Sa1198 Initial Vedolizumab Cohort: Patient Characteristics and Clinical Response

Abstract

Background: Vedolizumab, an α4β7 integrin antibody, was recently approved for use in Crohn's disease (CD) and ulcerative colitis (UC). Characteristics of patients with inflammatory bowel disease (IBD) who receive vedolizumab in clinical practice, and efficacy of vedolizumab in this patient population, is unknown. Objective: To characterize the background medical history and response of patients receiving vedolizumab in a referral center for IBD. Methods: All patients with IBD who received at least one dose of vedolizumab were identified. Demographics, IBD history, abdominal surgery history, comorbid diagnoses, laboratory results, and physician assessment of disease activity were abstracted from medical records. Results: Medical record data were abstracted from 62 IBD patients receiving at least one dose of vedolizumab from July 2014 through early November 2014. The median duration of vedolizumab use was 102 days, ranging from 1 to 129 days. Forty-eight patients had CD, 12 had UC, and 2 had indeterminate colitis. There were 23 (37%) males, and 58 (94%) were white. The average age was 38 (+/-3) years. The mean duration of disease for CD and UC patients was 19 years (+/5) and 31 years (+/-7), respectively. Nearly all patients had used biologic therapy (n=60, 97%); 34 (57%) also had at least one intestinal resection. More than two-thirds had discontinued 2 or more biologics (n=45, 73 %) and almost half had discontinued 3 or more biologics (n=27, 44%). Among subjects with CD, 17 (40%) had penetrating disease, and 14 of these also had perianal disease. Eight (75%) UC patients had pancolitis. Depression or anxiety affected 19 (31%) subjects. CRP rose from baseline to week 6 in CD patients (mean rate 1.21, 95% CI 1.05-1.54), but significant changes in CRP from baseline to week 12 were not observed (mean rate 1.18, 0.93-1.29). Among UC patients, no changes in CRP were observed from baseline to week 6 (2.01, 0.86-4.69) nor from baseline to week 12 (0.86, 0.29-2.56). Six patients were hospitalized while receiving vedolizumab for worsening IBD (median 47 days after initial infusion). Vedolizumab was discontinued in 4 patients (median 45 days after initial infusion): 3 for non-response and 1 due to an infusion reaction . Of the 33 subjects who have been on the medication for at least 12 weeks, patients' physicians assessed that 6 (18%) patients achieved remission, 16 (48%) had partial response, and 11 (33%) had no response. Conclusion: Patients receiving vedolizumab at a referral IBD center had severe disease history, including prior resection and failure of multiple biologic therapies. These findings should be taken in the context of the patient population with a history of severe and medically refractory disease, the short follow-up period, and relative lack of clinical measures in the medical record retrospectively assessing response to medications.