Clinical trial NCT06600009: Treatment Persistence of Biologics in Patients with PsA in Japan; Retrospective Cohort Study Using a Claims Database
Official title: Treatment Persistence of Biologics in Patients with PsA in Japan; Retrospective Cohort Study Using a Claims Database (The FLYWAY Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Keywords: PSA
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients with Persistence of Secukinumab Treatment at One Year
timeFrame: 1 year
Secondary outcomes:
measure: Sex
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Number of Patients, Categorized by Medical Facility Department
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Time from PsA Diagnosis to Index Date, Categorized by Medical Facility Department
timeFrame: Up approximately 6 months
measure: Number of Patients with Comorbidities, by Category
timeFrame: Baseline
measure: Number of Patients on Concomitant Treatments
timeFrame: Baseline
measure: C-reactive Protein (CRP)
timeFrame: Baseline
measure: 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
timeFrame: Up to approximately 5 years
measure: Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Who Discontinued the Drug
timeFrame: Up to approximately 5 years
measure: Time from Index Date to the Start of Methotrexate Add-on
timeFrame: Up to approximately 5 years
measure: Time from Index Date to Methotrexate Discontinuation in Methotrexate Naive Patients at Index Date
timeFrame: Up to approximately 5 years
measure: Time from Index Date to Methotrexate Discontinuation in Methotrexate Experienced Patients at Index Date
timeFrame: Up to approximately 5 years
measure: Secukinumab/adalimumab Dose at the Start of Methotrexate Add-on
timeFrame: Up to approximately 5 years
measure: Secukinumab/adalimumab Dose at Methotrexate Discontinuation
timeFrame: Up to approximately 5 years
measure: Number of Patients with Methotrexate Add-on During Follow-up
timeFrame: Up to approximately 5 years
measure: Average Secukinumab/adalimumab Dose at Index Date
timeFrame: Baseline
measure: Number of Patients with Persistence of Secukinumab or Adalimumab Treatment
timeFrame: 24 weeks, 1 year, 1.5 years, 2 years, 2.5 years, and 3 years
measure: Time from PsA Diagnosis to Index Date for Adalimumab Patients
timeFrame: Up approximately 6 months
measure: Number of Adalimumab Patients, Categorized by Medical Facility
timeFrame: Baseline
measure: Number of Patients with Presence or Absence of Methotrexate
timeFrame: Baseline
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Pharma K.K.
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: