European journal of neurology · 2026
Efficacy and Safety of Patients With Relapsing Multiple Sclerosis Switching to Ocrelizumab Due to Suboptimal Treatment Response: Results of the 4-Year CASTING-LIBERTO Trial.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
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.
Vermersch Patrick, Benedict Ralph H B, Van Wijmeersch Bart, Cutter Gary, Kister Llya, Oreja-Guevara Celia, Siva Aksel, Wiendl Heinz, Wuerfel Jens, El Azzouzi Bouchra, Kuenzel Thomas, Buffels Regine, Craveiro Licinio, Dirks Petra, Comi Giancarlo
Аннотация
BACKGROUND: Almost 75% of patients with relapsing multiple sclerosis (pwRMS) with suboptimal response to other disease-modifying therapies (DMTs) showed no evidence of disease activity (NEDA-3) when treated with ocrelizumab in a large single-arm multicentre trial over 2 years. We aimed to assess the 4-year effectiveness and safety of ocrelizumab in pwRMS who entered a 2-year extension trial.
METHODS: PwRMS completing CASTING were eligible to rollover into LIBERTO if available in the country of residence. PwRMS received ocrelizumab every 24 weeks; the same frequency was used for clinical assessments. Primary endpoint was the proportion of patients who had NEDA-3 over 4 years. Safety was assessed by rate and nature of adverse events (AEs).
RESULTS: A total of 439 pwRMS rolled over to LIBERTO, of which 68.1% completed the study; most patients discontinued from LIBERTO due to country-specific changes in reimbursement but most remained on ocrelizumab outside the trial. Over 4 years, 79.5% of patients showed no 24-week confirmed disability progression, 87.5% no relapses, and 90.0% no radiological activity. A total of 65.6% of patients (n = 290) showed NEDA-3, with the proportion of patients achieving NEDA-3 yearly remaining above 84.8%. Over 4 years, infections (72.9% of patients) and infusion-related reactions (44.2%) were the most reported AEs. Serious AEs were reported in 9.3% of patients. Five (1.1%) patients discontinued due to AEs.
CONCLUSIONS: Findings suggest that switching to ocrelizumab is safe for patients with early RRMS and suboptimal response to previous DMTs, resulting in significant and durable control of disease activity.
TRIAL REGISTRATION: LIBERTO (NCT03599245), extension study to CASTING (NCT02861014); first patient enrolled 12.07.2018; https://clinicaltrials.gov/study/NCT03599245. CHORDS (NCT02637856), ENSEMBLE (NCT03085810).
METHODS: PwRMS completing CASTING were eligible to rollover into LIBERTO if available in the country of residence. PwRMS received ocrelizumab every 24 weeks; the same frequency was used for clinical assessments. Primary endpoint was the proportion of patients who had NEDA-3 over 4 years. Safety was assessed by rate and nature of adverse events (AEs).
RESULTS: A total of 439 pwRMS rolled over to LIBERTO, of which 68.1% completed the study; most patients discontinued from LIBERTO due to country-specific changes in reimbursement but most remained on ocrelizumab outside the trial. Over 4 years, 79.5% of patients showed no 24-week confirmed disability progression, 87.5% no relapses, and 90.0% no radiological activity. A total of 65.6% of patients (n = 290) showed NEDA-3, with the proportion of patients achieving NEDA-3 yearly remaining above 84.8%. Over 4 years, infections (72.9% of patients) and infusion-related reactions (44.2%) were the most reported AEs. Serious AEs were reported in 9.3% of patients. Five (1.1%) patients discontinued due to AEs.
CONCLUSIONS: Findings suggest that switching to ocrelizumab is safe for patients with early RRMS and suboptimal response to previous DMTs, resulting in significant and durable control of disease activity.
TRIAL REGISTRATION: LIBERTO (NCT03599245), extension study to CASTING (NCT02861014); first patient enrolled 12.07.2018; https://clinicaltrials.gov/study/NCT03599245. CHORDS (NCT02637856), ENSEMBLE (NCT03085810).