Studies to test Briumvi in pregnant, breastfeeding MS patients
Post-marketing study currently seeks patients who are breastfeeding
TG Therapeutics is conducting two post-marketing studies to determine how safe Briumvi (ublituximab-xiiy) is among people with relapsing forms of multiple sclerosis (MS) who are pregnant or breastfeeding, as well as their babies.
The goal is to generate data on the use of Briumvi during pregnancy and lactation to help doctors make better, evidence-based decisions for those who are pregnant or planning to become pregnant.
Riley Bove, MD, a neurologist at the University of California, San Francisco’s Weill Institute of Neurosciences, presented the studies’ designs in two separate posters at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, held May 29-June 1 in Nashville.
Briumvi is a disease-modifying therapy that works by inhibiting a protein called CD20 on the surface of immune B-cells, causing their death. B-cells are thought to participate, along with other immune cells, in the inflammatory attacks that drive MS.
Given every six months as an hour-long infusion into the bloodstream, Briumvi is approved in the U.S. and Europe to reduce disease activity and slow disability progression in adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
Breastfeeding study now recruiting
When a therapy is first approved, there are usually no pregnancy or lactation data collected in humans to support its safe use in people of child-bearing age. Such data are generally collected only after the therapy has entered the market.
Because there are limited data on the use of Briumvi in pregnant or breastfeeding people, it’s recommended that women of child-bearing age take a pregnancy test before each dose and use birth control during treatment and for at least six months after the last dose.
Animal studies have suggested that Briumvi may be harmful to a developing fetus, so patients who are pregnant or planning to get pregnant should talk to their doctors before using Briumvi. It’s not known whether Briumvi can pass into breast milk or whether it has any harmful effects on a nursing infant.
One of the studies, PROVIDE (NCT06143514), is now recruiting virtually through a web-based application or at a virtual coordinator center in the U.S. It plans to enroll 16 breastfeeding women who independently decided to take Briumvi prior to entering the study.
To be eligible, their babies must have been born at 35 weeks of gestation or later with a body weight above the 10th percentile both at birth and at time of enrollment. That means babies who are heavier than 10% of their same-aged peers.
The study’s goal is to check the presence and levels of Briumvi in breast milk. Samples of breast milk will be collected before Briumvi infusion and at 13 different time points over the course of 90 days after the infusion.
“Exclusive breastfeeding post-delivery is often recommended for its general benefits and may reduce relapse risk in people with mild to moderate MS but not in people with highly active disease,” researchers wrote in the poster, “A Post-Marketing Study Evaluating the Presence and Concentration of BRIUMVI in Breast Milk (PROVIDE).” But they added that using effective disease-modifying therapies may further reduce the risk.
Secondary measures of the PROVIDE study include an estimate of the babies’ exposure to Briumvi, calculated based on the dose received and the mother’s body weight, and side effects experienced by the babies.
Pregnancy study will monitor mothers, babies
The second poster, “BRIUMVI Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated with BRIUMVI,” shared details from the pregnancy registry.
The study (NCT06433765), which is not yet recruiting, will check the health of mothers and their babies — while growing in the womb and after birth — after exposure to Briumvi at any time during pregnancy or within six months of conception.
It plans to enroll up to 728 pregnant adults and adolescents, ages 15 to 50, including 364 MS patients who received Briumvi, and 364 who didn’t take Briumvi or any other CD20 inhibitors but may have used other MS therapies during pregnancy.
“Currently, there are no adequate and well-controlled clinical studies of ublituximab in pregnant individuals, and available human data on exposure during pregnancy are insufficient to inform risk analysis,” the researchers wrote.
The registry’s main goal is to compare the rate of major congenital malformations, or structural or functional defects that occur during a baby’s development in the womb, between the two groups and also with the general population.
Secondary measures include minor congenital malformations, pregnancy complications like high blood pressure and diabetes, miscarriages, stillbirths, early or late births, slow infant growth, developmental delays, serious infections, and hospitalizations.
“This registry will provide information on maternal, fetal, and infant outcomes following exposure to ublituximab during pregnancy to support evidence-based clinical decision making for women of child-bearing age with MS,” the researchers wrote.
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