TBA (20W115)

The safety and efficacy of combination biological therapy in refractory inflammatory bowel disease in an Irish cohort.

Author(s)

Ciaran Judge 1, 2, Reza Saeidi 1,3, Kathleen Sugrue 1,2, Louise Rabbitte 1,4, Aine Keogh 1,4, Clodagh Byron 1,5, Syed Akbar Zulquernain 1, 5, Sarah Gleeson 1,2, Martin Buckley 1,2, Eoin Slattery 1,4, Glen Doherty 1,3, Jane McCarthy 1,2

Department(s)/Institutions

1. INITIative, Investigator Network for Inflammatory Bowel Disease Therapy in Ireland, Dublin, Ireland 2. Department of Gastroenterology, Mercy University Hospital, Cork 3. Department of Gastroenterology and Colorectal Disease, St Vincent’s University Hospital, Dublin 4. Department of Gastroenterology, Galway University Hospital, Galway 5. Department of Gastroenterology, Cork University Hospital, Cork

Introduction

Refractory inflammatory bowel disease (IBD) continues to pose a dilemma despite an increasing number of therapeutic options available. There has recently been renewed focus on combining biologic agents to tackle recalcitrant cases. In theory, combination of two therapeutic mechanisms may produce synergistic effects, however the clinical utility of such an approach remains undetermined.

Aims/Background

This study aims to provide real-world data on the use of combination biologic therapy (CBT) for refractory IBD in the Irish cohort.

Method

We conducted a retrospective review of patients receiving or who had received treatment with combination biological therapy (CBT) for IBD across four Irish teaching hospitals. Demographics and clinical data were collected by retrospective chart review. Clinical severity was assessed by partial Mayo Clinic Score (PMCS) and Harvey Bradshaw Index (HBI) in UC and CD, respectively. CBT was defined as the use of any two biologic agents for the treatment of IBD, for a period of at least 12 weeks. Clinical response and remission were assessed, in addition to changes in biochemical markers and adverse events.

Results

21 patients were identified (UC = 8, CD = 13). Median age was 40 [18 – 56], 71% were male and 19% smokers. In the UC cohort, 50% had extensive disease, baseline PMCS was 6 [5 – 8], FC 529 [77 – 1321], CRP 10 [1 – 92]. In the CD cohort, 54% had ileocolonic disease, 70% stricturing (Montreal B2) disease, 39% had perianal involvement and 85% had previous surgery. Baseline HBI was 7 [5 – 17], FC 687 ug/g [38 – 1194 ug/g] and CRP 8 mg/L [1 – 39 mg/L]. In the total cohort, patients had previously failed 4 [3 – 4] single biologic agents. Disease severity improved significantly in both UC and CD. Clinical response was seen in 50% of UC patients, and 69% of CD patients. Adverse events were seen in 14% (3) cases, involving UST + ADA (n=2) , and UST + VDZ (n=1). The commonest combination regimens were VDZ + ADA (26%), and VDZ + TOF (24%). VDZ was used in 86% of regimens.

Conclusions

Combining biological therapies may provide us with a novel therapeutic approach to refractory IBD. These real-world data suggest efficacy and safety with CBT in a cohort with significant previous biological exposure.