To evaluate the real-world clinical experience of patients with relapsing MS treated with ublituximab.

Ublituximab (UBL) significantly reduced MS disease activity vs. teriflunomide in ULTIMATE I and II. ENABLE (NCT06433752) is the first prospective phase 4 observational study to assess real-world efficacy, tolerability and safety of ublituximab.

The analysis included 393 participants enrolled in ENABLE from 67 US centers, as of 30 June 2025. Annualized relapse rate was calculated as cumulative number of relapses/cumulative treatment time. Infusion duration was calculated as time between start and stop of infusion.

Patients enrolled in the real-world ENABLE cohort compared to ULTIMATE were older (mean age 42.9 years vs 35.4 years) with a higher proportion of female participants (75.3% vs. 62.9%). Black/African American population represented 20.1% (vs. 1.5% from ULTIMATE) and Hispanic/Latino population represented 14.5% of enrollees. Participants also had longer disease duration since onset of MS symptoms (8.62 years vs. 7.4 years), were relapse-free (45%) or had at least one relapse (37.4%) in the 2 years prior to screening. Most participants did not have Gadolinium (Gd)-enhancing lesions (55%) or new/enlarging T2 hyperintense lesions (47.6%) compared to previous scan at baseline. At study start, 32% were treatment naïve, while 28% transitioned from an anti-CD20 therapy. On treatment ARR was 0.015 and 99.5% remained relapse-free on study. The median infusion duration (in mins) was 247, 63, and 62.5 for the first, second and third infusions, respectively, and first-dose IRRs were observed in 17.3% of participants. Significant improvements in TSQM and MSIS-29 were observed on Day 15 and week 24.

ENABLE’s real-world cohort demonstrated disease control and safety similar to pivotal trials, with lower rates of IRR vs. ULTIMATE. This study is ongoing, and data will be presented on a larger cohort of patients with longer term follow-up.