Phase 4 Study Reports Improved Patient-Reported Outcomes With Ublituximab in Multiple Sclerosis

New findings from the phase 4 observational ENABLE study (NCT06433752) showed that patients with multiple sclerosis (MS) receiving ublituximab (Briumvi; TG Therapeutics) reported significant improvements in patient-reported outcomes that were maintained through the end of 1 year on treatment. These real-world findings showed enhanced treatment satisfaction and reductions in patient-reported physical and psychological impact of MS.¹

Across 87 sites in the US, 658 participants were enrolled between study initiation in July 2024 and the data cutoff in December 2025. At year 1 of ublituximab treatment, least squares (LS) mean changes in the 4 Treatment Satisfaction Questionnaire for Medication (TSQM) subdomains showed statistically significant improvements. Specifically, improvements were observed in efficacy (LS mean, 15.62; 95% CI, 10.86–20.37; P <.0001), safety (LS mean, 5.27; 95% CI, 0.29–10.25; P = .038), convenience (LS mean, 10.95; 95% CI, 7.01–14.88; P <.0001), and global satisfaction (LS mean, 17.46; 95% CI, 13.34–21.58; P <.0001).

Using the Multiple Sclerosis Impact Scale version 2 (MSIS-29), LS mean changes also demonstrated significant improvements at year 1 in the physical impact domain (–4.25; 95% CI, –6.73 to –1.76; P = .0008) and the psychological impact domain (–5.57; 95% CI, –8.29 to –2.85; P <.0001). Lead author Carrie Hersh, DO, MSc, FAAN, associate professor of neurology at Cleveland Clinic Lerner College of Medicine, recently presented these findings at the 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, held May 27-29, Charlotte, North Carolina.

READ MORE: What Can We Expect From Machine Learning Predictions in Daily Clinical Neurology?

ENABLE is a 192-week, multicenter, phase 4 observational study designed to collect real-world data, including patient-reported outcomes, from patients with MS treated with ublituximab who were naïve to therapy prior to study initiation. Patient-reported outcomes in the trial were assessed using the TSQM and MSIS-29, with data collected directly from patients through electronic tablets via the uMotif platform and digitally stored for analysis. A mixed model for repeated measures, including visit number as a covariate and an unstructured covariance matrix, was used to analyze transformed scores.

Coming into the study, the mean age of patients was 43.0 years (SD, 11.47), 76.1% were women, 19.5% were Black or African American, and 13.1% were Hispanic or Latino. Among the 424 participants with prior treatment exposure, 44.5% transitioned from anti-CD20 therapies, 17.7% from natalizumab, and the remainder from oral or platform therapies. The mean time since MS symptom onset was 8.7 years (SD, 9.06). In the 2 years prior to study initiation, 41.6% of participants were relapse-free, and 28.6% had experienced 1 relapse.

In December 2022, the FDA approved ublituximab, an anti-CD20 monoclonal antibody, for the treatment of patients living with MS based on data from the phase 3 ULTIMATE 1 and 2 trials (NCT03277261; NCT03277248). These trials, which featured 1094 patients with relapsing MS across 10 countries, showed the superior efficacy and safety of ublituximab in comparison with teriflunomide (Aubagio; Sanofi), a relatively newer agent that received FDA approval in 2012.²

Click here for more coverage of CMSC 2026.

REFERENCES
1. Hersh CM, Chinea AR, Riser ES. Ublituximab Significantly Improves Patient-Reported Outcomes: Results From the Phase 4 Observational Study Enable. Presented at: 2026 CMSC Annual Meeting; May 27-29; Charlotte, North Carolina. Abstract DMT03.
2. TG Therapeutics Announces FDA Approval of BRIUMVI™ (ublituximab-xiiy). News release. TG Therapeutics. December 28, 2022. Accessed May 26, 2026. https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-fda-approval-briumvitm-ublituximab