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Steatocystoma Multiplex Suppurativa Treated Successfully with Adalimumab and Topical Tofacitinib 阿达木单抗和外用托法替尼成功治疗多发性湿性脂肪囊肿
Pub Date : 2024-07-23 DOI: 10.25251/skin.8.4.22
Mariana McCune, Aaron Graff, Christina Harview, Lindsay Ackerman
Steatocystoma multiplex (SM) is a rare chronic dermatologic condition which may cause significant distress and negatively impact quality of life. Currently, there is no consensus for treatment. When inflammatory, it is called steatocystoma multiplex suppurativa, an even more rare condition that has shown reported success with anti-TNF-alpha therapy. We describe a patient case wherein adalimumab prescribed for autoimmune arthritis resulted in SMS remission, further supported with evidence of sustained remission with topical tofacitinib. This patient case supports other evidence showing adalimumab as a treatment option for SMS and highlights the potential of tofacitinib as a novel treatment.
多发性脂肪囊肿(SM)是一种罕见的慢性皮肤病,可能会给患者带来极大的痛苦,并对生活质量产生负面影响。目前,治疗方法尚未达成共识。当出现炎症时,它被称为多发性化脓性脂肪囊肿,这是一种更为罕见的疾病,有报道称抗 TNF-α 治疗取得了成功。我们描述了一例患者的病例,该患者因阿达木单抗治疗自身免疫性关节炎而导致 SMS 缓解,并有证据显示局部使用托法替尼后病情持续缓解。该病例支持其他证据显示阿达木单抗是治疗SMS的一种选择,并强调了托法替尼作为一种新型疗法的潜力。
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引用次数: 0
Significant Improvement of Persistent Hailey-Hailey Disease with Dupilumab: A Case Report 杜匹单抗显著改善顽固性海利-海利病:病例报告
Pub Date : 2024-07-23 DOI: 10.25251/skin.8.4.19
Malvika Ramesh, Brinda Chellappan, Lindy Ross
Hailey-Hailey disease is a rare, genetic blistering disease characterized by erythematous, scaly plaques in intertriginous regions such as the axillary, inframammary, and groin regions. The plaques cause discomfort and are difficult to treat. Treatment ranges from topical to systemic and surgical. Despite the variety of treatment options, Hailey-Hailey disease is notoriously difficult to treat with each patient responding uniquely to treatment. There has been evidence of patients with Hailey-Hailey disease experiencing improvement of symptoms with dupilumab injections. Dupilumab has several off-label uses, including allergic contact dermatitis, hand dermatitis, chronic spontaneous urticaria, and alopecia areata, showing promise for its use in dermatology outside of atopic dermatitis and prurigo nodularis. Due to its minimal side effects, dupilumab can be tried for Hailey-Hailey disease with little risk. We present the case of a 37-year-old female with recalcitrant Hailey-Hailey disease who noticed significant improvement on dupilumab.   
海利-海利病是一种罕见的遗传性水疱病,其特征是在腋窝、乳房下和腹股沟等三叉神经间区域出现红斑、鳞屑性斑块。斑块会引起不适,而且难以治疗。治疗方法包括局部治疗、全身治疗和手术治疗。尽管治疗方法多种多样,但海利-海利病是出了名的难治病,每个患者对治疗的反应都不尽相同。有证据表明,海利-海利病患者在注射杜匹单抗后症状有所改善。杜比鲁单抗有几种标示外用途,包括过敏性接触性皮炎、手部皮炎、慢性自发性荨麻疹和斑秃,显示了它在特应性皮炎和结节性瘙痒症以外的皮肤科领域的应用前景。由于其副作用极小,杜比鲁单抗用于海利-海利病的风险很小。我们介绍了一例患有顽固性海利-海利病的 37 岁女性患者的病例。
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引用次数: 0
Representation of Skin Color, Disease Severity, and Anatomic Location in Hidradenitis Suppurativa Images 皮肤颜色、疾病严重程度和解剖位置在扁平湿疹图像中的体现
Pub Date : 2024-07-23 DOI: 10.25251/skin.8.4.8
D. De, Sarah Park, T. Shih, Vivian Y Shi, J. Hsiao
Introduction: Hidradenitis suppurativa (HS) is an inflammatory dermatosis disproportionately affecting patients of color. We evaluated characteristics of HS images in dermatology online image resources and textbooks. Methods: Images of HS were collected in December 2021 from online and textbook sources. Data regarding anatomic region, Hurley stage, and Fitzpatrick skin tone (FST) were collected and analyzed. Results: 318 images remained after exclusion criteria. VisualDx contained the highest number of dark skin (FST V-VI) images (59%, 47/79), followed by Google (4%, 2/52) and DermNetNZ (4%, 4/100). In textbook sources, dark skin represented 25% (4/16) of images. Across sources, 47% (151/318) of images represented Hurley stage 2, followed by 32% (101/318) stage 3, and 21% (66/318) stage 1. The axilla (49%, 156/318) was the most common anatomic location featured, followed by the groin (18%, 58/318) and breast/chest (9%, 28/318). Involvement of non-classic locations was represented in 3% (8/318) of images. There was a positive correlation between higher Hurley stage and darker skin (r=0.26, p<0.05). Discussion/Conclusion: Overall there is underrepresentation of dark skin tones, “non-classic” anatomic locations, and mild HS which may lead to missed opportunities for patient education and dermatology training. Dermatologists should take the lead to improve image diversity across educational resources.
导言:化脓性扁平湿疹(HS)是一种炎症性皮肤病,对有色人种患者的影响尤为严重。我们评估了皮肤病学在线图像资源和教科书中 HS 图像的特征。方法:2021 年 12 月,我们从网络和教科书中收集了有关 HS 的图片。收集并分析有关解剖区域、赫里分期和菲茨帕特里克肤色(FST)的数据。结果排除标准后,剩余 318 张图片。VisualDx包含的深色皮肤(FST V-VI)图片数量最多(59%,47/79),其次是谷歌(4%,2/52)和DermNetNZ(4%,4/100)。在教科书来源中,深色皮肤占图片的 25%(4/16)。在所有图片来源中,47%(151/318)的图片代表 Hurley 第 2 阶段,其次是 32%(101/318)的第 3 阶段和 21%(66/318)的第 1 阶段。腋窝(49%,156/318)是最常见的解剖位置,其次是腹股沟(18%,58/318)和乳房/胸部(9%,28/318)。3%(8/318)的图像涉及非经典部位。较高的赫利分期与较黑的皮肤呈正相关(r=0.26,p<0.05)。讨论/结论:总体而言,深肤色、"非经典 "解剖位置和轻度 HS 的代表性不足,这可能会导致错过患者教育和皮肤科培训的机会。皮肤科医生应率先改善教育资源中的图像多样性。
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引用次数: 0
Tapinarof Cream 1% Once Daily is Efficacious for the Treatment of Atopic Dermatitis in Patients with Skin of Color Down to 2 Years of Age in Two Pivotal Phase 3 Trials 在两项关键性 3 期试验中,1% Tapinarof 乳霜每日一次可有效治疗 2 岁以下有色皮肤患者的特应性皮炎
Pub Date : 2024-07-23 DOI: 10.25251/skin.8.supp.411
Andrew F. Alexis, L. Kircik, Raj Chovatiya, Z. Rice, Tina Bhutani, P. Brown, Stephen C. Piscitelli, D. Rubenstein, A. Tallman, April W. Armstrong
Introduction: Patients with atopic dermatitis (AD) and skin of color can have heterogeneous presentations and treatment responses. In the pivotal phase 3 ADORING 1 and 2 trials, tapinarof cream 1% (VTAMA®, Dermavant Sciences, Inc.) once daily (QD) was significantly efficacious and well tolerated versus vehicle in adults and children down to 2 years of age with AD.Objective: Here, we report analyses of efficacy by skin color in ADORING 1 and 2, based on patients’ self-identified race and investigator-assessed Fitzpatrick skin type.Methods: In ADORING 1 and 2, patients with a Validated Investigator Global Assessment for Atopic DermatitisTM (vIGA-ADTM) score of ≥3, an Eczema Area and Severity Index score of ≥6, and body surface area involvement of 5–35% were randomized 2:1 to tapinarof cream or vehicle QD for 8 weeks. The primary efficacy endpoint was a vIGA-ADTM score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 8. Secondary endpoints included proportion of patients with a ≥75% improvement in Eczema Area and Severity Index (EASI75).Results: Of the 407 and 406 randomized patients, 8.8–15.3% were Asian, 26.5–35.0% were Black, 44.8–56.8% were White, and 2.7–5.2% were Other groups (American Indian or Alaska Native, Native Hawaiian or Pacific Islander, or multiple races) across trials. Patients with Fitzpatrick skin types IV, V, and VI represented 23.8–25.1%, 20.6–22.2%, and 7.6–8.9%, respectively, of patients (>50% in both trials). Across trials, vIGA-ADTM responses (ranges) for tapinarof versus vehicle were: Asian, 39.5–48.9% vs 3.7–18.5%; Black, 43.1–47.0% vs 17.5–24.1%; White, 49.4–52.1% vs 12.2–14.5%; and Other, 26.0–44.8% vs 0.0–40.2%. EASI75 responses for tapinarof versus vehicle were: Asian, 47.6–76.6% vs 17.7–20.2%; Black, 48.9–55.3% vs 25.7–30.0%; White, 61.4–67.8% vs 19.6–20.7%; and Other, 38.3–63.3% vs 0.0–40.6%. Similarly, high and consistent vIGA-ADTM and EASI75 responses were reported with tapinarof versus vehicle in patients with Fitzpatrick skin types I–III and IV–VI.Conclusion: Tapinarof cream 1% QD was consistently efficacious among all racial groups and Fitzpatrick skin types in adults and children down to 2 years of age with AD, including patients with skin of color, who were highly represented in these trials.
简介:特应性皮炎(AD)患者和有色皮肤患者的表现和治疗反应各不相同。在关键的 3 期 ADORING 1 和 2 试验中,1% 塔替那罗乳膏(VTAMA®,Dermavant Sciences, Inc:在 ADORING 1 和 2 中,研究者对特应性皮炎全球评估(vIGA-ADTM)评分≥3 分、湿疹面积和严重程度指数评分≥6 分、体表面积受累程度为 5%-35% 的患者按 2:1 随机分配使用 tapinarof 乳膏或载体 QD,疗程为 8 周。主要疗效终点是第8周时vIGA-ADTM评分为0分(清晰)或1分(基本清晰),且比基线改善≥2级。次要终点包括湿疹面积和严重程度指数(EASI75)改善≥75%的患者比例:在407例和406例随机患者中,亚洲人占8.8%-15.3%,黑人占26.5%-35.0%,白人占44.8%-56.8%,其他群体(美国印第安人或阿拉斯加原住民、夏威夷原住民或太平洋岛民或多种种族)占2.7%-5.2%。菲茨帕特里克皮肤类型 IV、V 和 VI 患者分别占 23.8-25.1%、20.6-22.2% 和 7.6-8.9%(两项试验中均超过 50%)。在所有试验中,vIGA-ADTM 对 tapinarof 和载体的反应(范围)如下:亚裔,39.5-48.9% vs 3.7-18.5%;黑人,43.1-47.0% vs 17.5-24.1%;白人,49.4-52.1% vs 12.2-14.5%;其他,26.0-44.8% vs 0.0-40.2%。EASI75 对 tapinarof 与车辆的响应情况如下:亚裔,47.6-76.6% vs 17.7-20.2%;黑人,48.9-55.3% vs 25.7-30.0%;白人,61.4-67.8% vs 19.6-20.7%;其他,38.3-63.3% vs 0.0-40.6%。同样,在菲茨帕特里克皮肤类型 I-III 型和 IV-VI 型患者中,使用 Tapinarof 与使用载体相比,vIGA-ADTM 和 EASI75 反应高且一致:在所有种族群体和 Fitzpatrick 皮肤类型的成人和 2 岁以下儿童 AD 患者中,1% QD 塔匹那洛芙乳膏具有一致的疗效,包括有色皮肤患者,他们在这些试验中的比例很高。
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引用次数: 0
Efficacy of Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 (TYK2) Inhibitor, in Scalp Psoriasis by Baseline Psoriasis Area and Severity Index (PASI) and Baseline Body Surface Area (BSA): A Subanalysis of the Phase 3 Clinical Trial Data 按基线银屑病面积和严重程度指数 (PASI) 和基线体表面积 (BSA) 划分的口服选择性异位酪氨酸激酶 2 (TYK2) 抑制剂 Deucravacitinib 对头皮银屑病的疗效:对 3 期临床试验数据的子分析
Pub Date : 2024-07-23 DOI: 10.25251/skin.8.supp.405
Andrew Blauvelt, H. Sofen, Jo Lambert, Joseph F. Merola, M. Lebwohl, K. Hoyt, Subhashis Banerjee, Thomas Scharnitz, Jeffrey J. Crowley
Introduction: Deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was effective and well tolerated in the global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials. Here, efficacy of deucravacitinib in scalp psoriasis was evaluated by baseline severity of psoriasis in the trial patients with scalp involvement. Methods: Patients with moderate to severe scalp involvement (scalp-specific Physician Global Assessment [ss-PGA] ≥3) at baseline were included in this analysis. Efficacy outcomes (ss-PGA 0/1 and Psoriasis Scalp Severity Index [PSSI] 90) were reported through Week 24 (pooled PSO-1/PSO-2, before PSO-2 rerandomization, n=514) and Week 52 (PSO-1, continuous deucravacitinib treatment, n=192). Outcomes were stratified by baseline PASI score 12-<15 (low) or ≥15 (high) and baseline BSA involvement 10%-≤15% (low) or >15% (high). Results: ss-PGA 0/1 response rates were high and slightly greater in the high versus low PASI subgroup at Week 24 (65.8% and 58.3%, respectively) and Week 52 (73.5% and 60.0%). Similarly, PSSI 90 response rates were high and also somewhat greater in the high versus low PASI subgroup at Week 24 (55.3% and 45.8%) and Week 52 (66.0% and 53.3%). Across the 2 baseline BSA subgroups, ss-PGA 0/1 and PSSI 90 response rates were comparable at Weeks 24 and 52. Conclusion: Deucravacitinib treatment was effective in patients with scalp involvement in psoriasis regardless of overall baseline disease severity.
简介Deucravacitinib是一种口服、选择性、异位TYK2抑制剂,已在美国、欧盟和其他国家获得批准,用于治疗可接受系统疗法的中重度斑块状银屑病成人患者。在为期52周的全球3期POETYK PSO-1(NCT03624127)和POETYK PSO-2(NCT03611751)试验中,Deucravacitinib疗效显著,耐受性良好。在此,我们根据试验中头皮受累患者的银屑病基线严重程度评估了德拉瓦替尼对头皮银屑病的疗效。研究方法基线时头皮受累程度为中度至重度(头皮特异性医生总体评估[ss-PGA]≥3)的患者被纳入本次分析。疗效结果(ss-PGA 0/1和银屑病头皮严重程度指数[PSSI] 90)报告至第24周(PSO-1/PSO-2汇总,PSO-2重新随机化前,n=514)和第52周(PSO-1,持续去氯法替尼治疗,n=192)。结果按基线 PASI 评分 12-15% (高)进行分层。结果:在第24周(分别为65.8%和58.3%)和第52周(分别为73.5%和60.0%),PASI高的亚组与PASI低的亚组相比,ss-PGA 0/1应答率较高且略高。同样,在第 24 周(55.3% 和 45.8%)和第 52 周(66.0% 和 53.3%),PSSI 90 反应率在 PASI 高的亚组与 PASI 低的亚组中也较高(分别为 55.3% 和 45.8%)和较高(分别为 66.0% 和 53.3%)。在第 24 周和第 52 周,两个基线 BSA 亚组的 ss-PGA 0/1 和 PSSI 90 反应率相当。结论无论总体基线疾病严重程度如何,Deucravacitinib治疗对头皮受累的银屑病患者均有效。
{"title":"Efficacy of Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 (TYK2) Inhibitor, in Scalp Psoriasis by Baseline Psoriasis Area and Severity Index (PASI) and Baseline Body Surface Area (BSA): A Subanalysis of the Phase 3 Clinical Trial Data","authors":"Andrew Blauvelt, H. Sofen, Jo Lambert, Joseph F. Merola, M. Lebwohl, K. Hoyt, Subhashis Banerjee, Thomas Scharnitz, Jeffrey J. Crowley","doi":"10.25251/skin.8.supp.405","DOIUrl":"https://doi.org/10.25251/skin.8.supp.405","url":null,"abstract":"Introduction: Deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was effective and well tolerated in the global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials. Here, efficacy of deucravacitinib in scalp psoriasis was evaluated by baseline severity of psoriasis in the trial patients with scalp involvement. \u0000Methods: Patients with moderate to severe scalp involvement (scalp-specific Physician Global Assessment [ss-PGA] ≥3) at baseline were included in this analysis. Efficacy outcomes (ss-PGA 0/1 and Psoriasis Scalp Severity Index [PSSI] 90) were reported through Week 24 (pooled PSO-1/PSO-2, before PSO-2 rerandomization, n=514) and Week 52 (PSO-1, continuous deucravacitinib treatment, n=192). Outcomes were stratified by baseline PASI score 12-<15 (low) or ≥15 (high) and baseline BSA involvement 10%-≤15% (low) or >15% (high). \u0000Results: ss-PGA 0/1 response rates were high and slightly greater in the high versus low PASI subgroup at Week 24 (65.8% and 58.3%, respectively) and Week 52 (73.5% and 60.0%). Similarly, PSSI 90 response rates were high and also somewhat greater in the high versus low PASI subgroup at Week 24 (55.3% and 45.8%) and Week 52 (66.0% and 53.3%). Across the 2 baseline BSA subgroups, ss-PGA 0/1 and PSSI 90 response rates were comparable at Weeks 24 and 52. \u0000Conclusion: Deucravacitinib treatment was effective in patients with scalp involvement in psoriasis regardless of overall baseline disease severity.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":"67 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141810744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Low Occurrence of Predefined Safety Events Across Six Randomized Clinical Trials of Spesolimab in Dermatologic Conditions 斯派索利单抗治疗皮肤病的六项随机临床试验中预定义安全事件发生率较低
Pub Date : 2024-07-23 DOI: 10.25251/skin.8.supp.410
Kenneth B Gordon, K. Eyerich, Milan J Anadkat, S. Choon, Boni Elewski, Jonathan N. Barker, Arash Mostaghimi, Ming Tang, T. Haeufel, C. Thoma, Diamant Thaçi
Introduction In the randomized, placebo-controlled Effisayil 2 trial, the anti-interleukin (IL)-36 receptor antibody spesolimab demonstrated a reassuring safety profile when given over 48 weeks for flare prevention in patients with generalized pustular psoriasis (GPP). Nevertheless, given its novel mechanistic approach, it is important to characterize events relating to IL-36 inhibition with spesolimab as well as those of potential relevance to an intravenously/subcutaneously administered biologic. Methods In this analysis, rates of such predefined events – severe/serious/opportunistic infections, potential hypersensitivity reactions, peripheral neuropathies, and malignant tumors – were examined using available data from six randomized trials of spesolimab across various dermatologic conditions. Results Events reported in patients receiving spesolimab at various doses and schedules in two trials in GPP, two in palmoplantar pustulosis (PPP), one in atopic dermatitis (AD), and one in hidradenitis suppurativa (HS) were included (total n=345 for spesolimab and 145 for placebo). Exposure to spesolimab was: GPP, 244.3; PPP, 327.8; AD, 40.0; and HS, 45.7 patient-years, respectively. Rates of severe/serious/opportunistic infections were low with spesolimab (3.2% in one GPP trial; otherwise, 0% vs. 0% with placebo), and the incidences of hypersensitivity reactions were similar for spesolimab (7.7–33.3%) and placebo (5.6–44.4%) across trials. There was one report of peripheral neuropathy with spesolimab in a PPP trial (incidence 0–0.9% across trials) versus two (one GPP, one PPP) with placebo (0–3.3%), and one malignancy with spesolimab in GPP (0–1.1% across trials) versus one with placebo in PPP (0–2.3%). Conclusion These results support the favorable safety profile of spesolimab seen in Effisayil 2.
导言:在随机安慰剂对照的Effisayil 2试验中,抗白细胞介素(IL)-36受体抗体spesolimab用于预防泛发性脓疱型银屑病(GPP)患者复发,用药48周后显示出令人放心的安全性。尽管如此,由于斯派索利单抗采用了新颖的机理方法,因此对与斯派索利单抗抑制IL-36相关的事件以及与静脉注射/皮下注射生物制剂可能相关的事件进行描述非常重要。方法 在这项分析中,我们利用斯派索利单抗的六项随机试验中涉及各种皮肤病的现有数据,研究了这些预定义事件的发生率--严重/严重/机会性感染、潜在超敏反应、周围神经病和恶性肿瘤。结果 纳入了两项GPP试验、两项掌跖脓疱病(PPP)试验、一项特应性皮炎(AD)试验和一项化脓性扁桃体炎(HS)试验中以不同剂量和疗程接受斯来索利单抗治疗的患者所发生的事件(斯来索利单抗的总人数=345,安慰剂的总人数=145)。斯派索利单抗的暴露量为GPP为244.3人年;PPP为327.8人年;AD为40.0人年;HS为45.7人年。斯派索利单抗的严重/严重/机会性感染率较低(一项GPP试验中为3.2%;其他试验中为0%,安慰剂为0%),各试验中斯派索利单抗(7.7-33.3%)和安慰剂(5.6-44.4%)的超敏反应发生率相似。在一项PPP试验中,斯派索利单抗有1例外周神经病变报告(各试验发生率为0-0.9%),而安慰剂有2例(1例GPP,1例PPP)(0-3.3%);在GPP试验中,斯派索利单抗有1例恶性肿瘤报告(各试验发生率为0-1.1%),而安慰剂有1例恶性肿瘤报告(0-2.3%)。结论 这些结果支持了在 Effisayil 2 中观察到的斯派索利单抗良好的安全性。
{"title":"Low Occurrence of Predefined Safety Events Across Six Randomized Clinical Trials of Spesolimab in Dermatologic Conditions","authors":"Kenneth B Gordon, K. Eyerich, Milan J Anadkat, S. Choon, Boni Elewski, Jonathan N. Barker, Arash Mostaghimi, Ming Tang, T. Haeufel, C. Thoma, Diamant Thaçi","doi":"10.25251/skin.8.supp.410","DOIUrl":"https://doi.org/10.25251/skin.8.supp.410","url":null,"abstract":"Introduction In the randomized, placebo-controlled Effisayil 2 trial, the anti-interleukin (IL)-36 receptor antibody spesolimab demonstrated a reassuring safety profile when given over 48 weeks for flare prevention in patients with generalized pustular psoriasis (GPP). Nevertheless, given its novel mechanistic approach, it is important to characterize events relating to IL-36 inhibition with spesolimab as well as those of potential relevance to an intravenously/subcutaneously administered biologic. \u0000Methods In this analysis, rates of such predefined events – severe/serious/opportunistic infections, potential hypersensitivity reactions, peripheral neuropathies, and malignant tumors – were examined using available data from six randomized trials of spesolimab across various dermatologic conditions. \u0000Results Events reported in patients receiving spesolimab at various doses and schedules in two trials in GPP, two in palmoplantar pustulosis (PPP), one in atopic dermatitis (AD), and one in hidradenitis suppurativa (HS) were included (total n=345 for spesolimab and 145 for placebo). Exposure to spesolimab was: GPP, 244.3; PPP, 327.8; AD, 40.0; and HS, 45.7 patient-years, respectively. Rates of severe/serious/opportunistic infections were low with spesolimab (3.2% in one GPP trial; otherwise, 0% vs. 0% with placebo), and the incidences of hypersensitivity reactions were similar for spesolimab (7.7–33.3%) and placebo (5.6–44.4%) across trials. There was one report of peripheral neuropathy with spesolimab in a PPP trial (incidence 0–0.9% across trials) versus two (one GPP, one PPP) with placebo (0–3.3%), and one malignancy with spesolimab in GPP (0–1.1% across trials) versus one with placebo in PPP (0–2.3%). \u0000Conclusion These results support the favorable safety profile of spesolimab seen in Effisayil 2.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":"134 35","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141810830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Deucravacitinib Long-Term Efficacy Through 4 years in Week 16 Placebo Crossover Patients in the Phase 3 POETYK PSO-1, PSO-2, and LTE Program POETYK PSO-1、PSO-2 和 LTE 3 期项目中第 16 周安慰剂交叉患者服用 Deucravacitinib 4 年后的长期疗效
Pub Date : 2024-07-23 DOI: 10.25251/skin.8.supp.408
M. Lebwohl, Richard B Warren, Shinichi Imafuku, J. Bagel, April W. Armstrong, T. Passeron, Subhashis Banerjee, Matthew J Colombo, Thomas Scharnitz, K. Hoyt, Diamant Thaçi, Andrew Blauvelt
Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was efficacious and well tolerated in two global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) parent trials, and through 2 additional years in the POETYK long-term extension (LTE) (NCT04036435) trial in patients treated with deucravacitinib from Day 1 of PSO-1/PSO-2. Here, long-term efficacy was assessed through 4 years in patients who crossed over from placebo to deucravacitinib at Week 16 in PSO-1 or PSO-2 and entered the LTE trial. Methods: PSO-1 and PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. At Week 16, patients randomized to placebo crossed over to deucravacitinib. At Week 52, patients could enroll in the LTE and receive open-label deucravacitinib. Efficacy was evaluated in patients who crossed over from placebo to deucravacitinib at Week 16 of the parent trial and received continuous deucravacitinib through 4 years (Week 208; data cutoff, November 1, 2023). Outcomes included ≥75%/≥90% reduction from baseline in Psoriasis Area and Severity Index (PASI 75/90) and static Physician Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1). Efficacy is reported using modified nonresponder imputation (mNRI) in patients who reached the Week 208 assessment or discontinued before Week 208. Results: Of 421 patients originally randomized to placebo, 348 crossed over to deucravacitinib at Week 16; 298 completed the parent trials and entered the LTE, with 291 meeting mNRI criteria. Efficacy response rates improved from Week 16 on placebo (PASI 75, 12.0% [95% CI, 8.5%-16.3%]; PASI 90, 3.4% [1.7%-6.2%]; sPGA 0/1, 10.0% [6.8%-14.0%]) through Week 52 on deucravacitinib (PASI 75, 75.2% [70.2%-80.2%]; PASI 90, 47.4% [41.6%-53.1%]; sPGA 0/1, 60.1% [54.5%-65.7%]). Response rates were maintained well through Week 208 (PASI 75, 75.6% [70.0%-81.2%]; PASI 90, 46.6% [40.4%-52.7%]; sPGA 0/1, 55.1% [48.8%-61.4%]). Conclusion: These findings support the long-term efficacy profile of once-daily oral deucravacitinib for treatment of patients with moderate to severe plaque psoriasis.
简介Deucravacitinib是一种口服、选择性、异位酪氨酸激酶2抑制剂,已在美国、欧盟和其他国家获得批准,用于治疗可接受系统疗法的中重度斑块状银屑病成人患者。在两项为期52周的全球3期POETYK PSO-1(NCT03624127)和POETYK PSO-2(NCT03611751)母体试验中,以及在POETYK长期扩展(LTE)(NCT04036435)试验中,从PSO-1/PSO-2第1天开始接受deucravacitinib治疗的患者中,deucravacitinib具有良好的疗效和耐受性。在此,我们对在PSO-1或PSO-2中第16周从安慰剂转为服用deucravacitinib并进入LTE试验的患者4年的长期疗效进行了评估。研究方法PSO-1和PSO-2将患者按1:2:1的比例随机分配到口服安慰剂、每天一次、每次6毫克的deucravacitinib或每天两次、每次30毫克的apremilast。第16周,随机接受安慰剂治疗的患者转为接受deucravacitinib治疗。第52周时,患者可加入LTE,接受开放标签的deucravacitinib治疗。疗效评估的对象是在母体试验第16周从安慰剂转为服用德拉瓦替尼并持续服用德拉瓦替尼4年(第208周;数据截止日期为2023年11月1日)的患者。疗效包括银屑病面积和严重程度指数(PASI 75/90)较基线下降≥75%/≥90%,以及静态医生总体评估评分为0(清晰)或1(基本清晰)(sPGA 0/1)。疗效报告采用修正的无应答者归因(mNRI)方法,对达到第 208 周评估标准或在第 208 周前停药的患者进行归因。结果:在最初随机接受安慰剂治疗的421名患者中,有348名患者在第16周时接受了deucravacitinib治疗;298名患者完成了母体试验并进入LTE,其中291名患者符合mNRI标准。从第 16 周开始,安慰剂的疗效反应率有所提高(PASI 75,12.0% [95% CI,8.5%-16.3%];PASI 90,3.4% [1.7%-6.2%];sPGA 0/1,10.0% [6.8%-14.0%])。PASI90,47.4% [41.6%-53.1%];sPGA 0/1,60.1% [54.5%-65.7%])。反应率在第 208 周保持良好(PASI 75,75.6% [70.0%-81.2%];PASI 90,46.6% [40.4%-52.7%];sPGA 0/1,55.1% [48.8%-61.4%])。结论这些研究结果支持每日口服一次的德拉瓦替尼治疗中重度斑块状银屑病患者的长期疗效。
{"title":"Deucravacitinib Long-Term Efficacy Through 4 years in Week 16 Placebo Crossover Patients in the Phase 3 POETYK PSO-1, PSO-2, and LTE Program","authors":"M. Lebwohl, Richard B Warren, Shinichi Imafuku, J. Bagel, April W. Armstrong, T. Passeron, Subhashis Banerjee, Matthew J Colombo, Thomas Scharnitz, K. Hoyt, Diamant Thaçi, Andrew Blauvelt","doi":"10.25251/skin.8.supp.408","DOIUrl":"https://doi.org/10.25251/skin.8.supp.408","url":null,"abstract":"Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was efficacious and well tolerated in two global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) parent trials, and through 2 additional years in the POETYK long-term extension (LTE) (NCT04036435) trial in patients treated with deucravacitinib from Day 1 of PSO-1/PSO-2. Here, long-term efficacy was assessed through 4 years in patients who crossed over from placebo to deucravacitinib at Week 16 in PSO-1 or PSO-2 and entered the LTE trial. \u0000Methods: PSO-1 and PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. At Week 16, patients randomized to placebo crossed over to deucravacitinib. At Week 52, patients could enroll in the LTE and receive open-label deucravacitinib. Efficacy was evaluated in patients who crossed over from placebo to deucravacitinib at Week 16 of the parent trial and received continuous deucravacitinib through 4 years (Week 208; data cutoff, November 1, 2023). Outcomes included ≥75%/≥90% reduction from baseline in Psoriasis Area and Severity Index (PASI 75/90) and static Physician Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1). Efficacy is reported using modified nonresponder imputation (mNRI) in patients who reached the Week 208 assessment or discontinued before Week 208. \u0000Results: Of 421 patients originally randomized to placebo, 348 crossed over to deucravacitinib at Week 16; 298 completed the parent trials and entered the LTE, with 291 meeting mNRI criteria. Efficacy response rates improved from Week 16 on placebo (PASI 75, 12.0% [95% CI, 8.5%-16.3%]; PASI 90, 3.4% [1.7%-6.2%]; sPGA 0/1, 10.0% [6.8%-14.0%]) through Week 52 on deucravacitinib (PASI 75, 75.2% [70.2%-80.2%]; PASI 90, 47.4% [41.6%-53.1%]; sPGA 0/1, 60.1% [54.5%-65.7%]). Response rates were maintained well through Week 208 (PASI 75, 75.6% [70.0%-81.2%]; PASI 90, 46.6% [40.4%-52.7%]; sPGA 0/1, 55.1% [48.8%-61.4%]). \u0000Conclusion: These findings support the long-term efficacy profile of once-daily oral deucravacitinib for treatment of patients with moderate to severe plaque psoriasis.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":"87 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141812739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Dermatology Education for Medical Students: Assessing Participation Rates in Clinical Dermatology Electives 医学生皮肤病学教育:评估临床皮肤病学选修课的参与率
Pub Date : 2024-07-23 DOI: 10.25251/skin.8.4.9
Ashima Agarwal, Lauryn M. Falcone, Emily D. Cai, Alaina J. James
Introduction: Skin conditions affect 1.9 billion people worldwide and are a common reason for patients to seek health care1. With the high prevalence of skin disease, it is vital that medical students should receive clinic-based education in recognizing and treating skin disorders. University of Pittsburgh School of Medicine (UPSoM) currently offers a 4-week clinical dermatology elective to third or fourth year medical students. However, in an increasingly crowded clinical curricula, the dermatology elective is not taken by many students. Methods: We assessed the percentage of UPSoM students who completed the dermatology elective and analyzed the residency selection of these students between academic years 2012 to 2022. We also explored dermatology elective offerings of medical schools across the United Sates that have a dermatology residency program and investigated the number of schools offering a shortened elective through the American Medical Association’s FREIDA database. Results: During academic years (AY) 2012 to 2022, 1579 students were enrolled at UPSOM. In this time period, 205(13.0%) students participated in the elective course. Of these 205 students, 31(15.1%) pursued dermatology residency, 105(51.2%) pursued primary care and 22(10.7%) students pursued surgical subspecialties. Of the 142 dermatology residency programs, only nineteen programs (17.0%) offer a shortened elective. Discussion: Many medical students graduate medical school with little to no dermatology training, despite a high likelihood of encountering skin disease in their future careers. Offering a shortened clinical dermatology elective may allow for more students to participate in hands-on dermatology training.
导言:全世界有 19 亿人受到皮肤病的影响,皮肤病是患者寻求医疗服务的常见原因1。由于皮肤病的发病率很高,医科学生必须接受识别和治疗皮肤病的临床教育。匹兹堡大学医学院(UPSoM)目前为三年级或四年级医学生开设了为期 4 周的临床皮肤病学选修课。然而,在临床课程日益拥挤的情况下,很多学生并没有选修皮肤病学选修课。方法:我们评估了完成皮肤病学选修课的 UPSoM 学生比例,并分析了这些学生在 2012 至 2022 学年期间的住院医师选择情况。我们还通过美国医学协会的 FREIDA 数据库,调查了全美设有皮肤病学住院医师培训项目的医学院的皮肤病学选修课程,并调查了提供缩短选修课程的学校数量。结果:在 2012 至 2022 学年期间,共有 1579 名学生在 UPSOM 就读。在此期间,有 205 名学生(13.0%)参加了选修课程。在这205名学生中,31人(15.1%)选择了皮肤科住院医师培训,105人(51.2%)选择了初级保健,22人(10.7%)选择了外科亚专科。在 142 个皮肤科住院医师培训项目中,只有 19 个项目(17.0%)提供缩短的选修课。讨论:许多医学生在医学院毕业时几乎没有接受过皮肤病学培训,尽管他们在未来的职业生涯中很有可能会遇到皮肤病。提供缩短的临床皮肤病学选修课可以让更多学生参加皮肤病学实践培训。
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引用次数: 0
Lymphocytoma Cutis - A Case Report 切缘淋巴细胞瘤 - 病例报告
Pub Date : 2024-05-13 DOI: 10.25251/skin.8.3.23
Grace Hingtgen, Rafael Mojica, Douglas Robins
Without tissue biopsy and holistic review of presentation, histology, and immunohistochemistry, lymphocytoma cutis (LC) can often be misdiagnosed as other benign conditions or malignant pathologies such as cutaneous B cell lymphoma (CBCL). A 36-year-old female presented with a two-year history of a progressive indurated, edematous plaque in the preauricular area. At presentation, the patient also had labs significant for thrombocytopenia and eosinophilia. Original treatment with topical steroids did not lead to clinical improvement of the lesions. Punch biopsy revealed reactive lymphoid hyperplasia with polyclonal lymphoid infiltrates of small lymphocytes, histiocytes, eosinophils, and plasma cells. Diagnosis of LC was made and our patient was treated with serial 5 mg intralesional triamcinolone injections. Clinical improvement was seen beginning at 2 months. Diagnosing LC can be particularly difficult as the clinical presentation is ubiquitous and can resemble several other conditions such as CBCL, cutaneous lupus erythematosus, sarcoid, or hypersensitivity reactions. Recognition of the typical histologic findings of top-heavy dermal mixed-cellular infiltrates along with polyclonal kappa and lambda hybridization on immunohistochemistry is often essential in arriving at the correct diagnosis. Following diagnosis of LC, long-term surveillance is recommended as malignant transformation is a possibility. 
如果不进行组织活检并对表现、组织学和免疫组化进行全面审查,切缘淋巴细胞瘤(LC)往往会被误诊为其他良性疾病或恶性病变,如皮肤 B 细胞淋巴瘤(CBCL)。一名 36 岁的女性患者因耳前区出现进行性凹陷性水肿斑块就诊两年。就诊时,患者的实验室检查结果为血小板减少和嗜酸性粒细胞增多。最初使用局部类固醇激素治疗后,病变并未得到临床改善。穿刺活检发现反应性淋巴增生,伴有小淋巴细胞、组织细胞、嗜酸性粒细胞和浆细胞的多克隆淋巴浸润。诊断结果为 LC,患者接受了连续 5 毫克曲安奈德内注射治疗。两个月后,患者的临床症状有所改善。诊断 LC 尤为困难,因为其临床表现无处不在,可能与其他几种疾病相似,如 CBCL、皮肤红斑狼疮、类肉芽肿或超敏反应。要做出正确的诊断,通常需要识别典型的组织学特征,即真皮混合细胞浸润以及免疫组化的多克隆 kappa 和 lambda 杂交。确诊为 LC 后,建议进行长期监测,因为有可能发生恶性转化。
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引用次数: 0
Application of Lean Six Sigma in Dermatology Practice 精益六西格玛在皮肤科实践中的应用
Pub Date : 2024-05-13 DOI: 10.25251/skin.8.3.2
Kaycee Nguyen, Parneet Dhaliwal, Clay Cockerell
The Lean Six Sigma (LSS) methodology integrates two quality improvement techniques to enhance efficiency, reduce waste, and improve the quality of processes and products within an organization. While it has found application in various healthcare settings, to the best of our knowledge, there is currently no literature addressing its utilization in a community dermatology clinic. This study aimed to identify efficiency issues within a local dermatology clinic and implement targeted strategies to bolster collaboration, streamline processes, reduce wait times, augment patient volume, and enhance clinical outcomes and the quality of care. Five areas for improvement were identified: the building complex, front office, EMA system, medical assistants, and general improvements. The executed changes effectively standardized multiple processes, mitigated the potential for errors, and minimized task duration. These findings underscore the efficacy of LSS as a potent tool for enhancing efficiency and reducing waste. Efforts should be directed toward the incorporation of LSS techniques for quality improvement within healthcare systems, both internally and across interconnected entities.
精益六西格玛(LSS)方法整合了两种质量改进技术,以提高效率、减少浪费并改进组织内的流程和产品质量。虽然精益六西格玛已在各种医疗机构中得到应用,但据我们所知,目前还没有任何文献介绍其在社区皮肤科诊所中的应用。本研究旨在确定当地一家皮肤科诊所的效率问题,并实施有针对性的策略来加强合作、简化流程、减少等待时间、增加患者数量、提高临床效果和护理质量。确定了五个需要改进的领域:综合大楼、前台、EMA 系统、医疗助理和总体改进。所实施的改革有效地规范了多个流程,减少了出错的可能性,并最大限度地缩短了任务持续时间。这些发现强调了 LSS 作为提高效率和减少浪费的有效工具的功效。应努力在医疗系统内部和相互关联的实体中采用 LSS 技术来提高质量。
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引用次数: 0
期刊
SKIN The Journal of Cutaneous Medicine
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