Vedolizumab for the Treatment of Chronic Pouchitis.


Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
30 Mar 2023
Historique:
medline: 31 3 2023
entrez: 29 3 2023
pubmed: 30 3 2023
Statut: ppublish

Résumé

Approximately half the patients with ulcerative colitis who undergo restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) will subsequently have pouchitis, and among those patients, one fifth will have chronic pouchitis. We conducted a phase 4, double-blind, randomized trial to evaluate vedolizumab in adult patients in whom chronic pouchitis had developed after undergoing IPAA for ulcerative colitis. Patients were assigned (in a 1:1 ratio) to receive vedolizumab intravenously at a dose of 300 mg or placebo on day 1 and at weeks 2, 6, 14, 22, and 30. All the patients received concomitant ciprofloxacin from weeks 1 to 4. The primary end point was modified Pouchitis Disease Activity Index (mPDAI)-defined remission (an mPDAI score of ≤4 and a reduction from baseline of ≥2 points in the mPDAI total score; scores range from 0 to 12, with higher scores indicating more severe pouchitis) at week 14. The mPDAI is based on clinical symptoms and endoscopic findings. Other efficacy end points included mPDAI-defined remission at week 34, mPDAI-defined response (a reduction from baseline of ≥2 points in the mPDAI score) at weeks 14 and 34, and PDAI-defined remission (a PDAI score of ≤6 and a reduction from baseline of ≥3 points; scores range from 0 to 18, with higher scores indicating more severe pouchitis) at weeks 14 and 34. The PDAI is based on clinical symptoms, endoscopic findings, and histologic findings. Among the 102 patients who underwent randomization, the incidence of mPDAI-defined remission at week 14 was 31% (16 of 51 patients) with vedolizumab and 10% (5 of 51 patients) with placebo (difference, 21 percentage points; 95% confidence interval [CI], 5 to 38; P = 0.01). Differences in favor of vedolizumab over placebo were also seen with respect to mPDAI-defined remission at week 34 (difference, 17 percentage points; 95% CI, 0 to 35), mPDAI-defined response at week 14 (difference, 30 percentage points; 95% CI, 8 to 48) and at week 34 (difference, 22 percentage points; 95% CI, 2 to 40), and PDAI-defined remission at week 14 (difference, 25 percentage points; 95% CI, 8 to 41) and at week 34 (difference, 19 percentage points; 95% CI, 2 to 37). Serious adverse events occurred in 3 of 51 patients (6%) in the vedolizumab group and in 4 of 51 patients (8%) in the placebo group. Treatment with vedolizumab was more effective than placebo in inducing remission in patients who had chronic pouchitis after undergoing IPAA for ulcerative colitis. (Funded by Takeda; EARNEST ClinicalTrials.gov number, NCT02790138; EudraCT number, 2015-003472-78.).

Sections du résumé

BACKGROUND BACKGROUND
Approximately half the patients with ulcerative colitis who undergo restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) will subsequently have pouchitis, and among those patients, one fifth will have chronic pouchitis.
METHODS METHODS
We conducted a phase 4, double-blind, randomized trial to evaluate vedolizumab in adult patients in whom chronic pouchitis had developed after undergoing IPAA for ulcerative colitis. Patients were assigned (in a 1:1 ratio) to receive vedolizumab intravenously at a dose of 300 mg or placebo on day 1 and at weeks 2, 6, 14, 22, and 30. All the patients received concomitant ciprofloxacin from weeks 1 to 4. The primary end point was modified Pouchitis Disease Activity Index (mPDAI)-defined remission (an mPDAI score of ≤4 and a reduction from baseline of ≥2 points in the mPDAI total score; scores range from 0 to 12, with higher scores indicating more severe pouchitis) at week 14. The mPDAI is based on clinical symptoms and endoscopic findings. Other efficacy end points included mPDAI-defined remission at week 34, mPDAI-defined response (a reduction from baseline of ≥2 points in the mPDAI score) at weeks 14 and 34, and PDAI-defined remission (a PDAI score of ≤6 and a reduction from baseline of ≥3 points; scores range from 0 to 18, with higher scores indicating more severe pouchitis) at weeks 14 and 34. The PDAI is based on clinical symptoms, endoscopic findings, and histologic findings.
RESULTS RESULTS
Among the 102 patients who underwent randomization, the incidence of mPDAI-defined remission at week 14 was 31% (16 of 51 patients) with vedolizumab and 10% (5 of 51 patients) with placebo (difference, 21 percentage points; 95% confidence interval [CI], 5 to 38; P = 0.01). Differences in favor of vedolizumab over placebo were also seen with respect to mPDAI-defined remission at week 34 (difference, 17 percentage points; 95% CI, 0 to 35), mPDAI-defined response at week 14 (difference, 30 percentage points; 95% CI, 8 to 48) and at week 34 (difference, 22 percentage points; 95% CI, 2 to 40), and PDAI-defined remission at week 14 (difference, 25 percentage points; 95% CI, 8 to 41) and at week 34 (difference, 19 percentage points; 95% CI, 2 to 37). Serious adverse events occurred in 3 of 51 patients (6%) in the vedolizumab group and in 4 of 51 patients (8%) in the placebo group.
CONCLUSIONS CONCLUSIONS
Treatment with vedolizumab was more effective than placebo in inducing remission in patients who had chronic pouchitis after undergoing IPAA for ulcerative colitis. (Funded by Takeda; EARNEST ClinicalTrials.gov number, NCT02790138; EudraCT number, 2015-003472-78.).

Identifiants

pubmed: 36988594
doi: 10.1056/NEJMoa2208450
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Ciprofloxacin 5E8K9I0O4U
vedolizumab 9RV78Q2002
Gastrointestinal Agents 0
Anti-Bacterial Agents 0

Banques de données

ClinicalTrials.gov
['NCT02790138']
EudraCT
['2015-003472-78']

Types de publication

Clinical Trial, Phase IV Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

1191-1200

Investigateurs

Marc Ferrante (M)
Brian Bressler (B)
Mark Silverberg (M)
Richmond Sy (R)
Cyrielle Gilletta de Saint Joseph (C)
Laurent Peyrin-Biroulet (L)
Laurent Siproudhis (L)
Daniel Baumgart (D)
Andreas Fischer (A)
Tanja Kuehbacher (T)
Andreas Stallmach (A)
Alessandro Armuzzi (A)
Silvio Danese (S)
Paolo Gionchetti (P)
Edoardo Savarino (E)
Mark Löwenberg (M)
Marie Pierik (M)
Guillermo Bastida Paz (G)
Ailsa Hart (A)
Gareth Parkes (G)
Simon Travis (S)
Dawn Beaulieu (D)
Robin Dalal (R)
Sushila Dalal (S)
John Hanson (J)
Hans Herfarth (H)
Darrell Pardi (D)
Jessica Philpott (J)
Timothy Ritter (T)
Bo Shen (B)
John Valentine (J)
Byron Vaughn (B)
Eugene Yen (E)

Informations de copyright

Copyright © 2023 Massachusetts Medical Society.

Auteurs

Simon Travis (S)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Mark S Silverberg (MS)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Silvio Danese (S)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Paolo Gionchetti (P)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Mark Löwenberg (M)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Vipul Jairath (V)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Brian G Feagan (BG)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Brian Bressler (B)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Marc Ferrante (M)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Ailsa Hart (A)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Dirk Lindner (D)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Armella Escher (A)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Stephen Jones (S)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

Bo Shen (B)

From the Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, Oxford (S.T.), and the Inflammatory Bowel Disease Unit, St. Mark's Hospital and Imperial College London, London (A.H.) - both in the United Kingdom; the Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto (M.S.S.), the Department of Medicine, Division of Gastroenterology, Western University (V.J.), and Alimentiv (V.J., B.G.F.), London, ON, and the Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver (B.B.) - all in Canada; the Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Milan (S.D.), and the Inflammatory Bowel Disease Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna, Bologna (P.G.) - both in Italy; the Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam (M.L.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium (M.F.); Takeda Pharmaceuticals International, Zurich, Switzerland (D.L., A.E., S.J.); and the Interventional Inflammatory Bowel Disease Center and the Center for Ileal Pouch Disorders, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York (B.S.).

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