Details
In response to a sponsor’s reported difficulty in accruing patients for a postmarket required study (PMR) using administrative healthcare data to retrospectively assess pregnancy outcomes in a cohort of women exposed to ixekizumab, the FDA conducted a Sentinel analysis to obtain contemporary information about the utilization of ixekizumab in pregnancy. Specifically, the study estimated the number of pregnancies with a pharmacy dispensing for ixekizumab and comparator drugs, overall and among patients with approved indications for ixekizumab. Between March 2016 and June 2021, there were 29 ixekizumab-exposed pregnancies, of which 19 had no concomitant exposure to comparators. For the 19 uniquely exposed pregnancies, use increased from no pregnancies in 2016 and 2017 to three pregnancies in 2018 (15.8%), two (10.5%) in 2019, and 10 pregnancies in 2020 (52.6%). Although the number of pregnancies exposed to ixekizumab is low, the analysis showed that the number of pregnancies exposed to ixekizumab is increasing over time. This contributed to FDA’s decision to continue evaluating potential risks associated with ixekizumab use during pregnancy via the pregnancy safety PMR.