Real-world comparative effectiveness of tofacitinib, tumour necrosis factor inhibitors, and interleukin 17 inhibitors among patients with axial spondylarthritis and psoriatic arthritis

Study identification

• EU PAS number:
  EUPAS1000000226
• Study ID:
  1000000226
• Official title and acronym:
  Real-world comparative effectiveness of tofacitinib, tumour necrosis factor inhibitors, and interleukin 17 inhibitors among patients with axial spondylarthritis and psoriatic arthritis
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a non-interventional, population-based retrospective cohort study of adults (ages ≥18 years of age) with Axial spondylarthritis (AxSpA), and Psoriatic arthritis (PsA) identified through a United States (US) administrative claims database. ; This study aims to provide data on the comparative real-world clinical effectiveness of advanced therapies (tofacitinib, TNFi, and IL-17i) as well as their associated costs and resource utilization. ; The results are intended to provide useful information to healthcare professionals and patients in clinical decision making for patients with these conditions. ; De-identified individual who initiated one of the study treatments will be selected from a database between December 14, 2021, and most recent data available for the AxSpA sample and December 14, 2017, and most recent data available for the PsA sample. ; The index date will be defined as the date of initiation (first time use) of one of the selected treatments (ie, tofacitinib, TNFi or IL-17i) within the specified identification period for each sample. Patients will be required to have at least 12 months of continuous enrollment (medical and pharmacy benefits) prior to the index date and at least 6 months after the index date. ; Analysis will be replicated for a subset of patients with at least 12 months of continuous enrollment after the index date. ; The baseline period will be defined as the 12 months before index date. Patient’s demographic and clinical characteristics will be characterized at index date or during the baseline period, depending on the study variable. Treatment effectiveness and healthcare resource utilization and costs will be assessed over the 6 and 12 months following the index date. ; Persistence on the index treatment will be assessed over the 12 months following the index date.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Komodo Health

Study timelines

Date when funding contract was signed

Planned: 05/04/2024

Actual: 05/04/2024

Study start date

Planned: 05/02/2025

Actual: 18/02/2025

Date of final study report

Planned: 15/05/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable