Introduction:
Tofacitinib is approved for moderately to severely active ulcerative
colitis (UC).1 Animal studies showed increased
pregnancy loss, lower foetal weight, and congenital malformations; the
doses used were much higher than the maximum recommended dose of 10mg
twice daily in humans.2 The only evidence for use in
pregnancy in patients with inflammatory bowel disease (IBD) is from the
registration studies, which revealed 11 maternal exposures with
foeto-maternal adverse events rates comparable to the general population
and patients with similar conditions not taking tofacitinib; however,
the number of cases was small, the comparison was indirect, and subjects
received pre-emptive pregnancy testing at every study visit to permit
early treatment cessation.3 Until further advice is
available, tofacitinib should be avoided in
pregnancy.4
We present a case of exposure to tofacitinib in the first trimester
until six weeks of gestation in a patient with UC.