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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: Secukinumab; Drug: Adalimumab

• Study Type: Observational
• Enrollment (Actual): 534

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 105-6333
    • Novartis Pharma K.K.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

Inclusion criteria:

• Having at least one biologic agent prescription of interest (secukinumab or adalimumab - princeps or biosimilars) recorded, in accordance with package insert, during the inclusion period (first prescription: index date).
• 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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Secukinumab; Patients had received secukinumab treatment.	Drug: Secukinumab; Patients had received secukinumab per their dosing regimens prior to this observational study.
Adalimumab; Patients had received adalimumab treatment.	Drug: Adalimumab; Patients had received adalimumab per their dosing regimens prior to this observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Patients with Persistence of Secukinumab Treatment at One Year	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Height	Baseline
Weight	Baseline
Age	Baseline
Sex	Baseline
Body Mass Index (BMI)	Baseline
Number of Patients, Categorized by Medical Facility Department	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

Collaborators and Investigators

• Sponsor: Novartis
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): August 21, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: PSA
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Arthritis; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis, Psoriatic; Anti-Inflammatory Agents; Antirheumatic Agents; Tumor Necrosis Factor Inhibitors; Adalimumab
• Other Study ID Numbers: CAIN457FJP01

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No