Journal Article

Effects of Vunakizumab Treatment on Detailed Dimensions of Patient-Reported Outcomes in Moderate-to-Severe Plaque Psoriasis Patients: A Post-Hoc Analysis of a Randomized Controlled Trial (NCT04839016)

Lv, Lijing, Zhang, Yan

2025

Overview

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.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Adult / Antibodies, Monoclonal, Humanized - administration & dosage / Antibodies, Monoclonal, Humanized - adverse effects / Antibodies, Monoclonal, Humanized - therapeutic use / Anxiety / Clinical outcomes / Double-Blind Method / Female / Humans / Injections, Subcutaneous / Internal Medicine / Male / Mental and physical function / Mental depression / Middle Aged / Moderate-to-severe plaque psoriasis / Pain / Patient Reported Outcome Measures / Patient-reported outcomes / Patients / Placebo effect / Placebos / Pruritus / Psoriasis / Psoriasis - drug therapy / Psoriasis - psychology / Quality of Life / Severity of Illness Index / Skin / Symptoms / Treatment Outcome / Vunakizumab