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.
Patients 18 years of age or older;
Patients with a confirmed clinical diagnosis of moderate to severe plaque psoriasis at the time of screening;
Patients who are deemed suitable for xeligekimab therapy by a clinician and are anticipated to receive xeligekimab treatment for the first time;
Patients who are willing to sign the informed consent form.
Patients with drug-induced psoriasis (such as new-onset or exacerbated psoriasis caused by β-blockers, calcium channel blockers, or lithium);
Patients with hypersensitivity to the active ingredient or any excipient in xeligekimab injection solution;
Patients with other contraindications specified in the prescribing information;
Patients concurrently participating in other clinical studies;
Adult patients with moderate to severe plaque psoriasis who are anticipated to receive treatment with xeligekimab
Cohort
Prospective
Xeligekimab injection
DrugThis 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.
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.
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.
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.
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.
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.
Absolute change and percentage change from baseline in PASI scores at Weeks 4, 12, 24, 36, and 52
The absolute change (PASI score at each observation time point - baseline PASI score) and the percentage change (\[PASI score at each observation time point - baseline PASI score\] / baseline PASI score \* 100%) in PASI scores at Weeks 4, 12, 24, 36, and 52 compared to the baseline.
Absolute change and percentage change from baseline in PGA scores at Weeks 4, 12, 24, 36, and 52
The absolute change (PGA score at each observation time point - baseline PGA score) and the percentage change (\[PGA score at each observation time point - baseline PGA score\] / baseline PGA score \* 100%) in PGA score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.
Absolute change and percentage change from baseline in DLQI scores at Weeks 4, 12, 24, 36, and 52
The absolute change (DLQI score at each observation time point - baseline DLQI score) and the percentage change (\[DLQI score at each observation time point - baseline DLQI score\] / baseline DLQI score \* 100%) in DLQI score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.
Absolute change from baseline in peak pruritus numerical rating scale (NRS) scores at Weeks 4, 12, 24, 36, and 52
The absolute change (peak pruritus NRS score at each observation time point - baseline peak pruritus NRS score) in peak pruritus NRS score at Weeks 4, 12, 24, 36, and 52 compared to the baseline.
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Chongqing Genrix Biopharmaceutical Co., Ltd
Lead sponsor
Xiangya Hospital of Central South University
Collaborator
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