The FDA has determined that human pregnancy data for Ebglyss® remain insufficient. By enrolling U.S. and Canadian participants, this study will help generate the evidence needed to inform future treatment decisions.

PRESS RELEASE

San Diego, CA — Pregnant women with moderate-to-severe eczema and their healthcare providers face a difficult evidence gap: how to make treatment decisions when human pregnancy data for newer therapies remain limited.MotherToBaby has launched a new observational pregnancy study to learn more about Ebglyss® (lebrikizumab) when used during pregnancy to treat moderate-to-severe atopic dermatitis (eczema). The study is now enrolling pregnant women across the United States and Canada.

The research is part of MotherToBaby Pregnancy Studies’ ongoing commitment to generating evidence that helps patients and healthcare providers make informed decisions about medication use during pregnancy. The study is led by internationally recognized epidemiologist Christina D. Chambers, PhD, MPH, Professor of Pediatrics at the UC San Diego’s School of Medicine and one of the world’s leading experts in pregnancy exposure research. Dr. Chambers has spent more than three decades leading landmark observational studies that have advanced understanding of medication safety during pregnancy.

Atopic dermatitis affects many people during their reproductive years, and managing the condition during pregnancy can be challenging. While effective treatment is important for the health and well-being of the pregnant person, information about the use of newer medications during pregnancy remains limited. This study aims to help fill that knowledge gap.

The MotherToBaby Ebglyss Pregnancy Study will follow participants throughout pregnancy and after delivery to better understand pregnancy and infant outcomes associated with Ebglyss exposure. Researchers will compare pregnancy outcomes among people who used at least one dose of Ebglyss a few months before or during pregnancy with those of people who have atopic dermatitis and received other systemic treatments, phototherapy, or no systemic treatment during pregnancy. These comparison groups will help researchers better understand the effects of both the medication and the underlying condition.

The study is observational, meaning participants will not be asked to take any study medication or change the treatment recommended by their healthcare providers. Instead, researchers collect health information through interviews and medical record review, with participants’ permission, to better understand real-world pregnancy outcomes. Observational research plays a critical role in generating evidence about medication safety during pregnancy because pregnant people are rarely included in clinical trials.

“Every participant who shares their experience helps expand the evidence available to support informed eczema treatment decisions during pregnancy,” said Christina D. Chambers, PhD, MPH. “Our goal is to provide reliable, science-based information that benefits patients, healthcare providers, and future families.”

MotherToBaby is seeking pregnant individuals across the United States and Canada who:

• Are currently pregnant
• Have used Ebglyss during pregnancy
• Have been diagnosed with atopic dermatitis (eczema) with or without treatment for our comparison group

Participation is voluntary, and all information is kept confidential. The study is expected to continue enrolling participants through 2033, helping build one of the largest sources of information on pregnancy outcomes associated with Ebglyss and atopic dermatitis treatment.

Individuals interested in participating or learning more about the study can contact MotherToBaby at 877.311.8972 or visit https://mothertobaby.org/ongoing-study/ebglyss-lebrikizumab-lbkz.

About MotherToBaby

MotherToBaby is the nation’s leading source of evidence-based information on medications and other exposures during pregnancy and while breastfeeding. MotherToBaby provides free, expert information to the public and healthcare providers through phone, text, chat, and email, while conducting pregnancy studies that help improve knowledge about the safety of medications and vaccines during pregnancy.

Media Contact: Nicole Chavez, 619-368-3259, nchavez@mothertobaby.org