Xeligekimab Injection was approved in China on August 20, 2024, for treating adults with moderate to severe plaque psoriasis who are candidates for systemic treatment or phototherapy. Despite the promising efficacy and safety shown in the phase III clinical trial, real-world data is needed to further support clinical decisions for this patient group. This study aims to evaluate the effectiveness and safety of xeligekimab in real-world clinical settings for adults with moderate to severe plaque psoriasis.
This multicenter, prospective, real-world study will consecutively enroll moderate to severe plaque psoriasis adult patients who are anticipated to receive xeligekimab for the first time. All patients will receive routine clinical care. The study will evaluate the treatment's effectiveness and safety and observe treatment patterns for up to 52 weeks. Objectives: Primary Objective: To evaluate the effectiveness and safety of xeligekimab in adult patients with moderate to severe plaque psoriasis in clinical practice. Secondary Objective: To observe the treatment patterns of xeligekimab in adult patients with moderate to severe plaque psoriasis in clinical practice. Exploratory Objectives: * To explore the effectiveness of xeligekimab in subgroup patients with psoriatic arthritis. * To explore the effectiveness of xeligekimab in subgroup patients with psoriasis involving special areas (scalp, nails, palmoplantar areas, genital areas, etc.). * To explore the effectiveness of xeligekimab in subgroup patients with comorbidities of psoriasis. * To explore the effectiveness and safety of xeligekimab in subgroup patients with psoriasis who have previously received treatment with other biologic agents.
Study Type
OBSERVATIONAL
Enrollment
1,000
This is a real-world study. All treatment regimens are developed and implemented through detailed communication between patients and their treating clinicians. Treatment recommendations are consistent with the medication's prescribing information and treatment guidelines. The recommended dosing for xeligekimab is 200 mg at weeks 0, 2, 4, 6, 8, 10, and 12, followed by every 4 weeks thereafter. Each 200 mg dose is given in 2 separate 100 mg subcutaneous injections. The preferred injection site is the abdomen. Upper arms or thighs are recommended as alternative sites.
Xiangya Hospital of Central South University
Hunan, Changsha, China
Psoriasis Area and Severity Index 90 (PASI90) response rate at Week 12
The proportion of patients achieving a ≥90% improvement in PASI score at Week 12 compared to the baseline.
Time frame: Week 12
PASI90 response rates at Weeks 4, 24, 36, and 52
The proportions of patients achieving a ≥90% improvement in PASI score at Weeks 4, 24, 36, and 52 compared to the baseline.
Time frame: Weeks 4, 24, 36, and 52
PASI75 and PASI100 response rates at Weeks 4, 12, 24, 36, and 52
The proportions of patients achieving a ≥75% improvement and those achieving a 100% improvement in PASI score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.
Time frame: Weeks 4, 12, 24, 36, and 52
Physician's Global Assessment (PGA) 0/1 response rates at Weeks 4, 12, 24, 36, and 52
The proportions of patients achieving a PGA score of 0 or 1 at Weeks 4, 12, 24, 36, and 52.
Time frame: Weeks 4, 12, 24, 36, and 52
Dermatology Life Quality Index (DLQI) 0/1 response rates at Weeks 4, 12, 24, 36, and 52
The proportions of patients achieving a DLQI score of 0 or 1 at Weeks 4, 12, 24, 36, and 52.
Time frame: Weeks 4, 12, 24, 36, and 52
Treatment patterns: treatment statuses
The proportions of patients with different treatment statuses (including adherence, persistence, non-persistence, discontinuation, switching, and re-initiation of therapy) will be recorded by the investigators at Weeks 12, 24, 36, and 52.
Time frame: Weeks 12, 24, 36, and 52
Treatment patterns: reasons for non-persistence, discontinuation, switching, and re-initiation of therapy
The proportions of patients with different treatment statuses (non-persistence, discontinuation, switching, and re-initiation of therapy) categorized by reasons will be recorded by the investigators at Weeks 12, 24, 36, and 52.
Time frame: Weeks 12, 24, 36, and 52
Treatment patterns: treatment regimens after switching
The proportions of patients who receive different treatment regimens following a switch from xeligekimab will be recorded by the investigators at Weeks 12, 24, 36, and 52.
Time frame: Weeks 12, 24, 36, and 52
Adverse Events (AEs)
All AEs occurring after the initiation of treatment will be recorded. Investigators should assess the causal relationship between the AEs and the treatment to identify Treatment-Related AEs (TRAEs). The severity of adverse events will be evaluated according to CTCAE Version 5.0. Additionally, Serious Adverse Events (SAEs) and AEs leading to the temporary suspension or permanent discontinuation of the study treatment will be recorded.
Time frame: Week 52
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