NCT06391996

Biologic Therapy for Generalized Pustular Psoriasis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Chao Ji · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-12-30
• Completion: 2023-12-30
• First posted: 2024-04-30
• Last updated: 2024-04-30

Locations

1 site across 1 country: China