Biologic Therapy for Generalized Pustular Psoriasis

Generalized Pustular Psoriasis Clinical Trial

Official title:

Genetics-based Efficacy Analysis: Ustekinumab Versus Secukinumab for the Treatment of Generalized Pustular Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06391996
• Other study ID #: MRCTA,ECFAH of FMU [2022]007
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2024
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Generalized Pustular Psoriasis
• Psoriasis

Intervention

Drug:
• After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy.
During the treatment period, participants received either ustekinumab at weeks 0, 4, 16, and every 12 weeks thereafter until week 48, or secukinumab at weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter until week 48. The dose of ustekinumab/secukinumab was referenced to the dose used for moderate to severe plaque psoriasis. The single dose of ustekinumab was 45 mg for adult subjects weighing = 100 kg, and 90 mg for subjects weighing > 100 kg. The ustekinumab dosage for pediatric participants was 0.75 mg/kg for participants weighing < 60 kg; 45 mg for pediatric participants weighing 60 kg to 100 kg; and 90 mg for pediatric participants weighing > 100 kg. The secukinumab dosage was 300mg for adult humans. Pediatric participants received a dose based on their weight category ( <50 kg, =50 kg): participants weighing < 50 kg received 75 mg, those weighing = 50 kg received 150 mg.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Chao Ji

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the clinical efficacy difference between ustekinumab and secukinumab in the treatment of GPP through evaluation of GPPASI.	Efficacy analyses were performed based on the scores of Generalized Pustular Psoriasis Area and Severity Index (GPPASI) at week 0, 2, 4, 12, 24, and 48. GPPASI provided a numeric scoring system to assess patient's overall disease state of GPP, ranging from 0 to 72, with higher scores indicating more severe conditions. Clinical efficacy was evaluated by GPPASI -50, -75, -90, and -100 responses at each time point.	48 weeks
Secondary	To compare the clinical efficacy difference between ustekinumab and secukinumab in the treatment of GPP through evaluation of GPPGA.	Efficacy analyses were performed based on the scores of Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) at week 0, 2, 4, 12, 24, and 48. The investigator scored the erythema, pustules, and scale of all GPP lesions from 0 to 4 using GPPGA. Each component was graded separately, and the average was calculated. The final GPPGA was determined by this composite score.	48 weeks
Secondary	By saliva-based genetic testing, analyze the mutation rates of common mutation gene sites in GPP.	To analyze whether gene mutations cause different responses to ustekinumab and secukinumab in GPP patients.	48 weeks
Secondary	Analyzing the incidence of adverse reactions to ustekinumab and secukinumab in the treatment of GPP.	During the follow-up period, participants are requested to report all adverse reactions experienced since their last visit, such as rash, diarrhea, infections, etc., and record the type, onset time, severity, duration, triggering, and relieving factors of the adverse reactions.	48 weeks