Leoni Rolfes1, Marc Pawlitzki1, Steffen Pfeuffer1, Christopher Nelke1, Anke Lux1, Refik Pul1, Christoph Kleinschnitz1, Konstanze Kleinschnitz1, Rebeca Rogall1, Katrin Pape1, Stefan Bittner1, Frauke Zipp1, Clemens Warnke1, Yasemin Goereci1, Michael Schroeter1, Jens Ingwersen1, Orhan Aktas1, Luisa Klotz1, Tobias Ruck1, Heinz Wiendl1, Sven G Meuth2. 1. From the Department of Neurology with Institute of Translational Neurology (L.R., M.P., S.P., C.N., L.K., H.W.), University Hospital Muenster, Germany; Institute for Biometrics and Bioinformatic (A.L.), Otto-von-Guericke University, Magdeburg, Germany; Department for Neurology (R.P., C.K., K.K., R.R.), University Hospital Essen, Germany; Focus Program Translational Neurosciences (FTN) and Immunology (FZI) (K.P., S.B., F.Z.), Rhine Main Neuroscience Network (rmn2), Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Germany; Department of Neurology (C.W., Y.G., M.S.), University Hospital Cologne, Germany; and Department of Neurology (J.I., O.A., T.R., S.G.M.), Heinrich-Heine University, Duesseldorf, Germany. 2. From the Department of Neurology with Institute of Translational Neurology (L.R., M.P., S.P., C.N., L.K., H.W.), University Hospital Muenster, Germany; Institute for Biometrics and Bioinformatic (A.L.), Otto-von-Guericke University, Magdeburg, Germany; Department for Neurology (R.P., C.K., K.K., R.R.), University Hospital Essen, Germany; Focus Program Translational Neurosciences (FTN) and Immunology (FZI) (K.P., S.B., F.Z.), Rhine Main Neuroscience Network (rmn2), Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Germany; Department of Neurology (C.W., Y.G., M.S.), University Hospital Cologne, Germany; and Department of Neurology (J.I., O.A., T.R., S.G.M.), Heinrich-Heine University, Duesseldorf, Germany. sven.meuth@uni-duesseldorf.de.
Abstract
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.
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%) EIDpatients remained relapse free (p = 0.903). Three-month confirmed progression of disability was observed in 18 SIDpatients (8.9%) and 11 EIDpatients (9.5%, p = 0.433). MRI progression was documented in 9 SIDpatients (4.5%) and 8 EIDpatients (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.
Authors: Lutz Achtnichts; Barbara Jakopp; Michael Oberle; Krassen Nedeltchev; Christoph Andreas Fux; Johann Sellner; Oliver Findling Journal: Vaccines (Basel) Date: 2021-12-11
Authors: Anne H Cross; Silvia Delgado; Mario Habek; Maria Davydovskaya; Brian J Ward; Bruce A C Cree; Natalia Totolyan; Ratnakar Pingili; Linda Mancione; Xixi Hu; Roseanne Sullivan; Wendy Su; Ronald Zielman; Ayan Das Gupta; Xavier Montalban; Kevin Winthrop Journal: Neurol Ther Date: 2022-03-13
Authors: Lutz Achtnichts; Arkady Ovchinnikov; Barbara Jakopp; Michael Oberle; Krassen Nedeltchev; Christoph Andreas Fux; Johann Sellner; Oliver Findling Journal: Vaccines (Basel) Date: 2022-02-21
Authors: Hamza Mahmood Bajwa; Frederik Novak; Anna Christine Nilsson; Christian Nielsen; Dorte K Holm; Kamilla Østergaard; Agnes Hauschultz Witt; Keld-Erik Byg; Isik S Johansen; Kristen Mittl; William Rowles; Scott S Zamvil; Riley Bove; Joseph J Sabatino; Tobias Sejbaek Journal: Mult Scler Relat Disord Date: 2022-03-06 Impact factor: 4.808