Effectiveness and safety of ofatumumab in treatment-naive and oral DMT-switched multiple sclerosis patients: a multicenter observational study in China.
Multiple sclerosis and related disorders – November 01, 2025
Source: PubMed
Summary
Many people living with Multiple sclerosis saw significant improvements in their condition after starting Ofatumumab. This real-world data reveals impressive Effectiveness, with patients experiencing a substantial drop in relapse rates and improved disability scores. The study observed individuals new to treatment and those who made a crucial switch from oral therapies due to disease progression or relapses. Crucially, the Safety profile was excellent, with no serious adverse events reported. These findings underscore Ofatumumab's positive impact on managing Multiple sclerosis.
Abstract
Ofatumumab, a fully humanized anti-CD20 monoclonal antibody, is the only highly effective disease modifying therapy (DMT) approved for the treatment of relapsing multiple sclerosis (RMS) in China up to data. Real-world data are necessary to investigate the factors for switching from oral DMTs and to assess the effectiveness and safety of ofatumumab in the Chinese MS population. We conducted a multicenter observational study (GY2024-038-0) to evaluate the effectiveness and safety of ofatumumab in RMS patients who were either treatment-naïve or had switched from oral DMTs, including teriflunomide, siponimod, fingolimod, dimethyl fumarate. Medical records at three tertiary hospitals were collected between December 2021 and May 2024. Clinical relapses, MRI activity, confirmed disease progression, and adverse events were reviewed. Treatment-naïve and switched data were obtained for 38 (31.5 % men, mean age 35.42 years, median disease duration 2.31±4.08 years, median follow-up 12.00 months) and 59 (16.9 % men, mean age 34.75 years, median disease duration 5.30±4.17 years, median follow-up 20.00 months) patients, respectively. Among treatment-naïve patients, the annualized relapse rate (ARR) at the final follow-up decreased from 0.27 ± 0.47 to 0.05 ± 0.23 (p < 0.001), while the Expanded Disability Status Scale (EDSS) score at month 12 after treatment dropped from 2.50(2.00-4.00) to 2.00(1.00-3.00) (p < 0.001). For patients switched from oral DMT, the mean reasons for transitioning were disease progression (28.8 %), clinical relapse (28.8 %), MRI activity (25.4 %) and adverse reaction (6.8 %). After switching, ARR and EDSS score at month 12 reduced from 0.45 ± 0.54 to 0.08 ± 0.28(p = 0.039), and from 2.00(2.00-3.38) to 1.00(1.00-2.00) (p < 0.001), respectively. And no increase in T1 Gd-enhancing lesions or new/enlarged T2 lesions identified. No clinical relapses, EDSS worsening, and MRI activity were observed in either treatment-naïve or oral DMT-switched MS patient. During follow-up, no serious adverse events were reported. This real-world study revealed a significant decrease in disease activity and progression among MS patients treated with ofatumumab, both in treatment-naïve and oral DMTs-switched patients, while maintaining a well-tolerated safety profile.