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

15/11/2024
29/07/2025
EU PAS number:
EUPAS1000000226
Study
Ongoing
Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Data collection methods

Secondary use of data
Study drug and medical condition

Medicinal product name

Study drug International non-proprietary name (INN) or common name

TOFACITINIB

Medical condition to be studied

Axial spondyloarthritis

Additional medical condition(s)

Psoriatic Arthritis
Study design details

Main study objective

Primary objectives:
1. To compare the proportion of AxSpA patients fulfilling effectiveness criteria within 6 months after initiating treatment with tofacitinib vs TNFi vs IL-17i among patients with at least 6 months of continuous enrollment after index date.
2. To compare the proportion of b/tsDMARD-naïve PsA patients fulfilling effectiveness criteria within 6 months after initiating treatment with tofacitinib vs TNFi vs IL-17i among patients with at least 6 months of continuous enrollment after index date.

Secondary objectives:
1. To compare the proportion of AxSpA patients fulfilling effectiveness criteria within 12 months after initiating treatment with tofacitinib vs TNFi vs IL-17i among patients with at least 12 months of continuous enrollment after index date.
2. To compare the proportion of b/tsDMARD-naïve PsA patients fulfilling effectiveness criteria within 12 months after initiating treatment with tofacitinib vs TNFi vs IL-17i among patients with at least 12 months of continuous enrollment after index date.
3. Evaluate drug persistence (median time to therapy discontinuation) among AxSpA patients within 12 months of treatment with tofacitinib vs TNFi vs IL-17i among patients with at least 12 months of continuous enrollment after index date.
4. Evaluate drug persistence (median time to therapy discontinuation) among b/tsDMARD-naive PsA patients within 12 months of treatment with tofacitinib vs TNFi vs IL-17i among the sample of patients with at least 12 months of continuous enrollment after index date.
5. Evaluate health care resource utilization and cost data for AxSpA patients within 6 and 12 months of treatment with tofacitinib vs TNFi vs IL-17i among patients with at least 6 or 12 months of continuous enrollment after index date, respectively.