Lv Lijing, Zhang Yan
Department of Dermatology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Department of Dermatology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Clin Ther. 2025 Sep;47(9):729-739. doi: 10.1016/j.clinthera.2025.06.017. Epub 2025 Jul 24.
This post-hoc analysis aimed to explore the effect of vunakizumab treatment on detailed dimensions of patient-reported outcomes (PROs) in moderate-to-severe plaque psoriasis patients.
This post-hoc analysis derived data from a randomized controlled trial (NCT04839016), which compared the efficacy and safety of vunakizumab with placebo in patients with moderate-to-severe plaque psoriasis. Patients were randomized 2:1 to receive vunakizumab 240 mg or placebo subcutaneously. At week (W)12, patients on placebo were switched to vunakizumab 240 mg. A total of 461 moderate-to-severe plaque psoriasis patients receiving vunakizumab and 229 patients receiving placebo were included in this post-hoc analysis. PROs included the Dermatology Life Quality Index (DLQI), itch numeric rating scale, EuroQol five-dimensional five-level (EQ-5D-5L), and Short Form-36 (SF-36). Items related to anxiety, depression, pruritus, pain, physical function, vitality, and health transitions were extracted from the DLQI, EQ-5D-5L, and SF-36.
DLQI and itch numeric rating scale scores at W4, W8, and W12 were lower in the vunakizumab group than in the placebo group (all P < 0.001). EQ-5D-5L and SF-36 mental/physical component scores at W4, W8, and W12 were higher in the vunakizumab group than in the placebo group (all P < 0.001). The mean DLQI (W0: 11.3 ± 6.9, W12: 2.2 ± 3.0, W52: 1.5 ± 3.1) and itch numeric rating scale (W0: 5.6 ± 2.6, W12: 1.6 ± 1.7, W52: 1.0 ± 1.5) scores were decreased from W0 to W52 after vunakizumab treatment. EQ-5D-5L scores (W0: 80.3 ± 16.3, W12: 90.4 ± 8.0, W52: 92.4 ± 8.1) as well as SF-36 mental (W0: 47.8 ± 10.2, W12: 53.7 ± 7.1, W52: 54.5 ± 6.9) and physical (W0: 51.4 ± 6.3, W12: 55.6 ± 4.5, W52: 55.7 ± 5.0) component scores increased from W0 to W52 after vunakizumab treatment. Anxiety, depression, pruritus, and pain were attenuated after vunakizumab treatment. Physical function, vitality, and health transitions were enhanced after vunakizumab treatment.
Vunakizumab sustainedly improves overall PROs in Chinese moderate-to-severe plaque psoriasis patients, especially in the dimensions of mental, neurological, and behavioral feelings.
本事后分析旨在探讨布罗达单抗治疗对中度至重度斑块状银屑病患者报告结局（PROs）详细维度的影响。
本事后分析的数据来自一项随机对照试验（NCT04839016），该试验比较了布罗达单抗与安慰剂在中度至重度斑块状银屑病患者中的疗效和安全性。患者按2:1随机分组，皮下注射布罗达单抗240mg或安慰剂。在第12周时，接受安慰剂治疗的患者换用布罗达单抗240mg。本事后分析共纳入461例接受布罗达单抗治疗的中度至重度斑块状银屑病患者和229例接受安慰剂治疗的患者。PROs包括皮肤病生活质量指数（DLQI）、瘙痒数字评定量表、欧洲五维健康量表（EQ-5D-5L）和简明健康调查问卷（SF-36）。从DLQI、EQ-5D-5L和SF-36中提取与焦虑、抑郁、瘙痒、疼痛、身体功能、活力和健康转变相关的条目。
布罗达单抗组在第4周、第8周和第12周时的DLQI和瘙痒数字评定量表评分低于安慰剂组（所有P<0.001）。布罗达单抗组在第4周、第8周和第12周时的EQ-5D-5L和SF-36精神/身体成分评分高于安慰剂组（所有P<0.001）。布罗达单抗治疗后，从第0周至第52周，平均DLQI（第0周：11.3±6.9，第12周：2.2±3.0，第52周：1.5±3.1）和瘙痒数字评定量表（第0周：5.6±2.6，第12周：1.6±1.7，第52周：1.0±1.5）评分降低。布罗达单抗治疗后，从第0周至第52周，EQ-5D-5L评分（第0周：80.3±16.3，第12周：90.4±8.0，第52周：92.4±8.1）以及SF-36精神（第0周：47.8±10.2，第12周：53.7±7.1，第52周：54.5±6.9）和身体（第0周：51.4±6.3，第12周：55.6±4.5，第52周：55.7±5.0）成分评分升高。布罗达单抗治疗后，焦虑、抑郁、瘙痒和疼痛减轻。布罗达单抗治疗后，身体功能、活力和健康转变得到改善。
布罗达单抗持续改善中国中度至重度斑块状银屑病患者的总体PROs，尤其是在精神、神经和行为感受方面。
