Multiple sclerosis and related disorders · 2025
Effectiveness and safety of ofatumumab in treatment-naive and oral DMT-switched multiple sclerosis patients: a multicenter observational study in China.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Yang Yang, Duan Xinyi, Wang Jing, Xu Yuhui, Yan Zichun, Deng Hao, Li Yongmei, Zhang Lili, Xiao Haibing, Feng Jinzhou, Qin Xinyue
Аннотация
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.