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Phase 4 PROVIDE Study Aims to Assess Presence and Concentration of Ublituximab in Breastmilk
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Study establishes protocols for ublituximab use in breastfeeding patients with MS, enhancing treatment decision-making.
Riley Bove, MD
At the 2024 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, held May 29-June 2, in Nashville, Tennessee, a poster outlined a new post-marketing study, dubbed PROVIDE (NCT06143514), that will evaluate the presence and concentration of ublituximab (Briumvi; TG Therapeutics) in breastmilk of patients with multiple sclerosis (MS). The hope is that results from the study will help support evidence-based decision making for lactating women with relapsing MS.1
The multicenter, prospective, post-marketing study aims to enroll 16 breastfeeding women with relapsing MS receiving to obtain 10 completed mother-infant dyads. Based in the US, the primary objective of the study is to characterize the presence and concentration of ublituximab in breast milk using area under the concentration-time curve, concentration at the end of dosing interval, maximum observed concentration, and time of first occurrence of maximum concentration.
Led by Riley Bove, MD, an associate professor of neurology at the University of California, San Francisco, secondary end points of the trial include amount of ublituximab excreted in milk, fraction of dose excreted in milk, estimates of infant exposure, and infant adverse events (AEs). Milk collection will occur at a series of 14 time points over 90 days: 1 pre-infusion (spot) and 13 post-infusion: day 1 (0-4 hr, 4-8 hrs, 12-18 hrs, 18-24 hrs), and spot collection on days 2, 3, 7, 10, 14, 28, 60, and 90. During spot collection, each participant will be instructed to pump all milk (pump to empty) from both breasts for a pooled sample.
The study has a few key inclusion and exclusion criteria for patients to be eligible. For inclusion, maternal figures must be treated with ublituximab prior to consent, have a diagnosis of relapsing MS, have established lactation in the index post-partum period, and are willing to breastfeed or pump during the study period and exclusively pump for 24 hours of breastmilk collection day 1 following intravenous dose. For infants, to be included, they must have at least 35 weeks of gestational age at delivery, have a birthweight that is at least in the 10th percentile, and have weight that is at least in the 10th percentile as reported by the mother at the time of enrollment.
In terms of exclusion criteria, maternal patients who received any investigational compound or biologic within 30 days other than ublituximab are not allowed to participate. Similarly, those with an active infection, history of breast implants, breast augmentation, or breast reduction surgery, are excluded. Maternal patients on drugs known to transfer to the breastmilk and with established or potential delirious effects for the infant are also excluded. On the infant side, cases may be disqualified if the infant shows any abnormality or clinical significant medical condition at the time of screening, as well as if the infant has an abnormality that may interfere with breastfeeding or milk absorption.
Ublituximab, a glycoengineered monoclonal IgG1 antibody targeting CD20, was the most recent agent to join the MS treatment landscape. The therapy, administered in a 1-hour infusion, was approved in early 2022 based on data from the phase 3 ULTIMATE 1 and 2 trials (NCT03277261; NCT03277248). In those studies, ublitixumab showed superior efficacy and safety to its comparator, teriflunomide (Aubagio; Sanofi), a relatively newer agent that received FDA approval in 2012.
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