Biologic Therapy for Generalized Pustular Psoriasis

NCT06391996 | Completed DMC

• 1 other identifier: MRCTA,ECFAH of FMU [2022]007
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Pustular Psoriasis

Keywords

Secukinumab; Ustekinumab; Clinical efficacy; Generalized pustular psoriasis; Safety; Gene mutations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To compare the clinical efficacy difference between ustekinumab and secukinumab in the treatment of GPP through evaluation of GPPGA.

  48 weeks

• By saliva-based genetic testing, analyze the mutation rates of common mutation gene sites in GPP.

  48 weeks

• Analyzing the incidence of adverse reactions to ustekinumab and secukinumab in the treatment of GPP.

  48 weeks

Study Arms (2)

the ustekinumab group

Before treatment, participants underwent routine blood and urine tests, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), liver and kidney function tests, tuberculous infection of T cells spot tests, hepatitis B virus marker tests, chest CT scans, etc. After exclusion of relevant contraindications, participants received subcutaneous ustekinumab therapy. During the treatment period, participants received ustekinumab at weeks 0, 4, 16, and every 12 weeks thereafter until week 48. 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.

Drug: After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy.

the secukinumab group

Before treatment, participants underwent routine blood and urine tests, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), liver and kidney function tests, tuberculous infection of T cells spot tests, hepatitis B virus marker tests, chest CT scans, etc. After exclusion of relevant contraindications, participants received subcutaneous secukinumab therapy. During the treatment period, participants received secukinumab at weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter until week 48. 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.

Drug: After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy.

Interventions

After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy. DRUG

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.

Also known as: The investigators collected participants' saliva for genotyping.

the secukinumab group; the ustekinumab group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnant and lactating patients.
• Patients with malignant tumors.
• Patients with a history of multiple drug allergies or a severe allergic constitution.
• Contraindications for ustekinumab/secukinumab, including active tuberculosis, active hepatitis B, hepatitis C, or inflammatory bowel disease.
• Patients who were severely immunocompromised.

Sponsors & Collaborators

• Chao Ji: lead

Study Sites (1)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Genotype

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of dermatology

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 30, 2024
• Study Start: July 1, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

CN (1)