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

• Published in: Journal of Crohn's and colitis 2018-01, Vol.12 (supplement_1), p.S032-S032
• Main Authors: Bossuyt, P, Atreya, R, Taxonera, C, Hebuterne, X, Isaacs, K, Higgins, P D, Lindsay, J, Heap, G, Arikan, D, Kuehnl, V, Petersson, J, Robinson, A M, Loftus, E V
• Format: Article
• Language: English
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjx180.041

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. Methods 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 ≤70 days (for ADA) or 30 days (for IMM) after the last dose in the registry or up to the cut-off date of May 31, 2017, were assessed by incidence proportions and as events per 100 patient-years (E/100 PYs) of ADA and IMM exposure, respectively. For the ADA registry group, data are reported with or without concurrent IMM and for overall ADA; patient use of concurrent IMM was variable and AEs were recorded based on concurrent IMM use at the time of occurrence. Results A total of 4245 patients have enrolled in the registry; 4203 patients are analysed (ADA, N = 1984; IMM, N = 2219). Mean (SD) age at enrolment was 44.5 (14.71) years with a mean (SD) UC duration of 10.3 (8.55) years. Approximately half (54%) of patients are male and 95% are white. Overall, 137 and 135 patients in the ADA and IMM groups, respectively, have discontinued the registry. The registry data cut-off represented 2707.77 and 3364.54 PYs of exposure to ADA and IMM, respectively. Incidence and event rates of TEAEs are shown in Table 1. The most common serious infections were pneumonia (n = 4), appendicitis, cellulitis and sepsis (each n = 3) in the ADA registry group and anal abscess, appendicitis, and pneumonia (each n = 4) in the IMM registry group. Malignancies were observed in 15 patients in the ADA group and 24 patients in the IMM group. Deaths were recorded for six (0.3%) and 4 (0.2%) patients in the ADA and IMM registry groups, respectively. Conclusions In patients with moderately to severely active UC, safety was consistent with the known safety profile for ADA and no new safety signals were identified.