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P454 Can calcineurin inhibitors induce a durable remission that is maintained with vedolizumab in IBD?

Kassim O.1, Micic D.2, Christensen B.1, Pekow J.1, Sakuraba A.1, Dalal S.1, Rubin D.1, Cohen R.*1

1University of Chicago Medical Center, Department of Gastroenterology, Chicago, United States 2University of Chicago, Department of Gastroenterology, Chicago, United States

Background

Vedolizumab (Vedo) is an anti-integrin antibody approved for use in IBD. Sick patients often need a bridging therapy to induce an initial clinical response or remission. We describe our success using tacrolimus (TAC) or cyclosporin (CSA) to induce a clinical response or remission to be maintained with VEDO.

Methods

All IBD patients treated with an induction course of oral TAC or IV/oral CSA with a subsequent maintenance regimen of VEDO at the University of Chicago were identified. Demographics, duration of therapy, drug levels, serious adverse events (deaths, hospitalizations, operations) and drug related adverse effects (AEs) were recorded. The Harvey Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) were prospectively assessed at each patient encounter. Remission was defined as an HB≤4, or SCCAI≤2, with response as a decrease in either score by ≥3 from baseline. Clinical activity was assessed at baseline, 14 weeks, 6 months and 1 year after induction with Vedo. Patients with at least 6 months of follow-up were included in the analysis

Results

22 patients (11 UC, 11 CD) were identified; 16 were induced with TAC, and 6 with CSA. Mean age 35.6 (20–64); 13 were female. Patients excluded: liver transplant (2, TAC); <6 month follow-up (2 TAC, 1 CSA); initiation of TAC after VEDO (2). 10 TAC and 5 CSA patients were included in the final analysis.

Median duration of TAC induction was 5 months (1–12); median trough level was 8.95 (1.5–18.4). Median duration of CSA was 3 months (1–8); median trough level was 336.5 (92–415) for IV CSA and 293 (37–758) for oral CSA.

3/15 patients were in clinical remission at initiation of VEDO; 2 on TAC, 1 on steroids. At week 14, 9/15 (6 TAC, 3 CSA) were in clinical remission. 6 and 12 month clinical remissions were seen in 4/14 (28.5%) and 5/9 pts, respectively. Of patients who achieved clinical remission at 14 weeks, 2 remained in remission at 6 months; 1 at 12 months (the other lost to follow-up).

Table 1. Clinical results

ParameterNumber of patients
Active disease at baseline12/15
14 week: Clinical remission9/15
14 week: Clinical response9 /15
6 month: Clinical remission4/14
6 month: Clinical response8/14
1 year: Clinical remission5/9
1 year: Clinical response5/9

11 patients were steroid dependent at baseline; 6 successfully weaned off steroids (2 at 6 months and 4 at a year).

4 patients underwent colectomy. AEs attributed to TAC included tremor, malaise, gum sensitivity, headache, leg cramps, herpes outbreak and marrow suppression. CSA was associated with acute kidney injury and a possible allergic reaction. There were no deaths.

Conclusion

Calcineurin inhibitors successfully induced remission in over ½ of patients; vedolizumab maintained remission in 28.5% at 6 months and 55.6% at 1 year. Steroids were weaned in over half of patients.