b. n=504（部分患者因新冠大流行而错过了疗效评估） c. Deucravacitinib 对比安慰剂、及 deucravacitinib 对比阿普米司特的p值≤0.0001 d. Deucravacitinib 对比阿普米司特的p值<0.001 e. Deucravacitinib 对比阿普米司特的p值<0.01 在完成为期 52 周的 POETYK PSO-1 和 POETYK PSO-2 的研究后，患者可参加 POETYK PSO 长期扩展（LTE）试验（NCT04036435），以开放标签形式继续接受 deucravacitinib（6 mg，每日一次）治疗。（截至LTE试验2年数据发表时）共计 1,221 名患者参加了LTE试验，并接受了至少 1 次deucravacitinib 治疗。研究使用治疗失败规则（TFR）插补法来分析疗效，同时使用改良无应答插补法和实际观察法进行了敏感性分析，这些分析已用于其他药剂的类似分析。 除 POETYK PSO-1、POETYK PSO-2 和 POETYK PSO-LTE 外，百时美施贵宝目前还开展了另外两项 III 期研究以评估 deucravacitinib 用于银屑病治疗的情况，它们分别是 POETYK PSO-3（NCT04167462）和 POETYK PSO-4（NCT03924427）[1],[2]。 关于银屑病 银屑病是一种常见的慢性、系统性免疫介导疾病，严重损害患者的身体健康、生活质量和工作效率[3]-[6]。作为一个全球性严重问题，全世界至少1亿人受到各类银屑病的影响，其中欧洲约有1,400万人，美国约有750 万人[7]-[8]。近四分之一银屑病患者的疾病严重程度为中度至重度[9]。高达90%的银屑病患者为寻常型银屑病或斑块状银屑病，其特征是界限清楚的圆形或椭圆形斑块，表面通常覆有银白色鳞屑[5],[8],[10]-[13]。尽管目前已有有效的系统性治疗方案，但许多中重度银屑病患者仍未得到充分治疗甚至未经治疗，且目前的治疗方案并无法满足其治疗需求14-15。银屑病影响患者的情绪健康，带来日常与职场的社交压力，造成生活质量下降[16]-[18]。此外，银屑病还与多种可能影响患者健康的合并症相关，包括银屑病关节炎、心血管疾病、代谢综合征、肥胖、糖尿病、炎症性肠病和抑郁症[3],[18],[19]。 关于deucravacitinib Deucravacitinib是一种具有独特作用机制的口服、选择性酪氨酸激酶 2（TYK2）变构抑制剂，也是一类新的小分子药物代表。它是首个正在进行多种免疫介导疾病临床研究的选择性 TYK2抑制剂。百时美施贵宝的科学家们设计 deucravacitinib 来选择性地靶向 TYK2，从而抑制 IL-23、IL-12 和 I 型干扰素（IFN）的信号传导，而这些细胞因子都是参与多种免疫介导疾病发病机制的关键细胞因子。Deucravacitinib 通过与 TYK2 的调节结构域结合实现高度选择性，促成对 TYK2 及其下游功能的变构抑制。在生理浓度范围内，deucravacitinib 选择性地抑制 TYK2。在治疗剂量下，deucravacitinib 不会抑制JAK1、JAK2 或 JAK3。 参考资料： [1]. Bristol Myers Squibb. Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants with Psoriasis (POETYK PSO-1).https://clinicaltrials.gov/ct2/show/NCT03624127. NLM identifier: NCT03624127. [2]. Bristol Myers Squibb. An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants with Moderate-to-Severe Plaque Psoriasis (POETYK-PSO-2).https://clinicaltrials.gov/ct2/show/NCT03611751. NLM identifier: NCT03611751. [3]. Michalek, I. M., Loring, B. & John, S. M. Global report on psoriasis. (2016). Geneva, Switzerland: World Health Organization. [4]. Langley RGB et al. Psoriasis: epidemiology, clinical features, and quality of life.Ann Rheum Dis.2005;64(Suppl II):ii18–ii23. doi: 10.1136/ard.2004.033217. [5]. Pariser et al. A multicenter, non-interventional study to evaluate patient-reported experiences of living with psoriasis.J Dermatolog Treat.2015;27(1):19-26. doi: 10.3109/09546634.2015.1044492. [6]. Kimball A.B. et al. Psoriasis: is the impairment to a patient's life cumulative?J Eur Acad Dermatol Venereol.2010 Sep;24(9):989-1004. doi: 10.1111/j.1468-3083.2010.03705. [7]. Menter A et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics.J Am Acad Dermatol.2008 May;58(5):826-50. doi: 10.1016/j.jaad.2008.02.039. [8]. Ortonne JP, Prinz JC. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. Eur J Dermatol. 2004 Jan-Feb;14(1):41-5. PMID: 14965795. [9]. National Psoriasis Foundation. Psoriasis Statistics.https://www.psoriasis.org/psoriasis-statistics/. Accessed September 8, 2021. [10]. Griffiths C & Barker J. Pathogenesis and clinical features of psoriasis.Lancet. 2007 Jul 21;370(9583):263-271. doi: 10.1016/S0140-6736(07)61128-3. [11]. Alwan W et al. Pathogenesis and treatment of psoriasis: exploiting pathophysiological pathways for precision medicine.Clin Exp Rheumatol.Sep-Oct 2015;33(5 Suppl 93):S2-6. [12]. Mahil S, Capon F & Barker J. Update on psoriasis immunopathogenesis and targeted immunotherapy.SeminImmunopathol. 2016 Jan;38(1):11-27. doi: 10.1007/s00281-015-0539-8. [13]. Horn EJ et al. Are patients with psoriasis undertreated? Results of National Psoriasis Foundation survey.J Am Acad Dermatol. 2007;57:957-962. [14]. Armstrong A. et al. Under-treatment of patients with moderate to severe psoriasis in the United States: analysis of medication usage with health plan data.Dermatol Ther (Heidelb).2017 Mar; 7(1): 97–109. [15]. Hrehorow, E et al. (2012). Patients with psoriasis feel stigmatized,Acta Derm Venereol.92(1):67-72. doi:10.2340/00015555-1193. [16]. Armstrong A, Harskamp C & Armstrong E. The association between psoriasis and obesity: a systematic review and meta-analysis of observational studies.Nutr Diabetes.2013. Dec 3;2(12):e54. doi: 10.1038/nutd.2012.26. [17]. Dubertret L et al. European patient perspectives on the impact of psoriasis: the EUROPSO patient membership survey.Br J Dermatol.2006 Oct;155(4):729-36. [18]. Oliveira, M., Rocha, B., & Duarte, G. V. Psoriasis: classical and emerging comorbidities.Anais brasileiros de dermatologia. Jan-Feb2015; 90(1), 9–20. https://doi.org/10.1590/abd1806-4841.20153038. [19]. Neimann A et al. Prevalence of cardiovascular risk factors in patients with psoriasis.J Am Acad Dermatol. 2006;55(5), 829–835. https://doi.org/10.1016/j.jaad.2006.08.040. [20]. Lebwohl MG et al. US Perspectives in the Management of Psoriasis and Psoriatic Arthritis: Patient and Physician Results from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey.Am J Clin Dermatol. 2016 Feb;17(1):87-97. doi: 10.1007/s40257-015-0169-x. [21]. Lebwohl MG et al. Patient perspectives in the management of psoriasis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey.J Am Acad Dermatol. 2014 May;70(5):871-81.e1-30. doi: 10.1016/j.jaad.2013.12.018. 来源：金色财经lg...
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