2026 American Academy of Neurology Abstract Website

Carrie Hersh¹, Angel Chinea², Emily Riser³, Christina Weber⁴, Sidarth Dasari⁵, Jacqueline Rosenthal⁶, Andrew Bouley⁷, Diana Andino⁸, Matthew Carraro⁹, Jeanie Cote¹⁰, Jean-Raphael Schneider¹¹, Jonathan Calkwood¹², Sangjin Oh¹³, Bhupendra Khatri¹⁴, Jackie Parker¹⁵, Karthik Bodhinathan¹⁵, Peter Sportelli¹⁵, Hari Miskin¹⁵, Edward Fox¹⁵
¹Cleveland Clinic Lou Ruvo Center for Brain Health, ²San Juan MS Center, San Juan Bautista School of Medicine, ³Alabama Neurology Associates, ⁴University of Iowa Hospitals and Clinics, ⁵Advanced Neurology of Colorado, ⁶Shepherd Center, ⁷The Elliot Lewis Center, ⁸Austin Regional Clinic, ⁹Piedmont Healthcare - Lake Norman Neurology, ¹⁰Memorial Healthcare, ¹¹MS and Neuromuscular Center of Excellence, ¹²Minnesota Center for MS, ¹³Maryland Center for Neurology and Sleep, ¹⁴Center for Neurologic Disorders/St. Francis OP Center, ¹⁵TG Therapeutics

Objective:

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

Background:

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.

Design/Methods:

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.

Results:

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.

Conclusions:

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.