The BSR-PsA: study protocol for the British Society for Rheumatology psoriatic arthritis register

Area of Science:

• Rheumatology
• Clinical Trials
• Pharmacovigilance

Background:

• Psoriatic arthritis (PsA) is a complex condition impacting joints, skin, and quality of life.
• Biologic and targeted synthetic disease-modifying anti-rheumatic drugs (bDMARDs/tsDMARDs) have improved PsA treatment.
• Long-term safety, effectiveness, and cost-effectiveness of bDMARDs/tsDMARDs in real-world settings require further investigation.

Purpose of the Study:

• To establish the British Society for Rheumatology Psoriatic Arthritis Register (BSR-PsA).
• To collect real-world data on the safety and effectiveness of bDMARDs/tsDMARDs in PsA patients.
• To evaluate treatment response predictors and cost-effectiveness of therapies.

Main Methods:

• Prospective registry (BSR-PsA) of PsA patients across Great Britain.
• Inclusion of patients commencing or naive to bDMARDs/tsDMARDs.
• Annual follow-up with clinical data extraction, physical measurements, and patient-reported outcomes via questionnaires. Includes C-reactive protein assessment and optional biobanking.

Main Results:

• Data collection ongoing for 5-year study duration.
• Includes detailed clinical, functional, and quality-of-life parameters.
• Biobank established for future biomarker research.

Conclusions:

• Real-world data from BSR-PsA will complement randomized trial findings.
• Evidence base for clinical management of PsA will be strengthened.
• Effectiveness, safety, cost-effectiveness, and patient-reported outcomes of bDMARDs/tsDMARDs will be determined.