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Tuesday Poster Session

Category: IBD

P3558 - Vedolizumab Is Effective for the Treatment of Chronic Inflammatory Conditions of the Pouch in a Prospective Multicenter Study

Tuesday, October 24, 2023
10:30 AM – 4:00 PM PT
Location: Exhibit Hall
Has Audio
Edward Barnes, MD, MPH, FACG1, Laura Raffals, FACG, MD, MS2, Taha Qazi, MD3, Maia Kayal, MD4, Parakkal Deepak, MBBS, MS5, Poonam Beniwal-Patel, MD6, Marla C. Dubinsky, MD7, Shannon Chang, MD, MBA8, Peter Higgins, MD, PhD, MSc9, Jennifer I. Barr, BA1, Chelsea Anderson, PhD, MPH10, Raymond K.. Cross, MD, MS, FACG11, Millie D. Long, MD, MPH12, Hans Herfarth, MD, PhD1
1University of North Carolina at Chapel Hill, Chapel Hill, NC; 2Mayo Clinic, Rochester, MN; 3Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH; 4Icahn School of Medicine at Mount Sinai, New York, NY; 5Washington University in St. Louis School of Medicine, St. Louis, MO; 6Medical College of Wisconsin, Wauwatosa, WI; 7Mount Sinai Kravis Children’s Hospital, New York, NY; 8NYU Langone Health, New York, NY; 9University of Michigan Hospital, Ann Arbor, MI; 10University of North Carolina School of Medicine, Chapel Hill, NC; 11University of Maryland School of Medicine, Baltimore, MD; 12UNC Chapel Hill, Chapel Hill, NC

Introduction: Vedolizumab has recently demonstrated efficacy in the treatment of chronic pouchitis in a randomized, placebo-controlled trial (EARNEST). Often, patients treated in real-world settings differ from those in clinical trials, thus we compared the clinical characteristics of patients treated with vedolizumab for chronic inflammatory conditions of the pouch in a prospective registry to those in the EARNEST study as well as the overall effectiveness of vedolizumab in this setting.

Methods: Patients with chronic pouchitis or Crohn’s disease of the pouch (CDP) were recruited from nine centers at the time of initiation of vedolizumab for their pouch-related disorder. Clinical assessments were performed at enrollment and 3 and 6 months after enrollment. The diagnosis of CDP was made by the enrolling physician and was based on the following criteria: inflammation of the pre-pouch ileum, strictures involving the pouch or pre-pouch ileum, and/or fistulae involving the pouch or pre-pouch ileum. Clinical remission was defined as a clinical modified Pouchitis Disease Activity Index (mPDAI) score <2 with both the bowel frequency and urgency subscores <1.

Results: Among 18 patients initiating vedolizumab, 9 (50%) had chronic pouchitis and 9 (50%) had CDP. At the time of induction with vedolizumab, 8 (44%) patients were using antibiotics, with 5 (28%) patients having prior exposure to tumor necrosis factor alpha antagonist (anti-TNF) therapy after IPAA, 2 (11%) having prior exposure to ustekinumab after IPAA and 1 (6%) having prior exposure to tofacitinib after IPAA (Table 1). Among patients with eligible follow-up data, at 3 months after induction with vedolizumab, 6 of 16 (38%) patients were in clinical remission and at 6 months, 7 of 11 (64%) were in clinical remission (Figure 1). Similar rates of effectiveness were seen in patients with chronic pouchitis and CDP at both time points.

Discussion: In a prospective evaluation of the real-world effectiveness of vedolizumab for the treatment of chronic inflammatory conditions of the pouch, patients with both chronic pouchitis and CDP demonstrated favorable response to vedolizumab. In a population that demonstrated several potential indicators of refractory disease, vedolizumab showed a consistent treatment effect and should receive strong consideration for patients with chronic inflammatory conditions of the pouch.

Figure: Figure 1. Clinical remission among patients treated with vedolizumab for chronic inflammatory conditions of the pouch, assessed at 3 and 6 months post induction


Note: historical placebo rate from week 14 and week 34 assessment in EARNEST


Disclosures:
Edward Barnes: AbbVie, Inc. – Consultant. Bristol-Meyers Squibb – Consultant. Eli Lilly – Consultant. Target RWE – Consultant.
Laura Raffals: Fresenius Kabi – Advisory Committee/Board Member. Janssen – Advisory Committee/Board Member. Roivant – Advisory Committee/Board Member.
Taha Qazi: Abbvie – Advisor or Review Panel Member, Speakers Bureau. BMS – Advisor or Review Panel Member, Speakers Bureau. Itierative Scope – Advisor or Review Panel Member. Janssen – Speakers Bureau.
Maia Kayal: AbbVie – Consultant. Bristol Myers Squibb – Consultant. Fresenius – Consultant. GoodRx – Consultant. Pfizer – Consultant.
Parakkal Deepak: Abbvie – Advisory Committee/Board Member. BMS – Advisory Committee/Board Member. Boehringer Ingelheim – Grant/Research Support. Fresenius Kabi – Consultant. Janssen – Grant/Research Support. Pfizer/Arena Pharmaceuticals – Grant/Research Support. Prometheus Biosciences – Grant/Research Support. Prometheus Labs – Grant/Research Support. Roche – Grant/Research Support, PI on a study. Sandoz – Advisory Committee/Board Member. Takeda – Grant/Research Support.
Poonam Beniwal-Patel indicated no relevant financial relationships.
Marla Dubinsky: AbbVie – Consultant, Grant/Research Support. Arena Pharmaceuticals – Consultant. Astra Zeneca – Consultant. Celgene – Consultant. Genentech Inc. – Consultant. Gilead Sciences – Consultant. Janssen – Consultant, Grant/Research Support. Merck – Consultant. Pfizer – Consultant, Grant/Research Support. Prometheus Biosciences – Consultant, Grant/Research Support. Prometheus Labs – Consultant, Grant/Research Support. Takeda – Consultant, Licensing fees. Thabor – Consultant. Trellus Health – Stock-publicly held company(excluding mutual/index funds). UCB Pharma – Consultant.
Shannon Chang: Abbvie – Consultant. Bristol Myers Squibb – Consultant. Pfizer – Consultant.
Peter Higgins: AbbVie – Consultant. Amgen – Consultant. Buhlmann Laboratories – Consultant. Celltrion – Consultant. Curacle – Consultant. Eli Lilly – Consultant. Genentech – Consultant.
Jennifer Barr indicated no relevant financial relationships.
Chelsea Anderson indicated no relevant financial relationships.
Raymond Cross: AbbVie – Consultant. Bristol Myers Squibb – Consultant. Janssen – Consultant. LabCorp – Consultant. Pfizer – Consultant. Samsung Bioepis – Consultant. Takeda – Consultant.
Millie D. Long: AbbVie – Consultant. Bristol Myers Squibb – Consultant. Eli Lilly – Consultant, Grant/Research Support. Genentech – Consultant. Intercept – Consultant. Janssen – Consultant. Pfizer – Consultant, Grant/Research Support. Prometheus – Consultant. Roche – Consultant. Salix – Consultant. Takeda – Consultant, Grant/Research Support. Target PharmaSolutions – Consultant. UCB – Consultant. Valeant – Consultant.
Hans Herfarth: BMS – Consultant. EXE-GI – Consultant. Fresenius Kabi – Consultant. Galapagos – Consultant. Gilead – Consultant. Janssen – Consultant. NovoNordisk – Grant/Research Support. Pfizer – Grant/Research Support. Ventyx – Consultant.


Edward Barnes, MD, MPH, FACG1, Laura Raffals, FACG, MD, MS2, Taha Qazi, MD3, Maia Kayal, MD4, Parakkal Deepak, MBBS, MS5, Poonam Beniwal-Patel, MD6, Marla C. Dubinsky, MD7, Shannon Chang, MD, MBA8, Peter Higgins, MD, PhD, MSc9, Jennifer I. Barr, BA1, Chelsea Anderson, PhD, MPH10, Raymond K.. Cross, MD, MS, FACG11, Millie D. Long, MD, MPH12, Hans Herfarth, MD, PhD1. P3558 - Vedolizumab Is Effective for the Treatment of Chronic Inflammatory Conditions of the Pouch in a Prospective Multicenter Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.