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

Novartis534 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

534

Conditions

Psoriatic Arthritis

Interventions

SecukinumabDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Patients with Persistence of Secukinumab Treatment at One Year

Time frame: 1 year

Secondary Outcomes

Sex

Time frame: Baseline

Age

Time frame: Baseline

Number of Patients, Categorized by Medical Facility Department

Time frame: Baseline

Height

Time frame: Baseline

Weight

Time frame: Baseline

Body Mass Index (BMI)

Time frame: Baseline

Time from PsA Diagnosis to Index Date, Categorized by Medical Facility Department

Time frame: Up approximately 6 months

Number of Patients with Comorbidities, by Category

Time frame: Baseline

Number of Patients on Concomitant Treatments

Time frame: Baseline

C-reactive Protein (CRP)

Time frame: 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