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Extended interval dosing with ocrelizumab in multiple sclerosis.

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  • 1Department of Neurology, Esbjerg Hospital, University Hospital of Southern Denmark, Esbjerg, Denmark.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|April 22, 2024
PubMed
Summary

Extending ocrelizumab dosing intervals for multiple sclerosis (MS) patients by an average of 9 weeks did not show clinical or biomarker worsening. This extended interval dosing (EID) approach maintained treatment efficacy compared to standard interval dosing (SID).

Keywords:
Multiple sclerosisNEDA-3anti-CD20biomarkersextended dosingneuroimagingocrelizumabpersonalized medicinetreatment interval

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Area of Science:

  • Neurology
  • Immunology
  • Pharmacology

Background:

  • Multiple sclerosis (MS) management involves targeted therapies like ocrelizumab.
  • Optimizing dosing schedules, such as standard interval dosing (SID) versus extended interval dosing (EID), is crucial for patient outcomes and treatment adherence.
  • Investigating the clinical and biomarker implications of EID versus SID for ocrelizumab is essential for refining MS treatment strategies.

Purpose of the Study:

  • To compare clinical and biomarker outcomes between patients receiving standard interval dosing (SID) and extended interval dosing (EID) of ocrelizumab in multiple sclerosis.
  • To evaluate the safety and efficacy of extending ocrelizumab treatment intervals.
  • To assess differences in B-cell levels, ocrelizumab serum concentrations, and neurofilament light chain (NFL) and glial fibrillary acidic protein (GFAP) levels between EID and SID groups.

Main Methods:

  • A prospective, multi-center, open-label study involving 184 participants with MS on ocrelizumab therapy for over 12 months.
  • Participants were divided into EID (n=107) and SID (n=77) groups, with EID averaging a 9-week extension.
  • Outcomes included MRI disease activity, relapses, neurostatus worsening, and No Evidence of Disease Activity-3 (NEDA-3), alongside biomarker analysis (B-cells, ocrelizumab, NFL, GFAP).

Main Results:

  • Extended interval dosing (EID) showed higher B-cell counts and lower ocrelizumab serum concentrations compared to standard interval dosing (SID).
  • No significant differences were observed in age-adjusted neurofilament light chain (NFL) and glial fibrillary acidic protein (GFAP) levels between the groups.
  • The combined endpoint of No Evidence of Disease Activity-3 (NEDA-3) did not differ between EID and SID groups (hazard ratio: 1.174, p=0.69).
  • Higher NFL levels were associated with disease activity, and body mass index correlated with ocrelizumab and B-cell levels.

Conclusions:

  • Extending ocrelizumab treatment intervals by an average of 9 weeks (up to 78 weeks) did not lead to clinical, radiological, or biomarker evidence of worsening in MS patients.
  • Extended interval dosing (EID) appears to maintain treatment efficacy comparable to standard interval dosing (SID) in this cohort.
  • Further research may explore long-term outcomes and individualized EID strategies in multiple sclerosis management.