Psoriasis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Chinese men or women aged >=18 or older; 2. Patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy, who meet any of the following criteria for moderate to severe plaque psoriasis according to the 'Chinese Psoriasis Diagnosis and Treatment Guidelines 2023' published by the Chinese Medical Association: (1) Psoriasis Area and Severity Index (PASI) score >=3; (2) Body Surface Area (BSA) affected >=3%; (3) Dermatology Life Quality Index (DLQI) score >=6; 3. Based on the investigator's routine clinical judgment and the patient's willingness, treatment with Bimekizumab is intended to be initiated.
Exclusion criteria
Exclusion criteria: 1. History of malignancy; 2. Severe infection; 3. Patients with severe heart failure; 4. Patients with immunodeficiency; 5. Women who are pregnant, breastfeeding, or planning to become pregnant in the near future; 6. Patients with active hepatitis B virus (HBV) infection (according to the *Chinese Guidelines for the Treatment of Psoriasis with Biologics (2021 Edition)*, patients who are HBsAg-positive or HBcAb-positive only must undergo HBV-DNA and liver function tests; active HBV infection is defined as quantitative HBV-DNA positivity accompanied by abnormal liver function or a copy number greater than 10^5/mL. Here, abnormal liver function refers to ALT/AST > upper limit of normal); 7. Patients with active tuberculosis (according to the *Technical Guidelines for Tuberculosis Prevention and Control in China*, active tuberculosis is defined as the presence of clinical symptoms and signs related to tuberculosis, with evidence of active tuberculosis from Mycobacterium tuberculosis-related microbiological, pathological, and imaging tests; see the guidelines for details); 8. History of substance abuse or psychiatric disorders; 9. Allergy to biologics or a history of multiple drug allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index,PASI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body surface area, BSA;Physician's global assessment, PGA;Nail Psoriasis Severity Index, NAPSI;Dermatology life quality index, DLQI; | — |
Countries
China
Contacts
Dematology Hospital of Southern Medical University