Pub Date : 2024-07-23DOI: 10.25251/skin.8.supp.416
L. Kircik, Z. Draelos, Michael Gold, Neil Sadick, Neal Bhatia
Introduction: Combination therapies targeting multiple processes of acne pathogenesis are recommended for most acne patients. A three-pronged approach using an antibiotic, retinoid, and antibacterial may also increase treatment efficacy versus monotherapy or dual-combination products. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (BPO) polymeric mesh gel (CAB) is the first fixed-dose, triple-combination topical approved by the FDA for the treatment of acne. The objective of this analysis was to compare treatment success and effect size of once-daily CAB with its three constituent dyad gels, branded adapalene 0.3%/BPO 2.5% gel, and vehicle across four clinical studies. Methods: Two phase 2 (NCT03170388, NCT04892706) and two phase 3 (NCT04214652, NCT04214639) double-blind, randomized, 12-week studies enrolled participants with moderate-to-severe acne. In all studies, treatment success at week 12 (defined as a ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) was a co-primary endpoint. Other co-primary endpoints (reduction from baseline in inflammatory and noninflammatory lesions) are not shown here. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. A post hoc analysis of number needed to treat (NNT)—the number of patients who need to be treated with an intervention for one additional patient to achieve success versus vehicle—was performed to provide an additional measure of treatment effect and to indirectly compare data across studies. Results: Across studies, approximately half of CAB-treated participants achieved treatment success by week 12 (range: 49.6-52.5%) versus less than one-fourth with vehicle (range: 8.1%-24.9%; P<0.01, all) and less than one-third with component dyads or branded adapalene 0.3%/BPO 2.5% (range: 27.8%-32.9%; P≤0.001, all). Treatment success rates were significantly greater for all active treatments versus vehicle (P<0.01, all). NNT values for CAB (3-5) were lower (better) than for constituent dyads (5-6) or branded adapalene 0.3%/BPO 2.5% (7), further indicative of greater efficacy. TEAEs with CAB were mostly of mild-to-moderate severity. TEAE and discontinuation rates were similar or lower with CAB gel than with adapalene/BPO dyad gels. Mean cutaneous safety/tolerability scores with CAB gel were <1 (mild) at all timepoints. Conclusions: CAB gel demonstrated significantly greater efficacy in the treatment of moderate-to-severe acne than dyad gels and branded adapalene 0.3%/BPO 2.5% gel, with approximately half of participants achieving clear/almost clear skin by 12 weeks with CAB. Due to acne pathogenesis, a triple-combination treatment may result in clinical success more often than two-ingredient combination products. Funding: Ortho Dermatologics.
{"title":"Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: Comparison of 4 Clinical Trials","authors":"L. Kircik, Z. Draelos, Michael Gold, Neil Sadick, Neal Bhatia","doi":"10.25251/skin.8.supp.416","DOIUrl":"https://doi.org/10.25251/skin.8.supp.416","url":null,"abstract":"Introduction: Combination therapies targeting multiple processes of acne pathogenesis are recommended for most acne patients. A three-pronged approach using an antibiotic, retinoid, and antibacterial may also increase treatment efficacy versus monotherapy or dual-combination products. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (BPO) polymeric mesh gel (CAB) is the first fixed-dose, triple-combination topical approved by the FDA for the treatment of acne. The objective of this analysis was to compare treatment success and effect size of once-daily CAB with its three constituent dyad gels, branded adapalene 0.3%/BPO 2.5% gel, and vehicle across four clinical studies. \u0000Methods: Two phase 2 (NCT03170388, NCT04892706) and two phase 3 (NCT04214652, NCT04214639) double-blind, randomized, 12-week studies enrolled participants with moderate-to-severe acne. In all studies, treatment success at week 12 (defined as a ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) was a co-primary endpoint. Other co-primary endpoints (reduction from baseline in inflammatory and noninflammatory lesions) are not shown here. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. A post hoc analysis of number needed to treat (NNT)—the number of patients who need to be treated with an intervention for one additional patient to achieve success versus vehicle—was performed to provide an additional measure of treatment effect and to indirectly compare data across studies. \u0000Results: Across studies, approximately half of CAB-treated participants achieved treatment success by week 12 (range: 49.6-52.5%) versus less than one-fourth with vehicle (range: 8.1%-24.9%; P<0.01, all) and less than one-third with component dyads or branded adapalene 0.3%/BPO 2.5% (range: 27.8%-32.9%; P≤0.001, all). Treatment success rates were significantly greater for all active treatments versus vehicle (P<0.01, all). NNT values for CAB (3-5) were lower (better) than for constituent dyads (5-6) or branded adapalene 0.3%/BPO 2.5% (7), further indicative of greater efficacy. TEAEs with CAB were mostly of mild-to-moderate severity. TEAE and discontinuation rates were similar or lower with CAB gel than with adapalene/BPO dyad gels. Mean cutaneous safety/tolerability scores with CAB gel were <1 (mild) at all timepoints. \u0000Conclusions: CAB gel demonstrated significantly greater efficacy in the treatment of moderate-to-severe acne than dyad gels and branded adapalene 0.3%/BPO 2.5% gel, with approximately half of participants achieving clear/almost clear skin by 12 weeks with CAB. Due to acne pathogenesis, a triple-combination treatment may result in clinical success more often than two-ingredient combination products. \u0000Funding: Ortho Dermatologics.","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":"141812019","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}
Discoid lupus erythematosus (DLE) is the most common subtype of chronic cutaneous lupus erythematosus (CLE) that may present with or without systemic lupus erythematosus (SLE). Treatment for DLE remains limited, as there are no medications specifically approved to treat DLE. Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is currently being studied for adults with moderate-to-severe discoid and/or subacute CLE. We report a case of successful treatment of refractory DLE with deucravacitinib. A 65-year-old female with a longstanding history of systemic lupus erythematosus presented with prominent discoid lesions involving the nose, cheeks, and mid upper cutaneous lip. Having tried topical medications, multiple courses of systemic steroids were attempted, but the patient flared shortly after the tapers. Despite the patient experiencing some improvement on mycophenolate mofetil and prednisone, the decision to switch to deucravacitinib was made due to the patient developing multiple infections while on the former regimen. Three months after starting deucravacitinib, the patient returned with their skin completely clear. A better understanding of the molecular pathogenesis of CLE is informing the development of more targeted therapeutic strategies. TYK2 and Janus Kinases (JAKs) both mediate the signaling of cytokines, some of which play a role in the pathogenesis of SLE. Deucravacitinib binds to TYK2 at the regulatory domain, which is unique to its respective kinase unlike conventional Janus Kinase (JAK) inhibitors that bind to the active domain conserved across all JAKs. Deucravacitinib offers more targeted inhibition with a potentially improved safety profile compared to conventional JAK inhibitors.
{"title":"Successful Treatment of Refractory Discoid Lupus Erythematosus with Deucravacitinib","authors":"Alice Sohn, Nicole Bouché, G. Lewitt, E. Song","doi":"10.25251/skin.8.4.18","DOIUrl":"https://doi.org/10.25251/skin.8.4.18","url":null,"abstract":"Discoid lupus erythematosus (DLE) is the most common subtype of chronic cutaneous lupus erythematosus (CLE) that may present with or without systemic lupus erythematosus (SLE). Treatment for DLE remains limited, as there are no medications specifically approved to treat DLE. Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is currently being studied for adults with moderate-to-severe discoid and/or subacute CLE. We report a case of successful treatment of refractory DLE with deucravacitinib. \u0000A 65-year-old female with a longstanding history of systemic lupus erythematosus presented with prominent discoid lesions involving the nose, cheeks, and mid upper cutaneous lip. Having tried topical medications, multiple courses of systemic steroids were attempted, but the patient flared shortly after the tapers. Despite the patient experiencing some improvement on mycophenolate mofetil and prednisone, the decision to switch to deucravacitinib was made due to the patient developing multiple infections while on the former regimen. Three months after starting deucravacitinib, the patient returned with their skin completely clear. \u0000A better understanding of the molecular pathogenesis of CLE is informing the development of more targeted therapeutic strategies. TYK2 and Janus Kinases (JAKs) both mediate the signaling of cytokines, some of which play a role in the pathogenesis of SLE. Deucravacitinib binds to TYK2 at the regulatory domain, which is unique to its respective kinase unlike conventional Janus Kinase (JAK) inhibitors that bind to the active domain conserved across all JAKs. Deucravacitinib offers more targeted inhibition with a potentially improved safety profile compared to conventional JAK inhibitors.","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":"141812946","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}
M. Roohaninasab, M. Nilforoushzadeh, Zahra Ebrahimi, A. Goodarzi, Abolfazl Abouei, E. Ziaeifar, Sona Zare, Maryam Nouri, Samaneh Mozafarpoor
Background: Melasma is a chronic, acquired, focal pigment disorder showing symmetrical hyperpigmentation or hypermelanosis of photo-exposed areas on the face. Tranexamic acid (TXA) is a treatment for melasma. The regression of melasma after platelet-rich plasma (PRP) treatment is an interesting finding. Objectives: To evaluate the effect of PRP plus microneedling vs. tranexamic acid plus microneedling on the quality of melasma. Methods: This is a left-right split-face comparison study with 18 patients with melasma. The patients underwent four sessions of PRP plus microneedling and tranexamic acid (5%) plus microneedling on right and left sides of the face, respectively, at monthly intervals. Evaluations were performed before the start of treatment and one month after the last treatment session. Results: Totally, 20 female patients with melasma were included with a mean age of 41 years (range: 34-49 years). Five participants had Fitzpatrick phototype II, eleven had phototype III, and others had phototype IV skin. Both TXA + microneedling and PRP + micro-needling caused a significant reduction in the Tewameter measurement (mean difference PRP =-3.33, P=0.003, and mean difference TXA =-2.15, P=0.003). In addition, the median delta E in the patients who received both treatments was significantly decreased after the treatment (mean difference =6.66, P<0.001 in TXA + microneedling group; mean difference =1.90, P<0.001 in PRP + microneedling group). The patients who received TXA + microneedling showed a significant reduction in melanin mexameter measurement. The patients were satisfied with both treatments. Conclusion: This study showed that PRP and tranexamic acid with microneedling have a significant effect in reducing the MASI score and are considered an effective treatment. Although none of these two methods was superior over the other one, they can be a good combination or alternative for the treatment of melasma because they have good efficacy, safety, tolerability, and satisfaction among patients.
{"title":"The Effect of Platelet Rich Plasma (PRP) Plus Microneedling Versus Tranexamic Acid Plus Microneedling in the Biometric Characteristics of Melasma: A Before-After, Assessor Analysis, Blinded, Clinical Trial","authors":"M. Roohaninasab, M. Nilforoushzadeh, Zahra Ebrahimi, A. Goodarzi, Abolfazl Abouei, E. Ziaeifar, Sona Zare, Maryam Nouri, Samaneh Mozafarpoor","doi":"10.25251/skin.8.4.3","DOIUrl":"https://doi.org/10.25251/skin.8.4.3","url":null,"abstract":"Background: Melasma is a chronic, acquired, focal pigment disorder showing symmetrical hyperpigmentation or hypermelanosis of photo-exposed areas on the face. Tranexamic acid (TXA) is a treatment for melasma. The regression of melasma after platelet-rich plasma (PRP) treatment is an interesting finding. \u0000Objectives: To evaluate the effect of PRP plus microneedling vs. tranexamic acid plus microneedling on the quality of melasma. \u0000Methods: This is a left-right split-face comparison study with 18 patients with melasma. The patients underwent four sessions of PRP plus microneedling and tranexamic acid (5%) plus microneedling on right and left sides of the face, respectively, at monthly intervals. Evaluations were performed before the start of treatment and one month after the last treatment session. \u0000Results: Totally, 20 female patients with melasma were included with a mean age of 41 years (range: 34-49 years). Five participants had Fitzpatrick phototype II, eleven had phototype III, and others had phototype IV skin. Both TXA + microneedling and PRP + micro-needling caused a significant reduction in the Tewameter measurement (mean difference PRP =-3.33, P=0.003, and mean difference TXA =-2.15, P=0.003). In addition, the median delta E in the patients who received both treatments was significantly decreased after the treatment (mean difference =6.66, P<0.001 in TXA + microneedling group; mean difference =1.90, P<0.001 in PRP + microneedling group). The patients who received TXA + microneedling showed a significant reduction in melanin mexameter measurement. The patients were satisfied with both treatments. \u0000Conclusion: This study showed that PRP and tranexamic acid with microneedling have a significant effect in reducing the MASI score and are considered an effective treatment. Although none of these two methods was superior over the other one, they can be a good combination or alternative for the treatment of melasma because they have good efficacy, safety, tolerability, and satisfaction among patients.","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":"141813788","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}
Michael Adkison, Andrew Armenta, Frank T. Winsett, Richard F Wagner
Background: The optimal surgical margins required for the excision of lentigo maligna remains a topic of debate. Recent literature suggests that wider margins are warranted. Objective: Comparison of lentigo maligna margin sizes and clearance rates from a single center to existing literature. Methods: A retrospective analysis of primary and recurrent lentigo maligna treated by staged excision with complete circumferential and deep margin assessment between 2011 and 2023 at a single institution was conducted. The percentage of tumors with clear margins after the initial excision with 5 mm margins was determined. Results: A total of 65 tumors were identified. Fifty-eight patients (89.2%) had clear margins after initial excision with 5 mm margins. Conclusions: This study reports a higher percentage of lentigo maligna clearance following the initial staged excision with 5 mm margins than reports in the literature. These differences may be attributed to variations in section processing, staining techniques, and factors associated with differences in subclinical spread.
{"title":"Review of Tumor Margins for Lentigo Maligna with Staged Surgical Excision and Permanent Section en face Processing","authors":"Michael Adkison, Andrew Armenta, Frank T. Winsett, Richard F Wagner","doi":"10.25251/skin.8.4.5","DOIUrl":"https://doi.org/10.25251/skin.8.4.5","url":null,"abstract":"Background: The optimal surgical margins required for the excision of lentigo maligna remains a topic of debate. Recent literature suggests that wider margins are warranted. \u0000Objective: Comparison of lentigo maligna margin sizes and clearance rates from a single center to existing literature. \u0000Methods: A retrospective analysis of primary and recurrent lentigo maligna treated by staged excision with complete circumferential and deep margin assessment between 2011 and 2023 at a single institution was conducted. The percentage of tumors with clear margins after the initial excision with 5 mm margins was determined. \u0000Results: A total of 65 tumors were identified. Fifty-eight patients (89.2%) had clear margins after initial excision with 5 mm margins. \u0000Conclusions: This study reports a higher percentage of lentigo maligna clearance following the initial staged excision with 5 mm margins than reports in the literature. These differences may be attributed to variations in section processing, staining techniques, and factors associated with differences in subclinical spread.","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":"141813815","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}
Kaitlin Fields, Amena Alkeswani, Maria Tirado, Allison Jones
Atrophoderma of Pasini and Pierini (APP) is a rare cutaneous entity of unknown etiology. It usually presents with sharply demarcated dermal atrophy, giving a “cliff-drop” appearance. Very few cases occurring in a zosteriform distribution have been reported. In this article, the author reports a rare case of APP in a 42-year-old women where the lesions presented in a zosteriform distribution on the trunk. Diagnosis is made with high clinical suspicion and confirming histopathology.
{"title":"Zosteriform Atrophoderma of Pasini and Pierini: A Case Report","authors":"Kaitlin Fields, Amena Alkeswani, Maria Tirado, Allison Jones","doi":"10.25251/skin.8.4.23","DOIUrl":"https://doi.org/10.25251/skin.8.4.23","url":null,"abstract":"Atrophoderma of Pasini and Pierini (APP) is a rare cutaneous entity of unknown etiology. It usually presents with sharply demarcated dermal atrophy, giving a “cliff-drop” appearance. Very few cases occurring in a zosteriform distribution have been reported. In this article, the author reports a rare case of APP in a 42-year-old women where the lesions presented in a zosteriform distribution on the trunk. Diagnosis is made with high clinical suspicion and confirming histopathology.","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":"141810665","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.406
April W. Armstrong, M. Lebwohl, Richard B Warren, H. Sofen, Akimchi Morita, Shinichi Imafuku, M. Ohtsuki, L. Spelman, T. Passeron, Kim A. Papp, Matthew J Colombo, John Vaile, E. Vritzali, K. Hoyt, C. Daamen, Subhashis Banerjee, B. Strober, Diamant Thaçi, Andrew Blauvelt
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 superior to placebo and apremilast in the phase 3 POETYK PSO-1 and PSO-2 trials in moderate to severe plaque psoriasis. Upon trial completion, patients could enroll in the ongoing POETYK long-term extension (LTE) trial. Here, deucravacitinib safety and efficacy are reported through 4 years. Methods: PSO-1/PSO-2 randomized patients 1:2:1 to placebo, deucravacitinib 6 mg QD, or apremilast 30 mg BID. At Week 52, patients in the LTE received open-label deucravacitinib 6 mg QD. Safety was evaluated in patients receiving ≥1 deucravacitinib dose. Exposure-adjusted incidence rate (EAIR) per 100 person-years (PY) was used to assess adverse events (AEs). Efficacy outcomes included PASI 75, PASI 90, and sPGA 0/1 and were analyzed using mNRI in LTE patients receiving continuous deucravacitinib from Day 1 of the parent trials. Results: 1519 patients received ≥1 deucravacitinib dose; cumulative exposure was 4392.8 PY. EAIRs/100 PY were decreased/comparable from the 1- to 4-year cumulative period, respectively: AEs (229.2, 131.7), serious AEs (5.7, 5.0), deaths (0.2, 0.3), discontinuation due to AEs (4.4, 2.2), herpes zoster (0.8, 0.6), malignancies (1.0, 0.9), MACE (0.3, 0.3), and venous thromboembolism (0.2, 0.1). With continuous deucravacitinib treatment (n = 513), clinical response rates were maintained from Year 3 (PASI 75, 73.8% [95% CI, 69.6, 78.0]; PASI 90, 49.0% [95% CI, 44.4, 53.7]; sPGA 0/1, 55.2% [95% CI, 50.5, 59.9]) to Year 4 (PASI 75, 71.7% [95% CI, 67.0, 76.3]; PASI 90, 47.5% [95% CI, 42.6, 52.4]; sPGA 0/1, 57.2% [95% CI, 52.1, 62.2]) by mNRI. Conclusion: Deucravacitinib demonstrated durable efficacy with continuous treatment and a safety profile through 4 years consistent with that at 3 years, without new or long-term safety signals.
{"title":"Deucravacitinib in Plaque Psoriasis: 4-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials","authors":"April W. Armstrong, M. Lebwohl, Richard B Warren, H. Sofen, Akimchi Morita, Shinichi Imafuku, M. Ohtsuki, L. Spelman, T. Passeron, Kim A. Papp, Matthew J Colombo, John Vaile, E. Vritzali, K. Hoyt, C. Daamen, Subhashis Banerjee, B. Strober, Diamant Thaçi, Andrew Blauvelt","doi":"10.25251/skin.8.supp.406","DOIUrl":"https://doi.org/10.25251/skin.8.supp.406","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 superior to placebo and apremilast in the phase 3 POETYK PSO-1 and PSO-2 trials in moderate to severe plaque psoriasis. Upon trial completion, patients could enroll in the ongoing POETYK long-term extension (LTE) trial. Here, deucravacitinib safety and efficacy are reported through 4 years. \u0000Methods: PSO-1/PSO-2 randomized patients 1:2:1 to placebo, deucravacitinib 6 mg QD, or apremilast 30 mg BID. At Week 52, patients in the LTE received open-label deucravacitinib 6 mg QD. Safety was evaluated in patients receiving ≥1 deucravacitinib dose. Exposure-adjusted incidence rate (EAIR) per 100 person-years (PY) was used to assess adverse events (AEs). Efficacy outcomes included PASI 75, PASI 90, and sPGA 0/1 and were analyzed using mNRI in LTE patients receiving continuous deucravacitinib from Day 1 of the parent trials. \u0000Results: 1519 patients received ≥1 deucravacitinib dose; cumulative exposure was 4392.8 PY. EAIRs/100 PY were decreased/comparable from the 1- to 4-year cumulative period, respectively: AEs (229.2, 131.7), serious AEs (5.7, 5.0), deaths (0.2, 0.3), discontinuation due to AEs (4.4, 2.2), herpes zoster (0.8, 0.6), malignancies (1.0, 0.9), MACE (0.3, 0.3), and venous thromboembolism (0.2, 0.1). With continuous deucravacitinib treatment (n = 513), clinical response rates were maintained from Year 3 (PASI 75, 73.8% [95% CI, 69.6, 78.0]; PASI 90, 49.0% [95% CI, 44.4, 53.7]; sPGA 0/1, 55.2% [95% CI, 50.5, 59.9]) to Year 4 (PASI 75, 71.7% [95% CI, 67.0, 76.3]; PASI 90, 47.5% [95% CI, 42.6, 52.4]; sPGA 0/1, 57.2% [95% CI, 52.1, 62.2]) by mNRI. \u0000Conclusion: Deucravacitinib demonstrated durable efficacy with continuous treatment and a safety profile through 4 years consistent with that at 3 years, without new or long-term safety signals.","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":"141812975","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}
Hyperkeratosis of the nipple/areola (HNA) is a wart-like thickening of the nipple and/or areola with concomitant hyperpigmentation. It can be further classified into groups based on etiology. Nevoid (NHNA) is a rare subtype with an unknown cause. It is a benign, idiopathic condition, which typically presents bilaterally in females or in times of hormonal changes. We present a case of a 51-year-old Bahraini male who presented with skin changes of the nipple and was ultimately found to have NHNA.
{"title":"A Case of Nevoid Hyperkeratosis of the Nipple in a Male Bahraini Patient","authors":"M. Dirr, Sara Alkhanaizi, Fatema Khamdan","doi":"10.25251/skin.8.4.12","DOIUrl":"https://doi.org/10.25251/skin.8.4.12","url":null,"abstract":"Hyperkeratosis of the nipple/areola (HNA) is a wart-like thickening of the nipple and/or areola with concomitant hyperpigmentation. It can be further classified into groups based on etiology. Nevoid (NHNA) is a rare subtype with an unknown cause. It is a benign, idiopathic condition, which typically presents bilaterally in females or in times of hormonal changes. We present a case of a 51-year-old Bahraini male who presented with skin changes of the nipple and was ultimately found to have NHNA.","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":"141813390","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.409
Alice B. Gottlieb, B. Strober, Georgios Kokolakis, Joseph F. Merola, Min Zheng, Richard G. Langley, Ming Tang, Patrick Hofmann, C. Thoma, Richard B Warren
Introduction Generalized pustular psoriasis (GPP) is a chronic and potentially life-threatening disease characterized by flares of widespread skin pustulation. In Effisayil 2 (NCT04399837), high‑dose spesolimab was superior to placebo in GPP flare prevention and numerically reduced the risk of Dermatology Life Quality Index (DLQI) worsening (≥4-point increase in total score from baseline; secondary endpoint), up to Week 48. Methods Here, we further analyze the effect of high-dose spesolimab versus placebo on DLQI in Effisayil 2. Results Baseline characteristics were generally similar in the high-dose spesolimab (600 mg loading dose then 300 mg every 4 weeks [N=30]) and placebo groups (N=31) in terms of sex, age, length of disease, and historical flare frequency, although the high‑dose spesolimab group had a higher mean±SD DLQI score (11.1±6.9 [missing=1]) versus placebo (7.2±5.6 [missing=0]). At Week 4 in exploratory analysis, more patients in the high-dose spesolimab group (N=29) had no GPP flare and ≥4-point improvement in their DLQI score versus placebo (N=31) (n/N [%]: 10/29 [34.5%] [missing=1] versus 3/31 [9.7%] [missing=0]) at Week 4; this was also seen at Week 48 (11/29 [37.9%] [missing=6] versus 8/31 [25.8%] [missing=0], respectively). Furthermore, a higher proportion of patients treated with spesolimab had no GPP flare and reached a DLQI score of 0 or 1 at all visits up to Week 48 versus placebo (7/29 [24.1%] versus 1/31 [3.2%], respectively). Conclusion Adding to previous data from Effisayil 2, this analysis demonstrates that patients treated with spesolimab (including high-dose) rapidly gained improvements in DLQI scores versus placebo, which were sustained through to Week 48.
{"title":"Spesolimab Rapidly Improves Quality of Life in Patients with Generalized Pustular Psoriasis, as per Dermatology Life Quality Index Scores: Data from the Effisayil 2 Trial","authors":"Alice B. Gottlieb, B. Strober, Georgios Kokolakis, Joseph F. Merola, Min Zheng, Richard G. Langley, Ming Tang, Patrick Hofmann, C. Thoma, Richard B Warren","doi":"10.25251/skin.8.supp.409","DOIUrl":"https://doi.org/10.25251/skin.8.supp.409","url":null,"abstract":"Introduction Generalized pustular psoriasis (GPP) is a chronic and potentially life-threatening disease characterized by flares of widespread skin pustulation. In Effisayil 2 (NCT04399837), high‑dose spesolimab was superior to placebo in GPP flare prevention and numerically reduced the risk of Dermatology Life Quality Index (DLQI) worsening (≥4-point increase in total score from baseline; secondary endpoint), up to Week 48. \u0000Methods Here, we further analyze the effect of high-dose spesolimab versus placebo on DLQI in Effisayil 2. \u0000Results Baseline characteristics were generally similar in the high-dose spesolimab (600 mg loading dose then 300 mg every 4 weeks [N=30]) and placebo groups (N=31) in terms of sex, age, length of disease, and historical flare frequency, although the high‑dose spesolimab group had a higher mean±SD DLQI score (11.1±6.9 [missing=1]) versus placebo (7.2±5.6 [missing=0]). At Week 4 in exploratory analysis, more patients in the high-dose spesolimab group (N=29) had no GPP flare and ≥4-point improvement in their DLQI score versus placebo (N=31) (n/N [%]: 10/29 [34.5%] [missing=1] versus 3/31 [9.7%] [missing=0]) at Week 4; this was also seen at Week 48 (11/29 [37.9%] [missing=6] versus 8/31 [25.8%] [missing=0], respectively). Furthermore, a higher proportion of patients treated with spesolimab had no GPP flare and reached a DLQI score of 0 or 1 at all visits up to Week 48 versus placebo (7/29 [24.1%] versus 1/31 [3.2%], respectively). \u0000Conclusion Adding to previous data from Effisayil 2, this analysis demonstrates that patients treated with spesolimab (including high-dose) rapidly gained improvements in DLQI scores versus placebo, which were sustained through to Week 48.","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":"141814097","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}
Atopic dermatitis (AD) is a common chronic inflammatory skin condition that disproportionately affects skin of color patients. New targeted biological therapies such as tralokinumab are available for the management of AD, but real-world evidence of their clinical effectiveness in skin of color patients is limited, particularly in patients with difficult-to-treat hand and foot involvement. In this report, we present a case of recalcitrant atopic dermatitis with hand-foot involvement in a skin of color patient successfully treated with tralokinumab.
{"title":"Successful Tralokinumab Treatment for Hand and Foot Atopic Dermatitis in a Patient with Skin of Color: A Case Report","authors":"Porcia Love, Chloe Walker","doi":"10.25251/skin.8.4.20","DOIUrl":"https://doi.org/10.25251/skin.8.4.20","url":null,"abstract":"Atopic dermatitis (AD) is a common chronic inflammatory skin condition that disproportionately affects skin of color patients. New targeted biological therapies such as tralokinumab are available for the management of AD, but real-world evidence of their clinical effectiveness in skin of color patients is limited, particularly in patients with difficult-to-treat hand and foot involvement. In this report, we present a case of recalcitrant atopic dermatitis with hand-foot involvement in a skin of color patient successfully treated with tralokinumab.","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":"141814158","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}
Psoriatic arthritis (PsA) is a chronic inflammatory condition commonly affecting peripheral joints and the skin. Recent studies have shown an association between PsA and vestibulocochlear dysfunction. Here, we present the case of a 43 year-old male with a history of controlled psoriasis (Pso) and PsA who presented with sudden-onset severe vertigo, nausea, and vomiting. Diagnostic evaluation ruled out a central etiology, leading to a diagnosis of vestibular neuritis of unknown origin. Despite minimal improvement with conventional medications, the patient experienced significant relief from vertigo symptoms following treatment with ixekizumab, an IL-17 inhibitor used to manage his PsA and Pso. This case highlights a potential therapeutic effect of biological agents on vestibular dysfunction associated with PsA. Future research in this area may provide insights into novel treatment strategies for vestibular symptoms in patients with PsA.
{"title":"Improvement of Vestibular Neuritis in a Patient with Psoriatic Arthritis following Ixekizumab Administration","authors":"Sherry Ershadi, Shivkar Amara, M. Lebwohl","doi":"10.25251/skin.8.4.10","DOIUrl":"https://doi.org/10.25251/skin.8.4.10","url":null,"abstract":"Psoriatic arthritis (PsA) is a chronic inflammatory condition commonly affecting peripheral joints and the skin. Recent studies have shown an association between PsA and vestibulocochlear dysfunction. Here, we present the case of a 43 year-old male with a history of controlled psoriasis (Pso) and PsA who presented with sudden-onset severe vertigo, nausea, and vomiting. Diagnostic evaluation ruled out a central etiology, leading to a diagnosis of vestibular neuritis of unknown origin. Despite minimal improvement with conventional medications, the patient experienced significant relief from vertigo symptoms following treatment with ixekizumab, an IL-17 inhibitor used to manage his PsA and Pso. This case highlights a potential therapeutic effect of biological agents on vestibular dysfunction associated with PsA. Future research in this area may provide insights into novel treatment strategies for vestibular symptoms in patients with PsA. ","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":"141811266","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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