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.
{"title":"Steatocystoma Multiplex Suppurativa Treated Successfully with Adalimumab and Topical Tofacitinib","authors":"Mariana McCune, Aaron Graff, Christina Harview, Lindsay Ackerman","doi":"10.25251/skin.8.4.22","DOIUrl":"https://doi.org/10.25251/skin.8.4.22","url":null,"abstract":"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.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141812188","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}
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.
{"title":"Significant Improvement of Persistent Hailey-Hailey Disease with Dupilumab: A Case Report","authors":"Malvika Ramesh, Brinda Chellappan, Lindy Ross","doi":"10.25251/skin.8.4.19","DOIUrl":"https://doi.org/10.25251/skin.8.4.19","url":null,"abstract":"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. ","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141812834","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}
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.
{"title":"Representation of Skin Color, Disease Severity, and Anatomic Location in Hidradenitis Suppurativa Images","authors":"D. De, Sarah Park, T. Shih, Vivian Y Shi, J. Hsiao","doi":"10.25251/skin.8.4.8","DOIUrl":"https://doi.org/10.25251/skin.8.4.8","url":null,"abstract":"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. \u0000Methods: 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. \u0000Results: 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). \u0000Discussion/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.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141812862","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}
Pub Date : 2024-07-23DOI: 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。
{"title":"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","authors":"Andrew F. Alexis, L. Kircik, Raj Chovatiya, Z. Rice, Tina Bhutani, P. Brown, Stephen C. Piscitelli, D. Rubenstein, A. Tallman, April W. Armstrong","doi":"10.25251/skin.8.supp.411","DOIUrl":"https://doi.org/10.25251/skin.8.supp.411","url":null,"abstract":"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.\u0000Objective: 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.\u0000Methods: 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).\u0000Results: 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.\u0000Conclusion: 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.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141813276","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}
Pub Date : 2024-07-23DOI: 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.
{"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":null,"pages":null},"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}
Pub Date : 2024-07-23DOI: 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.
{"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":null,"pages":null},"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}
Pub Date : 2024-07-23DOI: 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.
{"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":null,"pages":null},"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}
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.
{"title":"Dermatology Education for Medical Students: Assessing Participation Rates in Clinical Dermatology Electives","authors":"Ashima Agarwal, Lauryn M. Falcone, Emily D. Cai, Alaina J. James","doi":"10.25251/skin.8.4.9","DOIUrl":"https://doi.org/10.25251/skin.8.4.9","url":null,"abstract":"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. \u0000Methods: 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. \u0000Results: 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. \u0000Discussion: 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.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141814079","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}
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.
{"title":"Lymphocytoma Cutis - A Case Report","authors":"Grace Hingtgen, Rafael Mojica, Douglas Robins","doi":"10.25251/skin.8.3.23","DOIUrl":"https://doi.org/10.25251/skin.8.3.23","url":null,"abstract":"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. ","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140985253","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}
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.
{"title":"Application of Lean Six Sigma in Dermatology Practice","authors":"Kaycee Nguyen, Parneet Dhaliwal, Clay Cockerell","doi":"10.25251/skin.8.3.2","DOIUrl":"https://doi.org/10.25251/skin.8.3.2","url":null,"abstract":"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.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140985504","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}
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