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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

534 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-17

Study Completion Date

2023-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Secukinumab

Patients had received secukinumab treatment.

Secukinumab

Intervention Type DRUG

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

Adalimumab

Patients had received adalimumab treatment.

Adalimumab

Intervention Type DRUG

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

Interventions

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Secukinumab

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

Intervention Type DRUG

Adalimumab

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No