Biologic Therapy Screening Requirements

Mandatory Screening Tests

The British Society of Gastroenterology requires baseline screening tests for second-line therapy, including Hepatitis B and C virus serology and Tuberculosis screening with clinical risk stratification, chest X-ray, and interferon-gamma release assay, before starting treatment with biologics like infliximab 1, 2, 3, 4
The American Gastroenterological Association recommends that these tests must be documented before starting treatment with biologics like infliximab, to identify patients who need prophylactic antiviral therapy or anti-tuberculous treatment 1, 2

Infliximab can cause HBV reactivation in patients with chronic or resolved HBV infection, potentially leading to fulminant hepatitis, and the screening requirement exists to identify patients who need prophylactic antiviral therapy 1, 2
Ideally, anti-tuberculous treatment or prophylaxis for active or latent TB should be started prior to commencing immunomodulators, as anti-TNF therapy carries substantial risk of TB reactivation 3, 4

Screening labs, including HIV, hepatitis A and B, and TB testing, should be repeated annually in patients who require biologic treatment for >1 year until treatment is completed, to ensure ongoing safety monitoring for patients on chronic immunosuppression 5, 6, 7

The European Society of Gastrointestinal Endoscopy recommends that colonoscopy is planned in 4 weeks, which is appropriate for disease monitoring, and the patient's history of CMV colitis indicates significant immunosuppression risk 1, 2, 8
The authorization should be held pending documentation of most recent Hepatitis B serology results and most recent TB screening results, with dates, and if these tests were performed at treatment initiation but are >1 year old, repeat testing is indicated before continuing therapy 1, 2, 3, 4, 5, 6, 7