A100 THE UNFINISHED SYMPHONY: GOLIMUMAB IS EFFICIENT AS SALVAGE THERAPY IN PATIENTS WITH REFRACTORY CROHN’S DISEASE

Abstract

Background: Golimumab is a fully human, IgG1k monoclonal antibody against anti-tumor necrosis factor (anti-TNF) agent approved for the treatment of moderate-to-severely active ulcerative colitis. However, there have been no formal trials to date to assess its utility in Crohn's disease (CD). Aim(s): This study's aim was to assess the efficacy and safety of golimumab use in patients with anti-TNF refractory CD. Method(s): Consecutive patients with CD who were treated at a single IBD centre with golimumab between March 2010 and September 2016 were included in a retrospective observational study. Clinical response was defined as significant reduction in symptoms and biochemical markers of CD, with no requirement for surgery or introduction of immunomodulators. Outcome was assessed after 6 and 12 months and at last clinical follow-up. Result(s): Forty-five patients were included, with a median follow-up of 22 months (interquartile range 12-34) following initiation of golimumab. Induction regimens were generally higher than the standard protocol with first month cumulative doses of 300 mg and greater in all patients and 400 mg and above in 75% of the patients. All patients had previously failed at least 2 anti-TNF agents. In 64% of patients, anti-TNF failure was due to loss of response and in 23% due to adverse effects. Clinical response at 6 months was achieved in 32/45 (71%) patients. The proportion of patients still in clinical response at 1 year and 3 years were 79% and 65%. Throughout follow-up 59% remained on treatment. Conclusion(s): This study demonstrates the efficacy of golimumab in CD patients who were previously refractory to at least 2 biologics. An initial response is successfully maintained in the majority of patients for up to 3 years. Future studies should be performed in CD to formally assess the efficacy of golimumab in a randomized controlled trial and to establish the optimal dosing regimen.