Efgartigimod Safety for Myasthenia Gravis During Pregnancy

This trial aims to assess the safety of efgartigimod, a medication, for pregnant or breastfeeding women and their babies. Researchers seek to determine if efgartigimod affects the health of mothers, fetuses, and infants. The study includes two groups: women who are pregnant or breastfeeding and have been exposed to the drug, and women who were exposed during pregnancy but are no longer pregnant. Women who have used efgartigimod within 25 days before becoming pregnant or during pregnancy or breastfeeding may be suitable candidates. As a Phase 4 trial, this study involves an FDA-approved treatment, providing insights into its benefits for more patients.

The trial information does not specify whether you need to stop taking your current medications. It focuses on women who have been exposed to efgartigimod during pregnancy or breastfeeding.

Research shows that efgartigimod, available in both intravenous (IV) and subcutaneous forms, has been tested in healthy individuals before. These studies found that the treatment is generally well-tolerated, with most participants not experiencing serious side effects. Some reported mild issues, such as headaches or reactions at the injection site.

While this trial examines the safety of efgartigimod during pregnancy, it is important to note that the FDA has already approved it for other uses, indicating its safety for those purposes.

Researchers are excited about efgartigimod because it offers a novel approach to managing autoimmune conditions during pregnancy and breastfeeding. Unlike traditional treatments that may pose risks to the developing fetus or infant, efgartigimod is designed to selectively reduce harmful antibodies by targeting the neonatal Fc receptor (FcRn). This mechanism allows for more precise modulation of the immune system without broadly suppressing it, potentially offering a safer option for expectant and new mothers. Additionally, its ability to be administered subcutaneously adds convenience, making it easier for patients to manage their treatment.

This trial focuses on the safety of efgartigimod during pregnancy and breastfeeding. Participants will join either the "Prospective Pregnancy" arm, where the woman is pregnant or breastfeeding at enrollment, or the "Retrospective Pregnancy" arm, where the woman is no longer pregnant but was exposed to efgartigimod or efgartigimod PH20 SC within 25 days before conception or during pregnancy. Studies have shown that efgartigimod effectively treats conditions like myasthenia gravis, which causes muscle weakness, by reducing harmful antibodies that attack the body. Research indicates that this treatment improves muscle strength and patient outcomes. Although the trial does not test its efficacy during pregnancy, its success in treating autoimmune conditions suggests potential benefits. Early data shows promising results for similar conditions, warranting further study.¹⁶⁷⁸⁹