Clinical trial NCT06391996: Biologic Therapy for Generalized Pustular Psoriasis
Official title: Genetics-based Efficacy Analysis: Ustekinumab Versus Secukinumab for the Treatment of Generalized Pustular Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Generalized Pustular Psoriasis
Keywords: Secukinumab
Ustekinumab
Clinical efficacy
Generalized pustular psoriasis
Safety
Gene mutations
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective study of adult and pediatric patients with GPP. The investigators obtained data for 65 patients (33 children, 32 adults) who were admitted to the Department of Dermatology in the First Affiliated Hospital of Fujian Medical University because of GPP between July 2019 and Dec 2022. All patients were followed for 48 weeks.

Brief summary: The investigators aim to compare the efficacy and safety of secukinumab and ustekinumab in patients with generalized pustular psoriasis (GPP), and to explore the impact of genetic mutation types on clinical efficacy. The main questions the study aims to answer are:

Is there a difference in the effectiveness of secukinumab and ustekinumab in the treatment of GPP? How is the safety of secukinumab and ustekinumab in the treatment of GPP? Does the type of genetic mutation in GPP patients affect the efficacy of secukinumab and ustekinumab? The investigators will compare patients treated with secukinumab to those treated with ustekinumab to see the difference in the effectiveness of the two drugs in treating GPP.

Participants will:

The investigators conducted a 48-week follow-up study on 65 participants who were admitted to the dermatology department of the First Affiliated Hospital of Fujian Medical University for GPP from July 2019 to December 2022. All participants underwent saliva-based genetic testing.

Efficacy analyses were performed based on the scores of Generalized Pustular Psoriasis Area and Severity Index (GPPASI) and Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) at week 0, 2, 4, 12, 24, and 48.

Participants were also asked to report all adverse events (AEs) during follow-up.


Eligibility criteria: Inclusion Criteria:

1. Patients meet the diagnostic criteria for GPP.
2. Patients had an average GPPGA score of 3 or higher (moderate to severe disease).
3. Patients had discontinued the treatment with non-biologic agents before they started the treatment with ustekinumab/secukinumab.

Exclusion Criteria:

1. Pregnant and lactating patients.
2. Patients with malignant tumors.
3. Patients with a history of multiple drug allergies or a severe allergic constitution.
4. Contraindications for ustekinumab/secukinumab, including active tuberculosis, active hepatitis B, hepatitis C, or inflammatory bowel disease.

Patients who were severely immunocompromised.

Primary outcomes:
measure: To compare the clinical efficacy difference between ustekinumab and secukinumab in the treatment of GPP through evaluation of GPPASI.
timeFrame: 48 weeks
Secondary outcomes:
measure: To compare the clinical efficacy difference between ustekinumab and secukinumab in the treatment of GPP through evaluation of GPPGA.
timeFrame: 48 weeks
measure: By saliva-based genetic testing, analyze the mutation rates of common mutation gene sites in GPP.
timeFrame: 48 weeks
measure: Analyzing the incidence of adverse reactions to ustekinumab and secukinumab in the treatment of GPP.
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References: