Three‐year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: a prospective multi‐centre cohort study

Amiot, Aurélien; Serrero, Mélanie; Peyrin–Biroulet, Laurent; Filippi, Jérôme; Pariente, Benjamin; Roblin, Xavier; Buisson, Anthony; Stefănescu, Carmen; Trang-Poisson, Caroline; Altwegg, Romain; Marteau, Philippe; Vaysse, Thibaut; Bourrier, Anne; Nancey, Stéphane; Laharie, David; Allez, Matthieu; Savoye, Guillaume; Moreau, Jacques; Vuitton, Lucine; Viennot, Stéphanie; Bouguen, Guillaume; Abitbol, Véred; Fuméry, Mathurin; Gagniere, Charlotte; Bouhnik, Yoram; Getaid, Groupe d'Etude Thérapeutique Des Affections

doi:10.1111/apt.15294

Cited by 47 publications

(74 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The primary endpoint was steroid-free clinical remission at weeks [12][13][14][15][16]. Clinical remission was defined as a partial Mayo Clinic score ≤2, with a combined stool frequency and rectal bleeding subscore ≤1.…”

Section: Outcome Measuresmentioning

confidence: 99%

See 1 more Smart Citation

Effectiveness and safety of ustekinumab induction therapy for 103 patients with ulcerative colitis: a GETAID multicentre real‐world cohort study

Amiot¹,

Filippi²,

Abitbol³

et al. 2020

Aliment Pharmacol Ther

Self Cite

View full text Add to dashboard Cite

Background: Phase III trials have demonstrated the efficacy and safety of ustekinumab in moderate-to-severe ulcerative colitis (UC), but few real-world data are currently available.Aim: To assess short-term effectiveness and safety of ustekinumab in patients with UC.Methods: From January to September 2019, all patients with UC treated with ustekinumab in 20 French GETAID centres were retrospectively included. The primary outcome was steroid-free clinical remission (partial Mayo Clinic score ≤2) at weeks 12-16 without a rectal bleeding subscore >1.Results: Among the 103 patients included, 70% had been previously exposed to ≥2 anti-TNF agents and 85% to vedolizumab. At weeks 12-16, steroid-free clinical remission and clinical remission rates were 35.0% and 39.8% respectively; the absence of rectal bleeding with normal stool frequency was noted in 19.4% of patients. Two patients discontinued ustekinumab before the week 12-16 visit and underwent surgery. In multivariable analysis, a partial Mayo Clinic score >6 at inclusion (18.6% vs 46.7%, P = 0.003) and a history of both exposure to anti-TNF and vedolizumab therapies (27.3% vs 80.0%, P = 0.001) were negatively associated with steroid-free clinical remission at weeks 12-16. Adverse events occurred in 7.8% of patients and serious adverse events in 3.9% of patients. Conclusion:In a cohort of highly refractory patients with UC with multiple prior drug failures, ustekinumab provided steroid-free clinical remission in one-third of cases at weeks 12-16. Clinical severity and previous use of anti-TNF and vedolizumab therapies were associated with ustekinumab failure at weeks 12-16.

show abstract

Section: Outcome Measuresmentioning

confidence: 99%

“…9 Real-world studies allow bridging of some data gaps by describing patient experiences that are lacking in clinical trials that tend to exclude certain groups of patients. [10][11][12] Real-world experience series bring important data on the effectiveness and safety of new therapeutic options.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness and safety of ustekinumab induction therapy for 103 patients with ulcerative colitis: a GETAID multicentre real‐world cohort study

Amiot¹,

Filippi²,

Abitbol³

et al. 2020

Aliment Pharmacol Ther

Self Cite

View full text Add to dashboard Cite

show abstract

“…Patients from the pivotal phase III clinical studies (GEMINI) could be included in the long‐term open‐label studies (GEMINI‐LTS) and these trials indicated that the effectiveness of vedolizumab remained fairly stable in patients who responded to vedolizumab induction . However, only one study presented the safety and effectiveness results beyond 1 year in a real‐world population . In this study, the steroid‐free clinical remission rate for UC remained fairly stable beyond the first year of treatment, whereas the steroid‐free clinical remission rate of patients with CD tended to decrease over time.…”

mentioning

confidence: 79%

Vedolizumab for Inflammatory Bowel Disease: Two‐Year Results of the Initiative on Crohn and Colitis (ICC) Registry, A Nationwide Prospective Observational Cohort Study

Biemans

Woude

Dijkstra

et al. 2019

Clin Pharma and Therapeutics

View full text Add to dashboard Cite

on behalf of the Dutch Initiative on Crohn and ColitisProspective data of vedolizumab treatment for patients with inflammatory bowel disease (IBD) beyond 1 year of treatment is scarce but needed for clinical decision making. We prospectively enrolled 310 patients with IBD (191 with Crohn's disease (CD) and 119 patients with ulcerative colitis (UC)) with a follow-up period of 104 weeks (interquartile range: 103-104) in a nationwide registry. The corticosteroid-free clinical remission rate (Harvey Bradshaw Index ≤ 4, Short Clinical Colitis Activity index ≤ 2) at weeks 52 and 104 were 28% and 19% for CD and 27% and 28% for UC, respectively. Fifty-nine percent maintained corticosteroid-free clinical remission between weeks 52 and 104. Vedolizumab with concomitant immunosuppression showed comparable effectiveness outcomes compared with vedolizumab monotherapy (week 104: 21% vs. 23%; P = 0.77), whereas 8 of 13 severe infections occurred in patients treated with concomitant immunosuppression. To conclude, the clinical effect was 19% for CD and 28% for UC after 2 years of follow-up regardless of concomitant immunosuppression.

show abstract

“…Previous studies have shown that disease remission prior to conception and throughout pregnancy is crucial for favourable pregnancy outcomes . In order to achieve disease remission, patients with IBD are frequently treated with biological therapies such as vedolizumab (VDZ), a monoclonal antibody directed against the α4β7 integrin—mucosal vascular addressin cell adhesion molecule 1 (MAdCAM‐1) interaction in the gut . By blocking this interaction, VDZ inhibits the trafficking of gut‐homing lymphocytes .…”

Section: Introductionmentioning

confidence: 99%

“…2 In order to achieve disease remission, patients with IBD are frequently treated with biological therapies such as vedolizumab (VDZ), a monoclonal antibody directed against the α4β7 integrin-mucosal vascular addressin cell adhesion molecule 1 (MAdCAM-1) interaction in the gut. [3][4][5][6] By blocking this interaction, VDZ inhibits the trafficking of gut-homing lymphocytes. 3 However, data on the use of VDZ during conception and pregnancy remain sparse.…”

Section: Introductionmentioning

confidence: 99%

Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti‐TNF or conventional therapy: results of the European CONCEIVE study

Moens¹,

Woude²,

Julsgaard³

et al. 2019

Aliment Pharmacol Ther

102

View full text Add to dashboard Cite

Summary Background Women with inflammatory bowel diseases (IBD) often receive biologicals during pregnancy to maintain disease remission. Data on outcome of vedolizumab‐exposed pregnancies (VDZE) are sparse. Aims To assess pregnancy and child outcomes of VDZE pregnancies and to compare these results to anti‐TNF exposed (TNFE) or both immunomodulatory and biologic unexposed (CON IBD) pregnancies. Methods A retrospective multicentre case‐control observational study was performed. Results VDZE group included 79 pregnancies in 73 IBD women. The TNFE and CON IBD group included 186 pregnancies (162 live births) in 164 IBD women and 184 pregnancies (163 live births) in 155 IBD women, respectively. At conception, cases more often had active disease ([VDZE: 36% vs TNFE: 17%, P = .002] and [VDZE: 36% vs CON IBD: 24%, P = .063]). No significant difference in miscarriage rates were found between groups (VDZE and TNFE: 16% vs 13%, P = .567; VDZE and CON IBD: 16% vs 10%, P = .216). In live‐born infants, median gestational age and birthweight were similar between groups. Median Apgar score at birth was numerically equal. Prematurity was similar in the VDZE group compared to the control groups, even when correcting for disease activity during pregnancy. The frequency of congenital anomalies was comparable between groups as were the percentages of breastfed babies. During the first year of life, no malignancies were reported and infants' infection risk did not significantly differ between groups. Conclusion No new safety signal was detected in VDZE pregnancies although larger, prospective studies are required for confirmation.

show abstract

Three‐year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: a prospective multi‐centre cohort study

Cited by 47 publications

References 27 publications

Effectiveness and safety of ustekinumab induction therapy for 103 patients with ulcerative colitis: a GETAID multicentre real‐world cohort study

Effectiveness and safety of ustekinumab induction therapy for 103 patients with ulcerative colitis: a GETAID multicentre real‐world cohort study

Vedolizumab for Inflammatory Bowel Disease: Two‐Year Results of the Initiative on Crohn and Colitis (ICC) Registry, A Nationwide Prospective Observational Cohort Study

Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti‐TNF or conventional therapy: results of the European CONCEIVE study

Contact Info

Product

Resources

About