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upadacitinib（rinvoq）在特应性皮炎国家药物...
o EASI75响应的共同结果和经过验证的研究者的AD评估（清晰）或1（几乎是明确）的全球评估的结果 o，从基线（VIGA-AD 0/1响应）提高了2年级（几乎是明确）的结果，显示了两项试验之间一致的显着治疗益处。 o最早在第2周和最严重的NRS-4反应中就达到了EASI75反应的显着治疗差异。 在两项试验中，EAI90的第1周和EASI100的第1周，迅速发生了显着的治疗差异（upadacitinib 15或30 mg vs安慰剂）。 o这两个试验还始终显示出AD耀斑减少，皮肤疼痛，对睡眠影响，对日常活动的影响，焦虑或抑郁的影响以及对生活质量的影响的严重治疗差异。 o长期扩展表明，在第16周达到EASI75反应的患者中有82.0％和79.1％保持对upadacitinib 15 mg的反应，直到该度量的第52周提高1，并分别测量2次试验。 4 upadacitinib 30 mg的相应响应率分别为84.9％和84.3％。 IgA0/1响应较低：15 mg的59.2％和52.6％，30 mg的62.5％和65.1％的响应分别为1毫克，分别为1和2。 5,6o，从基线（VIGA-AD 0/1响应）提高了2年级（几乎是明确）的结果，显示了两项试验之间一致的显着治疗益处。o最早在第2周和最严重的NRS-4反应中就达到了EASI75反应的显着治疗差异。 在两项试验中，EAI90的第1周和EASI100的第1周，迅速发生了显着的治疗差异（upadacitinib 15或30 mg vs安慰剂）。 o这两个试验还始终显示出AD耀斑减少，皮肤疼痛，对睡眠影响，对日常活动的影响，焦虑或抑郁的影响以及对生活质量的影响的严重治疗差异。 o长期扩展表明，在第16周达到EASI75反应的患者中有82.0％和79.1％保持对upadacitinib 15 mg的反应，直到该度量的第52周提高1，并分别测量2次试验。 4 upadacitinib 30 mg的相应响应率分别为84.9％和84.3％。 IgA0/1响应较低：15 mg的59.2％和52.6％，30 mg的62.5％和65.1％的响应分别为1毫克，分别为1和2。 5,6o最早在第2周和最严重的NRS-4反应中就达到了EASI75反应的显着治疗差异。在两项试验中，EAI90的第1周和EASI100的第1周，迅速发生了显着的治疗差异（upadacitinib 15或30 mg vs安慰剂）。o这两个试验还始终显示出AD耀斑减少，皮肤疼痛，对睡眠影响，对日常活动的影响，焦虑或抑郁的影响以及对生活质量的影响的严重治疗差异。o长期扩展表明，在第16周达到EASI75反应的患者中有82.0％和79.1％保持对upadacitinib 15 mg的反应，直到该度量的第52周提高1，并分别测量2次试验。4 upadacitinib 30 mg的相应响应率分别为84.9％和84.3％。IgA0/1响应较低：15 mg的59.2％和52.6％，30 mg的62.5％和65.1％的响应分别为1毫克，分别为1和2。5,6•一个为期52周，第3阶段，安慰剂对照的RCT（AD）表明，upadacitinib加上局部皮质类固醇（TCS）优于安慰剂加上TCS，可以实现第16周EASI75响应的共同成果，并在成年人（87％）（87％）（87％）响应的患者中获得响应的百分比（87％）（87％）严重的广告。
761055orig1s000 -AccessData.fda.gov
表32。Schedule of Events - Screening, Baseline, and Treatment Period – Visits 1 through 14* ......................................................................................................................................................87 Table 33.事件时间表 - 治疗期限续。- 访问15至27* .........................................................................................................................................................................................................................................................................................................................................................................................................................................................活动时间表 - 后续行动，外观访问和提前终止*............................................................................................................................................................................................................................. 91表35。Initial (16-week) Treatment Period Subject Disposition for Trial 1224*.......................95 Table 36.Summary of Subject Accountability and Study Disposition – All Randomized Subjects* ......................................................................................................................................................96 Table 37.Summary of Major Protocol Deviations – All Randomized Patients*...........................98 Table 38.Baseline Demographics for Trial 1224* ........................................................................99 Table 39.Baseline Disease Severity for Trial 1224* ...................................................................100 Table 40.Medical History Findings (≥5% of Patients in Any Treatment Group) by Primary System Organ Class and Preferred Term– SAF*......................................................................................101 Table 41.Atopic/Allergic Disease History – SAF* .......................................................................102 Table 42.Compliance with Background Moisturizer (Emollient)* .............................................103 Table 43.Rescue Medication Taken during the 16-Week Period – SAF*...................................105 Table 44.Rescue Medication Taken during the 52-Week Period*.............................................106 Table 45.在第16周联合试验中获得治疗成功的受试者的比例1224*.......................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................在第16周* ...............................................................................................................................................................................................................从基线到第16周的峰值每日瘙痒率≥4的每周峰值平均每周平均每周的受试者比例（减少）*...............................................................................................................................................................................................................Proportion of Subjects with at least 4-point change from baseline Weeks 2, 4, 16 for Trial 1224*..................................................................................................................................109 Table 49.Proportion of Subjects with IGA success(1) at Week 52 among those that were IGA responders(1) at Week 16 for Trial 1224*..................................................................................109 Table 50.Success on the IGA at Week 16 by Baseline IGA Severity for Trial 1224*...................110 Table 51.在研究第16周实现治疗成功的受试者的比例1224*... 112表55。效力（IgA 0或1）通过基线人口统计学研究1334和1416*..................................................................................................................................... 113表56。Proportion of Subjects Achieving Treatment Success at Week 16 for Monotherapy Studies 1334, 1416* ...................................................................................................................111 Table 52.Proportion of Subjects Achieving Treatment Success at Week 16 for Combination Study 1224*................................................................................................................................111 Table 53.Proportion of Subjects Achieving Treatment Success at Week 16 for Monotherapy Studies 1334, 1416* ...................................................................................................................112 Table 54.效力（IgA 0或1）通过基线人口统计学的试验1224*。IgA响应者由基线IgA严重程度1334和1416*........................................................................................................................................................................................................................................................................................................................................................................................................................................................... 114表58。研究在第16周的IGA成功，基线IgA严重程度研究1224*.............................................................................................................................................................................................................................................................................................................................................................................................................................................Efficacy Results of DUPIXENT Monotherapy at Week 16 (FAS) ..................................119 Table 60.Efficacy Results of DUPIXENT with Concomitant TCS a at Week 16.............................120 Table 61.按研究编号按样本量 - 初级安全池 - （所有注册受试者）*......... 123