Introducción
Off-label rituximab was noninferior to ocrelizumab (Ocrevus) in people with newly diagnosed relapsing multiple sclerosis (MS) and recent disease activity, the phase III OVERLORD-MS trial showed.
Resultados del estudio
At 2 years, the estimated probability of having no new or enlarging lesions on T2-weighted MRI was 92.2% with rituximab and 94.8% with ocrelizumab, reported Øivind Torkildsen, MD, PhD, of the University of Bergen in Norway, and co-authors.
The risk difference (-2.6 percentage points, 95% CI -9.4 to 4.3) met the prespecified noninferiority criterion for the 218-person study, the researchers wrote in the New England Journal of Medicine.
The annualized relapse rates were low in both study groups – 0.09 for rituximab and 0.04 for ocrelizumab. Additionally, disability outcomes and cognitive performance profiles appeared similar between the two groups.
Implicaciones para la práctica clínica
Torkildsen suggested that the OVERLORD-MS findings may have important implications for healthcare systems. Rituximab is substantially less expensive than ocrelizumab in many countries, and wider use could free up considerable healthcare resources while maintaining access to highly effective treatment.
John Corboy, MD, of the University of Colorado Anschutz School of Medicine, emphasized that this trial provides important information for healthcare decisions. Rituximab should be strongly considered as a first-line CD20 drug at a much lower cost.
Consideraciones sobre la seguridad
Confirmed disability progression that was sustained for at least 6 months occurred in 3% of the rituximab group and 7% of the ocrelizumab group. Infections occurred more frequently among participants receiving rituximab than among those receiving ocrelizumab (82% vs 69%), although serious adverse events were comparable between groups.
Limitaciones y futuras investigaciones
Follow-up was limited to 30 months, and potential longer-term differences cannot be ruled out. Additionally, participants were mainly of Northern European ancestry.
Three other randomized trials are currently comparing rituximab and ocrelizumab in relapsing MS. These initiatives aim to pool individual participant data for further analysis.
Disclaimer: Siempre consulte a un médico o a un profesional de la salud antes de comenzar, cambiar o detener un tratamiento médico.
Fuente: https://www.medpagetoday.com/neurology/multiplesclerosis/122021
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