Outcome of Pregnancies in Female Patients With Inflammatory Bowel Diseases Treated With Vedolizumab

Moens, Annick; Hoeve, Karen van; Humblet, Evelien; Rahier, Jean–François; Bossuyt, Peter; Dewit, Sophie; Franchimont, Denis; Macken, Elisabeth; Nijs, Jochen; Posen, Annelies; Strubbe, Beatrijs; Hootegem, Anneleen Van; Moerkercke, Wouter Van; Vermeire, Séverine; Ferrante, Marc

doi:10.1093/ecco-jcc/jjy142

Cited by 51 publications

(47 citation statements)

References 28 publications

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“…When being in the second trimester of pregnancy, vedolizumab therapy is usually discontinued because of the potential risks for the unborn child. [14][15][16] As AVA do not increase upon stop of therapy, pregnant patients can discontinue treatment without the risk of developing AVA, which may reduce the probability of regaining a clinical response when resuming vedolizumab therapy.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity is not the driving force of treatment failure in vedolizumab‐treated inflammatory bowel disease patients

Berghe

Verstockt

Tops

et al. 2019

J of Gastro and Hepatol

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Background and Aim The pivotal GEMINI trials reported low immunogenicity of vedolizumab. However, anti‐vedolizumab antibodies (AVA) are frequently underestimated because most assays are not drug‐tolerant and unable to detect antidrug antibodies while there is drug in the circulation. This study aimed to explore which antidrug antibody assay is best suited to detect AVA and investigated immunogenicity of vedolizumab in inflammatory bowel disease (IBD) patients discontinuing vedolizumab therapy. Methods A drug‐tolerant affinity capture elution (ACE) assay was developed for the measurement of AVA in the presence of vedolizumab and compared with the previously established drug‐resistant and drug‐sensitive assays. Vedolizumab and AVA were measured at week 6, at the last infusion, and 12–20 weeks after treatment discontinuation in a cohort of 40 vedolizumab‐treated IBD patients who stopped treatment due to primary non‐response, loss of response, or adverse events. Results The drug‐tolerant ACE assay could detect AVA in samples that the drug‐resistant and drug‐sensitive assays were unable to. Using the drug‐tolerant ACE assay, 3 (8%) out of 40 vedolizumab‐treated IBD patients who discontinued therapy were AVA positive at week 6, whereas no AVA were detected at the last infusion nor after treatment discontinuation. Primary non‐responders had numerically lower median vedolizumab concentrations at week 6 compared with patients with loss of response (20.3 vs 30.7 μg/mL, respectively, P = 0.0570). Conclusions Immunogenicity of vedolizumab is not the driving force of treatment failure, and AVA do not increase upon treatment discontinuation in vedolizumab‐treated IBD patients. Underexposure during induction might partially be responsible for primary non‐response.

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Section: Discussionmentioning

confidence: 99%

Immunogenicity is not the driving force of treatment failure in vedolizumab‐treated inflammatory bowel disease patients

Berghe

Verstockt

Tops

et al. 2019

J of Gastro and Hepatol

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“…Further inclusion criteria were that infants had to be at least 3 months old at the time of inclusion in the study. A subset of this study population was already published in previous studies . The control groups of anti‐TNF‐exposed (TNFE) and IMs and biologics unexposed (CON IBD) pregnancies were prospectively collected in collaboration with two centres with a specialised IBD pregnancy clinic (Erasmus Medical Center, Rotterdam, The Netherlands and Shaare Zedek Medical Centre, Jerusalem, Israel).…”

Section: Methodsmentioning

confidence: 99%

“…Information from VDZE pregnancies was collected through a structured electronic case report form (CRF), adapted from the CRF used in the previous Belgian observational study, and had to be filled out by the treating gastroenterologist (Figure S1).…”

Section: Methodsmentioning

confidence: 99%

“…By blocking this interaction, VDZ inhibits the trafficking of gut‐homing lymphocytes . However, data on the use of VDZ during conception and pregnancy remain sparse . We previously reported several pregnancy and neonatal complications among female IBD patients treated with VDZ in a retrospective Belgian study.…”

Section: Introductionmentioning

confidence: 99%

“…In particular, a relatively high number of congenital malformations were reported (three out of 23 live births: hip dysplasia, pulmonary valve stenosis and Hirschsprung's disease). Additionally, the published case of a congenital corpus callosum agenesis anomaly in a healthy volunteer exposed to VDZ gave rise to concerns . Since the Belgian study was too small to draw firm conclusions and underlying active disease was a major confounding factor, a pan‐European study was performed to increase the number of VDZ‐exposed (VDZE) pregnancies and thus the statistical power.…”

Section: Introductionmentioning

confidence: 99%

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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

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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.

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Inflammatory Bowel Disease and Pregnancy

Patel

Yarur

2019

Gastrointestinal and Liver Disorders in Women’s Health

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Outcome of Pregnancies in Female Patients With Inflammatory Bowel Diseases Treated With Vedolizumab

Cited by 51 publications

References 28 publications

Immunogenicity is not the driving force of treatment failure in vedolizumab‐treated inflammatory bowel disease patients

Immunogenicity is not the driving force of treatment failure in vedolizumab‐treated inflammatory bowel disease patients

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

Inflammatory Bowel Disease and Pregnancy

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