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

NCT06600009 | Completed

• 1 other identifier: CAIN457FJP01
• Study Type: observational
• Target: 534
• Locations: 1 country
• Sites: 1

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.
• The index date was defined as the date of the first prescription of secukinumab or adalimumab within the inclusion period.
• The pre-index period was defined as the 6-month period before the index date (exclusive).
• Patients were followed until death, discontinuation of treatments of interest or end of the study period, whichever occurred first.

Conditions

Psoriatic Arthritis

Keywords

PSA

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Persistence of Secukinumab Treatment at One Year

  1 year

Secondary Outcomes (23)

• Sex

  Baseline

• Age

  Baseline

• Number of Patients, Categorized by Medical Facility Department

  Baseline

• Height

  Baseline

• Weight

  Baseline

Study Arms (2)

Secukinumab

Patients had received secukinumab treatment.

Drug: Secukinumab

Adalimumab

Patients had received adalimumab treatment.

Drug: Adalimumab

Interventions

Secukinumab DRUG

Patients had received secukinumab per their dosing regimens prior to this observational study.

Secukinumab

Adalimumab DRUG

Patients had received adalimumab per their dosing regimens prior to this observational study.

Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• Having a confirmed diagnosis of PsA (the international classification of diseases, 10th revision \[ICD-10\]: L405) (at least 1 inpatient or outpatient claim without any doubtful flag) recorded during the pre-index period or at the index date.
• Being age 18 years or older at the index date.
• Having at least a 6-month pre-index period.
• Bio-naive subgroup:
• Patients were considered as bio-naive if no record of any biologic agent prescriptions indicated for psoriasis or PsA (infliximab, adalimumab, certolizumab pegol, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab - princeps or biosimilars) were retrieved during the pre-index period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharma K.K.

Tokyo, 105-6333, Japan

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

secukinumab; Adalimumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: October 17, 2022
• Primary Completion: August 21, 2023
• Study Completion: September 15, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

JP (1)