Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study - PubMed
6 days ago
- #Clinical Trial
- #Ublituximab
- #Multiple Sclerosis
- Ublituximab showed significant reduction in disease activity compared to teriflunomide in relapsing multiple sclerosis (RMS) patients over 2 years in ULTIMATE I and II studies.
- Long-term efficacy and safety of ublituximab were evaluated in an open-label extension (OLE) study, with data up to January 2024.
- Participants continuing ublituximab (UBL-UBL) or switching from teriflunomide to ublituximab (TER-UBL) were analyzed for outcomes like annualized relapse rate (ARR), disability progression (CDP24), and improvement (CDI24).
- At year 5, UBL-UBL participants had an ARR of 0.020, CDP24 of 8.0%, and CDI24 of 17.0%, showing sustained benefits.
- TER-UBL participants experienced a 58.4% ARR reduction in the first year post-switch, with further decreases to 0.045 by year 5.
- Safety profiles remained consistent with previous trials, with low rates of serious infections and stable immunoglobulin levels.
- 92% of UBL-UBL participants remained free from CDP24 at year 5, highlighting long-term benefits and the advantage of early high-efficacy treatment.