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

Abstract

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.

Safety of vedolizumab in the treatment of pregnant women with inflammatory bowel disease: a targeted literature review

“…and 15% (CON-IBD), respectively. Compared with previously published data based on 31 study sites, Moens et al 33 , 35 , 36 reported slightly lower patient numbers, since their analysis was based on only 29 study sites.…”

“…In the work by Moens et al , median birth weight did not differ between the groups (VDZ, anti-TNF, immunomodulatory/biologic-naïve). 35 Congenital anomalies were reported for 5% (VDZ-exposed), 2% (TNF-exposed), and 2% (CON-IBD) of the observed cases, whereas serious infections during the first year of life were documented in 5% (VDZ-exposed), 10% (TNF-exposed), and 12% (CON-IBD) of the cases.…”

“…In one study, the pregnancy course of only five women was reported. 26 The other studies were based on 53 VDZ users in the research by Chambers et al 39 A total of 105 VDZ-exposed women (24 pregnancies from 6 clinical trials and 81 cases based on post-marketing data, including two indirect VDZ-exposed pregnant women, whose male partners were treated with VDZ) in the work by Mahadevan et al 24 There was a total of 79 pregnancies of 73 VDZ users in the study by Moens et al , 35 and 42 pregnancies of women who received at least one VDZ infusion during pregnancy in the study by Wils et al 32 Detailed information on the VDZ dosing regimen over the course of observed pregnancies for each study is outlined in Table 2 , if available. Only two studies were identified reporting either pregnancy or neonatal outcomes in comparison with a control group: disease-matched patients (DM) and healthy controls (HCs) in the study by Chambers et al , 39 and anti-TNF patients, as well as immunomodulator/biologic-naïve patients in the work of Moens et al 35 …”

“… * Including two pregnancies of VDZ-naïve women, whose male partners were exposed to VDZ. ** Including twin births; [(VDZ group: 3; TNFE: 1; CON-IBD: 1) 35 ; (VDZ: 2) 39 ]. DMs, disease-matched patients; HCs, healthy controls; IBD, inflammatory bowel disease; IM, immunomodulators; TNF, tumor necrosis factor; VDZ, vedolizumab.…”

“…Liveborn infant quotas in the three groups were 94.3%, 95.5% and 91.5%, preterm births occurred in 14.6%, 8.4% and 8.3% of the patients, respectively. In a retrospective, multicenter study published by Moens et al , 35 449 pregnant women with IBD, who were exposed to VDZ ( n = 79, VDZ-exposed) or anti-TNFs ( n = 186, TNF-exposed), as well as one cohort unexposed to immunomodulatory and biologic treatments ( n = 184, CON-IBD) were observed. At conception, 92 (50%) of these women were treated with 5-aminosalicylic acid (mesalazine) monotherapy, 12 (7%) with monotherapy of steroids, 12 (7%) with a combination of mesalazine and steroids, while the remaining 67 patients (36%) did not receive any IBD therapy.…”