Higher Adalimumab Maintenance Regimens Are More Effective Than Standard Maintenance Regimens in Crohnʼs Disease Patients Who Have Failed Infliximab: 745

Introduction: Most Crohn's disease (CD) patients experience a loss of response (LOR) over time and require dose escalation. The efficacy and safety of treating CD patients with higher maintenance regimens following induction remain unknown. Methods: We conducted a retrospective observational study with CD patients receiving adalimumab for luminal and perianal disease between 2007-2017 at a tertiary care IBD center. All subjects had previously failed infliximab. Patients were categorized according to their maintenance regimen; 40mg weekly, 80mg every other week (EOW) or greater was defined as a high dose maintenance regimen (HD) and 40mg EOW was defined as standard regimen (SD). All patients in HD group were started on high maintenance doses directly after induction. The primary outcome was time to treatment failure, defined as non-response, loss of response (LOR) with no benefit from dose optimization, the introduction of steroids, an adverse event requiring discontinuation or surgery. Secondary outcomes included clinical remission at 3 and 12 months, IBD-related surgery, hospitalization and the need for therapeutic optimization. Results: We identified 39 patients that were started on HD regimens following induction and compared them to 40 patients that received SD maintenance. Clinical and demographic characteristics were similar between both groups. According to a Kaplan-Meier survival curve analysis, time to treatment failure was significantly longer in patients in the HD group (p=0.0015). Patients in the HD group were more likely to achieve clinical remission at 3 and 12 months (89% vs 25%, p < 0.001 and 69% vs 31%, p=0.003, respectively). Patients in the SD group were more likely to require IBD-related surgery or therapy optimization (18% vs 3%, p=0.03 and 55% vs 33%, p=0.05). No difference in adverse events was identified between the groups (31% vs 30%, p=0.94). Conclusion: Higher dose maintenance regimens were more effective than the standard adalimumab maintenance protocol with better short-term and long-term clinical outcomes. No increased safety concerns were observed with higher maintenance dosing.FigureTable: No Caption availableTable: No Caption available