall AEs reported in this analysis. Overall, exposure-adjusted incidence rates for treatment-emergent AEs were lower in the secukinumab-treated pediatric pool (198.8/100 PY) compared with the etanercept (266.3/100 PY) and adult pools (256.1/100 PY). Up to 52 weeks, the incidence rates of the AEs in the secukinumab-treated patients in the 6 to < 12 years subgroup and 12 to < 18 years subgroup were 167.7/100 PY and 214.7/100 PY, respectively. Similarly, incidence rates of the AEs in the secukinumab-treated patients in the < 25 kg, 25 kg to < 50 kg, and ≥ 50 kg subgroups were 177.3/100 PY, 192.5/100 PY, and 206.8/100 PY, respectively. Nasopharyngitis was the most frequently reported AE in secukinumab-treated pediatric patients across age (< 12 years: 11.8/100 PY; ≥ 12 years: 42.4/100 PY) and bodyweight (< 25 kg: 22.8/100 PY; 25 kg to < 50 kg: 19.0/100 PY; ≥ 50 kg: 43.0/100 PY). Of the 198 secukinumab-treated pediatric patients, one reported nail Candida, one reported skin Candida, and two reported vulvovaginal Candida. Transient and mostly mild events of neutropenia were observed with secukinumab, none leading to study treatment discontinuation. No incidence of treatment-emergent anti-drug antibodies was reported in pediatric patients treated with secukinumab.

Conclusions

Secukinumab was well tolerated in pedi

背景斑块型银屑病影响约1%的儿科人群,对生活质量产生负面影响。在两项关键的3期试验中(开放标签,NCT03668613;双盲,NCT02471144),已经确定了secukinumab对患有中度至重度或重度慢性斑块型银屑病的儿童患者的疗效和安全性。目的报告两项按年龄和体重分层的儿科患者亚组研究中secukinumab在52周内的汇总安全性,并在提供儿科数据的同时,提供四项关键成人secukinu单抗试验的汇总安全数据。方法在合并人群中按年龄(6至<12岁和12至<18岁)和体重(<25 kg、25至<50 kg和≥50 kg)定义的儿科患者亚组中评估secukinumab的安全性。患者接受了secukinumab低剂量(LD;75/75/150 mg)、secukinu单抗高剂量(HD;75/150/300 mg)、安慰剂或依那西普(0.8 mg/kg)。对于安全性分析,汇集了儿科研究NCT03668613和NCT02471144的数据,并与四项成人关键研究(NCT01365455、NCT01636687、NCT01358578、NCT01555125)的汇集数据一起呈现。结果共有198名儿童患者(总暴露量:184.6患者年[PY])和1989名接受secukinumab治疗至第52周的成年患者(1749.5 PY)被纳入本分析。在第52周,低年龄和体重亚组的不良事件发生率较低。这些亚组中报告的不良事件与本分析中报告的总体不良事件一致。总体而言,与依那西普组(266.3/100 PY)和成人组(256.1/100 PY。高达52周,secukinumab治疗的患者在6至<;12年亚组和12至<;18岁亚组分别为167.7/100 PY和214.7/100 PY。类似地,在<;25千克、25千克至<;50 kg和≥50 kg亚组分别为177.3/100 PY、192.5/100 PY和206.8/100 PY。在不同年龄(<12岁:11.8/1000 PY;≥12岁:42.4/100 PY)和体重(<25公斤:22.8/100 PY;25公斤至<50公斤:19.0/100 PY;>50公斤:43.0/100 PY。在198名接受secukinumab治疗的儿科患者中,一名报告了指甲念珠菌,一名报道了皮肤念珠菌,两名报告了外阴阴道念珠菌。使用secukinumab观察到中性粒细胞减少症的短暂和大多数轻微事件,没有一例导致研究治疗中断。在接受secukinumab治疗的儿科患者中,没有出现治疗引发的抗药物抗体的报告。结论在不同年龄和体重亚组的中重度和重度斑块型银屑病患儿中,西库单抗具有良好的耐受性。secukinumab在儿科患者中的总体安全性与成人患者一致。ClinicalTrials.gov IdentifierNCT03668613(诺华研究代码CAIN457A2311,简称A2311),实际研究开始日期:2018年8月29日;实际一次竣工日期:2019年9月19日;预计研究完成日期:2023年9月14日。NCT02471144(诺华研究代码CAIN457A2310,简称A2310),研究开始日期:2015年9月29日;初步竣工日期:2018年12月13日;预计研究完成日期:2023年3月31日。
{"title":"Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials","authors":"Michael Sticherling,&nbsp;Arjen F. Nikkels,&nbsp;Ashraf M. Hamza,&nbsp;Pearl Kwong,&nbsp;Jacek C. Szepietowski,&nbsp;Mahira El Sayed,&nbsp;Pierre-Dominique Ghislain,&nbsp;Alkes A. Khotko,&nbsp;Manmath Patekar,&nbsp;Christine-Elke Ortmann,&nbsp;Pascal Forrer,&nbsp;Philemon Papanastasiou,&nbsp;Deborah Keefe","doi":"10.1007/s40257-023-00782-8","DOIUrl":"10.1007/s40257-023-00782-8","url":null,"abstract":"<div><h3>Background</h3><p>Plaque psoriasis affects ~ 1% of the pediatric population, negatively impacting quality of life. The efficacy and safety of secukinumab in pediatric patients with moderate to severe or severe chronic plaque psoriasis have been established in two pivotal phase 3 trials (open-label, NCT03668613; double-blind, NCT02471144).</p><h3>Objectives</h3><p>The aims were to report the pooled safety of secukinumab up to 52 weeks from two studies in subgroups of pediatric patients stratified by age and bodyweight, and to present, alongside the pediatric data, the pooled safety data from four pivotal adult secukinumab trials.</p><h3>Methods</h3><p>The safety of secukinumab was evaluated in subgroups of pediatric patients defined by age (6 to &lt; 12 and 12 to &lt; 18 years) and bodyweight (&lt; 25 kg, 25 to &lt; 50 kg, and ≥ 50 kg) in the pooled population. Patients received secukinumab low dose (LD; 75/75/150 mg), secukinumab high dose (HD; 75/150/300 mg), placebo, or etanercept (0.8 mg/kg). For safety analyses, data were pooled from the pediatric studies NCT03668613 and NCT02471144, and presented alongside the pooled data from four adult pivotal studies (NCT01365455, NCT01636687, NCT01358578, NCT01555125).</p><h3>Results</h3><p>A total of 198 pediatric patients (overall exposure: 184.6 patient-years [PY]) and 1989 adult patients (1749.5 PY) receiving secukinumab up to week 52 were included in this analysis. At week 52, the incidence of adverse events (AEs) was lower in the lower age and bodyweight subgroups. The AEs reported within these subgroups were consistent with the overall AEs reported in this analysis. Overall, exposure-adjusted incidence rates for treatment-emergent AEs were lower in the secukinumab-treated pediatric pool (198.8/100 PY) compared with the etanercept (266.3/100 PY) and adult pools (256.1/100 PY). Up to 52 weeks, the incidence rates of the AEs in the secukinumab-treated patients in the 6 to &lt; 12 years subgroup and 12 to &lt; 18 years subgroup were 167.7/100 PY and 214.7/100 PY, respectively. Similarly, incidence rates of the AEs in the secukinumab-treated patients in the &lt; 25 kg, 25 kg to &lt; 50 kg, and ≥ 50 kg subgroups were 177.3/100 PY, 192.5/100 PY, and 206.8/100 PY, respectively. Nasopharyngitis was the most frequently reported AE in secukinumab-treated pediatric patients across age (&lt; 12 years: 11.8/100 PY; ≥ 12 years: 42.4/100 PY) and bodyweight (&lt; 25 kg: 22.8/100 PY; 25 kg to &lt; 50 kg: 19.0/100 PY; ≥ 50 kg: 43.0/100 PY). Of the 198 secukinumab-treated pediatric patients, one reported nail <i>Candida</i>, one reported skin <i>Candida</i>, and two reported vulvovaginal <i>Candida</i>. Transient and mostly mild events of neutropenia were observed with secukinumab, none leading to study treatment discontinuation. No incidence of treatment-emergent anti-drug antibodies was reported in pediatric patients treated with secukinumab.</p><h3>Conclusions</h3><p>Secukinumab was well tolerated in pedi","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":7.3,"publicationDate":"2023-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2b/9a/40257_2023_Article_782.PMC10460311.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10175627","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: 2
Climate Change, Skin Health, and Dermatologic Disease: A Guide for the Dermatologist 气候变化、皮肤健康和皮肤病:皮肤科医生指南
IF 7.3 1区 医学 Q1 Medicine Pub Date : 2023-06-20 DOI: 10.1007/s40257-023-00770-y
Annika Belzer, Eva Rawlings Parker

Climate change has a pervasive impact on health and is of clinical relevance to every organ system. Climate change-related factors impact the skin’s capacity to maintain homeostasis, leading to a variety of cutaneous diseases. Stratospheric ozone depletion has led to increased risk of melanoma and keratinocyte carcinomas due to ultraviolet radiation exposure. Atopic dermatitis, psoriasis, pemphigus, acne vulgaris, melasma, and photoaging are all associated with rising levels of air pollution. Elevated temperatures due to global warming induce disruption of the skin microbiome, thereby impacting atopic dermatitis, acne vulgaris, and psoriasis, and high temperatures are associated with exacerbation of skin disease and increased risk of heat stroke. Extreme weather events due to climate change, including floods and wildfires, are of relevance to the dermatologist as these events are implicated in cutaneous injuries, skin infections, and acute worsening of inflammatory skin disorders. The health consequences as well as the economic and social burden of climate change fall most heavily on vulnerable and marginalized populations due to structural disparities. As dermatologists, understanding the interaction of climate change and skin health is essential to appropriately manage dermatologic disease and advocate for our patients.

气候变化对健康有着普遍的影响,对每个器官系统都有临床意义。气候变化相关因素影响皮肤维持体内平衡的能力,导致各种皮肤疾病。平流层臭氧消耗导致紫外线照射导致黑色素瘤和角质形成细胞癌的风险增加。特应性皮炎、银屑病、天疱疮、寻常痤疮、黄褐斑和光老化都与空气污染水平的上升有关。全球变暖导致的温度升高会导致皮肤微生物组的破坏,从而影响特应性皮炎、寻常痤疮和银屑病,高温与皮肤病恶化和中暑风险增加有关。气候变化导致的极端天气事件,包括洪水和野火,与皮肤科医生有关,因为这些事件与皮肤损伤、皮肤感染和炎症性皮肤病的急性恶化有关。由于结构性差异,气候变化对健康的影响以及经济和社会负担最严重地落在弱势和边缘化人群身上。作为皮肤科医生,了解气候变化和皮肤健康的相互作用对于适当管理皮肤病和为患者辩护至关重要。
{"title":"Climate Change, Skin Health, and Dermatologic Disease: A Guide for the Dermatologist","authors":"Annika Belzer,&nbsp;Eva Rawlings Parker","doi":"10.1007/s40257-023-00770-y","DOIUrl":"10.1007/s40257-023-00770-y","url":null,"abstract":"<div><p>Climate change has a pervasive impact on health and is of clinical relevance to every organ system. Climate change-related factors impact the skin’s capacity to maintain homeostasis, leading to a variety of cutaneous diseases. Stratospheric ozone depletion has led to increased risk of melanoma and keratinocyte carcinomas due to ultraviolet radiation exposure. Atopic dermatitis, psoriasis, pemphigus, acne vulgaris, melasma, and photoaging are all associated with rising levels of air pollution. Elevated temperatures due to global warming induce disruption of the skin microbiome, thereby impacting atopic dermatitis, acne vulgaris, and psoriasis, and high temperatures are associated with exacerbation of skin disease and increased risk of heat stroke. Extreme weather events due to climate change, including floods and wildfires, are of relevance to the dermatologist as these events are implicated in cutaneous injuries, skin infections, and acute worsening of inflammatory skin disorders. The health consequences as well as the economic and social burden of climate change fall most heavily on vulnerable and marginalized populations due to structural disparities. As dermatologists, understanding the interaction of climate change and skin health is essential to appropriately manage dermatologic disease and advocate for our patients.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":null,"pages":null},"PeriodicalIF":7.3,"publicationDate":"2023-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10174941","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: 3
期刊
American Journal of Clinical Dermatology
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