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* = Presenting author

P615 Post-marketing experience of vedolizumab for IBD: The University of Chicago experience

B. Christensen*, S.R. Goeppinger, R. Colman, D. Siddiqui, A. Yarur, A.A. Bochenek, A. Wichmann, A. Hirsch, J. Kinnucan, A. Sakuraba, R. Cohen, D.T. Rubin

University of Chicago Inflammatory Bowel Disease Center, Gastroenterology, Chicago, IL, United States

Background

Vedolizumab, a monoclonal antibody to alpha-4 beta-7 integrins was recently approved for both Crohn's disease (CD) and ulcerative colitis (UC). Its post-marketing experience in adults has not yet been described.

Methods

This was an IRB-approved post-marketing study of University of Chicago patients with CD and UC who received vedolizumab. Patients followed for at least 12 weeks were fully characterized and included. Clinical activity was assessed using Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) at baseline and at pre-defined times of follow-up. Clinical response was defined as a reduction of 3 or more in HBI or SCCAI and clinical remission was defined as HBI less than or equal to 4 or SCCAI less than or equal to 2. Variables influencing clinical response were examined using Chi-square test, Fisher's exact test and Wilcoxon rank-sum test.

Results

From May 2014-November 2014 130 patients (62% CD) started vedolizumab at our Center. At the time of this abstract, 69 patients (61% CD) had post-induction follow-up (45% male, median age 35 years). Of 46 patients with active disease at baseline, 39% achieved clinical remission and 54% achieved clinical response by week 14. Of 23 patients who were in clinical remission at baseline, the indications for vedolizumab included steroid/tacrolimus dependence (n=8), active disease on endoscopy (n=5), intolerance to anti-TNF therapy (n=2), transition from natalizumab (n=6), perianal disease (n=1) and active PSC (n=1). Clinical remission rates in those with UC and CD increased from 26% to 52% and 38% to 62%, respectively (CD v UC n.s.). Of 37 patients on prednisone at induction, 10 (27%) were steroid-free by week 14. Numerical but non-significant differences were found for response in ileocolonic CD v isolated ileal or colonic disease (44% v 100% v 67%, p = 0.109), pan UC v less extensive disease (40% v 80%, p = 0.303), number of failed anti-TNF therapies (71% v 67% v 46% for TNF-naïve, 1 failed TNF or 2 or more failed TNF therapies, respectively, p=0.602) and combination v monotherapy (59% v 52%, p = 0.641). 5/15 (33%) with arthralgias and 5/10 (50%) patients with active perianal disease had improvement. 30% of pts described an adverse event including worsening GI symptoms (n=10, 5 colectomies), minor infections, aches and pains, and one pt with an allergic reaction to vedolizumab

Conclusion

In this post-marketing experience of vedolizumab for IBD in a tertiary center, vedolizumab therapy demonstrated similar efficacy and safety as seen in the pivotal trials, with clinical response in the majority of patients, including those with complex disease phenotypes and those who have failed anti-TNF therapy. We did not see differences in response between CD and UC.