P544 Comparison of the efficacy of a second intravenous or subcutaneous anti-TNF in the treatment of ulcerative colitis: Real-world data from the ENEIDA registry

Abstract

Introduction: Three anti-TNFs (one intravenous and two subcutaneous) are currently licensed for the treatment of ulcerative colitis (UC). It is not known if the efficacy of a second anti-TNF changes on whether it is intravenous or subcutaneous; this could justify the indication of biological agents with a different mechanism of action in second line. Aims & Methods: Aim: To compare the efficacy of a second subcutaneous or intravenous anti-TNF in UC patients naive to other biological agents with different mechanisms of action. Method(s): Patients from the prospectively ENEIDA registry treated consecutively with intravenous and subcutaneous anti-TNF (or vice versa), who were naive to other biological agents, were identified. Patients were classified according to the administration route of the first anti-TNF in: IVi (intravenous initially) or SCi (subcutaneous initially). Patients treated for extraintestinal manifestations or pouchitis were excluded. Clinical activity and effectiveness were defined based on Partial Mayo Score (PMS) at baseline, 14 and 52 weeks. Loss of response, dose-escalation and treatment discontinuation were also assessed. Result(s): 468 UC patients were included (327 IVi & 141 SCi). Both cohorts were similar in clinical-epidemiological characteristics, except for a higher proportion of patients with moderate-to-severe clinical activity at the beginning of the first anti-TNF in the IVi group (81% vs. 69%; p=0.010) and at the beginning of the second anti-TNF in the SCi group (61% vs. 74%; p=0.007). Clinical response and remission rates at week 14 for the second anti-TNF were 43% and 31% in IVi vs. 49% and 27% in SCi, respectively (p=ns). At week 52, clinical response/remission rates of the second anti- TNF were 38%/33% in IVi vs. 41%/32% in SCi (p=ns). Higher clinical response and remission rates at 14 weeks with the second anti-TNF were detected in the SCi group (41% vs. 66%; p=0.008 and 26% vs. 50%, respectively; p=0.004) when the reason for withdrawal of the first anti-TNF was secondary loss of response. The cumulative persistence of the second anti-TNF treatment in IVi and SCi were 57% and 53% after 1 year, and 41% and 41% after 2 years, respectively (p=ns). The SCi group had lower rates of dose-escalation with the second anti-TNF than IVi (34% and 27% in SCi vs. 60% and 51% in EVi, at 12 and 24 months, respectively; p< 0.0001). Globally, dose-escalation of the first anti-TNF and moderate-to-severe clinical activity at the beginning of the second anti-TNF were associated with a lower probability of remission with the second anti-TNF in the short and long-term. Conclusion(s): In UC patients, the efficacy of infliximab after failure/intolerance of a subcutaneous anti-TNF is similar to that of subcutaneous anti-TNFs after infliximab failure/intolerance, suggesting that the type of anti-TNF used in the first line is not an issue when considering the need to change the mechanism of action in the second line of treatment.