SkinPub Date : 2023-11-13DOI: 10.25251/skin.7.supp.279
Eric Simpson, Gil Yosipovitch, Kilian Eyerich, Delphine Staumont-Sallé, Mona Shahriari, Gaia Gallo, Eric Wolf, Evangeline Pierce, Chunyuan Liu, Jinglin Zhong, Helena Agell, Marjolein De Bruin-Weller
{"title":"Lebrikizumab Provides Rapid Response in EASI Components and Itch in Moderate-to-Severe Atopic Dermatitis","authors":"Eric Simpson, Gil Yosipovitch, Kilian Eyerich, Delphine Staumont-Sallé, Mona Shahriari, Gaia Gallo, Eric Wolf, Evangeline Pierce, Chunyuan Liu, Jinglin Zhong, Helena Agell, Marjolein De Bruin-Weller","doi":"10.25251/skin.7.supp.279","DOIUrl":"https://doi.org/10.25251/skin.7.supp.279","url":null,"abstract":"","PeriodicalId":86868,"journal":{"name":"Skin","volume":"19 3","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136281699","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}
SkinPub Date : 2023-11-13DOI: 10.25251/skin.7.supp.297
Arash Mostaghimi, Melissa Piliang, Charles Lynde, Jacek C. Szepietowski, Jakub P. Jedynak, Najwa Somani, Na Lu, Guanglei Yu, Chiara Chiasserini, Maria Hordinsky
{"title":"Baricitinib Treatment Increases Eyebrow and Eyelash Regrowth Up to 52 Weeks","authors":"Arash Mostaghimi, Melissa Piliang, Charles Lynde, Jacek C. Szepietowski, Jakub P. Jedynak, Najwa Somani, Na Lu, Guanglei Yu, Chiara Chiasserini, Maria Hordinsky","doi":"10.25251/skin.7.supp.297","DOIUrl":"https://doi.org/10.25251/skin.7.supp.297","url":null,"abstract":"","PeriodicalId":86868,"journal":{"name":"Skin","volume":"16 7","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136281550","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}
SkinPub Date : 2023-11-13DOI: 10.25251/skin.7.supp.266
Peter Prieto
{"title":"Using 31-Gene Expression Profile Testing to Help Guide Adjuvant Therapy and Sentinel Lymph Node Biopsy Discussions with Patients: A Case Series ","authors":"Peter Prieto","doi":"10.25251/skin.7.supp.266","DOIUrl":"https://doi.org/10.25251/skin.7.supp.266","url":null,"abstract":"","PeriodicalId":86868,"journal":{"name":"Skin","volume":"18 3","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136281536","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}
SkinPub Date : 2023-11-13DOI: 10.25251/skin.7.supp.249
Andrew Ostor, Michael Chen, Byron Padilla, Cuiyong Yue, Huzefa Photowala, Jonathon Rocco, Joseph Merola
{"title":"Maintenance of Response to Risankizumab in Patients With Psoriatic Arthritis: A 3-year Analysis of the KEEPsAKE 1 and 2 Trials","authors":"Andrew Ostor, Michael Chen, Byron Padilla, Cuiyong Yue, Huzefa Photowala, Jonathon Rocco, Joseph Merola","doi":"10.25251/skin.7.supp.249","DOIUrl":"https://doi.org/10.25251/skin.7.supp.249","url":null,"abstract":"Introduction: Risankizumab, a humanized immunoglobulin G1 monoclonal antibody, specifically inhibits the p19 subunit of human interleukin 23 and is approved for treatment of active psoriatic arthritis (PsA) in adults. This post hoc analysis evaluated the long-term maintenance of clinical response through ~3 years of risankizumab treatment using data from 2 ongoing phase 3 trials, KEEPsAKE 1 and KEEPsAKE 2.
 Methods: Eligible patients had active PsA with inadequate response or intolerance to ≥1 conventional synthetic disease modifying antirheumatic drugs (KEEPsAKE 1 [NCT03675308]; KEEPsAKE 2 [NCT03671148]) and/or inadequate response or intolerance to 1–2 biologic therapies (KEEPsAKE 2 only). Patients received double-blinded risankizumab 150 mg or placebo at weeks 0, 4, and 16 and open-label risankizumab 150 mg every 12 weeks thereafter. This analysis includes patients who received continuous risankizumab through both treatment periods. Assessments included improvement of ≥20%/50%/70% in PsA symptoms using American College of Rheumatology criteria (ACR20/50/70), achievement of minimal disease activity (MDA), reduction of ≥90% in Psoriasis Area and Severity Index (PASI 90; in patients with ≥3% body surface area affected by psoriasis at baseline), and clinically meaningful reduction in pain (≥10 mm on a visual analog scale [VAS]). Maintenance of response analyses were based on patients who were responders at weeks 24 or 52 for each endpoint. Nonresponder imputation incorporating multiple imputation (NRI-MI) for missing data due to COVID-19 or geopolitical conflict was used. As-observed data were also reported.
 Results: Among patients receiving continuous risankizumab, ACR20 was achieved at week 24 in 267/454 (KEEPsAKE 1, 58.8%) and 111/208 (KEEPsAKE 2, 53.4%) patients (as observed). Maintenance of response in week 24 ACR20 responders (NRI-MI) was achieved for ACR20 by most patients at week 52 (KEEPsAKE 1, 89.1%; KEEPsAKE 2, 77.0 %) and week 148 (KEEPsAKE 1, 74.7%; KEEPsAKE 2; 68.5%). Similar patterns of maintenance of response were observed for ACR50 and ACR70. Week 24 responders also maintained MDA at weeks 52 (KEEPsAKE 1, 82.2%; KEEPsAKE 2, 66.7%) and 148 (KEEPsAKE 1, 77.1%; KEEPsAKE 2, 71.9%). The PASI 90 response was maintained at weeks 52 (KEEPsAKE 1, 86.6%; KEEPsAKE 2, 88.4%) and 148 (KEEPsAKE 1, 76.3%; KEEPsAKE 2, 81.2%). Week 24 responders maintained clinically meaningful reductions in pain VAS at weeks 52 (KEEPsAKE 1, 83.9%; KEEPsAKE 2, 74.4%) and 148 (KEEPsAKE 1, 75.0%; KEEPsAKE 2, 72.0%). Comparable maintenance of response was recorded at week 148 for each endpoint among week 52 responders (NRI-MI).
 Conclusion: Risankizumab demonstrated durable long-term efficacy in patients with active PsA. A high proportion of patients receiving continuous risankizumab treatment in KEEPsAKE 1 and KEEPsAKE 2 achieved responses in ACR20/50/70, MDA, PASI 90, or pain VAS at weeks 24 or 52 and maintained responses through week 148.","PeriodicalId":86868,"journal":{"name":"Skin","volume":"18 10","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136281704","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}
SkinPub Date : 2023-11-13DOI: 10.25251/skin.7.supp.268
Lisa Goberdhan, Katie Schneider, Arielle Bautista, Elizabeth Makino, Rahul Mehta
{"title":"Aesthetic Efficacy of a Novel Topical Combination Brightening Regimen to Treat Facial Hyperpigmentation","authors":"Lisa Goberdhan, Katie Schneider, Arielle Bautista, Elizabeth Makino, Rahul Mehta","doi":"10.25251/skin.7.supp.268","DOIUrl":"https://doi.org/10.25251/skin.7.supp.268","url":null,"abstract":"Purpose: Hyperpigmentation is a multifaceted condition that is often challenging to treat. Due to this complexity, a combination therapy providing a holistic approach of removal and prevention of pigmentation has shown greater efficacy than a monotherapy treatment. A clinical usage study was conducted to assess the cosmetic changes of a combination take-home skincare topical regimen of a novel brightening platform in subjects with mild to severe facial hyperpigmentation.
 Procedure: Participants received a take-home multimodal brightening skincare regimen (EC Regimen) that consisted of twice-daily use of EC brightening Pads and EC serum, and once-daily evening use of EC spot cream. Clinical Efficacy and tolerability assessments, and participant self-assessments of facial skin appearance were conducted.
 Results: Nineteen participants aged 31-69 years, with Fitzpatrick Skin Types I-IV, who self-identified their ethnicity as Asian, White, American Indian, and Hispanic, were included in the study. The EC Regimen provided statistically significant improvements as early as week 1 in Dark Spot Severity and Dark Spot Contrast grades with continued significant improvements through week 12 versus baseline (p<0.01). There were significant improvements in Overall Hyperpigmentation and the validated Modified Melasma Area and Severity Index scores as early as week 2 with continued significant improvements through week 12 versus baseline (p<0.03). Additionally, improvements in a variety of photoaging concerns such as Overall Photodamage, Tactile Roughness, Skin Tone Evenness, Fine and Coarse Lines/Wrinkles and Radiance were observed at all time points.
 The EC Regimen was highly rated by participants with an overall satisfaction of 94% by week 12. At week 12, participants stated that EC Regimen “faded the dark spots that I have had for more than 5 years” (89%), “helped prevent new dark spots” (94%), and “improved my most stubborn spots that bother me the most” (89%). At week 12, EC Regimen improved quality-of-life parameters and participants stated that EC Regimen “makes me feel happier with how I look” (83%) and “makes me more confident” (83%). EC Regimen was well-tolerated as tolerability assessments remained mild for the duration of the study.
 Conclusions: Combination therapy of EC Regimen provides a well-tolerated, effective treatment for multiple hyperpigmentation and photoaging parameters with high patient satisfaction.","PeriodicalId":86868,"journal":{"name":"Skin","volume":"68 11","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136281847","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}
SkinPub Date : 2023-11-13DOI: 10.25251/skin.7.6.23
Erica Mark, Stephany Vittitow, Alina Zufall, Joseph Nguyen, Richard Flowers
{"title":"Methotrexate Monitoring in Dermatology: A Follow-Up Retrospective Cohort Study","authors":"Erica Mark, Stephany Vittitow, Alina Zufall, Joseph Nguyen, Richard Flowers","doi":"10.25251/skin.7.6.23","DOIUrl":"https://doi.org/10.25251/skin.7.6.23","url":null,"abstract":"Introduction: There have been no large-scale studies looking at the efficacy and safety of methotrexate. Prior research by our team investigated whether certain monitoring practices were associated with lab abnormalities resulting in clinically relevant events (CREs) within the first 90 days of methotrexate treatment and concluded that dermatologists may consider postponing lab monitoring until 15 days after methotrexate initiation in patients without concerning baseline disease. This follow-up study was performed to determine when within the first 90 days of treatment CREs were most likely to occur and to define the specific numeric values at which abnormal labs resulted in a CRE.
 Methods: The medical records of 243 dermatology patients were retrospectively reviewed.
 Results: Week 11 had the highest percentage of CREs (11.1%, p=0.00003), with slight peaks at weeks 2 and 5. ALT (22%) and AST (27%) were the most commonly abnormal labs, and elevated ALT (p=0.00087) and AST (p=0.03) values were significantly higher in CREs.
 Discussion: This data suggests that lab frequency can be reduced within the first few months; optimal timing of lab draws may be around weeks 2-5 and 11-12. In summary, we found that 1) abnormal labs most frequently led to a CRE at week 11 of monitoring, 2) ALT and AST were the most frequently abnormal labs, and 3) abnormal ALT and AST values were significantly higher in patients with CREs. This study provides valuable insight into an understudied dermatologic topic and hopefully will inform clinicians regarding methotrexate laboratory monitoring and spur further investigation.","PeriodicalId":86868,"journal":{"name":"Skin","volume":"68 6","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136281852","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}
SkinPub Date : 2023-11-13DOI: 10.25251/skin.7.supp.286
Afsaneh Alavi, Errol Prens, Alexa Kimball, James Krueger, Sutirtha Mukhopadhyay, Hui Wang, Nathalie Ivanhoff, Ana Cristina Hernandez, Christos Zouboulis
{"title":"Spesolimab for Hidradenitis Suppurativa: A Proof-of-Concept Study","authors":"Afsaneh Alavi, Errol Prens, Alexa Kimball, James Krueger, Sutirtha Mukhopadhyay, Hui Wang, Nathalie Ivanhoff, Ana Cristina Hernandez, Christos Zouboulis","doi":"10.25251/skin.7.supp.286","DOIUrl":"https://doi.org/10.25251/skin.7.supp.286","url":null,"abstract":"Introduction: Hidradenitis suppurativa (HS) is a chronic, inflammatory disorder characterized by painful inflammatory nodules (N), abscesses (A) and draining tunnels (dT), primarily affecting intertriginous areas. Interleukin-36 (IL-36) signaling has been notably expressed within HS inflammatory lesions. To address the need for targeted therapies, this Phase IIa proof-of-clinical-concept (PoCC) study (NCT04762277) explored the effect of spesolimab, an anti-IL-36 receptor monoclonal antibody, in patients with moderate-to-severe HS.
 Methods: Eligible patients (N=52) were randomized (2:1) to receive spesolimab or placebo (1200 mg intravenous dosing once weekly for three weeks [loading dose], followed by 1200 mg subcutaneous dosing every 2 weeks for 12 weeks). No formal statistical tests were performed, as this was an exploratory study. Of patients who completed the study, 45 were enrolled in an ongoing open-label extension (OLE) study (NCT04876391) with spesolimab. For each study, endpoints included change from baseline at Weeks 12 and 24 in total A, N and dT (ANdT) counts, and adverse events (AEs).
 Results: Mean changes from baseline at Week 12 in dT, A and total ANdT counts were -1.30, -0.53 and -4.87 in the spesolimab arm, and 1.07, 3.07 and -0.86 in the placebo arm, respectively. Mean changes in N count were numerically similar between the spesolimab (-3.00) and placebo (-5.00) arms. Of patients with ≥1 dT at baseline, a numerically greater proportion had a decrease in dT count at Week 12 in the spesolimab (16/24, 66.7%) versus the placebo (5/13, 38.5%) arm. Least squares mean changes from baseline in total AN count at Week 12 were -38.8% and -34.7% in the spesolimab and placebo arms, respectively, which may have been affected by higher baseline AN and N counts in the spesolimab versus placebo arm. In the OLE, patients originally randomized to spesolimab (n=30) achieved sustained reductions in dT count and in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 24. The safety profile of spesolimab was similar to that reported in other trials; among the 52 patients enrolled in the PoCC study, 77.8% (spesolimab) and 87.5% (placebo) of patients reported ≥1 AE. No patients receiving spesolimab reported serious AEs, and no new safety concerns were identified by Week 24. No deaths were reported.
 Conclusion: Our findings show that spesolimab was well tolerated and decreased all HS lesions. These results support the development of spesolimab in HS.
 This study was supported and funded by Boehringer Ingelheim.","PeriodicalId":86868,"journal":{"name":"Skin","volume":"3 3","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136282289","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}
SkinPub Date : 2023-11-13DOI: 10.25251/skin.7.supp.247
Kenneth Gordon, Curdin Conrad, Mark Lebwohl, Jonathan Barker, Tsen-Fang Tsai, Joseph Merola, Curdin Conrad, Min Zheng, Na Hu, Patrick Hofmann, Christian Thoma, Kilian Eyerich
{"title":"Effect of Spesolimab on Achieving Sustained Disease Remission in Patients with Generalized Pustular Psoriasis: Results from the Effisayil 2 Study","authors":"Kenneth Gordon, Curdin Conrad, Mark Lebwohl, Jonathan Barker, Tsen-Fang Tsai, Joseph Merola, Curdin Conrad, Min Zheng, Na Hu, Patrick Hofmann, Christian Thoma, Kilian Eyerich","doi":"10.25251/skin.7.supp.247","DOIUrl":"https://doi.org/10.25251/skin.7.supp.247","url":null,"abstract":"Introduction: Generalized pustular psoriasis (GPP) is a chronic, rare and potentially life-threatening disease characterized by flares of widespread skin pustulation. Sustained skin clearance is a key treatment objective. Intravenous (IV) spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is approved for GPP flare treatment; however, the optimal dosing and long-term efficacy of subcutaneous (SC) spesolimab treatment in patients with GPP has not yet been reported. We report the effect of SC spesolimab on achieving sustained disease remission over 48 weeks in Effisayil 2 (NCT04399837), a trial that evaluated the efficacy and safety of SC spesolimab in preventing GPP flares.
 Methods: Patients with a history of GPP were randomized (1:1:1:1) to receive placebo (n=31), low- (n=31, 300 mg loading dose [LD]; 150 mg every 12 weeks [q12w]), medium- (n=31, 600 mg LD; 300 mg q12w) or high-dose (n=30, 600 mg LD; 300 mg every 4 weeks [q4w]) SC spesolimab over 48 weeks. Sustained remission was defined as GPP Physician Global Assessment (GPPGA) total score of 0 or 1 at all visits up to Week 48, or GPPGA total score of 0 or 1 and all GPPGA subscores ≤2 at all visits up to Week 48. Sustained pustular clearance was defined as GPPGA pustulation subscore of 0 at all visits from Week 4 to Week 48. Any use of IV spesolimab or another standard of care for GPP worsening was considered a failure of remission. Missing data were imputed by a sequential logistic regression multiple imputation method. Adjusted risk differences (RD) were calculated by the Mantel−Haenszel type-weighted average of differences.
 Results: 31 patients received placebo, and 30 patients received high-dose spesolimab. Compared to placebo, more patients had sustained remission in the high-dose arm using both GPPGA total score 0 or 1 (63.3% vs 29.0%; RD [95% CI] 0.35 [0.10–0.59]), and GPPGA total score 0 or 1 and all GPPGA subscores ≤2 (60.4% vs 29.0%; RD [95% CI] 0.32 [0.07–0.56]). Compared to placebo, more patients in the high-dose arm had sustained pustular clearance over 48 weeks (63.6% vs 25.8%; RD [95% CI] 0.38 [0.14–0.62]).
 Conclusion: Overall, high-dose SC spesolimab q4w is effective for the long-term management of GPP skin symptoms.","PeriodicalId":86868,"journal":{"name":"Skin","volume":"69 18","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136282298","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}
SkinPub Date : 2023-11-13DOI: 10.25251/skin.7.supp.285
Nisha Hazra, Steven R. Feldman, Annie Guerin, Marjolaine Gauthier-Loiselle, Ami J Claxton, Yan Meng, Kirsten Gallant, Sanjeev Balu
{"title":"Clinical Burden and Impairment in Moderate-to-Severe Atopic Dermatitis","authors":"Nisha Hazra, Steven R. Feldman, Annie Guerin, Marjolaine Gauthier-Loiselle, Ami J Claxton, Yan Meng, Kirsten Gallant, Sanjeev Balu","doi":"10.25251/skin.7.supp.285","DOIUrl":"https://doi.org/10.25251/skin.7.supp.285","url":null,"abstract":"","PeriodicalId":86868,"journal":{"name":"Skin","volume":"54 4","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136283064","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}