Enzo Errichetti, Peter Wolf, Saakshi Khattri, Patricia Gorecki, Megan Miller, Jingzhi Jiang, Chenglong Han, Brian Kirby
{"title":"在 3 期 NAVIGATE 试验中,接受过 Ustekinumab 治疗的顽固性轻度银屑病患者在改用 Guselkumab 后,皮肤清除率和患者报告结果均有较大改善。","authors":"Enzo Errichetti, Peter Wolf, Saakshi Khattri, Patricia Gorecki, Megan Miller, Jingzhi Jiang, Chenglong Han, Brian Kirby","doi":"10.2340/actadv.v104.41053","DOIUrl":null,"url":null,"abstract":"<p><p>Mild psoriasis may be burdensome; if symptoms are inadequately controlled, switching therapy may be warranted. In the Phase 3 NAVIGATE trial, patients with moderate-to-severe plaque psoriasis received ustekinumab for 16 weeks. Patients with inadequate response (Investigator's Global Assessment [IGA] ≥ 2) were randomized to switch to guselkumab or continue ustekinumab. This post-hoc analysis evaluated the patient subgroup with residual mild psoriasis (IGA = 2) after initial ustekinumab therapy. Outcomes assessed included the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and Psoriasis Symptoms and Signs Diary (PSSD). Initially, 871 patients received ustekinumab. At Week 16, 161 randomized patients had residual mild psoriasis (IGA = 2). Among guselkumab- vs ustekinumab-treated patients at Week 28, 59.0% vs 27.7% achieved PASI 90, and 50.0% vs 21.0% achieved DLQI 0/1. Mean changes from baseline in PSSD score were -44 vs -28 and -50 vs -32, respectively, with thresholds of -40 considered clinically meaningful. Mean changes in PSSD itch score were -4.6 vs -2.9, with reductions ≥ 4.0 considered clinically meaningful. Treatment differences were maintained/increased through Week 52. Among patients with residual mild psoriasis after 16 weeks of ustekinumab, those switching to guselkumab had greater improvements in skin clearance, health-related quality of life, and patient-reported symptoms and signs than those continuing ustekinumab.</p>","PeriodicalId":6944,"journal":{"name":"Acta dermato-venereologica","volume":"104 ","pages":"adv41053"},"PeriodicalIF":3.5000,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11388105/pdf/","citationCount":"0","resultStr":"{\"title\":\"Patients with Persistent Mild Psoriasis after Treatment with Ustekinumab Achieved Greater Improvements in Skin Clearance and Patient-reported Outcomes after Switching to Guselkumab in the Phase 3 NAVIGATE Trial.\",\"authors\":\"Enzo Errichetti, Peter Wolf, Saakshi Khattri, Patricia Gorecki, Megan Miller, Jingzhi Jiang, Chenglong Han, Brian Kirby\",\"doi\":\"10.2340/actadv.v104.41053\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Mild psoriasis may be burdensome; if symptoms are inadequately controlled, switching therapy may be warranted. In the Phase 3 NAVIGATE trial, patients with moderate-to-severe plaque psoriasis received ustekinumab for 16 weeks. Patients with inadequate response (Investigator's Global Assessment [IGA] ≥ 2) were randomized to switch to guselkumab or continue ustekinumab. This post-hoc analysis evaluated the patient subgroup with residual mild psoriasis (IGA = 2) after initial ustekinumab therapy. Outcomes assessed included the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and Psoriasis Symptoms and Signs Diary (PSSD). Initially, 871 patients received ustekinumab. At Week 16, 161 randomized patients had residual mild psoriasis (IGA = 2). Among guselkumab- vs ustekinumab-treated patients at Week 28, 59.0% vs 27.7% achieved PASI 90, and 50.0% vs 21.0% achieved DLQI 0/1. Mean changes from baseline in PSSD score were -44 vs -28 and -50 vs -32, respectively, with thresholds of -40 considered clinically meaningful. Mean changes in PSSD itch score were -4.6 vs -2.9, with reductions ≥ 4.0 considered clinically meaningful. Treatment differences were maintained/increased through Week 52. Among patients with residual mild psoriasis after 16 weeks of ustekinumab, those switching to guselkumab had greater improvements in skin clearance, health-related quality of life, and patient-reported symptoms and signs than those continuing ustekinumab.</p>\",\"PeriodicalId\":6944,\"journal\":{\"name\":\"Acta dermato-venereologica\",\"volume\":\"104 \",\"pages\":\"adv41053\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2024-09-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11388105/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Acta dermato-venereologica\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2340/actadv.v104.41053\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta dermato-venereologica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2340/actadv.v104.41053","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
轻度银屑病可能是一种负担;如果症状控制不佳,可能需要更换疗法。在 3 期 NAVIGATE 试验中,中度至重度斑块状银屑病患者接受了为期 16 周的乌司替尼治疗。反应不充分(研究者总体评估[IGA]≥2)的患者被随机转为使用古舍库单抗或继续使用乌斯特库单抗。这项事后分析评估了初始乌司替库单抗治疗后仍有轻度银屑病(IGA = 2)的患者亚组。评估结果包括银屑病面积和严重程度指数(PASI)、皮肤病生活质量指数(DLQI)以及银屑病症状和体征日记(PSSD)。最初有 871 名患者接受了乌司替尼治疗。第16周时,161名随机患者有轻度银屑病残留(IGA = 2)。在第28周时,古舍库单抗与乌司替库单抗治疗的患者中,59.0%与27.7%达到PASI 90,50.0%与21.0%达到DLQI 0/1。PSSD评分与基线相比的平均变化分别为-44 vs -28和-50 vs -32,其中-40的阈值被认为具有临床意义。PSSD瘙痒评分的平均变化为-4.6 vs -2.9,≥4.0的降幅被认为具有临床意义。治疗差异在第52周保持/增加。在服用乌司替库单抗16周后仍有轻度银屑病残留的患者中,与继续服用乌司替库单抗的患者相比,改用古舍库单抗的患者在皮肤清除率、健康相关生活质量以及患者报告的症状和体征方面都有更大改善。
Patients with Persistent Mild Psoriasis after Treatment with Ustekinumab Achieved Greater Improvements in Skin Clearance and Patient-reported Outcomes after Switching to Guselkumab in the Phase 3 NAVIGATE Trial.
Mild psoriasis may be burdensome; if symptoms are inadequately controlled, switching therapy may be warranted. In the Phase 3 NAVIGATE trial, patients with moderate-to-severe plaque psoriasis received ustekinumab for 16 weeks. Patients with inadequate response (Investigator's Global Assessment [IGA] ≥ 2) were randomized to switch to guselkumab or continue ustekinumab. This post-hoc analysis evaluated the patient subgroup with residual mild psoriasis (IGA = 2) after initial ustekinumab therapy. Outcomes assessed included the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and Psoriasis Symptoms and Signs Diary (PSSD). Initially, 871 patients received ustekinumab. At Week 16, 161 randomized patients had residual mild psoriasis (IGA = 2). Among guselkumab- vs ustekinumab-treated patients at Week 28, 59.0% vs 27.7% achieved PASI 90, and 50.0% vs 21.0% achieved DLQI 0/1. Mean changes from baseline in PSSD score were -44 vs -28 and -50 vs -32, respectively, with thresholds of -40 considered clinically meaningful. Mean changes in PSSD itch score were -4.6 vs -2.9, with reductions ≥ 4.0 considered clinically meaningful. Treatment differences were maintained/increased through Week 52. Among patients with residual mild psoriasis after 16 weeks of ustekinumab, those switching to guselkumab had greater improvements in skin clearance, health-related quality of life, and patient-reported symptoms and signs than those continuing ustekinumab.
期刊介绍:
Acta Dermato-Venereologica publishes high-quality manuscripts in English in the field of Dermatology and Venereology, dealing with new observations on basic dermatological and venereological research, as well as clinical investigations. Each volume also features a number of Review articles in special areas, as well as short Letters to the Editor to stimulate debate and to disseminate important clinical observations. Acta Dermato-Venereologica has rapid publication times and is amply illustrated with a large number of colour photographs.