PDF(Pubmed)
Abstract：
UNASSIGNED: Prurigo nodularis (PN) and chronic pruritus of unknown origin (CPUO) are chronic pruritic diseases that dramatically impair quality of life, but therapeutic options are limited. Abrocitinib, a Janus kinase 1 inhibitor, represents a promising therapy for both conditions.
UNASSIGNED: To assess the efficacy and safety of 200-mg oral abrocitinib administered once daily in adults with moderate to severe PN or CPUO.
UNASSIGNED: This phase 2, open-label, nonrandomized controlled trial conducted between September 2021 and July 2022 took place at a single center in the US. A total of 25 adult patients with moderate to severe PN or CPUO were screened. Ten patients with PN and 10 patients with CPUO were enrolled. All 20 patients completed the 12-week treatment period, 18 of whom completed the 4-week follow-up period.
UNASSIGNED: Abrocitinib, 200 mg, by mouth once daily for 12 weeks.
UNASSIGNED: The primary efficacy end point was the percent change in weekly Peak Pruritus Numerical Rating Scale (PP-NRS) scores from baseline to week 12. Key secondary end points included the percentage of patients achieving at least a 4-point reduction in weekly PP-NRS score from baseline to week 12 and the percent change in Dermatology Life Quality Index (DLQI) scores.
UNASSIGNED: A total of 10 patients with PN (mean [SD] age, 58.6 [13.1] years; all were female) and 10 patients with CPUO (mean [SD] age, 70.7 [5.6] years; 2 were female) enrolled in the study. The mean (SD) baseline PP-NRS score was 9.2 (1.0) for PN and 8.2 (1.2) for CPUO. PP-NRS scores decreased by 78.3% in PN (95% CI, -118.5 to -38.1; P < .001) and 53.7% in CPUO (95% CI, -98.8 to -8.6; P = .01) by week 12. From baseline to week 12, 8 of 10 patients with PN and 6 of 10 patients with CPUO achieved at least a 4-point improvement on the PP-NRS. Both groups experienced significant improvement in quality of life as demonstrated by percent change in DLQI scores (PN: -53.2% [95% CI, -75.3% to -31.1%]; P = .002; CPUO: -49.0% [95% CI, -89.6% to -8.0%]; P = .02). The most common adverse event among patients was acneiform eruption in 2 of 20 patients (10%). No serious adverse events occurred.
UNASSIGNED: The results of this nonrandomized controlled trial suggest that abrocitinib monotherapy may be effective and tolerated well in adults with PN or CPUO. Randomized, double-blind, placebo-controlled trials are warranted to validate these findings.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT05038982.
UNASSIGNED: To assess the efficacy and safety of 200-mg oral abrocitinib administered once daily in adults with moderate to severe PN or CPUO.
UNASSIGNED: This phase 2, open-label, nonrandomized controlled trial conducted between September 2021 and July 2022 took place at a single center in the US. A total of 25 adult patients with moderate to severe PN or CPUO were screened. Ten patients with PN and 10 patients with CPUO were enrolled. All 20 patients completed the 12-week treatment period, 18 of whom completed the 4-week follow-up period.
UNASSIGNED: Abrocitinib, 200 mg, by mouth once daily for 12 weeks.
UNASSIGNED: The primary efficacy end point was the percent change in weekly Peak Pruritus Numerical Rating Scale (PP-NRS) scores from baseline to week 12. Key secondary end points included the percentage of patients achieving at least a 4-point reduction in weekly PP-NRS score from baseline to week 12 and the percent change in Dermatology Life Quality Index (DLQI) scores.
UNASSIGNED: A total of 10 patients with PN (mean [SD] age, 58.6 [13.1] years; all were female) and 10 patients with CPUO (mean [SD] age, 70.7 [5.6] years; 2 were female) enrolled in the study. The mean (SD) baseline PP-NRS score was 9.2 (1.0) for PN and 8.2 (1.2) for CPUO. PP-NRS scores decreased by 78.3% in PN (95% CI, -118.5 to -38.1; P < .001) and 53.7% in CPUO (95% CI, -98.8 to -8.6; P = .01) by week 12. From baseline to week 12, 8 of 10 patients with PN and 6 of 10 patients with CPUO achieved at least a 4-point improvement on the PP-NRS. Both groups experienced significant improvement in quality of life as demonstrated by percent change in DLQI scores (PN: -53.2% [95% CI, -75.3% to -31.1%]; P = .002; CPUO: -49.0% [95% CI, -89.6% to -8.0%]; P = .02). The most common adverse event among patients was acneiform eruption in 2 of 20 patients (10%). No serious adverse events occurred.
UNASSIGNED: The results of this nonrandomized controlled trial suggest that abrocitinib monotherapy may be effective and tolerated well in adults with PN or CPUO. Randomized, double-blind, placebo-controlled trials are warranted to validate these findings.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT05038982.
摘要：
■结节性痒疹（PN）和不明原因的慢性瘙痒（CPUO）是严重损害生活质量的慢性瘙痒疾病，但治疗选择有限。阿布西替尼,Janus激酶1抑制剂，代表了两种情况的有希望的治疗方法。
■评估在中度至重度PN或CPUO的成人中每日一次口服200mgabrocitinib的疗效和安全性。
■此阶段2，开放标签，2021年9月至2022年7月在美国的一个中心进行了非随机对照试验.共筛查了25例中度至重度PN或CPUO的成年患者。纳入10例PN患者和10例CPUO患者。所有20例患者均完成了为期12周的治疗期，其中18人完成了为期4周的随访期。
■阿布西替尼，200毫克，每天一次，持续12周。
主要疗效终点是从基线到第12周的每周瘙痒峰数字评定量表（PP-NRS）评分的百分比变化。关键次要终点包括每周PP-NRS评分从基线到第12周至少降低4分的患者百分比以及皮肤病生活质量指数（DLQI）评分的百分比变化。
■共有10例PN患者（平均[SD]年龄，58.6[13.1]岁；均为女性）和10例CPUO患者（平均[SD]年龄，70.7[5.6]年；2人为女性）参加研究。PN的平均（SD）基线PP-NRS评分为9.2（1.0），CPUO为8.2（1.2）。到第12周，PN的PP-NRS评分下降了78.3%（95%CI，-118.5至-38.1；P<.001），CPUO的PP-NRS评分下降了53.7%（95%CI，-98.8至-8.6；P=.01）。从基线到第12周，10名PN患者中的8名和10名CPUO患者中的6名在PP-NRS上至少获得了4分的改善。两组患者的生活质量均有显著改善，表现为DLQI评分变化百分比（PN：-53.2%[95%CI，-75.3%至-31.1%]；P=.002；CPUO：-49.0%[95%CI，-89.6%至-8.0%]；P=.02）。患者中最常见的不良事件是20例患者中有2例（10％）出现痤疮样爆发。无严重不良事件发生。
■这项非随机对照试验的结果表明，abrocitinib单药治疗对PN或CPUO患者可能有效且耐受性良好。随机化,双盲,安慰剂对照试验有必要验证这些发现.
■ClinicalTrials.gov标识符：NCT05038982。
■评估在中度至重度PN或CPUO的成人中每日一次口服200mgabrocitinib的疗效和安全性。
■此阶段2，开放标签，2021年9月至2022年7月在美国的一个中心进行了非随机对照试验.共筛查了25例中度至重度PN或CPUO的成年患者。纳入10例PN患者和10例CPUO患者。所有20例患者均完成了为期12周的治疗期，其中18人完成了为期4周的随访期。
■阿布西替尼，200毫克，每天一次，持续12周。
主要疗效终点是从基线到第12周的每周瘙痒峰数字评定量表（PP-NRS）评分的百分比变化。关键次要终点包括每周PP-NRS评分从基线到第12周至少降低4分的患者百分比以及皮肤病生活质量指数（DLQI）评分的百分比变化。
■共有10例PN患者（平均[SD]年龄，58.6[13.1]岁；均为女性）和10例CPUO患者（平均[SD]年龄，70.7[5.6]年；2人为女性）参加研究。PN的平均（SD）基线PP-NRS评分为9.2（1.0），CPUO为8.2（1.2）。到第12周，PN的PP-NRS评分下降了78.3%（95%CI，-118.5至-38.1；P<.001），CPUO的PP-NRS评分下降了53.7%（95%CI，-98.8至-8.6；P=.01）。从基线到第12周，10名PN患者中的8名和10名CPUO患者中的6名在PP-NRS上至少获得了4分的改善。两组患者的生活质量均有显著改善，表现为DLQI评分变化百分比（PN：-53.2%[95%CI，-75.3%至-31.1%]；P=.002；CPUO：-49.0%[95%CI，-89.6%至-8.0%]；P=.02）。患者中最常见的不良事件是20例患者中有2例（10％）出现痤疮样爆发。无严重不良事件发生。
■这项非随机对照试验的结果表明，abrocitinib单药治疗对PN或CPUO患者可能有效且耐受性良好。随机化,双盲,安慰剂对照试验有必要验证这些发现.
■ClinicalTrials.gov标识符：NCT05038982。
