Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.391
Shanna Miranti
Introduction: Acne vulgaris is a common dermatologic disorder that may require treatment over months or years. Acne negatively impacts quality of life, and acne of any severity increases the risk of long-term sequelae such as scarring. Common treatments for severe/nodulocystic acne include oral isotretinoin, an oral antibiotic combined with a topical (benzoyl peroxide or a retinoid), an oral combined contraceptive, or oral spironolactone (females). Though oral antibiotics and isotretinoin are not recommended for long-term use, there is scarce guidance or published research on maintenance therapy. Topical retinoids—a mainstay of initial acne treatment—may be prescribed for maintenance once initial oral treatments are complete. Additionally, some retinoids such as tretinoin and tazarotene are indicated for the treatment of fine wrinkles and certain pigmentation disorders, and some studies have shown that adapalene and tazarotene may also reduce acne-induced scarring. Tazarotene 0.045% polymeric emulsion lotion is a well-tolerated retinoid that has demonstrated efficacy in acne treatment and may reduce acne-induced post-inflammatory hyperpigmentation (PIH) and melasma. Further, tazarotene lotion provides rapid and sustained improvements in skin barrier function/moisturization. Herein is presented a report of patients with acne who received maintenance treatment with topical tazarotene 0.045% lotion after an initial course of oral isotretinoin. Methods: Patients with severe recalcitrant acne vulgaris were treated with once daily oral isotretinoin for at least 20 weeks until deemed clinically clear. All patients received 40 mg isotretinoin once daily for the first 30 days. The dosage was then increased to 1 mg/kg of bodyweight (treatment naïve) or 1.5 mg/kg (repeat treatment). After 20 weeks, patients who achieved clinically clear skin initiated once-daily topical tazarotene 0.045% lotion monotherapy on the day of their last isotretinoin dose. Follow up visits occurred at 6 months and 1-year post-isotretinoin treatment. Results: Patients (n=12) had a mean age of 17.8 years (standard deviation [SD]: 3.8) and the majority were female (58.3%) and White (66.7%). Oral isotretinoin was used for an average of 24.3 weeks (SD: 6.7), with a mean cumulative dose of 184.6 mg/kg. One patient required a repeat course of isotretinoin prior to tazarotene initiation. Post-isotretinoin, patients received tazarotene 0.045% lotion for an average of 13.0 months (SD: 6.7). No patients relapsed and all showed subjective visual improvements in acne-related scarring with tazarotene maintenance treatment. None discontinued tazarotene lotion due to adverse events. Conclusions: There is little guidance or research published on acne maintenance treatment after initial oral isotretinoin or other treatments are complete. Topical tazarotene 0.045% polymeric emulsion lotion has previously demonstrated good efficacy, safety, and tolerability with acne and PIH reductions in patient
{"title":"Maintenance Acne Treatment With Topical Tazarotene after Oral Isotretinoin: Overview and Case Reports","authors":"Shanna Miranti","doi":"10.25251/skin.8.supp.391","DOIUrl":"https://doi.org/10.25251/skin.8.supp.391","url":null,"abstract":"Introduction: Acne vulgaris is a common dermatologic disorder that may require treatment over months or years. Acne negatively impacts quality of life, and acne of any severity increases the risk of long-term sequelae such as scarring. Common treatments for severe/nodulocystic acne include oral isotretinoin, an oral antibiotic combined with a topical (benzoyl peroxide or a retinoid), an oral combined contraceptive, or oral spironolactone (females). Though oral antibiotics and isotretinoin are not recommended for long-term use, there is scarce guidance or published research on maintenance therapy. Topical retinoids—a mainstay of initial acne treatment—may be prescribed for maintenance once initial oral treatments are complete. Additionally, some retinoids such as tretinoin and tazarotene are indicated for the treatment of fine wrinkles and certain pigmentation disorders, and some studies have shown that adapalene and tazarotene may also reduce acne-induced scarring. Tazarotene 0.045% polymeric emulsion lotion is a well-tolerated retinoid that has demonstrated efficacy in acne treatment and may reduce acne-induced post-inflammatory hyperpigmentation (PIH) and melasma. Further, tazarotene lotion provides rapid and sustained improvements in skin barrier function/moisturization. Herein is presented a report of patients with acne who received maintenance treatment with topical tazarotene 0.045% lotion after an initial course of oral isotretinoin. \u0000Methods: Patients with severe recalcitrant acne vulgaris were treated with once daily oral isotretinoin for at least 20 weeks until deemed clinically clear. All patients received 40 mg isotretinoin once daily for the first 30 days. The dosage was then increased to 1 mg/kg of bodyweight (treatment naïve) or 1.5 mg/kg (repeat treatment). After 20 weeks, patients who achieved clinically clear skin initiated once-daily topical tazarotene 0.045% lotion monotherapy on the day of their last isotretinoin dose. Follow up visits occurred at 6 months and 1-year post-isotretinoin treatment. \u0000Results: Patients (n=12) had a mean age of 17.8 years (standard deviation [SD]: 3.8) and the majority were female (58.3%) and White (66.7%). Oral isotretinoin was used for an average of 24.3 weeks (SD: 6.7), with a mean cumulative dose of 184.6 mg/kg. One patient required a repeat course of isotretinoin prior to tazarotene initiation. Post-isotretinoin, patients received tazarotene 0.045% lotion for an average of 13.0 months (SD: 6.7). No patients relapsed and all showed subjective visual improvements in acne-related scarring with tazarotene maintenance treatment. None discontinued tazarotene lotion due to adverse events. \u0000Conclusions: There is little guidance or research published on acne maintenance treatment after initial oral isotretinoin or other treatments are complete. Topical tazarotene 0.045% polymeric emulsion lotion has previously demonstrated good efficacy, safety, and tolerability with acne and PIH reductions in patient","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140234090","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}
Hannah McCowan, M. Olivet, Ruthie McTighe, Vinayak Nahar, Thy Huynh
{"title":"Nevus Sebaceous: A Midline Verrucous Lesion on a Neonate","authors":"Hannah McCowan, M. Olivet, Ruthie McTighe, Vinayak Nahar, Thy Huynh","doi":"10.25251/skin.8.2.25","DOIUrl":"https://doi.org/10.25251/skin.8.2.25","url":null,"abstract":"","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140389618","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}
Dowling-Degos Disease (DDD) is an inherited cutaneous disease which presents with classic and atypical cutaneous findings, including macules of hyperpigmentation and hypopigmentation in the flexural creases. A variant, termed Galli-Galli Disease (GGD), presents similarly, with the distinguishing feature of acantholysis on histology. Reports of GGD in the literature are rare, due to the infrequency of the diagnosis. This may contribute to a lack of available information and delayed diagnosis, which can result in a frustrating clinical course for patients. We present a female patient who presented with complaints of a burning sensation and painful rash for the last three years on a background of hypopigmented and hyperpigmented macules on the trunk, upper extremities and flexural creases. Comprehensive dermatopathological evaluation and clinical correlates led to the diagnosis of GGD.
{"title":"Galli Galli Disease: A Challenging Diagnosis in a Bahraini Female Patient","authors":"M. Dirr, Aysha Almedfa, Fatema Khamdan","doi":"10.25251/skin.8.2.18","DOIUrl":"https://doi.org/10.25251/skin.8.2.18","url":null,"abstract":"Dowling-Degos Disease (DDD) is an inherited cutaneous disease which presents with classic and atypical cutaneous findings, including macules of hyperpigmentation and hypopigmentation in the flexural creases. A variant, termed Galli-Galli Disease (GGD), presents similarly, with the distinguishing feature of acantholysis on histology. Reports of GGD in the literature are rare, due to the infrequency of the diagnosis. This may contribute to a lack of available information and delayed diagnosis, which can result in a frustrating clinical course for patients. We present a female patient who presented with complaints of a burning sensation and painful rash for the last three years on a background of hypopigmented and hyperpigmented macules on the trunk, upper extremities and flexural creases. Comprehensive dermatopathological evaluation and clinical correlates led to the diagnosis of GGD.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140231923","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}
Hannah Mumber, Jimmy Lam, Lynne Goldberg, Christina Lam
{"title":"Retiform Plaques: An Additional Diagnostic Consideration","authors":"Hannah Mumber, Jimmy Lam, Lynne Goldberg, Christina Lam","doi":"10.25251/skin.8.2.20","DOIUrl":"https://doi.org/10.25251/skin.8.2.20","url":null,"abstract":"","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140232482","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}
Background Scabies, a contagious skin infestation caused by Sarcoptes scabiei, is a significant public health concern [1]. Traditional surveillance methods for scabies suffer from time lag and incomplete data, hindering early detection and response [5]. The widespread use of the internet and search engines, such as GoogleTM, offer new opportunities for alternative surveillance approaches. Objective This study aimed to explore the association between scabies search volumes on Google TrendsTM (GTs) and scabies incidence at the state level across the United States. Methods GTs data for each U.S. state and scabies incidence from 2011 to 2019 were analyzed for summary statistics and association. Results The mean Spearman correlation coefficient for the period of 2011-2019 indicated a strong positive correlation between GTs RSVs for “scabies” and the incidence of scabies in the United States. Using an unpaired t-test, this correlation was found to be statistically significant. Conclusions In resource-scarce environments where access to care is a common barrier, healthcare providers and departments can leverage this information to effectively target populations and employ resources for scabies prevention and treatment. Analyzing search engine term patterns can enhance our understanding of people's behavior when they suspect a scabies infestation.
{"title":"The Association Between Internet Search Patterns and Scabies Incidence Across the United States","authors":"Kennedy Sparling, Pooja Dhupati","doi":"10.25251/skin.8.2.19","DOIUrl":"https://doi.org/10.25251/skin.8.2.19","url":null,"abstract":"Background \u0000Scabies, a contagious skin infestation caused by Sarcoptes scabiei, is a significant public health concern [1]. Traditional surveillance methods for scabies suffer from time lag and incomplete data, hindering early detection and response [5]. The widespread use of the internet and search engines, such as GoogleTM, offer new opportunities for alternative surveillance approaches. \u0000Objective \u0000This study aimed to explore the association between scabies search volumes on Google TrendsTM (GTs) and scabies incidence at the state level across the United States. \u0000Methods \u0000GTs data for each U.S. state and scabies incidence from 2011 to 2019 were analyzed for summary statistics and association. \u0000Results \u0000The mean Spearman correlation coefficient for the period of 2011-2019 indicated a strong positive correlation between GTs RSVs for “scabies” and the incidence of scabies in the United States. Using an unpaired t-test, this correlation was found to be statistically significant. \u0000Conclusions \u0000In resource-scarce environments where access to care is a common barrier, healthcare providers and departments can leverage this information to effectively target populations and employ resources for scabies prevention and treatment. Analyzing search engine term patterns can enhance our understanding of people's behavior when they suspect a scabies infestation.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140233010","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 : 2024-03-18DOI: 10.25251/skin.8.supp.400
Bela Pandit, Boni Elewski, Tracey C Vlahovic
Introduction: Females are more likely than males to seek help or treatment for onychomycosis and are more likely to camouflage affected nails with nail polish. Between 2016 and 2022, over half of prescriptions for topical efinaconazole 10% solution were written for females, suggesting that there may be particular interest in the interaction between nail polish use concurrent with efinaconazole treatment for onychomycosis. Methods: Review in vitro data on effects of nail polish on nail penetration of efinaconazole 10% solution and clinical studies on the impact of nail polish use on efficacy of topical efinaconazole in the treatment of toenail onychomycosis. Results: Only 4 small studies have assessed interactions between efinaconazole 10% solution and concurrent nail polish use. In vitro, penetration of efinaconazole 10% solution through cadaverous human nails coated with traditional nail polish was similar to penetration through uncoated nails. In a 1-year clinical study, once-daily efinaconazole treatment for 48 weeks was associated with improvements in onychomycosis severity and clear toenail growth that were similar for participants who used traditional nail polish and those who did not use nail polish. In a second, 6-month clinical study, participants received once-daily efinaconazole treatment concurrent with monthly gel nail polish pedicures. After 6 months, 100% of participants tested negative for fungal infection (mycological cure) and all participants experienced visible improvements in their treated toenails. In clinical and in vitro studies, efinaconazole application was associated with degradation of traditional nail polish texture and appearance as well as color transfer to the applicator and unused medication. In contrast, efinaconazole did not affect the duration, quality, or texture of gel nail polish. Conclusions: Application of nail polish did not prevent penetration of efinaconazole 10% solution through human nails or its successful use in the treatment of toenail onychomycosis. Further, efinaconazole did not impact the texture or appearance of gel-polished nails. To our knowledge, these findings represent the only available data on topical treatment of toenail onychomycosis with concurrent nail polish use, and may be of particular importance when selecting treatment options for female patients with onychomycosis. Funding: Ortho Dermatologics
{"title":"Concealing Meets Healing in the Treatment of Toenail Onychomycosis: A Review of Concurrent Nail Polish Use With Topical Efinaconazole 10% Solution","authors":"Bela Pandit, Boni Elewski, Tracey C Vlahovic","doi":"10.25251/skin.8.supp.400","DOIUrl":"https://doi.org/10.25251/skin.8.supp.400","url":null,"abstract":"Introduction: Females are more likely than males to seek help or treatment for onychomycosis and are more likely to camouflage affected nails with nail polish. Between 2016 and 2022, over half of prescriptions for topical efinaconazole 10% solution were written for females, suggesting that there may be particular interest in the interaction between nail polish use concurrent with efinaconazole treatment for onychomycosis. \u0000Methods: Review in vitro data on effects of nail polish on nail penetration of efinaconazole 10% solution and clinical studies on the impact of nail polish use on efficacy of topical efinaconazole in the treatment of toenail onychomycosis. \u0000Results: Only 4 small studies have assessed interactions between efinaconazole 10% solution and concurrent nail polish use. In vitro, penetration of efinaconazole 10% solution through cadaverous human nails coated with traditional nail polish was similar to penetration through uncoated nails. In a 1-year clinical study, once-daily efinaconazole treatment for 48 weeks was associated with improvements in onychomycosis severity and clear toenail growth that were similar for participants who used traditional nail polish and those who did not use nail polish. In a second, 6-month clinical study, participants received once-daily efinaconazole treatment concurrent with monthly gel nail polish pedicures. After 6 months, 100% of participants tested negative for fungal infection (mycological cure) and all participants experienced visible improvements in their treated toenails. In clinical and in vitro studies, efinaconazole application was associated with degradation of traditional nail polish texture and appearance as well as color transfer to the applicator and unused medication. In contrast, efinaconazole did not affect the duration, quality, or texture of gel nail polish. \u0000Conclusions: Application of nail polish did not prevent penetration of efinaconazole 10% solution through human nails or its successful use in the treatment of toenail onychomycosis. Further, efinaconazole did not impact the texture or appearance of gel-polished nails. To our knowledge, these findings represent the only available data on topical treatment of toenail onychomycosis with concurrent nail polish use, and may be of particular importance when selecting treatment options for female patients with onychomycosis. \u0000Funding: Ortho Dermatologics","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140233233","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}
Chronic generalized pruritus without a primary skin lesion presents a dilemma for clinicians. A minority can be attributed to systemic diseases. Iron deficiency anemia (IDA) presents one such poorly defined cause. We comprehensively review the literature to support IDA pruritus as a valid etiology in the patient with chronic, generalized pruritus. Several studies and case reports describe the association of pruritus and IDA, and more importantly, resolution of the pruritus upon iron supplementation, strongly suggesting IDA as the primary etiology. Thus, we recommend obtaining a CBC and iron studies in all cases of chronic generalized pruritus without a primary lesion. Based on currently available evidence, we also present novel mechanisms of actions in which iron deficiency may precipitate pruritus that have not been proposed in the literature. Iron deficiency may precipitate pruritus at the level of the skin through decreased skin thickness, elasticity, or barrier function, thereby promoting xerosis. Iron deficiency may also cause neurologic pruritus from damage, compression, or irritation of nerves. The levels of known chemical mediators of itch, such as serotonin, opioids, and neurotrophins, are also affected by iron homeostasis. IDA pruritus likely manifests from a complex interplay of multiple proposed pathways.
没有原发性皮肤病变的慢性全身性瘙痒症给临床医生带来了难题。少数可归因于全身性疾病。缺铁性贫血（IDA）就是其中一种定义不清的病因。我们全面回顾了相关文献，以支持将缺铁性贫血瘙痒症作为慢性全身性瘙痒症患者的有效病因。一些研究和病例报告描述了瘙痒症与 IDA 的关联，更重要的是，瘙痒症在补充铁剂后得到缓解，这强烈表明 IDA 是主要病因。因此，我们建议对所有无原发病变的慢性全身性瘙痒症病例进行全血细胞计数和铁测定。根据现有证据，我们还提出了文献中未提出的缺铁可能诱发瘙痒症的新作用机制。缺铁可能会导致皮肤厚度、弹性或屏障功能下降，从而促进皮肤干燥，从而引起皮肤瘙痒。缺铁还可能因神经受损、受压或受刺激而引起神经性瘙痒。已知的瘙痒化学介质（如血清素、类阿片和神经营养素）的水平也会受到铁平衡的影响。IDA瘙痒症可能是多种拟议途径复杂相互作用的结果。
{"title":"Iron Deficiency Anemia Pruritus: A Review with Proposed Mechanisms of Action","authors":"Christopher N. Nguyen, Monica M. Li","doi":"10.25251/skin.8.2.2","DOIUrl":"https://doi.org/10.25251/skin.8.2.2","url":null,"abstract":"Chronic generalized pruritus without a primary skin lesion presents a dilemma for clinicians. A minority can be attributed to systemic diseases. Iron deficiency anemia (IDA) presents one such poorly defined cause. We comprehensively review the literature to support IDA pruritus as a valid etiology in the patient with chronic, generalized pruritus. Several studies and case reports describe the association of pruritus and IDA, and more importantly, resolution of the pruritus upon iron supplementation, strongly suggesting IDA as the primary etiology. Thus, we recommend obtaining a CBC and iron studies in all cases of chronic generalized pruritus without a primary lesion.\u0000Based on currently available evidence, we also present novel mechanisms of actions in which iron deficiency may precipitate pruritus that have not been proposed in the literature. Iron deficiency may precipitate pruritus at the level of the skin through decreased skin thickness, elasticity, or barrier function, thereby promoting xerosis. Iron deficiency may also cause neurologic pruritus from damage, compression, or irritation of nerves. The levels of known chemical mediators of itch, such as serotonin, opioids, and neurotrophins, are also affected by iron homeostasis. IDA pruritus likely manifests from a complex interplay of multiple proposed pathways.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140233722","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 : 2024-03-18DOI: 10.25251/skin.8.supp.394
Melissa Piliang, J. Soung, B. King, Jerry Shapiro, Lidia Rudnicka, Paul Farrant, Nina Magnolo, Bianca Piraccini, Xin Luo, Deborah Woodworth, G. Schaefer, A. Lejeune, Robert Wolk
Introduction: Ritlecitinib demonstrated efficacy and safety to Week 48 in patients aged ≥12 years with alopecia areata (AA) in ALLEGRO-2b/3 (NCT03732807). ALLEGRO-LT (NCT04006457) is an ongoing, phase 3, open-label study investigating the long-term safety and efficacy of ritlecitinib in AA. We report updated interim efficacy results of ritlecitinib up to Month 24 from ALLEGRO-2b/3 and ALLEGRO-LT. Methods: Patients aged ≥12 years with AA and ≥50% scalp hair loss who rolled-over to ALLEGRO-LT from ALLEGRO-2b/3 were included. Data are reported for patients who received: 1) daily ritlecitinib 50-mg with a 4-week 200-mg daily loading dose (“200/50-mg”); 2) daily ritlecitinib 50-mg with no loading dose (“50-mg”). Outcomes include the proportions of patients with response (based on Severity of Alopecia Tool [SALT] score ≤20, SALT ≤10, and Patients’ Global Impression of Change [PGI-C] score of “moderately improved” or “greatly improved”) through Month 24, and the proportions of patients sustaining SALT ≤20 response from Month 12 through Month 24. Observed and imputed (modified last observation carried forward [mLOCF]) data, to account for missing values, are reported (data cutoff: December 9, 2022). Results: The 200/50-mg and 50-mg groups included 194 and 191 patients; 127 (65.5%) and 111 (58.1%) were ongoing at the data cutoff. SALT ≤20 response rates in the 200/50-mg and 50-mg groups increased from Month 12 (45.9% and 45.1% [observed]; 41.8% and 40.3% [mLOCF]) to Month 24 (63.1% and 60.8% [observed]; 50.8% and 46.1% [mLOCF]). SALT ≤10 response rates increased between Months 12 and 24 for the 200/50-mg group (39.4% to 51.1% [observed]; 35.6% to 40.9% [mLOCF]) and 50-mg group (34.2% to 50.8% [observed]; 30.9% to 37.7% [mLOCF]). Of SALT ≤20 responders at Month 12, 92.8% (200/50-mg) and 79.7% (50-mg) (observed) sustained this response through Month 24. PGI-C response rates were maintained from Month 12 (200/50-mg: 69.4% [observed], 65.3% [mLOCF]; 50-mg: 61.6% [observed], 57.7% [mLOCF]) to Month 24 (200/50-mg: 76.4% [observed], 65.4% [mLOCF]; 50-mg: 70.0% [observed], 56.6% [mLOCF]). Conclusion: Ritlecitinib 50-mg (with or without a 200-mg loading dose) demonstrated clinically meaningful and sustained clinician- and patient-reported efficacy through Month 24, which supports its long-term use in patients aged ≥12 years with severe AA.
{"title":"Long-Term Efficacy of Ritlecitinib up to Month 24 From the ALLEGRO Phase 2b/3 and Long-Term Phase 3 Clinical Studies in Alopecia Areata","authors":"Melissa Piliang, J. Soung, B. King, Jerry Shapiro, Lidia Rudnicka, Paul Farrant, Nina Magnolo, Bianca Piraccini, Xin Luo, Deborah Woodworth, G. Schaefer, A. Lejeune, Robert Wolk","doi":"10.25251/skin.8.supp.394","DOIUrl":"https://doi.org/10.25251/skin.8.supp.394","url":null,"abstract":"Introduction: Ritlecitinib demonstrated efficacy and safety to Week 48 in patients aged ≥12 years with alopecia areata (AA) in ALLEGRO-2b/3 (NCT03732807). ALLEGRO-LT (NCT04006457) is an ongoing, phase 3, open-label study investigating the long-term safety and efficacy of ritlecitinib in AA. We report updated interim efficacy results of ritlecitinib up to Month 24 from ALLEGRO-2b/3 and ALLEGRO-LT. \u0000Methods: Patients aged ≥12 years with AA and ≥50% scalp hair loss who rolled-over to ALLEGRO-LT from ALLEGRO-2b/3 were included. Data are reported for patients who received: 1) daily ritlecitinib 50-mg with a 4-week 200-mg daily loading dose (“200/50-mg”); 2) daily ritlecitinib 50-mg with no loading dose (“50-mg”). Outcomes include the proportions of patients with response (based on Severity of Alopecia Tool [SALT] score ≤20, SALT ≤10, and Patients’ Global Impression of Change [PGI-C] score of “moderately improved” or “greatly improved”) through Month 24, and the proportions of patients sustaining SALT ≤20 response from Month 12 through Month 24. Observed and imputed (modified last observation carried forward [mLOCF]) data, to account for missing values, are reported (data cutoff: December 9, 2022). \u0000Results: The 200/50-mg and 50-mg groups included 194 and 191 patients; 127 (65.5%) and 111 (58.1%) were ongoing at the data cutoff. SALT ≤20 response rates in the 200/50-mg and 50-mg groups increased from Month 12 (45.9% and 45.1% [observed]; 41.8% and 40.3% [mLOCF]) to Month 24 (63.1% and 60.8% [observed]; 50.8% and 46.1% [mLOCF]). SALT ≤10 response rates increased between Months 12 and 24 for the 200/50-mg group (39.4% to 51.1% [observed]; 35.6% to 40.9% [mLOCF]) and 50-mg group (34.2% to 50.8% [observed]; 30.9% to 37.7% [mLOCF]). Of SALT ≤20 responders at Month 12, 92.8% (200/50-mg) and 79.7% (50-mg) (observed) sustained this response through Month 24. PGI-C response rates were maintained from Month 12 (200/50-mg: 69.4% [observed], 65.3% [mLOCF]; 50-mg: 61.6% [observed], 57.7% [mLOCF]) to Month 24 (200/50-mg: 76.4% [observed], 65.4% [mLOCF]; 50-mg: 70.0% [observed], 56.6% [mLOCF]). \u0000Conclusion: Ritlecitinib 50-mg (with or without a 200-mg loading dose) demonstrated clinically meaningful and sustained clinician- and patient-reported efficacy through Month 24, which supports its long-term use in patients aged ≥12 years with severe AA.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140234063","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 : 2024-03-18DOI: 10.25251/skin.8.supp.377
Andreas Wollenberg, M. Cork, Chih-ho Hong, A. Kurbasic, Emilia Vacko, Amy S. Paller
Introduction: The ECZTRA 6 trial showed that tralokinumab 300mg provided progressive and sustained efficacy in adolescent patients with moderate-to-severe AD, and was well tolerated with a reassuring long-term safety profile over 52 weeks. Objective: To evaluate EASI response and PROs in adolescents from ECZTRA 6 treated with tralokinumab 300mg for the full 52-week treatment period. Methods: Patients were randomized to tralokinumab 300mg Q2W (n=97) or placebo (n=94) for 16 weeks. At Week 16, patients initiated on tralokinumab and achieving primary endpoints (IGA 0/1 and/or EASI-75) without rescue were re-randomized to tralokinumab 300mg Q2/4W monotherapy for 36 additional weeks; other patients were switched to open-label tralokinumab 300mg Q2W plus optional topical corticosteroids. Post-hoc analyses were conducted by pooling Week 16–52 data for all patients initially randomized to tralokinumab 300mg Q2W. Results: Greater proportions of tralokinumab- vs placebo-treated patients achieved primary endpoints at Week 16; progressive improvement was seen through Week 52. In addition, pruritus NRS score was improved for a greater proportion of tralokinumab- vs placebo-treated patients from baseline to Week 16, with further improvement up to Week 52. Progressive improvements over time were also observed for proportions of patients with reductions of pruritus NRS ≥4, POEM ≥4, and CDLQI ≥6, from baseline. The safety profile was consistent with prolonged treatment following Week 16. Conclusions: At Week 16, tralokinumab 300mg Q2W improved EASI and PROs in adolescents with AD, with progressive and sustained improvement seen up to Week 52.
{"title":"Progressive and Sustained Disease Control in Patients with Atopic Dermatitis (AD) Aged 12–17 Years Treated with Tralokinumab for 52 Weeks","authors":"Andreas Wollenberg, M. Cork, Chih-ho Hong, A. Kurbasic, Emilia Vacko, Amy S. Paller","doi":"10.25251/skin.8.supp.377","DOIUrl":"https://doi.org/10.25251/skin.8.supp.377","url":null,"abstract":"Introduction: The ECZTRA 6 trial showed that tralokinumab 300mg provided progressive and sustained efficacy in adolescent patients with moderate-to-severe AD, and was well tolerated with a reassuring long-term safety profile over 52 weeks.\u0000Objective: To evaluate EASI response and PROs in adolescents from ECZTRA 6 treated with tralokinumab 300mg for the full 52-week treatment period.\u0000Methods: Patients were randomized to tralokinumab 300mg Q2W (n=97) or placebo (n=94) for 16 weeks. At Week 16, patients initiated on tralokinumab and achieving primary endpoints (IGA 0/1 and/or EASI-75) without rescue were re-randomized to tralokinumab 300mg Q2/4W monotherapy for 36 additional weeks; other patients were switched to open-label tralokinumab 300mg Q2W plus optional topical corticosteroids. Post-hoc analyses were conducted by pooling Week 16–52 data for all patients initially randomized to tralokinumab 300mg Q2W.\u0000 Results: Greater proportions of tralokinumab- vs placebo-treated patients achieved primary endpoints at Week 16; progressive improvement was seen through Week 52. In addition, pruritus NRS score was improved for a greater proportion of tralokinumab- vs placebo-treated patients from baseline to Week 16, with further improvement up to Week 52. Progressive improvements over time were also observed for proportions of patients with reductions of pruritus NRS ≥4, POEM ≥4, and CDLQI ≥6, from baseline. The safety profile was consistent with prolonged treatment following Week 16.\u0000 Conclusions: At Week 16, tralokinumab 300mg Q2W improved EASI and PROs in adolescents with AD, with progressive and sustained improvement seen up to Week 52.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140234356","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}
J. Young, Anna Eversman, D. Poplausky, Yamato Suemitsu, G. Niedt, Matthew Galsky, Joseph Sparano, Nicholas Gulati
{"title":"A Case of Hand-Foot Skin Reaction-like Eruption Associated with Pembrolizumab","authors":"J. Young, Anna Eversman, D. Poplausky, Yamato Suemitsu, G. Niedt, Matthew Galsky, Joseph Sparano, Nicholas Gulati","doi":"10.25251/skin.8.2.21","DOIUrl":"https://doi.org/10.25251/skin.8.2.21","url":null,"abstract":"","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140234410","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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