Vedolizumab in IBD–Lessons From Real-world Experience; A Systematic Review and Pooled Analysis

Engel, Tal; Ungar, Bella; Yung, Diana E; Ben‐Horin, Shomron; Eliakim, Rami; Kopylov, Uri

doi:10.1093/ecco-jcc/jjx143

Cited by 130 publications

(114 citation statements)

References 56 publications

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“…1 Similar results were recently reported in a meta-analysis of observational studies with an estimated 1 year corticosteroid-free remission rate of 31% (95% confidence interval [CI] 20-45%). 2,3 These data underscore that while a substantial proportion of treatment-resistant patients respond to VDZ therapy, the majority do not. Although this circumstance is likely multifactorial, variability in VDZ pharmacokinetics (PK) is a potential explanation in some patients.…”

Section: Introductionmentioning

confidence: 87%

“…In the GEMINI 2 pivotal phase 3 clinical trial of vedolizumab (VDZ) for Crohn’s disease (CD), approximately one‐third of patients with active CD achieved corticosteroid‐free remission at week 52 . Similar results were recently reported in a meta‐analysis of observational studies with an estimated 1 year corticosteroid‐free remission rate of 31% (95% confidence interval [CI] 20‐45%) . These data underscore that while a substantial proportion of treatment‐resistant patients respond to VDZ therapy, the majority do not.…”

Section: Introductionmentioning

confidence: 99%

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A clinical decision support tool may help to optimise vedolizumab therapy in Crohn’s disease

Dulai

Amiot²,

Peyrin–Biroulet³

et al. 2019

Aliment Pharmacol Ther

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Background:A clinical decision support tool (CDST) has been validated for predicting treatment effectiveness of vedolizumab (VDZ) in Crohn's disease.Aim: To assess the utility of this CDST for predicting exposure-efficacy and disease outcomes.Methods: Using data from three independent datasets (GEMINI, GETAID and VICTORY), we assessed clinical remission rates and measured VDZ exposure, rapidity of onset of action, response to dose optimisation and progression to surgery by CDST-defined response groups (low, intermediate and high). Results:A linear relationship existed between CDST-defined groups, measured VDZ exposure, rapidity of onset of action and efficacy in GEMINI through week 52 (P < 0.001 at all time points across three CDST-defined groups). In GETAID, CDST predicted differences in clinical remission at week 14 (AUC = 0.68) and rapidity of onset of action (P = 0.04) between probability groups. The high-probability patients did not benefit from shortening of infusion intervals, and differences in onset of action between the highintermediate and low-probability groups within GETAID were no longer significant when including low-probability patients who received a week 10 infusion. CDST predicted a twofold increase in surgery risk over 12 months of VDZ therapy among low-to intermediate-probability vs high-probability patients (adjusted HR 2.06, 95% CI 1.33-3.21). Conclusions:We further extended the clinical utility of a previously validated VDZ CDST, which accurately predicts at baseline exposure-efficacy relationships and rapidity of onset of action and could be used to help identify patients who would mostThis is an open access article under the terms of the Creat ive Commo ns Attri butio n-NonCo mmerc ial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. AA has received consulting fees from AbbVie, Hospira, Takeda, Gilead and Biocodex, as well as lecture fees and travel accommodations from AbbVie, Janssen, Biocodex, Hospira, Ferring, Takeda and MSD. AA has also received advisory board fees from Gilead, Takeda and AbbVie. LPB has received consulting fees from Merck,

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Section: Introductionmentioning

confidence: 87%

Section: Introductionmentioning

confidence: 99%

A clinical decision support tool may help to optimise vedolizumab therapy in Crohn’s disease

Dulai

Amiot²,

Peyrin–Biroulet³

et al. 2019

Aliment Pharmacol Ther

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“…2,3 Although the efficacy and safety of VDZ induction and maintenance therapy in CD has been confirmed in real-life cohorts, only limited data are available on endoscopic and histological remission. [4][5][6][7][8] Endoscopic remission is an important treatment goal in CD that is associated with improved clinical outcomes, including reduced hospitalization and surgery rates. 9,10 Moreover, endoscopic response is recommended as a co-primary endpoint in clinical trials by regulatory agencies.…”

Section: Background and Aimsmentioning

confidence: 99%

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

et al. 2019

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See editorial on page 925. 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.

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“…Vedolizumab (VDZ) is a monoclonal antibody that targets the α4β7 integrin and blocks its interaction with the mucosal vascular addressin cell adhesion molecule 1 (MAdCAM‐1). It has shown to be effective in ulcerative colitis (UC) in randomized controlled trials and real‐world studies . Nevertheless, 20% to 35% of patients receiving VDZ can lose response (LOR) during the first 12 months of treatment .…”

Section: Introductionmentioning

confidence: 99%

“…It has shown to be effective in ulcerative colitis (UC) in randomized controlled trials and real-world studies. 1,2 Nevertheless, 20% to 35% of patients receiving VDZ can lose response (LOR) during the first 12 months of treatment. 3 The intensification of VDZ can restore the response in some cases, but this strategy is only effective in approximately 54% of secondary nonresponders.…”

Section: Introductionmentioning

confidence: 99%

The combination of granulocyte‐monocyte apheresis and vedolizumab: A new treatment option for ulcerative colitis?

Rodríguez‐Lago

Benítez

Sempere

et al. 2019

J of Clinical Apheresis

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Objectives To assess the effectiveness and safety of combining granulocyte‐monocyte apheresis (GMA) and vedolizumab (VDZ) in patients with refractory ulcerative colitis (UC). Methods This retrospective, multicentre pilot study included all UC patients receiving both GMA and VDZ. We recorded data on GMA sessions, demographic characteristics, and clinical response. Effectiveness was assessed 1 and 6 months after finishing the GMA using the partial Mayo score, C‐reactive protein, and fecal calprotectin levels. Data were also compiled on VDZ intensification, use of new immunomodulators and colectomy during follow‐up. Results Eight patients were included (mean age 46 years; 63% female; mean disease duration, 132 months; 50% E3). GMA was started after a loss of response to VDZ in all cases (25% primary nonresponse and 75% secondary loss of response). All had previously received anti‐TNF agents. VDZ was prescribed as the second‐, third‐, or fourth‐line biologic in 37%, 50%, and 13% of cases, respectively. Patients had a mean baseline partial Mayo score of 7.5 (SD 2.1) and received a median of 15 GMA sessions (range 5‐38). After a median follow‐up of 7.5 months (IQR 5‐12), partial Mayo score decreased after 1 and 6 months (P = .01 and .06, respectively). Three patients (38%) achieved steroid‐free clinical remission and five (63%) withdrew VDZ. Colectomy rate was 38%. No adverse events were observed during the combination therapy. Conclusions This small case series suggests that combining GMA with VDZ could be a treatment option in selected cases of UC with an inadequate response to this biologic agent.

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Vedolizumab in IBD–Lessons From Real-world Experience; A Systematic Review and Pooled Analysis

Abstract: VDZ is efficacious in CD and UC and has a favourable safety profile in RWE studies.

Cited by 130 publications

References 56 publications

A clinical decision support tool may help to optimise vedolizumab therapy in Crohn’s disease

A clinical decision support tool may help to optimise vedolizumab therapy in Crohn’s disease

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

The combination of granulocyte‐monocyte apheresis and vedolizumab: A new treatment option for ulcerative colitis?

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