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Value of PASI90 Versus Merit-Based Incentive Payment System Efficacy Measures. PASI90与基于绩效的激励支付系统效能衡量的价值
Q3 Medicine Pub Date : 2022-07-01 Epub Date: 2022-04-19 DOI: 10.1177/24755303221082623
Jason E Hawkes, Paulo Reis, Chen-Yen Lin, Talia Muram, William J Eastman

Background: Achieving ≥90% improvement in Psoriasis Area and Severity Index (PASI90) is achievable with newer biologic therapies, such as ixekizumab. Standard of care payment systems such as the Merit-based Incentive Payment System (MIPS) responder criteria could lead to under treatment and lower quality of life (QoL) outcomes compared with PASI90.

Objective: Show PASI90 is a higher standard than MIPS and is associated with greater improvements in QoL and other PRO outcomes.

Methods: Patients with moderate-to-severe psoriasis meeting PASI90 and MIPS criteria were compared in 3 phase 3 clinical trials of the interleukin-17A inhibitor ixekizumab (pooled UNCOVER-2/3 and IXORA-S). Patients satisfying MIPS criteria met either static Physician Global Assessment score ≤2, body surface area <3%, PASI <3, or Dermatology Life Quality Index ≤5. Improvements in QoL were compared between patients meeting PASI90 and MIPS criteria.

Results: All PASI90 responders were also MIPS responders (PASI90 responders). Not all MIPS responders met PASI90 (MIPS-only responders). Significantly larger change from baseline improvements for all health (skin pain, Itch NRS, DLQI, PtGA, WPAI-PsO work productivity loss, and WPAI-PsO activity impairment) and quality of life (EQ-5D 5L VAS and acute SF-36 PCS/MCS) outcome measures were observed in the PASI90 responders vs the MIPS-only responders.

Conclusion: PASI90 is a higher standard of response than MIPS and is associated with greater improvements in health and quality of life outcome measures.

背景使用新的生物疗法,如依昔单抗,可以实现银屑病面积和严重程度指数(PASI90)≥90%的改善。与PASI90相比,基于功绩的激励支付系统(MIPS)响应者标准等护理支付系统可能导致治疗不足和生活质量(QoL)结果降低。目的显示PASI90是比MIPS更高的标准,并且与生活质量和其他PRO结果的更大改善有关。方法对符合PASI90和MIPS标准的中重度银屑病患者进行白细胞介素-17A抑制剂依昔单抗(联合UNCOVER-2/3和IXORA-S)的3期临床试验的比较。符合MIPS标准的患者符合静态医师全球评估评分≤2、体表面积<3%、PASI<3或皮肤科生活质量指数≤5。比较符合PASI90和MIPS标准的患者生活质量的改善情况。结果所有PASI90应答者均为MIPS应答者(PASI90反应者)。并非所有MIPS应答者都符合PASI90(仅MIPS应答)。PASI90应答者与仅MIPS应答者相比,所有健康状况(皮肤疼痛、瘙痒NRS、DLQI、PtGA、WPAI PsO工作生产力损失和WPAI PsO活动障碍)和生活质量(EQ-5D 5L VAS和急性SF-36 PCS/MCS)结果指标的基线改善发生了显著更大的变化。结论PASI90是一种比MIPS更高的反应标准,与健康和生活质量指标的改善有关。
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引用次数: 0
Practice Patterns of Palmoplantar Pustulosis: Patient Demographics and Treatment Options. 掌跖Pustulosis的实践模式:患者人口学和治疗方案
Q3 Medicine Pub Date : 2022-07-01 Epub Date: 2022-05-06 DOI: 10.1177/24755303221099292
Antoinette Chandler, Hannah Wood, Novin Nezamololama, Melinda J Gooderham

Background: Palmoplantar pustulosis (PPP) is a chronic skin condition characterized by sterile pustules on the palms and soles. This condition is more commonly reported among women and smokers causing considerable discomfort and interference with daily activities. Although there are various off-label treatment options available for PPP, there remains a demand to identify more effective and safer treatments.

Objective: To review the patient demographics and treatment patterns of our PPP patient population.

Methods: A retrospective chart review was performed at a dermatology office with two locations in Ontario, Canada.

Results: We identified 71 adult PPP patients. A third of patients did not return for follow up after diagnosis. Among those who returned for follow-up, 20% were managed with topical therapy alone. Of our patients who took systemic treatment for PPP, apremilast, followed by ustekinumab and guselkumab, had the greatest retention of therapy.

Conclusion: Targeting PDE4, IL-12/23 and IL-23 provided some benefit for our patients with PPP leading to greatest retention of therapy over time. Further investigation is required into the cause for high no-show rates and the search for effective and safe treatment options.

背景掌跖脓疱病(PPP)是一种以手掌和足底无菌性脓疱为特征的慢性皮肤病。这种情况在女性和吸烟者中更为常见,会引起相当大的不适,并干扰日常活动。尽管PPP有各种标签外治疗选择,但仍需要确定更有效、更安全的治疗方法。目的回顾我国PPP患者群体的人口统计学特征和治疗模式。方法在加拿大安大略省的两个皮肤科办公室进行回顾性图表审查。结果我们确定了71名成年PPP患者。三分之一的患者在确诊后没有返回进行随访。在那些返回随访的患者中,20%的患者仅接受了局部治疗。在我们接受PPP系统治疗的患者中,阿普司特,其次是ustekinumab和guselkumab,治疗保留率最高。结论靶向PDE4、IL-12/23和IL-23为PPP患者提供了一些益处,随着时间的推移,治疗保留率最高。需要对高无症状率的原因进行进一步调查,并寻找有效和安全的治疗方案。
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引用次数: 0
TNF-alpha inhibitors and ustekinumab for the treatment of psoriasis: therapeutic utility in the era of IL-17 and IL-23 inhibitors. 治疗银屑病的 TNF-α 抑制剂和乌司他单抗:IL-17 和 IL-23 抑制剂时代的治疗效用。
Q3 Medicine Pub Date : 2022-04-01 Epub Date: 2022-01-12 DOI: 10.1177/24755303211047479
Julie J Hong, Edward K Hadeler, Megan L Mosca, Nicholas D Brownstone, Tina Bhutani, Wilson J Liao

Psoriasis is a chronic inflammatory condition for which eleven FDA-approved biologic therapies are approved. Over the past decade, studies have documented the higher efficacy of IL-17 and IL-23 inhibitors for the treatment of psoriasis compared to the TNF-alpha inhibitors and ustekinumab, an IL-12/23 inhibitor. Despite this, there remains an important role for the use of TNF-alpha inhibitors and ustekinumab in the treatment of psoriasis. Here, we review how considerations of infection and malignancy risk, patient demographics, treatment resistance, and co-morbidities may make certain TNF-alpha inhibitors or ustekinumab an excellent choice for therapy in particular patient subgroups.

银屑病是一种慢性炎症性疾病,美国食品和药物管理局已批准了 11 种生物疗法。在过去十年中,有研究表明,与TNF-α抑制剂和IL-12/23抑制剂ustekinumab相比,IL-17和IL-23抑制剂治疗银屑病的疗效更高。尽管如此,TNF-α抑制剂和乌斯特库单抗在银屑病治疗中仍然发挥着重要作用。在此,我们回顾了感染和恶性肿瘤风险、患者人口统计学、治疗耐药性和合并症等因素如何使某些 TNF-α 抑制剂或乌斯特库单抗成为特定患者亚群治疗的最佳选择。
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引用次数: 0
Improving Access to Care for Patients with Psoriasis and Psoriatic Arthritis: The Impact of the Temporary Reciprocity to Ensure Access to Treatment Act and Remote Care Policy Reform. 改善银屑病和银屑病关节炎患者获得护理的机会:确保获得治疗的临时互惠法案和远程护理政策改革的影响
Q3 Medicine Pub Date : 2022-04-01 Epub Date: 2021-12-23 DOI: 10.1177/24755303211067263
Edward Hadeler, John Koo, Megan Mosca, Julie Hong, Nicholas Brownstone, Mark Lebwohl
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引用次数: 0
Why so Blue? (Or Should I Say Red?) Recognizing the Emotional Impact of Psoriasis on Patients and Family Members: A Qualitative Study. 为什么这么蓝?(或者我应该说红色?)认识到银屑病对患者和家庭成员的情绪影响:一项定性研究
Q3 Medicine Pub Date : 2022-04-01 Epub Date: 2022-02-11 DOI: 10.1177/24755303211069335
Ashley M Snyder, Vanina L Taliercio, Bianca E Rich, Adelheid U Brandenberger, Lisa B Webber, Abram P Beshay, Joshua E Biber, Rachel Hess, Jamie Lw Rhoads, Aaron M Secrest

Background: Psoriasis is a chronic skin condition with significant effects on quality of life, including impacts on emotional health. However, these experiences are not always addressed in clinic visits, despite their potential for significant effects on daily life. This study is part of a larger project on the effects of psoriasis on quality of life. The current information was analyzed separately because the amount of information on emotional impacts mentioned by participants was so significant that it warranted a separate analysis to thoroughly assess these experiences. Objective: To describe emotional consequences of psoriasis for patients and their family members. Methods: This project was conducted at an academic medical center in Utah. Experiences were discussed in interviews and focus groups with 25 patients and 11 family members. Thematic analysis was used to determine themes and subthemes. Results: This study sheds light on the damaging effects of psoriasis on emotional well-being, illustrating the challenges patients face from internal conflict, consequences for family members trying to cope with psoriasis in a loved one, and judgment from others who do not understand psoriasis and its challenges. Conclusion: Living with psoriasis leads to emotional consequences that may be left unaddressed in clinic visits, yet these experiences contribute significantly to quality of life. The stories told through this study can help clinicians understand how to identify and address emotional concerns to improve care for psoriasis patients and, as a result, improve quality of life for both patients and their families.

背景:牛皮癣是一种对生活质量有显著影响的慢性皮肤病,包括对情绪健康的影响。然而,这些经历并不总是在诊所就诊中得到解决,尽管它们对日常生活有潜在的重大影响。这项研究是一个关于牛皮癣对生活质量影响的大型项目的一部分。目前的信息是单独分析的,因为参与者提到的情绪影响的信息量非常大,需要单独分析来彻底评估这些经历。目的:描述牛皮癣患者及其家属的情绪后果。方法:本项目在犹他州的一个学术医疗中心进行。对25名患者和11名家属进行访谈和焦点小组讨论。主题分析用于确定主题和副主题。结果:本研究揭示了牛皮癣对情绪健康的破坏性影响,说明了患者面临的内部冲突的挑战,家庭成员试图应对亲人患牛皮癣的后果,以及其他人不了解牛皮癣及其挑战的判断。结论:患有牛皮癣会导致情绪后果,这些后果可能在诊所就诊时未得到解决,但这些经历对生活质量有重要影响。通过本研究讲述的故事可以帮助临床医生了解如何识别和解决情绪问题,以改善对牛皮癣患者的护理,从而提高患者及其家人的生活质量。
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引用次数: 0
Psoriatic Onycho-Pachydermo-Periostitis. 牛皮癣性骨膜炎
Q3 Medicine Pub Date : 2022-04-01 Epub Date: 2021-12-23 DOI: 10.1177/24755303211066089
Susan Hesni, Davoud Khodatars, Richard Rees, Monica Khanna, Miny Walker

Psoriatic onycho-pachydermo-periostitis (POPP) is an unfamiliar and poorly recognised condition first described in 1989 by Fournie et al. It is a variant of psoriatic arthritis comprising the triad of onycholysis, soft tissue thickening and radiographically apparent periostitis. Whilst typically affecting the great toe, any of the digits of the hands and feet may be affected. A 'drumstick' appearance to the digits of the foot is the most common clinical presentation and can be extremely painful. Nail changes are another hallmark of POPP and can be mistakenly diagnosed as fungal infection leading to lengthy periods of incorrect treatment. In this article, we will outline the clinical presentation, imaging features, pathogenesis and treatment options for POPP. Currently, the existence of POPP is not widely known. Awareness of this unusual condition will allow early appropriate treatment and can aid in the diagnosis of indeterminate seronegative disease.

银屑病性甲厚皮骨膜炎(POPP)是一种不熟悉且鲜为人知的疾病,由Fournie等人于1989年首次描述。它是银屑病关节炎的一种变体,包括甲裂、软组织增厚和放射学上明显的骨膜炎。虽然通常影响大脚趾,但手和脚的任何手指都可能受到影响。足趾出现“鸡腿”是最常见的临床表现,可能会非常痛苦。指甲变化是POPP的另一个标志,可能被错误诊断为真菌感染,导致长时间的错误治疗。在这篇文章中,我们将概述POPP的临床表现、影像学特征、发病机制和治疗方案。目前,持久性有机污染物方案的存在还不广为人知。意识到这种不寻常的情况将有助于早期进行适当的治疗,并有助于诊断不确定的血清阴性疾病。
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引用次数: 0
Retrospective Analysis in Patients With Moderate to Severe Plaque Psoriasis Treated With Tildrakizumab: Real-Life Clinical Data. Tildrakizumab治疗中重度斑块型银屑病患者的回顾性分析:真实临床数据
Q3 Medicine Pub Date : 2022-04-01 Epub Date: 2022-03-29 DOI: 10.1177/24755303221077211
Nancy W Wei, Sunny Chi, Mark G Lebwohl

Background: Interleukin (IL)-23 antagonists have shown great efficacy with minimal side effect profile in clinical trial data for the treatment of moderate to severe plaque psoriasis. As of yet, there have been no published data regarding real-world patients who have received tildrakizumab therapy. Objectives: To analyze real-world efficacy and safety of tildrakizumab in patients with moderate to severe plaque psoriasis. Methods: A retrospective chart review was performed at a large urban academic medical center for all patients treated with tildrakizumab for moderate to severe plaque psoriasis. Demographic information, Psoriasis Area and Severity Indexs(PASIs) from initial presentation and 12-month follow-up, comorbidities, and any possible adverse events were collected and analyzed statistically. Results: 30 patients on tildrakizumab therapy were included in the analysis. Overall, the mean ± standard deviation of the PASIs was 15.8 ± 11.8 at initial visit and 1.5 ± 2.9 at 12-month follow-up (P < .001). No serious adverse events were reported. Conclusions: Tildrakizumab has shown efficacy in clinical trials and this real-world cohort for the treatment of moderate to severe plaque psoriasis with a good safety profile. Future studies should be done to assess the efficacy of tildrakizumab compared with other IL-23 inhibitors.

背景:白细胞介素(IL)-23拮抗剂在治疗中重度斑块型银屑病的临床试验数据中显示出良好的疗效和最小的副作用。到目前为止,还没有关于接受替德拉基单抗治疗的真实世界患者的公布数据。目的:分析替德拉基单抗治疗中重度斑块型银屑病的真实疗效和安全性。方法:在一家大型城市学术医疗中心对所有接受替拉单抗治疗的中重度斑块型银屑病患者进行回顾性图表审查。收集并统计分析了首次就诊和12个月随访的人口学信息、银屑病面积和严重程度指数(PASI)、合并症和任何可能的不良事件。结果:30例接受替拉单抗治疗的患者被纳入分析。总体而言,初次访视时PASI的平均值±标准差为15.8±11.8,12个月随访时为1.5±2.9(P<.001)。未报告严重不良事件。结论:Tildrakizumab在临床试验和这个现实世界的队列中显示出治疗中重度斑块型银屑病的疗效,具有良好的安全性。未来应进行研究,以评估替拉单抗与其他IL-23抑制剂的疗效。
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引用次数: 0
No Evidence that Variations in Ambient Solar Ultraviolet Radiation and Psoriasis Severity are Associated. 没有证据表明环境太阳紫外线辐射的变化与银屑病的严重程度有关
Q3 Medicine Pub Date : 2022-04-01 Epub Date: 2022-03-03 DOI: 10.1177/24755303221079810
Thomas S D Okun, Martin M Okun

Background: Seasonal variability in psoriasis severity may be related to changes in unintentional or intentional exposure to ultraviolet radiation (UVR), or more intensive medication use during summer. Objective: Change in psoriasis severity for placebo-randomized subjects in clinical trials of moderate-severe psoriasis, as a function of estimated change in ambient UVR exposure, allows assessment of temporal changes in UVR on psoriasis without confounding from therapies that are prohibited during trial conduct. Methods: Placebo-randomized subject data, including dates and PASI for baseline and Week 16 visits, and approximate investigator location, pooled from the placebo-controlled double-blinded periods (Weeks 0-16) of 3 moderate-severe psoriasis clinical trials, were accessed through the Vivli data platform. Investigator locations were geocoded and linked to estimated mean daily ambient erythemally weighted UVR for the months corresponding to baseline and Week 16, using data from the Ozone Monitoring Instrument on board the NASA EOS Aura spacecraft. Results: Simple linear regression of percentage PASI change for 542 placebo-treated subjects with non-missing observations yielded a beta coefficient for percentage change in UVR of -0.009 (standard error = 0.008), with p = 0.243 and adjusted R 2 = 0.0007. Lack of statistical significance was observed across multiple regression analyses adjusting for baseline covariates and for interaction terms, and for mean difference in percentage change UVR for PASI50 responders versus non-responders. Conclusion: Multiple analyses failed to provide evidence that temporal variations in ambient UVR are associated with variations in psoriasis severity.

背景:银屑病严重程度的季节性变化可能与无意或有意暴露于紫外线辐射(UVR)的变化有关,或与夏季更密集的药物使用有关。目的:在中重度银屑病临床试验中,安慰剂随机受试者银屑病严重程度的变化,作为环境紫外线暴露的估计变化的函数,可以评估银屑病紫外线暴露的时间变化,而不会与试验过程中禁止的治疗相混淆。方法:通过Vivli数据平台访问安慰剂随机受试者数据,包括基线和第16周访视的日期和PASI,以及研究者的大致位置,这些数据来自3项中重度银屑病临床试验的安慰剂对照双盲期(第0-16周)。使用美国国家航空航天局EOS Aura航天器上臭氧监测仪器的数据,对研究人员的位置进行了地理编码,并将其与基线和第16周对应月份的估计平均每日环境红斑加权紫外线R联系起来。结果:542名接受安慰剂治疗且观察结果无遗漏的受试者的PASI变化百分比的简单线性回归得出UVR变化百分比的β系数为−0.009(标准误差=0.008),p=0.243,调整后的R2=0.0007。在对基线协变量和相互作用项进行调整的多元回归分析中,PASI50应答者与无应答者的UVR百分比变化的平均差异缺乏统计学意义。结论:多项分析未能提供证据表明环境紫外线的时间变化与银屑病严重程度的变化有关。
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引用次数: 0
The Disease Burden of Generalized Pustular Psoriasis: Real-World Evidence From CorEvitas' Psoriasis Registry. 全身性脓疱性银屑病的疾病负担:来自CorEvitas银屑病登记处的真实证据
Q3 Medicine Pub Date : 2022-04-01 Epub Date: 2022-03-11 DOI: 10.1177/24755303221079814
M Lebwohl, R A Medeiros, R H Mackey, L R Harrold, W C Valdecantos, M Flack, A K Golembesky, N Kotowsky, B Strober

Background: Generalized pustular psoriasis (GPP) is a rare, systemic disease characterized by persistent or recurrent flares of painful neutrophilic pustules. There is limited real-world evidence characterizing patients with GPP. Objectives: To establish the distinguishing characteristics of GPP relative to plaque psoriasis, and help inform future treatment decisions and improve patient outcomes. Methods: North American adults with GPP or plaque psoriasis (without pustules) identified from CorEvitas' Psoriasis Registry were included in this dataset. Registry enrollment data, including patient sociodemographics, disease characteristics, medication use, and patient-reported outcome measures were compared for patients with GPP vs those with plaque psoriasis. This study was descriptive, and no hypothesis tests were performed. Results: In this sample, patients with GPP (N = 60) reported greater median (interquartile range) pain (20 [3-62] vs 5 [0-35]), fatigue (44 [15-73] vs 20 [4-50]), and itch (59 [10-85] vs 22 [5-70]) than those with plaque psoriasis (N = 4894). Descriptively, patients with GPP also reported more anxiety and depression (EQ-5D-3L: 38% vs 26%) and had more treatment experience (≥2 previous systemics: 15% vs 7%). Conclusions: A greater degree of symptom severity and impact on quality of life was reported by patients with GPP compared with plaque psoriasis in this sample. Importantly, patients with GPP had more treatment experience, suggesting that current treatment options do not adequately resolve the disease-highlighting the need to develop more effective GPP treatments.

背景:全身性脓疱性银屑病(GPP)是一种罕见的全身性疾病,其特征是疼痛的中性粒细胞性脓疱持续或复发。关于GPP患者的真实世界证据有限。目的:确定GPP与斑块型银屑病的区别特征,并有助于为未来的治疗决策提供信息,改善患者的预后。方法:从CorEvitas银屑病登记处鉴定出的患有GPP或斑块型银屑病(无脓疱)的北美成年人被纳入该数据集。将GPP患者与斑块型银屑病患者的注册登记数据,包括患者社会人口统计学、疾病特征、药物使用和患者报告的结果指标进行比较。这项研究是描述性的,没有进行假设检验。结果:在该样本中,GPP患者(N=60)报告的中位(四分位间距)疼痛(20[3-62]vs 5[0-35])、疲劳(44[15-73]vs 20[4-50])和瘙痒(59[10-85]vs 22[5-70])均高于斑块型银屑病患者(N=4894)。据描述,GPP患者也报告了更多的焦虑和抑郁(EQ-5D-3L:38%vs 26%),并有更多的治疗经验(≥2个既往系统:15%vs 7%)。结论:与该样本中的斑块型银屑病相比,GPP患者的症状严重程度和对生活质量的影响更大。重要的是,GPP患者有更多的治疗经验,这表明目前的治疗方案并不能充分解决这种疾病,这突出了开发更有效的GPP治疗方法的必要性。
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引用次数: 0
Abstracts from the 2021 NPF Research Symposium Meeting 2021年NPF研究研讨会摘要
Q3 Medicine Pub Date : 2022-03-11 DOI: 10.1177/24755303221084594
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引用次数: 0
期刊
Journal of Psoriasis and Psoriatic Arthritis
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