RESUMO
BACKGROUND: Natalizumab via subcutaneous administration was recently approved for patients with multiple sclerosis. OBJECTIVE: In light of personalized extended dosing, in which treatment intervals are prolonged to a concentration cut-off, it would be preferable to measure natalizumab drug concentrations in capillary blood. METHODS: In this cross-sectional study in patients treated with intravenous (IV) natalizumab, capillary blood samples by fingerprick and venous blood samples were collected in 30 participants prior to IV administration of natalizumab. RESULTS: Natalizumab concentrations were similar with a mean bias of -0.36 µg/mL (95% CI: 1.3 to -2 µg/mL). CONCLUSIONS: This study shows that physicians can monitor natalizumab drug concentrations by a fingerprick, which could be used for personalized extended dosing.
Assuntos
Esclerose Múltipla Recidivante-Remitente , Esclerose Múltipla , Humanos , Natalizumab/uso terapêutico , Estudos Transversais , Esclerose Múltipla/tratamento farmacológico , Fatores de Risco , Administração Intravenosa , Fatores Imunológicos/efeitos adversos , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológicoRESUMO
In this observational study, 159 patients with multiple sclerosis received personalized dosing of ocrelizumab incentivized by the COVID-19 pandemic. Re-dosing was scheduled when CD19 B-cell count was ⩾10 cells/µL (starting 24 weeks after the previous dose, repeated 4-weekly). Median interval until re-dosing or last B-cell count was 34 [30-38] weeks. No clinical relapses were reported and a minority of patients showed Expanded Disability Status Scale (EDSS) progression. Monthly serum neurofilament light levels remained stable during extended intervals. Two (1.9%) of 107 patients with a follow-up magnetic resonance imaging (MRI) scan showed radiological disease activity. Personalized dosing of ocrelizumab could significantly extend intervals with low short-term disease activity incidence, encouraging future research on long-term safety and efficacy.