Fetal death in utero and miscarriage in a patient with Crohn’s disease under therapy with ustekinumab: case-report and review of the literature

Abstract

BackgroundUstekinumab is a fully human monoclonal antibody against the p40 subunit of interleukin (IL) 12 and 23 which is involved in the pathogenesis of several inflammatory diseases. Ustekinumab is approved for psoriasis and psoriatic arthritis treatment and has been successfully evaluated in phase II and III trials for patients with Crohn’s disease (CD).Case presentationWe report here the case of a patient who became pregnant during treatment with ustekinumab for a refractory CD and which ended in miscarriage.ConclusionUstekinumab is a relatively new pharmacotherapy and in addition to this clinical case, we reviewed the published literature concerning the use of this treatment during pregnancy and its consequences on pregnancy and fetus outcome.

Biologics exposure during pregnancy and breastfeeding in a psoriasis patient

“…In the last decade, numerous pregnancies case series and registry data suggest that TNF inhibitor therapies are safe in pregnancy (Fischer‐Betz & Schneider, ). Ustekinumab exposure is less documented, the outcomes of inadvertent pregnancies registered in only 65 cases (Venturin et al, ). Although patients are advised to avoid pregnancy, the good quality of life they experience under biologics treatment, together with the unpredictable real‐life changes, allow pregnancy to occur, as in our experience.…”

Ustekinumab and Pregnancy: Continue or Cease Before You Conceive?

“…In 1 case report, a pregnant woman with Crohn's disease on ustekinumab had a miscarriage at week 8. 2 Ustekinumab is a humanized IgG monoclonal antibody against IL-12 and IL-23. It crosses the placenta by an active transport process.…”

“…Stopping a drug during pregnancy can affect the mother's health (disease flare and loss of response to an effective medication), 1 which then leads to adverse fetal and neonatal events(increased risk of spontaneous abortion, preterm birth, and complications of labor and delivery), not to mention a mother unable to care for her newborn. 2 Riley et al 3 specifically state that a risk to benefit analysis should be done and, in women with chronic diseases, preconception counselling should be provided along with written material. The care pathway recommends preconception counselling, provides a rationale for use of medications in pregnancy, and has a website for patients (Ibdparenthoodproject.org) with written materials about the impact of disease and drug safety.…”

A review of vedolizumab and ustekinumab for the treatment of inflammatory bowel diseases

“…The current dermatology literature has not reported an increased risk of miscarriage or congenital malformation . Case reports for its use in CD have observed conflicting pregnancy outcomes . As most of the patients had active disease during pregnancy, it is unclear if the adverse outcomes were related to the active disease state rather than the medication.…”

“…56 Case reports for its use in CD have observed conflicting pregnancy outcomes. [57][58][59] As most of the patients had active disease during pregnancy, it is unclear if the adverse outcomes were related to the active disease state rather than the medication. More data from prospective pregnancy registry will be needed.…”