Monitoring Pregnancy and Infant Outcomes After Anifrolumab Exposure Using the PRIM Program

What this Trial Is About

This research focuses on pregnancies exposed to anifrolumab, a drug used for treating systemic lupus erythematosus SLE. The program collects and analyzes data to understand pregnancy and infant outcomes when exposed to anifrolumab during pregnancy or shortly before conception. It aims to evaluate the safety of this exposure by gathering detailed information from patient reports and healthcare professionals. The study gathers initial pregnancy data through reports submitted to AstraZenecas pharmacovigilance system. Pregnancy outcome details are collected close to delivery, with additional follow-up data on infant health obtained 12 months after birth. For pregnancies already concluded at the time of reporting, retrospective data including pregnancy outcomes and infant health are collected. The main group studied includes pregnancies with anifrolumab exposure from 16 weeks before conception through pregnancy. Participants contribute information through reports and follow-ups, with data collected using targeted checklists to ensure completeness. Researchers measure major and minor congenital malformations, adverse pregnancy outcomes, and the frequency of these events from conception through 12 months of infant age. The studys observation period extends to 12 months after birth to gather comprehensive safety data regarding anifrolumab exposure in pregnancy.

The Anifrolumab PRIM Program