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September 2021; 8 (5) ArticleOpen Access

Ocrelizumab Extended Interval Dosing in Multiple Sclerosis in Times of COVID-19

Leoni Rolfes, Marc Pawlitzki, View ORCID ProfileSteffen Pfeuffer, Christopher Nelke, Anke Lux, Refik Pul, View ORCID ProfileChristoph Kleinschnitz, Konstanze Kleinschnitz, Rebeca Rogall, Katrin Pape, Stefan Bittner, View ORCID ProfileFrauke Zipp, Clemens Warnke, Yasemin Goereci, Michael Schroeter, Jens Ingwersen, View ORCID ProfileOrhan Aktas, View ORCID ProfileLuisa Klotz, Tobias Ruck, Heinz Wiendl, Sven G. Meuth
First published July 14, 2021, DOI: https://doi.org/10.1212/NXI.0000000000001035
Leoni Rolfes
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.
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  • For correspondence: leoni.rolfes@ukmuenster.de
Marc Pawlitzki
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.
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  • For correspondence: marc.pawlitzki@ukmuenster.de
Steffen Pfeuffer
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.
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  • For correspondence: steffen.pfeuffer@ukmuenster.de
Christopher Nelke
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.
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  • For correspondence: christopher.nelke@ukmuenster.de
Anke Lux
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.
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  • For correspondence: anke.lux@med.ovgu.de
Refik Pul
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.
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  • For correspondence: refik.pul@uk-essen.de
Christoph Kleinschnitz
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.
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Konstanze Kleinschnitz
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.
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  • For correspondence: konstanzekleinschnitz@hotmail.com
Rebeca Rogall
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.
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  • For correspondence: rebecca.rogall@gmx.de
Katrin Pape
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.
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  • For correspondence: katrin.pape@unimedizin-mainz.de
Stefan Bittner
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.
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Frauke Zipp
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.
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Clemens Warnke
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.
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  • For correspondence: clemens.warnke@uk-koeln.de
Yasemin Goereci
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.
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Michael Schroeter
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.
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Jens Ingwersen
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.
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Orhan Aktas
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.
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  • For correspondence: orhan.aktas@med.uni-duesseldorf.de
Luisa Klotz
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.
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Tobias Ruck
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.
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  • For correspondence: tobias.ruck@med.uni-duesseldorf.de
Heinz Wiendl
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.
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Sven G. Meuth
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.
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Citation
Ocrelizumab Extended Interval Dosing in Multiple Sclerosis in Times of COVID-19
Leoni Rolfes, Marc Pawlitzki, Steffen Pfeuffer, Christopher Nelke, Anke Lux, Refik Pul, Christoph Kleinschnitz, Konstanze Kleinschnitz, Rebeca Rogall, Katrin Pape, Stefan Bittner, Frauke Zipp, Clemens Warnke, Yasemin Goereci, Michael Schroeter, Jens Ingwersen, Orhan Aktas, Luisa Klotz, Tobias Ruck, Heinz Wiendl, Sven G. Meuth
Neurol Neuroimmunol Neuroinflamm Sep 2021, 8 (5) e1035; DOI: 10.1212/NXI.0000000000001035

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    Figure 1 Flowchart of Case Ascertainment

    This flowchart depicts how the 318 ocrelizumab-treated patients with relapsing-remitting multiple sclerosis (RRMS) were identified. The source population was all patients with multiple sclerosis (MS) treated with ocrelizumab in 5 German centers during the period between January 2020 and September 2020. We excluded patients with MS who were treated with ocrelizumab due to a primary progressive disease course (PPMS), if only the 2 induction cycles with 300 mg were administered (treatment duration with ocrelizumab <6 months (Mo) during the observational period). SID and EID do not refer to the first 2 half doses with 300 mg, respectively, if patients experienced an extended interval dosing (EID) before Infusion C (the infusion administered between January 2020 and September 2020 that led to the division of the 2 groups–standard interval dosing [SID] and EID), or if the patient for any other reason did not satisfy the inclusion criteria (e.g., loss of follow-up [LOF]).

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    Figure 2 Flowchart of the Study Procedure

    1Infusion A was defined as the second last ocrelizumab infusion (300 mg or 600 mg cycles) before January 2020 (before the coronavirus disease 2019 pandemic started in Germany). 2Infusion B was defined as the last ocrelizumab infusion (second 300 mg infusion or 600 mg dose) before January 2020 and as the beginning of the observation interval. 3The infusion that followed on, further referred to as Infusion C, was the infusion administered between January 2020 and September 2020 (always 600 mg maintenance cycle). EID = extended interval dosing; FU = follow-up; SID = standard interval dosing.

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    Figure 3 B-Cell Levels Before and During Ocrelizumab Treatment in Patients With Relapsing-Remitting Multiple Sclerosis

    (A) CD19+ B-cell levels at sampling immediately before ocrelizumab infusions 1 to 5 in the standard interval dosing (SID) group compared with the extended interval dosing (EID) group. Infusion number 1 represents both baseline ocrelizumab infusions (2 × 300 mg with a 2-week interval). The numbers of cases used to estimate the means and SDs are shown below the figure. B-cell counts are presented as mean absolute counts of CD19+ cells/μL of blood. (B) The CD19+ B-cell levels immediately before ocrelizumab Infusion C (the infusion administered between January 2020 and September 2020 that led to the division of the 2 groups—SID and EID). B-cell counts are presented as absolute numbers of CD19+ cells/μL of peripheral blood. The number of patients with absolute CD19+ B-cell counts available at Infusion C is shown below the figure. (C) CD19+ B-cell counts immediately before ocrelizumab Infusion C are depicted. CD19+ B-cell numbers of patients who experienced either a 3-month confirmed progression of disability (CPD, left), a relapse (center), or MRI progression (either new or enlarged T2-weighted lesions or T1-weighted gadolinium enhancement, right) between Infusion B and follow-up are highlighted in red. The number of patients with absolute CD19+ B-cell counts available at Infusion C as well as those with disease activity is shown below the figure.

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