S0795 Outcomes Combining Vedolizumab With Other Biologics or With Tofacitinib to Treat Inflammatory Bowel Disease

INTRODUCTION: Combining advanced therapies with different mechanisms is a potential strategy to improve outcomes in patients with inflammatory bowel disease who do not achieve a complete response to one drug, however little is known about outcomes of such an approach. METHODS: Outcomes of patients who utilized vedolizumab (VDZ) in combination with another advanced therapy (biologic or JAK inhibitor) between 4/1/2016 and 6/1/2020 were examined. VDZ was either added to the first advanced therapy or a second advanced therapy was added to VDZ. Data were retrospectively extracted from electronic medical records at a single tertiary center under an IRB-approved protocol. RESULTS: 14 patients received combination therapy. 10 had ulcerative colitis, 3 Crohn’s disease and 1 indeterminate colitis. All patients were receiving one advanced therapy and had objective evidence of active disease when a second drug was added. Prior to combination therapy, patients failed a median of 2 (range 1-4) other advanced therapies. VDZ was combined with tofacitinib in 9 patients, ustekinumab in 3, and adalimumab in 2. In 50% (7/14) of cases, patients previously received the added drug, with VDZ reutilized in 6 patients and adalimumab in 1. Median time on combination therapy was 31 weeks (IQR 13-47). In patients with elevated C-reactive protein (CRP) or fecal calprotectin (FC) prior to the addition of the second drug and who underwent repeat testing while on combination therapy, normalization of CRP (< 5 mg/L) or FC (< 150 mcg/g) was achieved in 75% (6/8) and 67% (4/6), respectively. Median FC was 326 mcg/g (n = 11) prior to combination therapy and 95 mcg/g (n = 8) on combination therapy. 71% (5/7) of patients on prednisone prior to combination therapy reduced their dose on combination therapy. There were 4 infections; two required hospitalization (rotavirus, C.difficile) and two did not (pneumonia, sinus). 5/14 patients discontinued combination therapy (2 non-response; 1 improvement and de-escalation; 1 non-infectious adverse effect; 1 loss of coverage) prior to the time of this report, while 64% of patients (9/14) remained on combination therapy. CONCLUSION: In this retrospective analysis of a small cohort, combination of VDZ with other biologics or tofacitinib appeared effective in reducing disease activity as measured by inflammatory markers and steroid use and was generally well tolerated.Table 1Table 2Table 3