背景:特应性皮炎(AD),有瘙痒和皮肤损伤的标志性症状,经常损害患者的生活质量。我们评估了中度至重度AD患者在upadacitinib治疗期间与安慰剂或dupilumab相比,皮肤透明/几乎透明且无/最小瘙痒的时间。
方法:此分析包括对MeasureUp1(NCT03569293)的事后分析,测量2(NCT03607422),和抬头(NCT03738397)。测量1和2是重复的,随机化,双盲,安慰剂对照3期研究,患者随机(1:1:1)接受每日一次口服upadacitinib15mg,upadacitinib30毫克,或安慰剂16周。抬头是一个头对头,随机化,双盲,双假人,3b期研究的患者随机(1:1)接受upadacitinib30mg或dupilumab300mg皮下治疗24周.用基线时的湿疹面积和严重程度指数(EASI)评估皮肤清除率,第1、2和4周,此后每4周。在16周内每天使用最严重瘙痒数值评定量表(WP-NRS)评估瘙痒,此后每2周一次至第24周。
结果:该分析包括测量1和测量2中的1683例患者和抬头观察中的673例患者。在测量1和2的16周内,接受upadacitinib的患者花费了9.8-13.4倍的EASI90反应天数和7.0-10.3倍的WP-NRS0/1反应天数。在抬头,接受upadacitinib的患者在16周和24周期间花费的天数分别为2.0和1.7倍,分别,与Dupilumab相比,EASI90反应。通过16周和24周,接受upadacitinib的患者花费了3.0和2.6倍的天数,分别,与dupilumab相比,WP-NRS0/1反应。
结论:中度至重度AD患者使用upadacitinib与安慰剂或dupiliumab相比,皮肤清晰/几乎清晰且无/轻微瘙痒的时间更长。
背景:ClinicalTrials.gov标识符,测量1(NCT03569293),测量2(NCT03607422),注意(NCT03738397)。
BACKGROUND: Atopic dermatitis (AD), with its hallmark symptoms of pruritus and skin lesions, often impairs patients\' quality of life. We assessed time spent with clear/almost clear skin and no/minimal itch during
upadacitinib treatment versus placebo or dupilumab among patients with moderate-to-severe AD.
METHODS: This analysis consisted of a post hoc analysis of Measure Up 1 (NCT03569293), Measure Up 2 (NCT03607422), and Heads Up (NCT03738397). Measure Up 1 and 2 were replicate, randomized, double-blind, placebo-controlled phase 3 studies with patients randomized (1:1:1) to once-daily oral upadacitinib 15 mg,
upadacitinib 30 mg, or placebo for 16 weeks. Heads Up was a head-to-head, randomized, double-blind, double-dummy, phase 3b study with patients randomized (1:1) to upadacitinib 30 mg or subcutaneous dupilumab 300 mg for 24 weeks. Skin clearance was assessed with the Eczema Area and Severity Index (EASI) at baseline, weeks 1, 2, and 4, and every 4 weeks thereafter. Itch was assessed using the Worst Pruritus Numerical Rating Scale (WP-NRS) daily over 16 weeks and every 2 weeks thereafter to week 24 in Heads Up.
RESULTS: This analysis included 1683 patients in Measure Up 1 and 2 and 673 patients in Heads Up. Through 16 weeks in Measure Up 1 and 2, patients receiving
upadacitinib spent 9.8-13.4 times as many days with an EASI 90 response and 7.0-10.3 times as many days with a WP-NRS 0/1 response versus placebo. In Heads Up, patients receiving
upadacitinib spent 2.0 and 1.7 times as many days through 16 and 24 weeks, respectively, with an EASI 90 response versus dupilumab. Through 16 and 24 weeks, patients receiving
upadacitinib spent 3.0 and 2.6 times as many days, respectively, with a WP-NRS 0/1 response versus dupilumab.
CONCLUSIONS: Patients with moderate-to-severe AD spent more time with clear/almost clear skin and no/minimal itch with upadacitinib versus placebo or dupilumab.
BACKGROUND: ClinicalTrials.gov identifier, Measure Up 1 (NCT03569293), Measure Up 2 (NCT03607422), Heads Up (NCT03738397).