Objectives and methodology of BIOBADASER phase iii

Area of Science:

• Rheumatology
• Pharmacovigilance
• Clinical Research

Background:

• The Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER) has been updated to BIOBADASER III.
• This new version aims to adapt to the evolving pharmacological landscape, including biosimilars and small molecules for rheumatic diseases.

Purpose of the Study:

• To describe the objectives, methods, and initial results of the first year of BIOBADASER III.
• To analyze adverse events associated with biological and targeted synthetic drugs in rheumatic diseases.
• To assess treatment effectiveness using activity indexes as a secondary objective.

Main Methods:

• A multicenter prospective registry was established in Spanish rheumatology departments.
• Patients with rheumatic inflammatory diseases treated with biological or targeted synthetic drugs were included.
• Data collection began on December 17, 2015, with annual patient evaluations and event-driven assessments.

Main Results:

• 35 centers participated in the first year, enrolling 2,664 patients by December 2016.
• The mean patient age was 53.7 years, with a median treatment duration of 8.1 years.
• Rheumatoid arthritis was diagnosed in 40.4% of patients; infections and infestations were the most frequent adverse events.

Conclusions:

• BIOBADASER Phase III is operational, reflecting changes in drug therapies for rheumatic diseases.
• The registry now incorporates adverse event reporting and treatment activity scores.
• This updated registry supports ongoing pharmacovigilance and effectiveness evaluation in a dynamic therapeutic environment.