Vedolizumab use in pregnancy conveys low risk of adverse outcomes

The risk of adverse pregnancy outcomes appears to be low in women treated with vedolizumab (VDZ) for inflammatory bowel disease (IBD), a study has found.

Researchers looked at the pregnancy and child outcomes in three IBD cohorts: 79 VDZ-exposed (VDZE) pregnancies in 73 patients, 186 anti-tumour necrosis factor–exposed (TNFE) pregnancies in 164 patients, and 184 pregnancies unexposed to both immunomodulatory and biologic drugs in 155 patients (CON IBD). These pregnancies resulted in 64, 162 and 163 live births, respectively.

At conception, women in the VDZE group were more likely to have active disease (36 percent vs 17 percent in the TNFE group and 24 percent in the CON IBD group; p=0.002 and p=0.063, respectively). Miscarriage rates were similar across the three patient groups (16 percent vs 13 percent and 10 percent, respectively; p=0.567 and p=0.216).

Likewise, there were no significant differences observed in median gestational age, birthweight and median Apgar score at birth among live‐born infants across the three groups.

The number of premature born infants in the VDZE group was comparable to that in the TNFE and CON IBD groups (16 percent vs 9 percent and 7 percent; p=0.151 and p=0.079), even after controlling for disease activity in pregnancy (8 percent vs 4 percent and 6 percent; p=0.363 and p=0.687).

The rate of congenital anomalies in live‐born children was similar in the three groups: 5 percent in VDZE vs 2 percent in TNFE and 2 percent in CON IBD (p=0.407 and p=0.354, respectively).

There were no malignancies documented during the first year of life, and the infection risk in infants was not significantly different among the patient groups.

The researchers underscored a need for larger, prospective studies to confirm the findings.