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A Response to "Letter to the Editor Regarding 'Dupilumab Versus Lebrikizumab Demonstrates Greater Likelihood of Achieving and Maintaining Improvements in Efficacy Outcomes Using a Placebo-Adjusted Indirect Treatment Comparison'". 关于“Dupilumab与Lebrikizumab证明使用安慰剂调整的间接治疗比较更有可能实现和维持疗效结果的改善”的致编辑信的回复。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-29 DOI: 10.1007/s13555-025-01627-4
Sonja Ständer, Andreas Pinter, Firas G Hougeir, Patricia Guyot, Yingxin Xu, Amy H Praestgaard, Nick Freemantle, Ana B Rossi, Gaëlle Bégo-Le-Bagousse, Zhixiao Wang, Kerry Noonan, Mike Bastian
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引用次数: 0
Letter to the Editor Regarding "Dupilumab Versus Lebrikizumab Demonstrates Greater Likelihood of Achieving and Maintaining Improvements in Efficacy Outcomes Using a Placebo Adjusted Indirect Treatment Comparison". 关于“Dupilumab与Lebrikizumab证明使用安慰剂调整的间接治疗比较更有可能实现和维持疗效结果的改善”的致编辑的信。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-29 DOI: 10.1007/s13555-025-01622-9
Raj Chovatiya, Lucia Seminario-Vidal, Gaia Gallo, Yuxin Ding, Chao Yang, Bülent Akmaz, Laia Solé-Feu, Kim Rand
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引用次数: 0
Defining Surgical Recurrence Patterns in Hidradenitis Suppurativa: Insights from 206 Procedures and Literature Review. 定义化脓性汗腺炎的手术复发模式:来自206例手术和文献综述的见解。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-27 DOI: 10.1007/s13555-025-01623-8
Carmen García-Moronta, Francisco Javier León-Pérez, Alberto Soto-Moreno, Julia Castro-Martín, Salvador Arias-Santiago, Alejandro Molina-Leyva

Introduction: Surgical treatment is a key strategy for managing advanced hidradenitis suppurativa (HS), but postoperative recurrence remains a challenge. Understanding recurrence patterns and associated risk factors may help improve outcomes. The objectives were to evaluate surgical outcomes in patients with HS undergoing wide excision, to characterise surgical recurrence patterns, and to identify factors associated with each recurrence type.

Methods: This was a retrospective, observational, single-centre study conducted on patients who underwent HS surgical procedures between 2018 and 2024. Demographic, clinical, surgical and follow-up data were analysed. Recurrence was defined as the reappearance of inflammatory lesions within 1 cm of the surgical scar and subclassified as tunnel or abscess/inflammatory nodule (AN) recurrence.

Results: A total of 165 patients underwent 206 surgical procedures. Wide excision with secondary intention healing was the most common approach. The mean time to complete wound healing was 46.4 days. The overall recurrence rate was 18.5%, with tunnel recurrence in 8.3% and AN recurrence in 10.2%. Tunnel recurrence was associated with Hurley stage III, larger and deeper excisions and higher postoperative IHS4 scores, while AN recurrence was associated with BMI > 30 and preoperative ultrasound assessment. In multivariate analysis of overall recurrence, excised area was the only independent predictor (OR per cm2, 1.03; p = 0.020), while poorer preoperative inflammatory control and lack of ultrasound assessment showed trends toward increased risk.

Conclusion: Differentiating between recurrence types may better reflect true surgical failure. Tunnel recurrence should be prioritized when evaluating surgical outcomes. Preoperative ultrasound and postoperative inflammatory control are key factors in minimizing recurrence.

手术治疗是治疗晚期化脓性汗腺炎(HS)的关键策略,但术后复发仍然是一个挑战。了解复发模式和相关危险因素可能有助于改善预后。目的是评估接受广泛切除的HS患者的手术结果,确定手术复发模式,并确定与每种复发类型相关的因素。方法:这是一项回顾性、观察性、单中心研究,对2018年至2024年间接受HS手术的患者进行了研究。对人口学、临床、手术和随访资料进行分析。复发定义为手术瘢痕1厘米内炎性病变的再次出现,并细分为隧道或脓肿/炎性结节(AN)复发。结果:165例患者共接受206例手术。广泛切除伴二次意向愈合是最常见的方法。平均创面完全愈合时间为46.4天。总复发率为18.5%,其中隧道复发率为8.3%,AN复发率为10.2%。隧道复发与Hurley III期、更大更深的切除和更高的术后IHS4评分相关,而AN复发与BMI bbb30和术前超声评估相关。在总体复发的多因素分析中,切除面积是唯一的独立预测因子(OR / cm2, 1.03; p = 0.020),而术前较差的炎症控制和缺乏超声评估则有增加风险的趋势。结论:区分复发类型能更好地反映手术失败的真实情况。在评估手术结果时应优先考虑隧道复发。术前超声检查和术后炎症控制是减少复发的关键因素。
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引用次数: 0
Transdermal Delivery of Poly-L-Lactic Acid via Fractional Microneedle Radiofrequency for Atrophic Acne Scars: A Split-Face Randomized Study in Fitzpatrick Skin Types III to V. 通过微针射频经皮给药聚l -乳酸治疗萎缩性痤疮疤痕:一项菲茨帕特里克皮肤III至V型的裂脸随机研究
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-24 DOI: 10.1007/s13555-025-01626-5
Rosalyn Kupwiwat, Thanya Techapichetvanich, Woramate Bhorntarakcharoen, Sariya Sittiwanaruk, Jayne Bernadeth Li, Woraphong Manuskiatti

Introduction: Fractional microneedle radiofrequency (FMRF) and poly-L-lactic acid (PLLA) each promote dermal remodeling through distinct mechanisms and have demonstrated efficacy as monotherapies for atrophic acne scars (AAS). The objective of this study is to evaluate the efficacy and safety of combining FMRF with transdermal PLLA delivery compared with sterile water in Asian patients with moderate-to-severe AAS.

Methods: In this randomized, split-face, evaluator-blinded clinical trial, 24 participants underwent two monthly FMRF sessions. Immediately after each session, a reconstituted PLLA suspension was applied to one facial half for transdermal delivery through the FMRF-created microchannels, while sterile water was applied to the contralateral side. Outcomes were assessed using three-dimensional imaging (Antera® 3D), standardized photography, and patient self-assessments over a 6-month follow-up. Safety was monitored throughout the study.

Results: PLLA-treated sides demonstrated statistically significant improvements in skin texture and scar volume at 6 months compared with baseline and with control sides (p < 0.05). Patient-reported outcomes paralleled objective findings, with a higher proportion of participants reporting > 75% improvement on the PLLA-treated side. Adverse events were of low incidence, transient, self-limited, and no serious complications occurred.

Conclusions: Combining FMRF with transdermal PLLA delivery is a safe and effective approach for moderate-to-severe AAS in Asian patients. The combination produced progressive, sustained, and clinically meaningful improvements compared with FMRF alone.

Trial registration: Thai Clinical Trials Registry: TCTR20250803007.

分数微针射频(FMRF)和聚l -乳酸(PLLA)各自通过不同的机制促进皮肤重塑,并已证明作为萎缩性痤疮疤痕(AAS)的单一疗法有效。本研究的目的是评估FMRF联合经皮PLLA给药与无菌水给药在亚洲中重度AAS患者中的疗效和安全性。方法:在这项随机、裂面、评估者盲法临床试验中,24名参与者每月接受两次FMRF治疗。每次疗程结束后,将重组PLLA悬浮液应用于面部一半,通过fmrf创建的微通道透皮输送,同时将无菌水应用于对侧。在6个月的随访中,使用三维成像(Antera®3D)、标准化摄影和患者自我评估来评估结果。在整个研究过程中都对安全性进行了监测。结果:与基线和对照组相比,pla治疗侧在6个月时的皮肤质地和疤痕体积有统计学意义上的改善(pla治疗侧改善75%)。不良事件发生率低、短暂性好、自限性好,未发生严重并发症。结论:FMRF联合经皮给药是治疗亚洲中重度AAS患者安全有效的方法。与单独使用FMRF相比,联合治疗产生了进行性、持续性和有临床意义的改善。试验注册:泰国临床试验注册中心:TCTR20250803007。
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引用次数: 0
Delgocitinib Cream Reduces Itch and Pain in Moderate to Severe Chronic Hand Eczema: Phase 3 DELTA 1 and 2 Pooled Analyses. Delgocitinib霜可减轻中度至重度慢性手部湿疹的瘙痒和疼痛:3期DELTA 1和2期汇总分析
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-24 DOI: 10.1007/s13555-025-01611-y
Andrea Bauer, Marie-Louise Schuttelaar, Keith Baranowski, Ursula Plohberger, Laura Sørensen, Margitta Worm

Introduction: Itch and pain are two of the most common and burdensome symptoms for moderate to severe Chronic Hand Eczema (CHE). Here, we assess changes in itch/pain in patients with moderate to severe CHE treated with delgocitinib cream 20 mg/g or cream vehicle for 16 weeks.

Methods: In a pooled DELTA 1 (NCT04871711)/DELTA 2 (NCT04872101) analysis (delgocitinib [n = 639]; cream vehicle [n = 321]; twice-daily), the Hand Eczema Symptom Diary captured patient-reported itch/pain severity on a numeric rating scale. Changes in itch/pain from baseline were assessed daily during week 1 and weekly from week 1 to 16.

Results: In delgocitinib-treated patients, a statistically significant least square mean reduction from baseline was observed for itch from day 1 ([delgocitinib cream/cream vehicle] 0.75/0.32; P < 0.001) and pain from day 3 (0.98/0.58; P = 0.001) after the first application. Among patients with ≥ 4-point baseline itch/pain score, a significantly greater percentage of delgocitinib-treated patients achieved ≥ 4-point reduction from week 2 (14.2%/17.3%) versus cream vehicle (6.3%/6.9%; P < 0.001). Reductions were maintained up to week 16 with delgocitinib cream treatment. Delgocitinib cream was well tolerated.

Conclusion: Early onset of itch/pain reduction was observed within week 1 for delgocitinib-treated patients, thereby providing further support of the use and efficacy of delgocitinib cream in adults with moderate to severe CHE.

简介:瘙痒和疼痛是中度至重度慢性手部湿疹(CHE)最常见和最繁重的两个症状。在这里,我们评估了使用delgocitinib乳膏20mg /g或乳膏体治疗16周的中重度CHE患者瘙痒/疼痛的变化。方法:在汇总DELTA 1 (NCT04871711)/DELTA 2 (NCT04872101)分析中(delgocitinib [n = 639];霜剂[n = 321];每日两次),手部湿疹症状日记以数字评定量表记录患者报告的瘙痒/疼痛严重程度。第1周每天评估瘙痒/疼痛基线变化,第1 - 16周每周评估瘙痒/疼痛基线变化。结果:在delgocitinib治疗的患者中,从第1天开始,瘙痒的最小二乘平均值较基线降低具有统计学意义([delgocitinib乳膏/乳膏对照物]0.75/0.32;P结论:delgocitinib治疗的患者在第1周内观察到早发性瘙痒/疼痛减轻,从而进一步支持delgocitinib乳膏在中度至重度成人CHE中的使用和疗效。
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引用次数: 0
Real-World Effectiveness of Brodalumab in Challenging Psoriasis Subgroups: Insights from the PSO-TARGET Cohort. Brodalumab在挑战性银屑病亚组中的实际有效性:来自PSO-TARGET队列的见解
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-23 DOI: 10.1007/s13555-025-01629-2
Ziad Reguiai, Pierre-Dominique Ghislain, Emilie Baudier, Aurita Zraik, Thierry Boyé

Introduction: Biologic therapies have significantly improved treatment options for patients with moderate-to-severe psoriasis. Brodalumab's effectiveness, efficacy, and safety have been demonstrated in clinical trials. Real-world data are now available to confirm these outcomes in diverse populations, including those at higher risk of reduced treatment response.

Methods: This observational, prospective, multicentre study included 143 patients between 2020 and 2022. Baseline data included demographics, medical history, Psoriasis Area and Severity Index (PASI), presence of high-impact areas (HIA), Dermatology Life Quality Index (DLQI), comorbidities, and prior treatments. Follow-up visits (weeks 12-16 and 52) documented PASI, DLQI, and drug survival. The analysis focused on four potential modifiers of treatment response: body mass index (BMI), biologic treatment history, number of HIA, and age.

Results: Brodalumab demonstrated effectiveness and safety in patients with moderate-to-severe psoriasis requiring systemic therapy. Time of exposure to brodalumab was 13 months (52 weeks ± 4). At weeks 12/16, 49.6% achieved PASI 100, sustained in 61.9% at week 52. DLQI scores improved at both follow-ups, with increased proportions achieving DLQI ≤ 1. At week 52, PASI 100 and DLQI ≤ 1 were observed in 62.5% and 73.2% of patients with overweight, 48.6% and 61.8% of patients with obesity, respectively. Among older patients, 60.9% achieved PASI 100 and 65.2% reported DLQI ≤ 1. In patients with ≥ 2 HIA, 60.0% achieved PASI 100 and 68.9% experienced DLQI ≤ 1. Response was favourable across treatment history: 65.5% of bionaïve and 51.7% of bioexperienced patients achieved PASI 100; DLQI ≤ 1 was observed in 75.0% and 64.3%, respectively. Drug survival was high overall (94.6%) and across subgroups (88.3-100%). The safety profile was consistent with clinical trial data.

Conclusion: Real-world data supports brodalumab use as a valuable long-term treatment for HIA and specific subpopulations such as older, bionaïve, bioexperienced, and patients with overweight or obesity. This article is a post hoc analysis of the PSO-TARGET clinical trial (Evaluation of the Sensitivity and Specificity of a Novel Quality of Life Tool to Assess the Treatment Satisfaction in Psoriasis Patients).

Trial registration: ClinicalTrial.gov, NCT04765332.

生物疗法显著改善了中重度牛皮癣患者的治疗选择。Brodalumab的有效性、有效性和安全性已在临床试验中得到证实。现实世界的数据现在可以在不同的人群中证实这些结果,包括那些治疗反应降低风险较高的人群。方法:这项观察性、前瞻性、多中心研究在2020年至2022年期间纳入143例患者。基线数据包括人口统计学、病史、银屑病面积和严重程度指数(PASI)、高影响区(HIA)的存在、皮肤病生活质量指数(DLQI)、合并症和既往治疗。随访(12-16周和52周)记录PASI、DLQI和药物生存期。分析的重点是治疗反应的四个潜在调节因素:身体质量指数(BMI)、生物治疗史、HIA数量和年龄。结果:Brodalumab在需要全身治疗的中重度牛皮癣患者中显示出有效性和安全性。用药时间为13个月(52周±4周)。在第12/16周,49.6%达到PASI 100,在第52周维持61.9%。DLQI评分在两次随访中均有所改善,DLQI≤1的比例增加。第52周,超重患者PASI 100、DLQI≤1的比例分别为62.5%、73.2%,肥胖患者为48.6%、61.8%。在老年患者中,60.9%达到PASI 100, 65.2%报告DLQI≤1。≥2 HIA患者中,60.0% PASI达到100,68.9% DLQI≤1。整个治疗史的反应良好:65.5%的bionaïve和51.7%的生物经验患者达到PASI 100;DLQI≤1的比例分别为75.0%和64.3%。总体生存率高(94.6%),亚组生存率高(88.3-100%)。安全性与临床试验数据一致。结论:实际数据支持将brodalumab作为HIA和特定亚群(如老年人、bionaïve、有生物经验的患者和超重或肥胖患者)的有价值的长期治疗方法。本文是对PSO-TARGET临床试验的事后分析(评估一种评估银屑病患者治疗满意度的新型生活质量工具的敏感性和特异性)。试验注册:ClinicalTrial.gov, NCT04765332。
{"title":"Real-World Effectiveness of Brodalumab in Challenging Psoriasis Subgroups: Insights from the PSO-TARGET Cohort.","authors":"Ziad Reguiai, Pierre-Dominique Ghislain, Emilie Baudier, Aurita Zraik, Thierry Boyé","doi":"10.1007/s13555-025-01629-2","DOIUrl":"https://doi.org/10.1007/s13555-025-01629-2","url":null,"abstract":"<p><strong>Introduction: </strong>Biologic therapies have significantly improved treatment options for patients with moderate-to-severe psoriasis. Brodalumab's effectiveness, efficacy, and safety have been demonstrated in clinical trials. Real-world data are now available to confirm these outcomes in diverse populations, including those at higher risk of reduced treatment response.</p><p><strong>Methods: </strong>This observational, prospective, multicentre study included 143 patients between 2020 and 2022. Baseline data included demographics, medical history, Psoriasis Area and Severity Index (PASI), presence of high-impact areas (HIA), Dermatology Life Quality Index (DLQI), comorbidities, and prior treatments. Follow-up visits (weeks 12-16 and 52) documented PASI, DLQI, and drug survival. The analysis focused on four potential modifiers of treatment response: body mass index (BMI), biologic treatment history, number of HIA, and age.</p><p><strong>Results: </strong>Brodalumab demonstrated effectiveness and safety in patients with moderate-to-severe psoriasis requiring systemic therapy. Time of exposure to brodalumab was 13 months (52 weeks ± 4). At weeks 12/16, 49.6% achieved PASI 100, sustained in 61.9% at week 52. DLQI scores improved at both follow-ups, with increased proportions achieving DLQI ≤ 1. At week 52, PASI 100 and DLQI ≤ 1 were observed in 62.5% and 73.2% of patients with overweight, 48.6% and 61.8% of patients with obesity, respectively. Among older patients, 60.9% achieved PASI 100 and 65.2% reported DLQI ≤ 1. In patients with ≥ 2 HIA, 60.0% achieved PASI 100 and 68.9% experienced DLQI ≤ 1. Response was favourable across treatment history: 65.5% of bionaïve and 51.7% of bioexperienced patients achieved PASI 100; DLQI ≤ 1 was observed in 75.0% and 64.3%, respectively. Drug survival was high overall (94.6%) and across subgroups (88.3-100%). The safety profile was consistent with clinical trial data.</p><p><strong>Conclusion: </strong>Real-world data supports brodalumab use as a valuable long-term treatment for HIA and specific subpopulations such as older, bionaïve, bioexperienced, and patients with overweight or obesity. This article is a post hoc analysis of the PSO-TARGET clinical trial (Evaluation of the Sensitivity and Specificity of a Novel Quality of Life Tool to Assess the Treatment Satisfaction in Psoriasis Patients).</p><p><strong>Trial registration: </strong>ClinicalTrial.gov, NCT04765332.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145809550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Evaluation of the Efficacy of a 2-MNG-Containing Serum on Improving Skin Tone and Hyperpigmentation. 含2mg血清改善肤色和色素沉着的疗效评价。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-23 DOI: 10.1007/s13555-025-01628-3
Rui Li, Baiyu Li, Yang Chen, Huijuan Liu, Qilin Zhang, Xiaofeng He, Shuting Li, Zailing Zhu, Xiaoyin Zhou, Kungchi Hsu, Yueqing Niu, Claire Huguet, Wei Xiong, Shermine Warde, Delphine Kerob, Yijie Zheng

Introduction: Hyperpigmentation disorders and skin tone unevenness are a very frequent concern worldwide, especially in China; 2-mercaptonicotinoyl glycine (2-MNG, Melasyl®) is an innovative anti-pigmentation ingredient which binds with melanin precursors, being an alternative to tyrosinase inhibitors. Our goal was to evaluate the effects of a 2-MNG-containing serum on improving facial skin tone evenness and hyperpigmentation.

Methods: Two clinical studies were conducted in China. Clinical study 1, a randomised controlled intra-individual study, included 32 healthy individuals (individual typology angle, ITA° value within 20-41° at test back area), using a ultraviolet (UV)-induced pigmentation model. Three areas were selected and treated with either the tested serum, a positive control, or a negative control. Skin pigmentation was assessed over 4 weeks of product use, comparing the results of treated areas with the negative control. Clinical study 2, an open label study, included 42 healthy female individuals presenting at least one dark spot on their face, treated during the 56 days with the tested serum twice a day. Skin colour and melanin index were assessed over time including 7 days after discontinuation. Individual typology angle, ITA°, is a parameter for characterising human skin colour by measuring skin L*a*b* colour-space data with a skin colorimeter or a reflectance spectrophotometer. Melanin index, MI, is a parameter for characterising skin melanin content by measuring the absorption of specific wavelengths at the skin surface.

Results: The 2-MNG-containing serum can significantly improve ITA° value, MI and visual skin colour score. It also significantly improves skin brightness and reduces melanin content in facial skin and dark spots. Additionally, it offers moisturising benefits, helps improve the appearance of wrinkles and shows good tolerance.

Conclusions: The 2-MNG-containing serum reduces melanin content in the skin and leads to significant improvements on dark spots and skin brightening. It also has good tolerance and is suitable for sensitive skin.

色素沉着症和肤色不均匀是世界范围内非常常见的问题,特别是在中国;2-巯基烟碱酰甘氨酸(2-MNG, Melasyl®)是一种创新的抗色素沉着成分,与黑色素前体结合,是酪氨酸酶抑制剂的替代品。我们的目的是评估含2mg的血清对改善面部肤色均匀和色素沉着的影响。方法:在中国进行两项临床研究。临床研究1是一项随机对照个体内研究,包括32名健康个体(个体类型角,测试背部ITA°值在20-41°范围内),使用紫外线(UV)诱导的色素沉着模型。选择三个区域,用检测血清、阳性对照或阴性对照进行处理。在产品使用4周后评估皮肤色素沉着,并将处理区域的结果与阴性对照进行比较。临床研究2是一项开放标签研究,包括42名健康女性,她们的脸上至少有一个黑斑,在56天内每天两次接受测试血清治疗。随着时间的推移,包括停药后7天,评估皮肤颜色和黑色素指数。个体类型角(ITA°)是用皮肤色度计或反射分光光度计测量皮肤L*a*b*色空间数据来表征人类皮肤颜色的参数。黑色素指数(Melanin index, MI)是通过测量皮肤表面对特定波长的吸收来表征皮肤黑色素含量的参数。结果:含2- mg血清能显著改善ITA°值、MI和视觉肤色评分。它还能显著提高皮肤的亮度,减少面部皮肤的黑色素含量和黑斑。此外,它提供保湿的好处,有助于改善皱纹的外观,并表现出良好的耐受性。结论:含2- mg血清可降低皮肤黑色素含量,显著改善黑斑,提亮肤色。它也有很好的耐受性,适合敏感皮肤。
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引用次数: 0
Short-Term Efficacy of Lebrikizumab Versus Dupilumab in Combination with Topical Corticosteroids in Adults with Moderate-to-Severe Atopic Dermatitis: Matching-Adjusted Indirect Comparison. Lebrikizumab与Dupilumab联合局部皮质类固醇治疗中度至重度特应性皮炎成人的短期疗效:匹配调整间接比较
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-20 DOI: 10.1007/s13555-025-01620-x
Raj Chovatiya, April Armstrong, Leon Kircik, Lluís Puig, Mark G Kirchhof, Tiago Torres, Yousef Binamer, Gleison Duarte, Bülent Akmaz, Martin Dossenbach, Gaia Gallo, Chao Yang, Lucia Seminario-Vidal, Yuxin Ding, Jonathan I Silverberg

Introduction: A matching-adjusted indirect comparison evaluated the short-term efficacy of lebrikizumab plus topical corticosteroids (TCS) versus dupilumab plus TCS in adults with moderate-to-severe atopic dermatitis (AD).

Methods: Individual patient data from the ADhere trial (lebrikizumab 250 mg every 2 weeks [Q2W] plus TCS) and aggregate data from the CHRONOS trial (dupilumab 300 mg Q2W plus TCS) were matched using the method of moments approach to adjust baseline differences. Matching was done at the study level (primary analysis) and at the study arm level (sensitivity analysis). Efficacy endpoints up to week 16 included the proportion of patients achieving an Investigator's Global Assessment of 0 or 1 (IGA 0/1); a ≥ 50%, ≥ 75%, and ≥ 90% improvement from baseline in the Eczema Area and Severity Index (EASI 50/75/90); a ≥ 4-point improvement from baseline in the Pruritus Numerical Rating Scale score (PNRS ≥ 4); and a ≥ 4-point improvement from baseline in the Dermatology Life Quality Index score (DLQI ≥ 4). Placebo-adjusted efficacy outcomes were compared using odds ratios (ORs), risk ratios (RRs), and risk differences (RDs) with 95% confidence intervals (CIs).

Results: At week 16, lebrikizumab plus TCS had comparable odds to dupilumab plus TCS of achieving EASI 75 (OR 1.14, 95% CI 0.42-3.09), IGA 0/1 (OR 1.39, 95% CI 0.42-4.59), PNRS ≥ 4 (OR 0.48, 95% CI 0.17-1.37), and DLQI ≥ 4 (OR 0.89, 95% CI 0.29-2.69). At earlier timepoints, lebrikizumab plus TCS had comparable odds to dupilumab plus TCS of achieving PNRS ≥ 4 at week 2 (OR 2.04, 95% CI 0.24-17.05) and week 4 (OR 3.59, 95% CI 0.90-14.36). RR and RD estimates were consistent with OR estimates of efficacy. Sensitivity analyses confirmed the findings of the primary analysis.

Conclusion: Lebrikizumab plus TCS was comparable to dupilumab plus TCS across all efficacy endpoints at week 16.

一项匹配调整的间接比较评估了lebrikizumab加局部皮质类固醇(TCS)与dupilumab加TCS治疗中度至重度特应性皮炎(AD)成人的短期疗效。方法:采用矩量法对来自粘附试验(lebrikizumab 250 mg每2周[Q2W] + TCS)的个体患者数据和来自CHRONOS试验(dupilumab 300 mg Q2W + TCS)的汇总数据进行匹配,以调整基线差异。在研究水平(初步分析)和研究臂水平(敏感性分析)进行匹配。截至第16周的疗效终点包括达到研究者总体评估0或1 (IGA 0/1)的患者比例;湿疹面积和严重程度指数(EASI 50/75/90)较基线改善≥50%、≥75%和≥90%;瘙痒症数值评定量表评分(PNRS≥4)较基线改善≥4分;皮肤科生活质量指数评分(DLQI≥4)较基线改善≥4分。采用95%置信区间(ci)的优势比(ORs)、风险比(RRs)和风险差异(RDs)对安慰剂调整后的疗效结果进行比较。结果:在第16周,lebrikizumab加TCS与dupilumab加TCS相比,达到EASI 75 (OR 1.14, 95% CI 0.42-3.09)、IGA 0/1 (OR 1.39, 95% CI 0.42-4.59)、PNRS≥4 (OR 0.48, 95% CI 0.17-1.37)和DLQI≥4 (OR 0.89, 95% CI 0.29-2.69)的几率相当。在较早的时间点,lebrikizumab + TCS与dupilumab + TCS在第2周(OR 2.04, 95% CI 0.24-17.05)和第4周(OR 3.59, 95% CI 0.90-14.36)达到PNRS≥4的几率相当。RR和RD估计值与OR估计值一致。敏感性分析证实了初步分析的结果。结论:在第16周的所有疗效终点上,Lebrikizumab加TCS与dupilumab加TCS相当。
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引用次数: 0
Real-World Treatment Patterns of Patients with Basal Cell Carcinoma Using Sonidegib and Vismodegib: Discontinuation Rates and Clinical Conditions During Treatment. 基底细胞癌患者使用Sonidegib和Vismodegib的真实世界治疗模式:停药率和治疗期间的临床状况。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-20 DOI: 10.1007/s13555-025-01621-w
Mark G Lebwohl, Darrell S Rigel, Zeynep Eroglu, Victoria E Barghout, Deepshekhar Gupta, Enrico Zanardo, Lynn Huynh, Mihran A Yenikomshian, Nicholas Squittieri, Thomas J Ferro, Kunal Patel

Introduction: Sonidegib and vismodegib are Hedgehog pathway inhibitors (HHIs) approved for the treatment of locally advanced basal cell carcinoma (laBCC), as well as metastatic basal cell carcinoma (mBCC) for vismodegib. Few studies have compared real-world treatment patterns associated with HHI treatment. The objective of this study was to investigate the real-world treatment patterns and conditions of patients receiving HHIs for BCC.

Methods: In this longitudinal study, claims from the Komodo Health Claims Database (between 2016 and 2023) were used to identify patients. Baseline characteristics and comorbidities of patients were assessed. Time to treatment discontinuation (TTD), odds of discontinuation, and clinical conditions experienced during treatment were analyzed.

Results: Patients who received sonidegib remained on treatment longer than those on vismodegib (log-rank test; P = 0.041) and were 23% less likely (P = 0.036) and 32% less likely (P = 0.013) to discontinue treatment at 6 and 9 months, respectively. Sonidegib-treated patients were less likely to experience gastrointestinal-related conditions (33% less likely; P = 0.045), taste- and smell-related conditions (71% less likely; P = 0.048), and muscle spasms (52% less likely; P = 0.009) during treatment compared with patients who received vismodegib.

Conclusion: In the real-world setting, sonidegib-treated patients remained on treatment longer than vismodegib-treated patients and were less likely to experience pharmacologically relevant clinical conditions.

Sonidegib和vismodegib是被批准用于治疗局部晚期基底细胞癌(laBCC)和转移性基底细胞癌(mBCC)的Hedgehog途径抑制剂(HHIs)。很少有研究比较现实世界中与艾滋病治疗相关的治疗模式。本研究的目的是调查现实世界中接受HHIs治疗BCC患者的治疗模式和情况。方法:在这项纵向研究中,使用Komodo健康声明数据库(2016年至2023年)中的声明来识别患者。评估患者的基线特征和合并症。分析停药时间(TTD)、停药几率和治疗期间的临床情况。结果:接受sonidegib治疗的患者比接受vismodegib治疗的患者持续治疗的时间更长(log-rank检验;P = 0.041),并且在6个月和9个月时停止治疗的可能性分别降低23% (P = 0.036)和32% (P = 0.013)。与接受vismodegib治疗的患者相比,接受sonidegib治疗的患者在治疗期间出现胃肠道相关疾病(33%的可能性降低,P = 0.045)、味觉和嗅觉相关疾病(71%的可能性降低,P = 0.048)和肌肉痉挛(52%的可能性降低,P = 0.009)的可能性较低。结论:在现实环境中,sonidegib治疗的患者比vismodegib治疗的患者持续治疗的时间更长,并且更不可能出现药理学相关的临床症状。
{"title":"Real-World Treatment Patterns of Patients with Basal Cell Carcinoma Using Sonidegib and Vismodegib: Discontinuation Rates and Clinical Conditions During Treatment.","authors":"Mark G Lebwohl, Darrell S Rigel, Zeynep Eroglu, Victoria E Barghout, Deepshekhar Gupta, Enrico Zanardo, Lynn Huynh, Mihran A Yenikomshian, Nicholas Squittieri, Thomas J Ferro, Kunal Patel","doi":"10.1007/s13555-025-01621-w","DOIUrl":"https://doi.org/10.1007/s13555-025-01621-w","url":null,"abstract":"<p><strong>Introduction: </strong>Sonidegib and vismodegib are Hedgehog pathway inhibitors (HHIs) approved for the treatment of locally advanced basal cell carcinoma (laBCC), as well as metastatic basal cell carcinoma (mBCC) for vismodegib. Few studies have compared real-world treatment patterns associated with HHI treatment. The objective of this study was to investigate the real-world treatment patterns and conditions of patients receiving HHIs for BCC.</p><p><strong>Methods: </strong>In this longitudinal study, claims from the Komodo Health Claims Database (between 2016 and 2023) were used to identify patients. Baseline characteristics and comorbidities of patients were assessed. Time to treatment discontinuation (TTD), odds of discontinuation, and clinical conditions experienced during treatment were analyzed.</p><p><strong>Results: </strong>Patients who received sonidegib remained on treatment longer than those on vismodegib (log-rank test; P = 0.041) and were 23% less likely (P = 0.036) and 32% less likely (P = 0.013) to discontinue treatment at 6 and 9 months, respectively. Sonidegib-treated patients were less likely to experience gastrointestinal-related conditions (33% less likely; P = 0.045), taste- and smell-related conditions (71% less likely; P = 0.048), and muscle spasms (52% less likely; P = 0.009) during treatment compared with patients who received vismodegib.</p><p><strong>Conclusion: </strong>In the real-world setting, sonidegib-treated patients remained on treatment longer than vismodegib-treated patients and were less likely to experience pharmacologically relevant clinical conditions.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145793471","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Establishment of the Kenyan Psoriasis Registry: A Case-Control Cohort. 肯尼亚牛皮癣登记的建立:一个病例对照队列。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-20 DOI: 10.1007/s13555-025-01598-6
Georgia Marquez-Grap, Petronilla Biwott, Miranda Chen, Gian Carlo Baldonado, Andrea Leung, Allison Kranyak, Isabel Muraguri, Toby Maurer, Wilson Liao, Samson Kiprono

Introduction: Psoriasis is a chronic inflammatory skin disease with a global prevalence of 1-5%, however its clinical and demographic profile in Kenya remains underexplored. This article describes the establishment of the Kenyan Psoriasis Registry at Moi Teaching and Referral Hospital in Eldoret, Kenya.

Methods: 214 subjects were enrolled between October 2024 and August 2025 at Moi Teaching and Referral Hospital. Both healthy controls and patients with psoriasis completed enrollment surveys and physical exams, and donated saliva samples.

Results: The initial cohort of 214 subjects (108 patients with psoriasis, 106 healthy controls) provides valuable insights into the demographics, clinical profiles, quality of life, and mental health characteristics of patients with psoriasis in Kenya. The mean age of psoriasis onset was 30.4 years, and mean age of diagnosis by a medical provider was 38.9 years old. 13.9% of patients with psoriasis reported a positive family history of psoriasis, and 9.3% of patients with psoriasis reported a diagnosis of psoriatic arthritis. The mean psoriasis area and severity index was 9.9 and mean Investigator Global assessment score was 3.0. Examination of treatment patterns revealed that moisturizers, prescription topical medications, and methotrexate were commonly tried while only 9.3% of individuals had ever received a biologic therapy. Patients with psoriasis reported significantly worse sleep disturbance, quality of life, and mental health compared to healthy controls.

Conclusion: This data highlights the unique characteristics of patients with psoriasis in Kenya. The Kenyan Psoriasis Registry continues to enroll patients and conduct yearly follow-ups, aiming to deepen the understanding of psoriasis in this population. These findings underscore the need for targeted research and advocacy to improve psoriasis care in Kenya.

银屑病是一种慢性炎症性皮肤病,全球患病率为1-5%,但其在肯尼亚的临床和人口统计学特征仍未得到充分研究。这篇文章描述了在肯尼亚埃尔多雷特的Moi教学和转诊医院建立肯尼亚牛皮癣登记处。方法:于2024年10月至2025年8月在莫伊教学与转诊医院招募214名受试者。健康对照组和牛皮癣患者都完成了登记调查和体检,并捐献了唾液样本。结果:214名受试者(108名牛皮癣患者,106名健康对照)的初始队列为肯尼亚牛皮癣患者的人口统计学、临床概况、生活质量和心理健康特征提供了有价值的见解。牛皮癣发病的平均年龄为30.4岁,被医疗提供者诊断的平均年龄为38.9岁。13.9%的银屑病患者报告有银屑病家族史,9.3%的银屑病患者报告诊断为银屑病关节炎。平均牛皮癣面积和严重程度指数为9.9,平均调查员全球评估评分为3.0。对治疗模式的检查显示,通常使用润肤霜、处方局部药物和甲氨蝶呤,而只有9.3%的人接受过生物治疗。与健康对照组相比,牛皮癣患者报告的睡眠障碍、生活质量和心理健康状况明显更差。结论:该数据突出了肯尼亚银屑病患者的独特特征。肯尼亚牛皮癣登记处继续招募患者并进行年度随访,旨在加深对该人群牛皮癣的了解。这些发现强调需要进行有针对性的研究和宣传,以改善肯尼亚的牛皮癣护理。
{"title":"Establishment of the Kenyan Psoriasis Registry: A Case-Control Cohort.","authors":"Georgia Marquez-Grap, Petronilla Biwott, Miranda Chen, Gian Carlo Baldonado, Andrea Leung, Allison Kranyak, Isabel Muraguri, Toby Maurer, Wilson Liao, Samson Kiprono","doi":"10.1007/s13555-025-01598-6","DOIUrl":"https://doi.org/10.1007/s13555-025-01598-6","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis is a chronic inflammatory skin disease with a global prevalence of 1-5%, however its clinical and demographic profile in Kenya remains underexplored. This article describes the establishment of the Kenyan Psoriasis Registry at Moi Teaching and Referral Hospital in Eldoret, Kenya.</p><p><strong>Methods: </strong>214 subjects were enrolled between October 2024 and August 2025 at Moi Teaching and Referral Hospital. Both healthy controls and patients with psoriasis completed enrollment surveys and physical exams, and donated saliva samples.</p><p><strong>Results: </strong>The initial cohort of 214 subjects (108 patients with psoriasis, 106 healthy controls) provides valuable insights into the demographics, clinical profiles, quality of life, and mental health characteristics of patients with psoriasis in Kenya. The mean age of psoriasis onset was 30.4 years, and mean age of diagnosis by a medical provider was 38.9 years old. 13.9% of patients with psoriasis reported a positive family history of psoriasis, and 9.3% of patients with psoriasis reported a diagnosis of psoriatic arthritis. The mean psoriasis area and severity index was 9.9 and mean Investigator Global assessment score was 3.0. Examination of treatment patterns revealed that moisturizers, prescription topical medications, and methotrexate were commonly tried while only 9.3% of individuals had ever received a biologic therapy. Patients with psoriasis reported significantly worse sleep disturbance, quality of life, and mental health compared to healthy controls.</p><p><strong>Conclusion: </strong>This data highlights the unique characteristics of patients with psoriasis in Kenya. The Kenyan Psoriasis Registry continues to enroll patients and conduct yearly follow-ups, aiming to deepen the understanding of psoriasis in this population. These findings underscore the need for targeted research and advocacy to improve psoriasis care in Kenya.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145793493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
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Dermatology and Therapy
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