Extended interval dosing with ocrelizumab in multiple sclerosis

Frederik Novak; Hamza Mahmood Bajwa; Kamilla Østergaard; Jonas Munksgaard Berg; Jonna Skov Madsen; Dorte Aalund Olsen; Inga Urbonaviciute; Zsolt Illes; Morten Leif Stilund; Jeppe Romme Christensen; Stephan Bramow; Finn Sellebjerg; Tobias Sejbaek

doi:10.1177/13524585241245296

Extended interval dosing with ocrelizumab in multiple sclerosis

Frederik Novak^*, Hamza Mahmood Bajwa, Kamilla Østergaard, Jonas Munksgaard Berg, Jonna Skov Madsen, Dorte Aalund Olsen, Inga Urbonaviciute, Zsolt Illes, Morten Leif Stilund, Jeppe Romme Christensen, Stephan Bramow, Finn Sellebjerg, Tobias Sejbaek

^*Corresponding author for this work

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

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Abstract

Background: This study investigates clinical and biomarker differences between standard interval dosing (SID) and extended interval dosing (EID) of ocrelizumab therapy in multiple sclerosis (MS). Methods: This is a prospective, double-arm, open-label, multi-center study in Denmark. Participants diagnosed with MS on ocrelizumab therapy >12 months were included (n = 184). Clinical, radiological, and blood-based biomarker outcomes were evaluated. MRI disease activity, relapses, worsening of neurostatus, and No Evidence of Disease Activity-3 (NEDA-3) were used as a combined endpoint. Results: Out of 184 participants, 107 participants received EID (58.2%), whereas 77 participants received SID (41.8%). The average extension was 9 weeks with a maximum of 78 weeks. When comparing EID to SID, we found higher levels of B-cells, lower serum concentrations of ocrelizumab, and similar levels of age-adjusted NFL and GFAP in the two groups. No difference in NEDA-3 between EID and SID was demonstrated (hazard ratio: 1.174, p = 0.69). Higher levels of NFL were identified in participants with disease activity. Body mass index correlated with levels of ocrelizumab and B-cells. Conclusion: Extending one treatment interval of ocrelizumab on average 9 weeks and up to 78 weeks did not result in clinical, radiological, or biomarker evidence of worsening compared with SID.

Original language	English
Journal	Multiple Sclerosis Journal
Volume	30
Issue	7
Pages (from-to)	847-856
Number of pages	10
ISSN	1352-4585
DOIs	https://doi.org/10.1177/13524585241245296
Publication status	Published - Jun 2024

Keywords

anti-CD20
biomarkers
extended dosing
Multiple sclerosis
NEDA-3
neuroimaging
ocrelizumab
personalized medicine
treatment interval

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10.1177/13524585241245296

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@article{8814d2f2bcc24bb6aedf9049223fec10,

title = "Extended interval dosing with ocrelizumab in multiple sclerosis",

abstract = "Background: This study investigates clinical and biomarker differences between standard interval dosing (SID) and extended interval dosing (EID) of ocrelizumab therapy in multiple sclerosis (MS). Methods: This is a prospective, double-arm, open-label, multi-center study in Denmark. Participants diagnosed with MS on ocrelizumab therapy >12 months were included (n = 184). Clinical, radiological, and blood-based biomarker outcomes were evaluated. MRI disease activity, relapses, worsening of neurostatus, and No Evidence of Disease Activity-3 (NEDA-3) were used as a combined endpoint. Results: Out of 184 participants, 107 participants received EID (58.2%), whereas 77 participants received SID (41.8%). The average extension was 9 weeks with a maximum of 78 weeks. When comparing EID to SID, we found higher levels of B-cells, lower serum concentrations of ocrelizumab, and similar levels of age-adjusted NFL and GFAP in the two groups. No difference in NEDA-3 between EID and SID was demonstrated (hazard ratio: 1.174, p = 0.69). Higher levels of NFL were identified in participants with disease activity. Body mass index correlated with levels of ocrelizumab and B-cells. Conclusion: Extending one treatment interval of ocrelizumab on average 9 weeks and up to 78 weeks did not result in clinical, radiological, or biomarker evidence of worsening compared with SID.",

keywords = "anti-CD20, biomarkers, extended dosing, Multiple sclerosis, NEDA-3, neuroimaging, ocrelizumab, personalized medicine, treatment interval",

author = "Frederik Novak and Bajwa, {Hamza Mahmood} and Kamilla {\O}stergaard and Berg, {Jonas Munksgaard} and Madsen, {Jonna Skov} and Olsen, {Dorte Aalund} and Inga Urbonaviciute and Zsolt Illes and Stilund, {Morten Leif} and {Romme Christensen}, Jeppe and Stephan Bramow and Finn Sellebjerg and Tobias Sejbaek",

note = "Publisher Copyright: {\textcopyright} The Author(s), 2024.",

year = "2024",

month = jun,

doi = "10.1177/13524585241245296",

language = "English",

volume = "30",

pages = "847--856",

journal = "Multiple Sclerosis Journal",

issn = "1352-4585",

publisher = "SAGE Publications Ltd",

number = "7",

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TY - JOUR

T1 - Extended interval dosing with ocrelizumab in multiple sclerosis

AU - Novak, Frederik

AU - Bajwa, Hamza Mahmood

AU - Østergaard, Kamilla

AU - Berg, Jonas Munksgaard

AU - Madsen, Jonna Skov

AU - Olsen, Dorte Aalund

AU - Urbonaviciute, Inga

AU - Illes, Zsolt

AU - Stilund, Morten Leif

AU - Romme Christensen, Jeppe

AU - Bramow, Stephan

AU - Sellebjerg, Finn

AU - Sejbaek, Tobias

N1 - Publisher Copyright: © The Author(s), 2024.

PY - 2024/6

Y1 - 2024/6

N2 - Background: This study investigates clinical and biomarker differences between standard interval dosing (SID) and extended interval dosing (EID) of ocrelizumab therapy in multiple sclerosis (MS). Methods: This is a prospective, double-arm, open-label, multi-center study in Denmark. Participants diagnosed with MS on ocrelizumab therapy >12 months were included (n = 184). Clinical, radiological, and blood-based biomarker outcomes were evaluated. MRI disease activity, relapses, worsening of neurostatus, and No Evidence of Disease Activity-3 (NEDA-3) were used as a combined endpoint. Results: Out of 184 participants, 107 participants received EID (58.2%), whereas 77 participants received SID (41.8%). The average extension was 9 weeks with a maximum of 78 weeks. When comparing EID to SID, we found higher levels of B-cells, lower serum concentrations of ocrelizumab, and similar levels of age-adjusted NFL and GFAP in the two groups. No difference in NEDA-3 between EID and SID was demonstrated (hazard ratio: 1.174, p = 0.69). Higher levels of NFL were identified in participants with disease activity. Body mass index correlated with levels of ocrelizumab and B-cells. Conclusion: Extending one treatment interval of ocrelizumab on average 9 weeks and up to 78 weeks did not result in clinical, radiological, or biomarker evidence of worsening compared with SID.

AB - Background: This study investigates clinical and biomarker differences between standard interval dosing (SID) and extended interval dosing (EID) of ocrelizumab therapy in multiple sclerosis (MS). Methods: This is a prospective, double-arm, open-label, multi-center study in Denmark. Participants diagnosed with MS on ocrelizumab therapy >12 months were included (n = 184). Clinical, radiological, and blood-based biomarker outcomes were evaluated. MRI disease activity, relapses, worsening of neurostatus, and No Evidence of Disease Activity-3 (NEDA-3) were used as a combined endpoint. Results: Out of 184 participants, 107 participants received EID (58.2%), whereas 77 participants received SID (41.8%). The average extension was 9 weeks with a maximum of 78 weeks. When comparing EID to SID, we found higher levels of B-cells, lower serum concentrations of ocrelizumab, and similar levels of age-adjusted NFL and GFAP in the two groups. No difference in NEDA-3 between EID and SID was demonstrated (hazard ratio: 1.174, p = 0.69). Higher levels of NFL were identified in participants with disease activity. Body mass index correlated with levels of ocrelizumab and B-cells. Conclusion: Extending one treatment interval of ocrelizumab on average 9 weeks and up to 78 weeks did not result in clinical, radiological, or biomarker evidence of worsening compared with SID.

KW - anti-CD20

KW - biomarkers

KW - extended dosing

KW - Multiple sclerosis

KW - NEDA-3

KW - neuroimaging

KW - ocrelizumab

KW - personalized medicine

KW - treatment interval

UR - http://www.scopus.com/inward/record.url?scp=85192384800&partnerID=8YFLogxK

U2 - 10.1177/13524585241245296

DO - 10.1177/13524585241245296

M3 - Journal article

C2 - 38646949

AN - SCOPUS:85192384800

SN - 1352-4585

VL - 30

SP - 847

EP - 856

JO - Multiple Sclerosis Journal

JF - Multiple Sclerosis Journal

IS - 7

ER -

Extended interval dosing with ocrelizumab in multiple sclerosis

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