Mark Löwenberg1, Severine Vermeire2, Nahid Mostafavi3, Frank Hoentjen4, Denis Franchimont5, Peter Bossuyt6, Pieter Hindryckx7, Theo Rispens8, Annick de Vries8, C Janneke van der Woude9, Sophie Berends10, Carmen A Ambarus11, Ron Mathot10, Esme Clasquin1, Filip Baert12, Geert D'Haens13. 1. Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands. 2. Division of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium. 3. Amsterdam UMC, University of Amsterdam, Biostatistics Unit of Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands. 4. Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands. 5. Department of Gastroenterology, Erasme Hospital - Université Libre de Bruxelles 808, Brussels, Belgium. 6. Imelda GI Clinical Research Center, Imelda General Hospital, Bonheiden, Belgium. 7. University Hospital of Ghent, Department of Gastroenterology, Ghent, Belgium. 8. Biologics Lab, Sanquin Diagnostic Services, Amsterdam, The Netherlands. 9. Erasmus MC, Department of Gastroenterology, Rotterdam, The Netherlands. 10. Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands; Amsterdam UMC, University of Amsterdam, Hospital Pharmacy, Amsterdam, The Netherlands. 11. Amsterdam UMC, University of Amsterdam, Department of Pathology, Amsterdam, The Netherlands. 12. AZ Delta, Division of Gastroenterology, Roeselare, Belgium. 13. Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands. Electronic address: g.dhaens@amc.uva.nl.
Abstract
BACKGROUND & AIMS: We evaluated the ability of vedolizumab to induce endoscopic and histologic remission in patients with Crohn's disease (CD). METHODS: We performed a prospective study of 110 patients with active CD, based on CD activity index (CDAI) scores >220 and mucosal ulcerations, who received open-label vedolizumab (300 mg) infusions at weeks 0, 2, and 6, and every 8 weeks thereafter through week 52 at tertiary centers in Europe. Patients received an additional infusion at week 10 if their CDAI score had not decreased by 70 points. Patients underwent ileocolonoscopy with collection of biopsies at baseline and weeks 26 and 52; a local and central reader determined simple endoscopic index for CD (SES-CD) scores. Histologic features were assessed by a blinded pathologist at week 26. Serum concentrations of vedolizumab were measured at serial time points. The primary outcome was endoscopic and histologic remission in patients with active CD treated with vedolizumab for 52 weeks. RESULTS: At weeks 26 and 52, 36 patients (29%) and 34 patients (31%), respectively, were in corticosteroid-free clinical remission (CDAI score <150), respectively. Based on intent-to-treat analysis, endoscopic remission (SES-CD score <4) was achieved by 36 patients (33%) and 40 patients (36%) at weeks 26 and 52. Endoscopic responses (decrease in SES-CD score ≥50%) occurred in 44 patients (40%) at week 26 and 5 patients (45%) at week 52. Serum concentrations of vedolizumab were higher at weeks 2, 10, and 22 in patients with lower SES-CD scores. Histologic remission at week 26 was observed in 43 (64%) of 67 patients based on Geboes Score and 37 (66%) of 56 patients based on Robarts Histopathology Index scores in analyses of paired biopsies with inflammation at baseline. Serum concentrations of vedolizumab above 10 mg/L at week 22 were associated with endoscopic remission at week 26. CONCLUSIONS: In a prospective trial, we found that approximately one-third of patients with CD achieve endoscopic remission after 52 weeks of treatment with vedolizumab and two-thirds achieve histologic remission at week 26. Higher serum concentrations of vedolizumab were associated with better outcomes. EUDRACT no: 2014-005376-29.
BACKGROUND & AIMS: We evaluated the ability of vedolizumab to induce endoscopic and histologic remission in patients with Crohn's disease (CD). METHODS: We performed a prospective study of 110 patients with active CD, based on CD activity index (CDAI) scores >220 and mucosal ulcerations, who received open-label vedolizumab (300 mg) infusions at weeks 0, 2, and 6, and every 8 weeks thereafter through week 52 at tertiary centers in Europe. Patients received an additional infusion at week 10 if their CDAI score had not decreased by 70 points. Patients underwent ileocolonoscopy with collection of biopsies at baseline and weeks 26 and 52; a local and central reader determined simple endoscopic index for CD (SES-CD) scores. Histologic features were assessed by a blinded pathologist at week 26. Serum concentrations of vedolizumab were measured at serial time points. The primary outcome was endoscopic and histologic remission in patients with active CD treated with vedolizumab for 52 weeks. RESULTS: At weeks 26 and 52, 36 patients (29%) and 34 patients (31%), respectively, were in corticosteroid-free clinical remission (CDAI score <150), respectively. Based on intent-to-treat analysis, endoscopic remission (SES-CD score <4) was achieved by 36 patients (33%) and 40 patients (36%) at weeks 26 and 52. Endoscopic responses (decrease in SES-CD score ≥50%) occurred in 44 patients (40%) at week 26 and 5 patients (45%) at week 52. Serum concentrations of vedolizumab were higher at weeks 2, 10, and 22 in patients with lower SES-CD scores. Histologic remission at week 26 was observed in 43 (64%) of 67 patients based on Geboes Score and 37 (66%) of 56 patients based on Robarts Histopathology Index scores in analyses of paired biopsies with inflammation at baseline. Serum concentrations of vedolizumab above 10 mg/L at week 22 were associated with endoscopic remission at week 26. CONCLUSIONS: In a prospective trial, we found that approximately one-third of patients with CD achieve endoscopic remission after 52 weeks of treatment with vedolizumab and two-thirds achieve histologic remission at week 26. Higher serum concentrations of vedolizumab were associated with better outcomes. EUDRACT no: 2014-005376-29.
Authors: Madeleine D Hu; Natasha B Golovchenko; Grace L Burns; Prema M Nair; Thomas J Kelly; Jonathan Agos; Mudar Zand Irani; Wai Sinn Soh; Matthew R Zeglinski; Alexander Lemenze; Edward M Bonder; Inga Sandrock; Immo Prinz; David J Granville; Simon Keely; Alastair J M Watson; Karen L Edelblum Journal: Gastroenterology Date: 2021-12-01 Impact factor: 22.682
Authors: Carl Eriksson; Sara Rundquist; Vyron Lykiardopoulos; Ruzan Udumyan; Per Karlén; Olof Grip; Charlotte Söderman; Sven Almer; Erik Hertervig; Jan Marsal; Jenny Gunnarsson; Carolina Malmgren; Jenny Delin; Hans Strid; Mats Sjöberg; David Öberg; Daniel Bergemalm; Henrik Hjortswang; Jonas Halfvarson Journal: Therap Adv Gastroenterol Date: 2021-07-03 Impact factor: 4.409