Yosipovitch Gil, Kim Brian S, Kwatra Shawn G, Mollanazar Nicholas K, Ständer Sonja, Satoh Takahiro, Mendes-Bastos Pedro, Tsai Tsen-Fang, Laws Elizabeth, Nivens Michael C, Maloney Jennifer, Shi Genming, Bansal Ashish, Dubost-Brama Ariane
Dr Phillip Frost Department of Dermatology and Cutaneous Surgery and Miami Itch Center, University of Miami, Miami, Florida.
Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.
JAAD Int. 2024 Apr 10;16:163-174. doi: 10.1016/j.jdin.2024.03.025. eCollection 2024 Sep.
Phase 3 PRIME/PRIME2 trials independently demonstrated efficacy and an acceptable safety profile of dupilumab adults with moderate-to-severe prurigo nodularis.
To obtain a more precise estimate of onset and magnitude of treatment effect using PRIME/PRIME2 pooled data.
In PRIME/PRIME2, patients were randomized to dupilumab or placebo for 24 weeks. Pooled analysis assessed proportion of patients achieving clinically meaningful improvement in itch, clear/almost-clear skin, or both; at weeks 12 and 24; overall and by demographic subgroups and changes from baseline to week 24 in symptoms, signs, and quality of life.
Patients receiving dupilumab ( = 153) vs placebo ( = 158) experienced significant improvements in all tested endpoints. At week 24, 90 (58.8%) dupilumab-treated vs 30 (19.0%) placebo-treated patients achieved clinically meaningful improvement in itch, 71 (46.4%) vs 27 (17.1%) clear/almost clear skin, and 54 (35.3%) vs 14 (8.9%) achieved both ( < .0001 for all). Treatment benefits were independent of baseline demographics. Safety to week 36 was generally consistent with the known dupilumab safety profile.
On-treatment data limited to 24 weeks.
Pooled analysis confirmed improvements reported in individual trials and revealed earlier effect onset in itch and skin pain. Dupilumab treatment showed benefits across demographics.
3期PRIME/PRIME2试验独立证明了度普利尤单抗治疗中度至重度结节性痒疹成人患者的疗效和可接受的安全性。
使用PRIME/PRIME2汇总数据更精确地估计治疗效果的起效时间和程度。
在PRIME/PRIME2试验中，患者被随机分配接受度普利尤单抗或安慰剂治疗24周。汇总分析评估了在第12周和第24周时，在瘙痒、皮肤清除/几乎清除或两者方面实现具有临床意义改善的患者比例；总体情况以及按人口统计学亚组分析，以及从基线到第24周症状、体征和生活质量的变化。
接受度普利尤单抗治疗的患者（n = 153）与接受安慰剂治疗的患者（n = 158）相比，在所有测试终点均有显著改善。在第24周时，接受度普利尤单抗治疗的患者中有90例（58.8%）在瘙痒方面实现了具有临床意义的改善，而接受安慰剂治疗的患者中有30例（19.0%）；71例（46.4%）接受度普利尤单抗治疗的患者皮肤清除/几乎清除，而接受安慰剂治疗的患者中有27例（17.1%）；54例（35.3%）接受度普利尤单抗治疗的患者两者均实现改善，而接受安慰剂治疗的患者中有14例（8.9%）（所有比较P <.0001）。治疗益处与基线人口统计学无关。至第36周的安全性总体上与已知的度普利尤单抗安全性特征一致。
治疗期数据限于24周。
汇总分析证实了各试验报告的改善情况，并揭示了瘙痒和皮肤疼痛方面更早的起效时间。度普利尤单抗治疗在各人口统计学亚组中均显示出益处。
