Psoriasis
Conditions
Brief summary
The goal of this investigator-initiated, real-world, observational study is to investigate the impact of weight loss on treatment efficacy in overweight or obese Chinese patients with moderate-to-severe plaque psoriasis. The main question it aims to answer is: Does a structured weight loss intervention (including dietary management, exercise, and/or pharmacotherapy) improve the clinical response to psoriasis therapy in this population, as measured by the proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score below 3 at Week 24? Researchers will compare the Weight Loss Intervention Group (receiving standard psoriasis care plus a personalized weight management program) to the Control Group (receiving standard psoriasis care only) to see if the addition of weight loss strategies leads to superior improvements in psoriasis severity, metabolic parameters, and quality of life. Participants will: Receive standardized treatment for their psoriasis based on disease severity. Be allocated (based on patient preference and clinical judgment) to either the intervention or control group. In the intervention group, receive and follow a personalized weight management plan, which may include dietary counseling, a tailored exercise regimen, and/or Glucagon-Like Peptide-1（GLP-1） receptor agonist therapy (e.g., Semaglutide, Tirzepatide) if indicated. Undergo scheduled assessments at baseline, Week 12, and Week 24, including: Clinical evaluations (PASI, Physician's Global Assessment, body surface area). Anthropometric measurements (weight, BMI, waist/hip circumference). Quality of life assessment (Dermatology Life Quality Index). Safety monitoring for adverse events. To investigate the impact of weight loss on treatment efficacy among overweight/obese Chinese patients with plaque psoriasis.
Interventions
COMBINATION_PRODUCTWeight loss and psoriasis treatment
In the weight loss group, receive standardized treatment for their psoriasis based on disease severity and follow a personalized weight management plan, which may include dietary counseling, a tailored exercise regimen, and/or GLP-1 receptor agonist therapy (e.g., Semaglutide, Tirzepatide) if indicated.
COMBINATION_PRODUCTpsoriasis treatment
Receive standardized treatment for their psoriasis based on disease severity.
Sponsors
Peking University Third Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years, regardless of gender. 2. Having signed the informed consent form. 3. Clinical diagnosis of plaque psoriasis. 4. Body Mass Index (BMI) categorized as overweight or obese. 5. For female patients: No plans for pregnancy or oocyte donation during the study period and voluntary use of highly effective physical contraception.
Exclusion criteria
1. Pregnant or lactating women. 2. Individuals deemed by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of PASI<3 at Week 24 | Week 24 | Proportion of patients undergoing weight loss treatment who achieve a Psoriasis Area and Severity Index (PASI) score below 3 at Week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of PASI<3 at Week 12 | Week 12 | Proportion of patients undergoing weight loss treatment who achieve a PASI score below 3 at Week 12. |
| Changes of BMI | Week 12 and Week 24 | Changes from baseline in Body Mass Index (BMI) at Week 12 and Week 24 in patients undergoing weight loss treatment. |
| Proportion of PGA 0/1 (Physician's Global Assessment) | Week 12 and Week 24 | Proportion of patients undergoing weight loss treatment who achieve a Physician's Global Assessment (PGA) score of 0 or 1 at Week 12 and Week 24. |
| Proportion of DLQI<6 | Week 12 and Week 24 | Proportion of patients undergoing weight loss treatment who achieve a Dermatology Life Quality Index (DLQI) score below 6 at Week 12 and Week 24 |
Outcome results
None listed