To Explore the Influencing Factors and Solutions for Patients With Plaque Psoriasis Undergoing Relapse
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- General Information
研究概览
简要总结
In recent years, an increasing number of patients who have experienced poor efficacy or adverse drug reactions using traditional treatment regimens have received biologic therapy and achieved satisfactory treatment results. However, we also found that some patients have poor reactions to biological agents. Biological agents are often the final treatment choice for most patients, and patients often have high expectations for this treatment plan. Therefore, exploring the factors that affect the efficacy of biological agents and effective follow-up treatment plans when there is poor response to biological agents is of great significance for the treatment of psoriasis patients.
The main research objective of this project is to observe and record the clinical characteristics and efficacy of plaque psoriasis patients treated with biological agents in the real world. 2. Explore the influencing factors of recurrence in plaque psoriasis patients receiving biological therapy in the real world, in order to increase awareness and awareness of this phenomenon, and provide guidance for preventing recurrence after biological therapy. 3. Record the follow-up treatment plans or response measures for recurrent patients, and compare the efficacy of different treatment plans.
This study is a case-control study that recruited patients with plaque psoriasis who have received biological therapy for more than half a year. A questionnaire survey was conducted to understand their general information, disease-related clinical data, and laboratory examination data. Univariate analysis was used to compare all variables between groups, and logistic regression analysis was performed on variables with statistical differences. Corresponding ROC curves were then drawn. Perform a separate analysis of the Adalimumab group according to the above steps. In addition, descriptive analysis was conducted on the characteristics that may be related to the disease in the recurrence group, and the efficacy of different treatment plans after recurrence was compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as plaque psoriasis.
- •Received biological therapy for more than six months.
- •Voluntarily participate in this study, with normal communication and understanding abilities.
- •Recurrent group: Patients with initial treatment effective (PGA or BSA improvement reduced by more than 75% from baseline), PGA ≥ 3 or BSA decreased by less than 50% from baseline after a period of time [218], and who were treated in the dermatology department of our hospital.
- •Control group: Treatment effective (PGA maintained at 0/1 or BSA improvement decreased by more than 75% from baseline), and no recurrence as mentioned in ④ occurred.
排除标准
- •Patients with other types of psoriasis.
- •Pregnant patients
- •Patients who refuse to cooperate with medical staff questionnaire surveys or refuse to provide auxiliary testing or examination materials.
结局指标
主要结局
General Information
时间窗: 12/1/2022-12/1/2024
Age, gender, occupation, education, height, weight, abdominal circumference, history of smoking or excessive drinking, dietary preferences, sleep quality, exercise status
Psoriasis related information
时间窗: 12/1/2022-12/1/2024
The duration of illness, the name and administration scheme of the biological agent, the age when using the biological agent, the age of the first onset of psoriasis, the body surface involved area (BSA) of the skin lesions when injecting the first dose of biological agent, whether to comply with medical advice, whether to have psoriasis comorbidity, whether to treat other diseases at the same time, whether to have a family history of psoriasis, whether to involve joints, whether to involve special parts, whether to have infectious diseases during the treatment period, whether to vaccinate COVID-19 vaccine
次要结局
- Laboratory testing indicators(12/1/2022-12/1/2024)
- Imaging examination(12/1/2022-12/1/2024)
研究者
Zhou Yan
Professor
First Affiliated Hospital Xi'an Jiaotong University