Efficacy of Fingolimod vs. Rituximab Compared in Patients with Highly Active MS
For relapsing-remitting multiple sclerosis patients infected with JC virus and taking natalizumab, switching treatment to rituximab was associated with better outcomes than switching to fingolimod. Those findings come from a new study of 256 patients in the Swedish MS register, with 114 and 142 switching from natalizumab to rituximab and fingolimod, respectively.
Results of MRI scans at ≥3 months into the treatment, showed 23 (16%) fingolimod patients with Gd+ lesions within the first 1.5 years compared to just 1 (1%) of rituximab. The number of patients who experienced clinical relapse in the fingolimod group was also significantly greater than the rituximab group; 25 (18%) versus 2 (2%), respectively.
The Cox proportional hazards model for time to first relapse, comparing RTX to FGL, resulted in a crude HR of 0.10 (95% CI = 0.02–0.43), and an HR of 0.09 (95% CI = 0.02–0.40) when adjusting for age, sex, EDSS, time on NTZ, washout time, and study center.
A greater number of adverse effects were recorded in the fingolimod treated cohort. There was 1 potentially life-threatening grade 4 event; a laryngeal edema occurring in the setting of a bacterial infection, which necessitated invasive ventilation in intensive care. In addition, 2 grade 3, 8 grade 2, and 28 grade 1 events. Whereas 1 grade 3, 1 grade 2, and 4 grade 1 events were recorded in the rituximab group.
Knowledge of second-line treatment following natalizumab is important because of the increased risk of progressive multifocal leukoencephalophaty (PML) associated with this therapy.
“Patients who switched to rituximab displayed significantly fewer MRI lesions, clinical relapses, and AEs, and had a better overall drug survival compared with fingolimod,” write the authors of the study. They acknowledge the studies limitations of their nonrandomized design, meaning the included rituximab patients all had a shorter washout time. For these reasons the authors suggest further study with a randomized controlled trial, in the context of switching treatment from natalizumab.
The authors concluded that in their observational study of RRMS patients, ‘switching from natalizumab due to JCV+ status strongly indicates a superior effectiveness and tolerability of rituximab compared with fingolimod."
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