Failure of Vedolizumab as First-Line Biologic Does Not Decrease Response Rates of Second-Line Therapy 681

• Published in: The American journal of gastroenterology Vol. 113; no. Supplement; pp. S382 - S383
• Main Authors: Ritter, Timothy E., Fourment, Chris, Okoro, Tracy C., Hardin, Thomas C., Van Anglen, Lucinda J.
• Format: Journal Article
• Language: English
• Published: New York Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins 01.10.2018
• Subjects: Crohns disease; Gastroenterology; Inflammatory bowel disease; Monoclonal antibodies; Remission (Medicine)
• ISSN: 0002-9270; 1572-0241
• DOI: 10.14309/00000434-201810001-00681

Introduction: Vedolizumab (VDZ), an anti-a4β7 integrin monoclonal antibody approved for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC), is increasingly being considered as first line biologic therapy in previously bio-naïve inflammatory bowel disease (IBD) patients (pts) who require more aggressive therapy. There is little guidance on the subsequent use of anti-TNF agents in those patients requiring a second biologic after VDZ. This study assesses the clinical response of IBD pts who were treated with an anti-TNF agent following VDZ discontinuation. Methods: A retrospective review of electronic medical records was conducted of all biologic-naïve IBD pts started on VDZ treatment at a large multicenter gastroenterology private practice. Data collection included demographics, diagnosis, therapy and disease activity during biologic therapy. Pts who failed initial VDZ treatment and were switched to an anti-TNF agent were identified. Disease activity assessed using the Harvey-Bradshaw Index (HBI) for CD or the partial Mayo (pMayo) score for UC, with clinical remission defined as HBI less than 5 or pMayo less than 2. Results: A total of 70 IBD pts (11 CD, 59 UC) received VDZ as their first-line biologic agent. Mean age was 49 years (yrs), median disease duration was 9 yrs, and 50% were male. VDZ was discontinued in 16 pts (23%) after a median length of therapy of 21 weeks (wks). Of those, 38% (n=6) discontinued within the 14-wk induction period, 50% (n=8) between 15 and 52 wks, and 12% (n=2) following 1 yr of VDZ therapy. Upon VDZ discontinuation, 88% (14/16) were switched to anti-TNF agents: 2 adalimumab (ADA) and 12 infliximab (IFX). As noted in Table 1, 75% of UC pts had improved pMayo scores, and 42% were in clinical remission on IFX. The overall decrease of 38% in the pMayo score was primarily due to the decline in rectal bleeding. Both CD pts were changed to ADA, with 1 pt achieving a lower HBI score at 3 mo, but not clinical remission. All pts who achieved remission had no prior IBD surgeries and stable or reduced disease activity while on VDZ. Conclusion: Our study sample is small but does suggest that biologic-naïve UC pts treated initially with VDZ may be successfully treated with IFX. Additional study is warranted on the use of other anti-TNF therapy in biologic-naive IBD patients following VDZ discontinuation.