Real-World 24-Month Outcomes of Ofatumumab in Relapsing Multiple Sclerosis: Efficacy, Safety, and the Impact of Frailty.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Ferrazzano Gina, Fantozzi Roberta, Haggiag Shalom, Landi Doriana, Napoli Francesca, Buscarinu Maria Chiara, Malimpensa Leonardo, Bianco Assunta, Borriello Giovanna, Barbuti Elena, Marinelli Fabiana, Monteleone Fabrizia, Marchione Francesca, Falcone Nicola, Altieri Marta, Leodori Giorgio, Belvisi Daniele, Buttari Fabio, Pozzilli Valeria, Cicia Alessandra, Cortese Antonio, Sica Francesco, Landi Anna Chiara, Ferraro Elisabetta, Pozzilli Carlo, Mirabella Massimiliano, Tortorella Carla, Marfia Girolama Alessandra, Centonze Diego, Salvetti Marco, Conte Antonella
Аннотация
METHODS: We retrospectively collected clinical and MRI data from 12 MS centers in Central Italy, including patients who initiated OFA between April 2022 and January 2024. We assessed annualized relapse rate (ARR), clinical relapses, radiological activity, and safety. Frailty, defined as increased vulnerability due to age-related health deficits, was measured using a frailty index (FI). The study was approved by the local Ethics Committee (No. 6357).
RESULTS: A total of 242 patients with MS were included (66.8% female and 33.2% male; mean age: 38.9 ± 10.3 years; disease duration: 7.7 ± 7.6 years). Of these, 95 (39.2%) were treatment-naïve, and 147 (60.8%) had switched from another therapy, mostly a first switch. The mean follow-up was 15.4 ± 5.4 months; all patients completed 12-month follow-up, and 103 completed 24 months. ARR dropped from 0.9 to 0.02 (p < 0.001). Only 4 patients (1.6%) had a clinical relapse, all within 6 months (mean time: 3.0 ± 1.8 months). Expanded Disability Status Scale (EDSS) scores remained stable (p > 0.05). MRI activity occurred in 10 patients (4.1%) at 6 months and 3 (1.2%) at 12 months; none at 24 months. Adverse events included flu-like symptoms (34.3%), injection site reactions (8.2%), and infections (18.5%). Among 239 patients assessed for frailty (mean FI: 0.06 ± 0.08), 187 were relatively fit (FI ≤ 0.10), 30 least fit, and 22 frail. FI predicted 24-month confirmed disability progression (p = 0.0068), with significant variation by frailty level (p = 0.0009).
CONCLUSION: This real-world study suggests that OFA is effective and safe for MS, offering rapid disease control. Lower frailty levels suggest preferential use in patients with lower baseline disability. Further large-scale, long-term studies are needed.