Treatment Persistence of Biologics in Patients with PsA in Japan; Retrospective Cohort Study Using a Claims Database

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Drug: Secukinumab; Drug: Adalimumab

• Registration Number: NCT06600009
• Lead Sponsor: Novartis

Brief Summary

This study was a retrospective non-interventional cohort study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The study setting was defined as follows:

* The inclusion period covered 01 February 2015 to 30 September 2020.

* The study period covered 01 August 2014 to 30 September 2021 inclusive.
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-10-17
• Primary Completion: 2023-08-21
• Study Completion: 2023-09-15
• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

Inclusion Criteria

Not provided

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Exclusion Criteria

• Having a biologic agent overdose (over 300 mg for secukinumab and over 80 mg for adalimumab) observed during the study period (off-label),
• Having at least one record of secukinumab (for secukinumab patients) or adalimumab (for adalimumab patients) retrieved during the pre-index period.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Secukinumab	Secukinumab	Patients had received secukinumab treatment.
Adalimumab	Adalimumab	Patients had received adalimumab treatment.

Primary Outcome Measures

Name	Time	Method
Number of Patients with Persistence of Secukinumab Treatment at One Year	1 year

Secondary Outcome Measures

Name	Time	Method
Sex	Baseline
Age	Baseline
Number of Patients, Categorized by Medical Facility Department	Baseline
Height	Baseline
Weight	Baseline
Body Mass Index (BMI)	Baseline
Time from PsA Diagnosis to Index Date, Categorized by Medical Facility Department	Up approximately 6 months
Number of Patients with Comorbidities, by Category	Baseline
Number of Patients on Concomitant Treatments	Baseline
C-reactive Protein (CRP)	Baseline
Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Still Treated with the Drug at the End of Follow-up	Up to approximately 5 years
Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Who Discontinued the Drug	Up to approximately 5 years
Time from Index Date to the Start of Methotrexate Add-on	Up to approximately 5 years
Time from Index Date to Methotrexate Discontinuation in Methotrexate Naive Patients at Index Date	Up to approximately 5 years
Time from Index Date to Methotrexate Discontinuation in Methotrexate Experienced Patients at Index Date	Up to approximately 5 years
Secukinumab/adalimumab Dose at the Start of Methotrexate Add-on	Up to approximately 5 years
Secukinumab/adalimumab Dose at Methotrexate Discontinuation	Up to approximately 5 years
Number of Patients with Methotrexate Add-on During Follow-up	Up to approximately 5 years
Average Secukinumab/adalimumab Dose at Index Date	Baseline
Number of Patients with Persistence of Secukinumab or Adalimumab Treatment	24 weeks, 1 year, 1.5 years, 2 years, 2.5 years, and 3 years
Time from PsA Diagnosis to Index Date for Adalimumab Patients	Up approximately 6 months
Number of Adalimumab Patients, Categorized by Medical Facility	Baseline
Number of Patients with Presence or Absence of Methotrexate	Baseline

Trial Locations

Locations (1)

Novartis Pharma K.K.; 🇯🇵 Tokyo, Japan