Naunyn-Schmiedeberg's archives of pharmacology · 2025
Comparison of patient-reported outcomes in patients achieving complete versus near-complete skin clearance following Vunakizumab treatment: a post-hoc analysis of a phase III trial.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Wang Shuang, Li Fuqiu
Аннотация
OBJECTIVE: This post-hoc analysis used the data from a previous randomized controlled trial (NCT04839016) and aimed to compare patient-reported outcomes (PROs) between patients who achieved complete (PASI 100; N = 178) and near-complete (PASI 90-99; N = 181) skin clearance during 12 weeks of Vunakizumab treatment.
METHODS: PROs included the Dermatology Life Quality Index (DLQI) score, DLQI 0/1 response rate, Itch Numerical Rating Scale (NRS) score, and Short Form-36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS).
RESULTS: The proportion of patients who achieved a DLQI of 0/1 at week (W)8 (P < 0.010), W12 (P < 0.010), W20 (P < 0.001), W28 (P < 0.050), W36 (P < 0.010), and W52 (P < 0.050) was higher in the PASI 100 group compared to the PASI 90-99 group. The mean DLQI score at W4 (P < 0.010), W8 (P < 0.010), W12 (P < 0.001), W20 (P < 0.001), W28 (P < 0.001), W36 (P < 0.001), W44 (P < 0.001), and W52 (P < 0.001), as well as itch NRS score at W8 (P < 0.001), W12 (P < 0.010), W20 (P < 0.001), W28 (P < 0.010), W36 (P < 0.001), W44 (P < 0.010), and W52 (P < 0.010) were lower in the PASI 100 group than in the PASI 90-99 group. The mean SF-36 MCS at W4 (P < 0.050), W12 (P < 0.001), W20 (P < 0.010), W28 (P < 0.001), W36 (P < 0.050), W44 (P < 0.010), and W52 (P < 0.050), as well as SF-36 PCS at W8 (P < 0.050) and W36 (P < 0.050) were higher in the PASI 100 group than in the PASI 90-99 group.
CONCLUSION: Patients with complete skin clearance following Vunakizumab treatment showed improved quality of life, reduced pruritus, and enhanced mental health compared to those with near-complete skin clearance.
METHODS: PROs included the Dermatology Life Quality Index (DLQI) score, DLQI 0/1 response rate, Itch Numerical Rating Scale (NRS) score, and Short Form-36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS).
RESULTS: The proportion of patients who achieved a DLQI of 0/1 at week (W)8 (P < 0.010), W12 (P < 0.010), W20 (P < 0.001), W28 (P < 0.050), W36 (P < 0.010), and W52 (P < 0.050) was higher in the PASI 100 group compared to the PASI 90-99 group. The mean DLQI score at W4 (P < 0.010), W8 (P < 0.010), W12 (P < 0.001), W20 (P < 0.001), W28 (P < 0.001), W36 (P < 0.001), W44 (P < 0.001), and W52 (P < 0.001), as well as itch NRS score at W8 (P < 0.001), W12 (P < 0.010), W20 (P < 0.001), W28 (P < 0.010), W36 (P < 0.001), W44 (P < 0.010), and W52 (P < 0.010) were lower in the PASI 100 group than in the PASI 90-99 group. The mean SF-36 MCS at W4 (P < 0.050), W12 (P < 0.001), W20 (P < 0.010), W28 (P < 0.001), W36 (P < 0.050), W44 (P < 0.010), and W52 (P < 0.050), as well as SF-36 PCS at W8 (P < 0.050) and W36 (P < 0.050) were higher in the PASI 100 group than in the PASI 90-99 group.
CONCLUSION: Patients with complete skin clearance following Vunakizumab treatment showed improved quality of life, reduced pruritus, and enhanced mental health compared to those with near-complete skin clearance.