Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
65 participants
OBSERVATIONAL
2019-07-01
2023-12-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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Chao Ji
OTHER
Responsible Party
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Chao Ji
Head of dermatology
Locations
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First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Countries
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Other Identifiers
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MRCTA,ECFAH of FMU [2022]007
Identifier Type: -
Identifier Source: org_study_id