DOP004 Long-term safety of adalimumab in patients with moderate-to-severe ulcerative colitis: Interim results of a non-interventional registry, LEGACY

Abstract

Background: The safety and efficacy of adalimumab (ADA) in adults with ulcerative colitis (UC) was demonstrated in the ULTRA 1 and ULTRA 2 trials. The post-marketing non-interventional registry, LEGACY, is designed to assess the long-term safety and effectiveness of ADA as used in routine clinical practice in adult patients with moderately to severely active UC. Method(s): LEGACY is an ongoing 10-year non-interventional, multinational registry evaluating the long-term safety and effectiveness of ADA (Humira) in adult patients (>=18 years) with moderately to severely active UC. The long-term safety of patients receiving immunomodulators (IMM; thiopurines) without concurrent biologic is also evaluated. Registry treatment-emergent adverse events (TEAEs), defined as AEs occurring from the first day in the registry