Psoriatic Arthritis
Conditions
Keywords
PSA
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.
Interventions
DRUGSecukinumab
Patients had received secukinumab per their dosing regimens prior to this observational study.
DRUGAdalimumab
Patients had received adalimumab per their dosing regimens prior to this observational study.
Sponsors
Novartis
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients with Persistence of Secukinumab Treatment at One Year | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Age | Baseline |
| Number of Patients, Categorized by Medical Facility Department | Baseline |
| Height | Baseline |
| Weight | Baseline |
| Body Mass Index (BMI) | 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 |
| Sex | Baseline |
| 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 |
| Time from Index Date to the Start of Methotrexate Add-on | Up to approximately 5 years |
Countries
Japan
Outcome results
None listed