PWE-057 Using an evidence-based, expert consensus tool to guide biologic decision-making is associated with favourable outcomes

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Abstract

Introduction

Treatment with biologic agents is costly and the mechanisms available for inflammatory bowel disease (IBD) remain limited. It is important to optimise the benefit and cost-effectiveness of their use. Therapeutic drug monitoring (TDM) is a strategy to help achieve this, through the measurement of drug and anti-drug antibody concentrations. The Building Research in IBD Globally (BRIDGe) groups ‘Anti-TNF Opimizer’, an online tool that helps interpretation of TDM and clinical decision-making.

Methods

We performed a retrospective study of IBD patients on infliximab (IFX) or adalimumab (ADA) at our institution, undergoing TDM between Jan 16-Mar 17. TDM was performed using a drug-tolerant ELISA (IDKmonitor, Immundiagnostik). Disease activity was defined by the combination of clinical symptoms and evidence of biochemical (CRP >10; FCP >150), endoscopic or radiological activity. Clinical decision-making was compared to recommendations made by the BRIDGe ‘Anti-TNF Optimizer’ tool, which suggests that objective evidence should be sought in all cases of suspected primary non-response (PNR) and loss of response (LOR). Subsequent disease course was evaluated using a Physicians Global Assessment (PGA), which took into account clinical, biochemical, endoscopic and/or radiological activity and the need to progress to surgery. Outcomes were described as ‘favourable’ or ‘unfavourable’. Groups were compared using Fisher’s exact test (GraphPad Prism V.7.0a).

Results

60 patients were included: 30 IFX and 30 ADA. Indications for TDM: LOR 45 (75%), PNR 8 (13%), routine monitoring during remission 7 (12%). Objective evidence of inflammation was sought in all 53 cases of LOR/PNR and found present in 42 (79%). Two patients were lost to follow up and were not included in the final analysis. Of these 40, subsequent clinical management was in keeping with BRIDGe recommendations in 19 (48%).

Results

Of the 19 LOR/PNR patients managed as per BRIDGe recommendations, 15 (79%) achieved a subsequent favourable outcome. The rate of subsequent favourable outcome in the group who were not managed in accordance with BRIDGe was significantly lower at 3/21 (14%, p<0.0001).

Conclusions

The rate at which objective evidence of inflammation was sought amongst our patients with symptoms suggestive of PNR/LOR was good. However, clinical decision-making deviated from BRIDGe recommendations in majority of cases and this appeared to adversely impact disease course. Results therefore, suggest that using an evidence-based, expert consensus, online tool to guide biologic decision-making with the results of biologic TDM provides benefit in IBD outcomes.

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