Pregnancy Outcomes Following Ravulizumab Exposure: A Pharmacovigilance Analysis

Background: Ravulizumab is indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD). Data from solicited and spontaneous cases from patients treated with ravulizumab in the Alexion pharmacovigilance database were analysed to provide insights into pregnancy-related safety following ravulizumab exposure. Methods: Theanalysis summarizes all available pregnancy data collected worldwide in the post-marketing setting of ravulizumab from the first approval up to December 31, 2024 on cases reported with ≥1 dose of exposure during pregnancy. The outcomes were summarized using descriptive statistics. Results: A total of 206 pregnancy cases with ≥1 dose of ravulizumab exposure were identified, of which 72 cases reported pregnancy outcomes (FIG). Among these, 23.6% of patients received treatment throughout pregnancy, 26.4% discontinued ravulizumab treatment and switched to eculizumab, and 41.6% had incomplete exposure details. Pregnancy outcomes reported include 47 live births, 20 spontaneous abortions, 3 fetal deaths, and 2 elective terminations. Detailed information was available for a subset of 32 cases comprised of 25 pregnancies leading to live births and 7 spontaneous abortions. Among the 25 live births, information reported on dosing indicated that 14 had ravulizumab exposure throughout the entire pregnancy, 3 had exposure beyond 12 weeks but discontinued prior to delivery, and 8 had ≤12 weeks of exposure. Medical history/ maternal co-morbidities reported in these 32 cases included aplastic anemia, Budd Chiari, thrombosis, gestational hypertension, pre-eclampsia, renal failure, and gestational diabetes. Conclusion: This analysis provides real-world insights on the use of ravulizumab in pregnancy and suggests no unexpected safety signals, similar to eculizumab. Alexion recently launched a global ravulizumab pregnancy registry (NCT06312644) to gather more data. Funding: Commercial Support - Alexion, AstraZeneca Rare Disease, Boston, MA, United States