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Gastroenterology. 2019 Jun 5. pii: S0016-5085(19)40985-2. doi: 10.1053/j.gastro.2019.05.067. [Epub ahead of print]

Vedolizumab Induces Endoscopic and Histologic Remission in Patients With Crohn's Disease.

Author information

1
Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
2
Division of Gastroenterology and Hepatology, University hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium.
3
Amsterdam UMC, University of Amsterdam, Biostatistic Unit of Department of Gastroenterology and Hepatology, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
4
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands.
5
Department of Gastroenterology, Erasme Hospital - Université libre de Bruxelles 808, Route de Lennik 1070 Brussels, Belgium.
6
Imelda GI clinical research center, Imelda general hospital, Imeldalaan 9, 2820 Bonheiden, Belgium.
7
University hospital of Ghent, Department of gastroenterology, De Pintelaan 185, 9000 Ghent, Belgium.
8
Biologics Lab, Sanquin Diagnostic Services, Plesmanlaan 125, 1066 CX Amsterdam, The Netherlands.
9
Erasmus MC, Department of Gastroenterology, Doctor Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.
10
Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands; Amsterdam UMC, University of Amsterdam, Hospital Pharmacy, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
11
Amsterdam UMC, University of Amsterdam, Department of Pathology, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
12
AZ Delta, Division of Gastroenterology, Wilgenstraat 2, 8800 Roeselare, Belgium.
13
Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, Meibergdreef 9, 1105 AZ 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 43/67 patients (64%) based on Geboes score and 37/56 patients (66%) 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 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.

KEYWORDS:

IBD; LOVE-CD trial; anti-integrin α(4)β(7); biologic

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