Extended interval dosing with ocrelizumab in multiple sclerosis
- PMID: 38646949
- DOI: 10.1177/13524585241245296
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: Multiple sclerosis; NEDA-3; anti-CD20; biomarkers; extended dosing; neuroimaging; ocrelizumab; personalized medicine; treatment interval.
Conflict of interest statement
Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: H. M. Bajwa, K. Østergaard, J. M. Berg, J. S. Madsen, D. A. Olsen, and I. Urbonaviciute have nothing to disclose. F. Novak served on advisory boards for Sanofi and received travel grants from Sanofi and Merck; Z. Illes has received speakers’ honoraria and/or research grants from Biogen, Roche, Sanofi, Novartis, Merck, and Lundbeckfonden; has been member of advisory boards at Alexion, Biogen, Sanofi, Merck, Roche, and Novartis; was a member of the adjudication relapse committee in phase 3 trials; and has been principal investigator in studies sponsored by Biogen, Merck, and Sanofi; M. L. Stilund reported serving on scientific advisory boards for Sanofi, receiving support for congress participation, or receiving speaker honoraria from Biogen, Teva, Merck, Roche, and Sanofi, grants for his research from Novartis, and being currently engaged in sponsor-initiated research projects by Bayer, Jansen, Shionogi, and Sanofi outside the submitted work; J. R. Christensen has received speaker honoraria from Biogen; S. Bramow received speaking honoraria from Merck Denmark and Novartis Denmark and support for congress participation from Novartis Denmark; F. Sellebjerg has served on scientific advisory boards for, served as consultant for, received support for congress participation, or received speaker honoraria from Alexion, Biogen, Merck, Novartis, Roche, and Sanofi Genzyme. His laboratory has received research support from Biogen, Merck, Novartis, Roche, and Sanofi Genzyme; T. Sejbaek received travel grants from Biogen, Merck, Novartis, and Roche and research grants from Biogen and served on advisory boards for Biogen, Merck, and Novartis.
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