Journal
NEUROLOGY-NEUROIMMUNOLOGY & NEUROINFLAMMATION
Volume 8, Issue 5, Pages -Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/NXI.0000000000001035
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Funding
- Deutsche Forschungsgemeinschaft (DFG)
- Hertie Foundation
- German Ministry for Education and Research (BMBF)
- Biogen
- Novartis
- Bundesinstitut fur Risikobewertung (BfR)
- Else Kroner Fresenius Foundation
- Gemeinsamer Bundesausschuss (G-BA)
- German Academic Exchange Service
- Interdisciplinary Center for Clinical Studies (IZKF) Muenster
- German Foundation Neurology
- Alexion
- Almirall
- Amicus Therapeutics Germany
- Biogen Idec
- Diamed
- Fresenius Medical Care
- Sanofi-Aventis
- HERZ Burgdorf
- Merck Serono
- ONO Pharma
- Roche
- Teva
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The study found that extending interval dosing of ocrelizumab for RRMS patients during the COVID-19 pandemic did not result in decreased effectiveness compared to standard interval dosing. Both treatment regimens were effective in maintaining clinical stability and preventing disease progression.
Objective To evaluate the clinical consequences of extended interval dosing (EID) of ocrelizumab in relapsing-remitting multiple sclerosis (RRMS) during the coronavirus disease 2019 (COVID-19) pandemic. Methods In our retrospective, multicenter cohort study, we compared patients with RRMS on EID (defined as >= 4-week delay of dose interval) with a control group on standard interval dosing (SID) at the same period (January to December 2020). Results Three hundred eighteen patients with RRMS were longitudinally evaluated in 5 German centers. One hundred sixteen patients received ocrelizumab on EID (median delay [interquartile range 8.68 [5.09-13.07] weeks). Three months after the last ocrelizumab infusion, 182 (90.1%) patients following SID and 105 (90.5%) EID patients remained relapse free (p = 0.903). Three-month confirmed progression of disability was observed in 18 SID patients (8.9%) and 11 EID patients (9.5%, p = 0.433). MRI progression was documented in 9 SID patients (4.5%) and 8 EID patients (6.9%) at 3-month follow-up (p = 0.232). Multivariate logistic regression showed no association between treatment regimen and no evidence of disease activity status at follow-up (OR: 1.266 [95% CI: 0.695-2.305]; p = 0.441). Clinical stability was accompanied by persistent peripheral CD19(+) B-cell depletion in both groups (SID vs EID: 82.6% vs 83.3%, p = 0.463). Disease activity in our cohort was not associated with CD19(+) B-cell repopulation. Conclusion Our data support EID of ocrelizumab as potential risk mitigation strategy in times of the COVID-19 pandemic. Classification of Evidence This study provides Class IV evidence that for patients with RRMS, an EID of at least 4 weeks does not diminish effectiveness of ocrelizumab.
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