M. Gooderham, L. Spelman, S. Imafuku, M. Romanelli, J. Merola, A. Armstrong, E. Colston, Subhashish Banerjee, T. Scharnitz, A. Blauvelt
{"title":"Deucravacitinib是一种口服、选择性、变质酪氨酸激酶2抑制剂,用于治疗中重度斑块型银屑病:POETYK PSO-1和PSO-2 3期试验中基线人口统计学和疾病特征的疗效","authors":"M. Gooderham, L. Spelman, S. Imafuku, M. Romanelli, J. Merola, A. Armstrong, E. Colston, Subhashish Banerjee, T. Scharnitz, A. Blauvelt","doi":"10.25251/skin.7.supp.219","DOIUrl":null,"url":null,"abstract":"Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In the POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials, deucravacitinib was superior to placebo and apremilast in patients with moderate to severe plaque psoriasis. This analysis evaluated deucravacitinib efficacy by baseline characteristics. \nMethods: Efficacy endpoints, including ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician’s Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1), were evaluated at Week 24 by baseline subgroups including weight, sex, and PASI in the pooled PSO-1 and PSO-2 population, and at Week 52 in PSO-1 patients who received continuous deucravacitinib treatment from Day 1. \nResults: In the pooled PSO-1 and PSO-2 population, deucravacitinib (n=843) was more efficacious than apremilast (n=422) at Week 24 across subgroups defined by baseline weight (<90 kg: PASI 75, 69.8% vs 43.8%, sPGA 0/1, 60.2% vs 34.2%; ≥90 kg: PASI 75, 55.4% vs 31.5%, sPGA 0/1, 45.9% vs 25.6%), sex (male: PASI 75, 59.3% vs 33.7%, sPGA 0/1, 49.6% vs 24.7%; female: PASI 75, 70.4% vs 45.2%, sPGA 0/1, 60.9% vs 39.4%), and PASI (≤20: PASI 75, 61.6% vs 38.6%, sPGA 0/1, 53.5% vs 32.4%; >20: PASI 75, 64.7% vs 37.0%, sPGA 0/1: 53.2% vs 27.1%). Consistent efficacy was observed through Week 52 in patients who received continuous deucravacitinib treatment in PSO-1 (n=332), regardless of baseline characteristics. \nConclusion: Deucravacitinib demonstrated consistent efficacy for up to 52 weeks regardless of baseline characteristics in patients with moderate to severe plaque psoriasis. \n \nAcknowledgments \n \nThis study was sponsored by Bristol Myers Squibb \nWriting and editorial assistance was provided by Liz Rockstein, PhD, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb \n","PeriodicalId":74803,"journal":{"name":"Skin (Milwood, N.Y.)","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: Efficacy by Baseline Demographic and Disease Characteristics in the Phase 3 POETYK PSO-1 and PSO-2 Trials\",\"authors\":\"M. Gooderham, L. Spelman, S. Imafuku, M. Romanelli, J. Merola, A. Armstrong, E. Colston, Subhashish Banerjee, T. Scharnitz, A. Blauvelt\",\"doi\":\"10.25251/skin.7.supp.219\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In the POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials, deucravacitinib was superior to placebo and apremilast in patients with moderate to severe plaque psoriasis. This analysis evaluated deucravacitinib efficacy by baseline characteristics. \\nMethods: Efficacy endpoints, including ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician’s Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1), were evaluated at Week 24 by baseline subgroups including weight, sex, and PASI in the pooled PSO-1 and PSO-2 population, and at Week 52 in PSO-1 patients who received continuous deucravacitinib treatment from Day 1. \\nResults: In the pooled PSO-1 and PSO-2 population, deucravacitinib (n=843) was more efficacious than apremilast (n=422) at Week 24 across subgroups defined by baseline weight (<90 kg: PASI 75, 69.8% vs 43.8%, sPGA 0/1, 60.2% vs 34.2%; ≥90 kg: PASI 75, 55.4% vs 31.5%, sPGA 0/1, 45.9% vs 25.6%), sex (male: PASI 75, 59.3% vs 33.7%, sPGA 0/1, 49.6% vs 24.7%; female: PASI 75, 70.4% vs 45.2%, sPGA 0/1, 60.9% vs 39.4%), and PASI (≤20: PASI 75, 61.6% vs 38.6%, sPGA 0/1, 53.5% vs 32.4%; >20: PASI 75, 64.7% vs 37.0%, sPGA 0/1: 53.2% vs 27.1%). Consistent efficacy was observed through Week 52 in patients who received continuous deucravacitinib treatment in PSO-1 (n=332), regardless of baseline characteristics. \\nConclusion: Deucravacitinib demonstrated consistent efficacy for up to 52 weeks regardless of baseline characteristics in patients with moderate to severe plaque psoriasis. \\n \\nAcknowledgments \\n \\nThis study was sponsored by Bristol Myers Squibb \\nWriting and editorial assistance was provided by Liz Rockstein, PhD, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb \\n\",\"PeriodicalId\":74803,\"journal\":{\"name\":\"Skin (Milwood, N.Y.)\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-07-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Skin (Milwood, N.Y.)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.25251/skin.7.supp.219\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Skin (Milwood, N.Y.)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.25251/skin.7.supp.219","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: Efficacy by Baseline Demographic and Disease Characteristics in the Phase 3 POETYK PSO-1 and PSO-2 Trials
Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In the POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials, deucravacitinib was superior to placebo and apremilast in patients with moderate to severe plaque psoriasis. This analysis evaluated deucravacitinib efficacy by baseline characteristics.
Methods: Efficacy endpoints, including ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician’s Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1), were evaluated at Week 24 by baseline subgroups including weight, sex, and PASI in the pooled PSO-1 and PSO-2 population, and at Week 52 in PSO-1 patients who received continuous deucravacitinib treatment from Day 1.
Results: In the pooled PSO-1 and PSO-2 population, deucravacitinib (n=843) was more efficacious than apremilast (n=422) at Week 24 across subgroups defined by baseline weight (<90 kg: PASI 75, 69.8% vs 43.8%, sPGA 0/1, 60.2% vs 34.2%; ≥90 kg: PASI 75, 55.4% vs 31.5%, sPGA 0/1, 45.9% vs 25.6%), sex (male: PASI 75, 59.3% vs 33.7%, sPGA 0/1, 49.6% vs 24.7%; female: PASI 75, 70.4% vs 45.2%, sPGA 0/1, 60.9% vs 39.4%), and PASI (≤20: PASI 75, 61.6% vs 38.6%, sPGA 0/1, 53.5% vs 32.4%; >20: PASI 75, 64.7% vs 37.0%, sPGA 0/1: 53.2% vs 27.1%). Consistent efficacy was observed through Week 52 in patients who received continuous deucravacitinib treatment in PSO-1 (n=332), regardless of baseline characteristics.
Conclusion: Deucravacitinib demonstrated consistent efficacy for up to 52 weeks regardless of baseline characteristics in patients with moderate to severe plaque psoriasis.
Acknowledgments
This study was sponsored by Bristol Myers Squibb
Writing and editorial assistance was provided by Liz Rockstein, PhD, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb