Multiple sclerosis (Houndmills, Basingstoke, England) · 2025
Finite-course ocrelizumab in relapsing multiple sclerosis: Results of two prospective open-label trials with matched controls.
Клиническое исследование IV фазыСтатьяНазвание и аннотация: Перевод в очереди
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Salazar-Camelo Andrea, Vega Lauren, Fadlallah Yasser, Bou Rjeily Nicole, Balshi Alexandra, Morris Bridget, Ghajarzadeh Mahsa, Mowry Ellen M, Waubant Emmanuelle, Nourbakhsh Bardia
Аннотация
BACKGROUND: Whether continuous anti-CD20 therapy is required for durable disease control in relapsing multiple sclerosis (MS) is uncertain.
OBJECTIVE: To determine if two standard courses of ocrelizumab can sustain clinical and radiological remission and to compare outcomes with patients who continue standard-interval dosing (SID).
METHODS: We pooled two single-center, prospective, open-label trials (NCT03853746, NCT04261790). Nineteen adults with active relapsing MS received two ocrelizumab courses (300 mg × 2 followed 6 months later by 600 mg) and were followed for up to 46 months. Fifty-two SID recipients were propensity-matched (⩽1:3). The primary endpoint was time to disease reactivation, analyzed with restricted mean survival time (RMST) computed to a common truncation time (τ = 46 months). We also included a post-hoc comparative analysis with a retrospectively identified standard interval-dosing (SID) cohort.
RESULTS: Disease reactivation occurred in 6/19 (32%) discontinuation participants and 0/52 propensity-score-matched controls. RMST to reactivation was 40.5 months with finite dosing versus 46.0 months with SID (difference -5.5 months; 95% confidence interval [CI] -9.8 to -1.3; p = 0.011). Peripheral CD19+ B-cell repopulation (⩾1% or ⩾40 cells/μL) did not predict reactivation.
CONCLUSION: Most patients remained clinically stable for more than 3 years after only two ocrelizumab courses. These hypothesis-generating findings warrant larger randomized or prospectively harmonized studies of finite-course anti-CD20 therapy as a de-escalation strategy in MS.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03853746 and NCT04261790.
OBJECTIVE: To determine if two standard courses of ocrelizumab can sustain clinical and radiological remission and to compare outcomes with patients who continue standard-interval dosing (SID).
METHODS: We pooled two single-center, prospective, open-label trials (NCT03853746, NCT04261790). Nineteen adults with active relapsing MS received two ocrelizumab courses (300 mg × 2 followed 6 months later by 600 mg) and were followed for up to 46 months. Fifty-two SID recipients were propensity-matched (⩽1:3). The primary endpoint was time to disease reactivation, analyzed with restricted mean survival time (RMST) computed to a common truncation time (τ = 46 months). We also included a post-hoc comparative analysis with a retrospectively identified standard interval-dosing (SID) cohort.
RESULTS: Disease reactivation occurred in 6/19 (32%) discontinuation participants and 0/52 propensity-score-matched controls. RMST to reactivation was 40.5 months with finite dosing versus 46.0 months with SID (difference -5.5 months; 95% confidence interval [CI] -9.8 to -1.3; p = 0.011). Peripheral CD19+ B-cell repopulation (⩾1% or ⩾40 cells/μL) did not predict reactivation.
CONCLUSION: Most patients remained clinically stable for more than 3 years after only two ocrelizumab courses. These hypothesis-generating findings warrant larger randomized or prospectively harmonized studies of finite-course anti-CD20 therapy as a de-escalation strategy in MS.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03853746 and NCT04261790.