This is a prospective, randomized, controlled study designed to evaluate the effectiveness of annual re-screening for tuberculosis infection (TBI) (previous) in patients with autoimmune rheumatic diseases (ARDs) receiving biologic and/or immunosuppressive therapy. Patients with negative baseline TBI screening will be randomized to undergo annual re-screening using interferon-gamma release assay (IGRA) or to a control group without routine re-screening. Patients with newly detected TBI will receive preventive treatment. The primary objective is to assess whether annual re-screening combined with TBI treatment reduces the incidence of active tuberculosis. Secondary objectives include determining TBI conversion rates and identifying risk factors for infection.
Tuberculosis remains highly prevalent in endemic countries such as Brazil. Patients with autoimmune rheumatic diseases (ARDs) receiving immunosuppressive therapies, particularly biologic agents, are at increased risk of progression from tuberculosis infection (TBI) to tuberculosis disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,660
Routine annual TB re-screening after negative (IGRA)
Standard clinical follow-up without routine annual TB re-screening
Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP
São Paulo, São Paulo, Brazil
Incidence of Tuberculosis Disease
Incidence of confirmed TBD cases during the follow-up period among patients with autoimmune rheumatic diseases using biologic and/or Immunosuppressive therapy in both arms: "annual IGRA rescreening" (intervention arm) and "no rescreening" (standard clinical follow-up).
Time frame: Up to 48 months
Risk Factors for TBD Development
Identification of demographic, clinical, nutritional, and therapeutic predictors (e.g., type of biologic, corticosteroid use) for TBD development.
Time frame: Up to 48 months
Rate of TBI Conversion
Proportion of patients converting from negative to positive IGRA during follow-up in the "annual IGRA rescreening group" (interventional arm).
Time frame: Up to 36 months
Risk Factors for TBI Conversion
Identification of demographic, clinical, nutritional, and therapeutic predictors (e.g., type of biologic, corticosteroid use) in the "annual IGRA rescreening group" (interventional arm).
Time frame: Up to 36 months
Adverse Events Related to TBI Treatment
Frequency of drug-related adverse events (e.g., hepatotoxicity)
Time frame: Up to 48 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.