Реальная оценка подкожного наследственного склероза у пациентов с весьма активным повторным излучением.
Обработка статьи · этапы, ошибки и управление
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Arun Tarunya, Al-Araji Sarmad, Pye Eleanor, Shehu Abdullah
Аннотация
Оригинал публикации
Real-world evaluation of subcutaneous natalizumab in patients with highly active relapsing-remitting multiple sclerosis.
BACKGROUND: Natalizumab is a highly effective therapy for highly active relapsing-remitting multiple sclerosis (RRMS), traditionally administered intravenously (IV). A subcutaneous (SC) formulation offers a more convenient alternative, but real-world data comparing its efficacy to the IV route are limited. This study aimed to evaluate the real-world outcomes of SC natalizumab in patients with highly active RRMS at a single UK center.
METHODS: A retrospective, observational cohort study was conducted on 63 patients receiving 300 mg SC natalizumab between November 2021 and January 2024. We analyzed clinical outcomes including annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) scores, and new magnetic resonance imaging (MRI) lesion activity.
RESULTS: In the 55 patients with at least 12 months of follow-up, the mean ARR was 0.03. Ninety-four percent of these patients remained relapse-free, and 85 % had stable or improved EDSS scores at the 12-month follow-up. No new MRI lesions were observed across the entire cohort (n = 55) after initiating SC natalizumab, and no significant adverse safety events were reported. Efficacy was comparable between treatment-naïve patients and those who switched from the IV formulation.
CONCLUSIONS: This real-world analysis demonstrates that SC natalizumab is a highly effective and safe treatment for patients with highly active RRMS. The observed clinical and radiological stability supports the use of SC natalizumab as a viable and convenient alternative to IV administration, aligning with outcomes from pivotal clinical trials.