To Explore the Influencing Factors and Solutions for Patients With Plaque Psoriasis Undergoing Relapse

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.

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Key information

Conditions

Plaque Psoriasis Biologic Agents Disease Attributes Influence Factors Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Relapse

Sex eligibility

All sexes

Study type

Observational

Primary location

Dermatology Department of the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Diagnosis and Physical Examination of Psoriasis

Diagnostic Test

This study divided patients with plaque psoriasis treated with biological agents into a recurrent group and a non recurrent group based on whether they recurred or not

Primary outcomes

General Information

Time frame: 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

Time frame: 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

Secondary outcomes

Laboratory testing indicators

Time frame: 12/1/2022-12/1/2024

Blood routine test (mainly collecting leukocyte series), liver and kidney function, blood lipids, TB infection T cell detection, five items of hepatitis B, Th subgroup cytokines series, eight items of immunity, antinuclear antibody titer, C-reactive protein
Imaging examination

Time frame: 12/1/2022-12/1/2024

chest X-ray or CT, abdominal ultrasound

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Jul 28, 2026
Registry last updated: Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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