Association Between Early Clinical Responses and Long-Term Outcomes With Ruxolitinib Cream Treatment in Mild to Moderate Atopic Dermatitis

V. H. Prajapati, Bob Geng, Andrew Blauvelt, L. Eichenfield, Parbeer S. Grewal, L. Kircik, Peter Lio, Charles Lynde, E. Simpson, Haobo Ren, D. Sturm, Grace Wong, Chih-ho Hong
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Abstract

In the TRuE-AD1/2 studies, patients aged ≥12 years with atopic dermatitis (Investigator’s Global Assessment [IGA] 2/3; 3%–20% affected body surface area) were randomized (2:2:1) to twice-daily 0.75%/1.5% ruxolitinib cream or vehicle for an 8-week, double-blind period followed by a 44-week long-term safety (LTS) period of as-needed ruxolitinib cream. This analysis examines associations between Week 8 responder status to 1.5% ruxolitinib cream with LTS outcomes. At Week 8, 57.0% (244/428) of LTS-evaluable patients applying 1.5% ruxolitinib cream achieved IGA–Treatment Success (IGA-TS; IGA 0/1 with ≥2-grade improvement from baseline); 66.6% (285/428) achieved ≥75% improvement in Eczema Area and Severity Index from baseline (EASI-75); 45.8% (196/428) achieved Itch numerical rating scale 0/1 (NRS 0/1). For patients with ≥2 visits (every 4 weeks) during LTS, mean percentages of visits with clear/almost clear skin were 83.2% vs 59.7%, 82.2% vs 54.9%, and 77.3% vs 70.1% for Week 8 IGA-TS, EASI-75, and Itch NRS 0/1 responders vs nonresponders, respectively. Mean percentages of visits with clear/almost clear skin were similar regardless of time to achieve IGA-TS (83.4%/77.4%/81.9% for those achieving at Week 2/4/8), EASI-75 (80.7%/78.8%/81.6%), and Itch NRS 0/1 (75.8%/70.7%/72.8%). During LTS, mean (SD) cumulative treatment-free days due to complete clearance were 149.2 (86.43) vs 104.0 (89.10), 146.4 (88.43) vs 95.9 (83.55), and 142.6 (87.58) vs 124.4 (91.47) for Week 8 IGA-TS, EASI-75, and Itch NRS 0/1 responders vs nonresponders, respectively. Percentage of treatment-free days between study visits (between Weeks 8 and 12 vs Weeks 48 and 52) among Week 8 responders and nonresponders increased from 44.1% to 50.2% and from 16.3% to 42.3% for IGA-TS; from 41.2% to 49.9% and from 14.9% to 40.6% for EASI-75; from 39.8% to 49.4% and from 29.9% to 46.0% for itch NRS 0/1. In summary, efficacy responses achieved with 8-week ruxolitinib cream treatment are associated with higher disease control in LTS; however, nonresponders approach similar disease control with continued treatment. As-needed ruxolitinib cream monotherapy demonstrated substantial long-term disease control regardless of time to first response achievement.
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芦可利替尼乳膏治疗轻度至中度特应性皮炎的早期临床反应与长期疗效之间的关系
在TRuE-AD1/2研究中,年龄≥12岁的特应性皮炎患者(研究者总体评估[IGA] 2/3;受影响体表面积3%-20%)被随机(2:2:1)分配到每天两次的0.75%/1.5%芦可利替尼乳膏或载体中,双盲期为8周,然后按需使用芦可利替尼乳膏,长期安全期(LTS)为44周。本分析探讨了1.5%芦可利替尼乳膏第8周应答者状态与长期安全期结果之间的关系。第8周时,57.0%(244/428)使用1.5% ruxolitinib乳膏的LTS有效患者达到了IGA-治疗成功(IGA-TS;IGA 0/1,与基线相比改善≥2级);66.6%(285/428)的湿疹面积和严重程度指数(EASI-75)与基线相比改善≥75%;45.8%(196/428)的瘙痒数字评分表达到0/1(NRS 0/1)。对于在长期治疗期间就诊次数≥2次(每4周一次)的患者,第8周IGA-TS、EASI-75和瘙痒NRS 0/1应答者与非应答者中,皮肤无瘙痒/几乎无瘙痒的就诊平均百分比分别为83.2% vs 59.7%、82.2% vs 54.9%和77.3% vs 70.1%。无论达到IGA-TS(第2/4/8周达到者为83.4%/77.4%/81.9%)、EASI-75(80.7%/78.8%/81.6%)和Itch NRS 0/1(75.8%/70.7%/72.8%)的时间长短,皮肤无瘙痒/几乎无瘙痒的就诊平均百分比相似。在长期治疗期间,第 8 周 IGA-TS、EASI-75 和 Itch NRS 0/1 有反应者与无反应者因完全清除而获得的平均(标度)累计无治疗天数分别为 149.2 (86.43) vs 104.0 (89.10)、146.4 (88.43) vs 95.9 (83.55) 和 142.6 (87.58) vs 124.4 (91.47)。第 8 周应答者和未应答者在两次研究访问之间(第 8 周和第 12 周 vs 第 48 周和第 52 周之间)的无治疗天数百分比分别从 44.1% 增加到 50.2%,IGA-TS 从 16.3% 增加到 42.3%;EASI-75 从 41.2% 增加到 49.9%,EASI-75 从 14.9% 增加到 40.6%;痒 NRS 0/1 从 39.8% 增加到 49.4%,痒 NRS 0/1 从 29.9% 增加到 46.0%。总之,8周鲁索利替尼乳膏治疗获得的疗效反应与LTS较高的疾病控制率相关;然而,无应答者继续治疗也能获得类似的疾病控制率。按需使用的鲁索利替尼乳膏单药治疗显示出很强的长期疾病控制能力,而与首次应答的时间无关。
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