Vedolizumab in Inflammatory Bowel Disease: A Retrospective Review of Clinical Efficacy, Extraintestinal Manifestations and Adverse Reactions

Abstract

Introduction: Vedolizumab is a humanized monoclonal antibody with gut-specific anti-inflammatory activity for treatment of moderate to severe ulcerative colitis (UC) or Crohn disease (CD). We describe our experience with vedolizumab in a real-world clinical setting. Methods: A retrospective review of patients with UC and CD treated with vedolizumab was performed over 16 months. Patients that completed induction at weeks 0, 2, and 6 and with adequate clinical follow up were included. Response to treatment was assessed using the Harvey Bradshaw Index (HBI) and partial Mayo Score (pMS) for CD and UC, respectively. Analysis included prednisone dose reduction, use of combination therapy, adverse reactions, and extra-intestinal manifestations (EIM). Results: Our study included 40 patients (25 CD, 15 UC). In the CD group, mean HBI at week 0 was 8.6 (sd 4.1, n=25), at week 8 was 6.1 (sd 3.5, n=25), and at week 24 was 5.4 (sd 3.6, n=23). Mean prednisone dose at week 0 was 20.4 (sd 19.5, n=25); at week 24 was 9.0 (sd 14.8, n=23). 18/25 (72%) of CD patients were on maintenance therapy beyond 24 weeks, mean 41.4 (24-70). 11/18 (61%) were on combination therapy, 5/11 (45%) required more frequent vedolizumab dosing. 7/25 (28%) were considered treatment failures (2/7 surgery, 5/7 alternate therapy). In the UC group, mean pMS at week 0 was 5.8 (sd 1.6, n=15), week 8 was 3.6 (sd 2.4, n=15), and week 24 was 2.5 (sd 1.9, n=13). Mean prednisone dose at week 0 was 10.0mg (sd 14.1); at week 24 was 5.7mg (sd 14.0). 10/15 (67%) were on maintenance therapy beyond 24 weeks, mean 41.6 (24-68). 5/10 (50%) were on combination therapy with 1/5 requiring q4 week dosing. 5/15 (33%) were considered treatment failures (3/5 colectomy, 2/5 alternate therapy). 11/40 patients reported EIM. 8/11 had improvement (arthralgia=6, erythema nodosum (EN)=2, aphthous ulcers=1). In 3/11, EIM did not improve (pyoderma gangrenosum (PG)=3). 3/11 with EIM were considered treatment failures (aphthous ulcers=1, PG=1, arthralgia= 1). Adverse reactions occurred in 7/40 patients (arthralgia=3, fatigue=1, headache=2, pruritus=1, URI=2). 1/7 required stopping therapy. Conclusion: Vedolizumab achieves clinical response and steroid reduction in a majority of patients with moderate to severe IBD. Strategies to improve response include combination therapy and shorter dosing intervals. The majority of EIM were controlled, though PG failed to improve in 3/3 patients. Vedolizumab is well tolerated with 1/40 patients stopping therapy due to adverse reactions.