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. 2023 Nov:79:105028.
doi: 10.1016/j.msard.2023.105028. Epub 2023 Sep 24.

Ocrelizumab B-cell repopulation-guided extended interval dosing versus standard dosing - similar clinical efficacy with decreased immunoglobulin M deficiency rates

Torge Rempe  1 , Aisha Elfasi  2 , Elsa Rodriguez  2 , Matthew Vasquez  2 , Jennifer Graves  3 , Revere Kinkel  3
Affiliations

Ocrelizumab B-cell repopulation-guided extended interval dosing versus standard dosing - similar clinical efficacy with decreased immunoglobulin M deficiency rates

Torge Rempe et al. Mult Scler Relat Disord. 2023 Nov.

Abstract

Background: Ocrelizumab (OCR) is a humanized anti-CD20 monoclonal antibody used in treatment of multiple sclerosis. The standard dosing (SD) regimen consists of OCR maintenance infusions every 6 months. In B-cell repopulation-guided extended interval dosing (EID), repeat infusions are delayed until there is evidence for B-cell repopulation.

Objectives: To compare frequencies of 'no evidence of disease activity' (NEDA-3) and immunoglobulin G (hypo-IgG; <600 mg/dL) and M (hypo-IgM; <40 mg/dL) deficiencies in persons with multiple sclerosis (PwMS) treated with OCR B-cell repopulation-guided EID versus SD.

Methods: Two-center retrospective study comparing frequencies of NEDA-3 and hypo-IgG and hypo-IgM in PwMS treated with OCR B-cell repopulation-guided EID versus SD using a multivariate generalized linear model adjusted for age, sex, and treatment duration.

Results: A total of 112 OCR-treated PwMS were included (B-cell repopulation-guided EID n = 52; SD n = 60) with average infusion intervals of 319 (246-485) days (EID) and 184 (170-218) days (SD). There was no significant difference in NEDA-3 (EID: 47/52 [90.4 %]; SD: 50/60 [83.3 %]; p = 0.161) or hypo-IgG (EID: 1/52 [1.9 %]; SD: 4/60 [6.7 %]; p = 0.298) rates. Hypo-IgM was significantly less common in EID (EID: 9/52 [17.3 %] vs. SD: 34/60 [55 %]; p<0.001) upon assessment 1099 (475-1436) days (EID) and 980 (409-1846) days (SD) post-initiation of OCR. Hypo-IgM was associated with average infusion interval length (p = 0.005) and total number of OCR cycles (p = 0.003).

Conclusions: OCR B-cell repopulation-guided EID may be a safe alternative to traditional SD with similar efficacy and significantly less hypo-IgM rates.

Keywords: Anti-CD20; Disease modifying therapy; Extended interval dosing; Hypogammaglobulinemia; Multiple sclerosis; Ocrelizumab.

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Conflict of interest statement

Declaration of Competing Interest Dr. Rempe received grant funding from the National Multiple Sclerosis Society. He served on an advisory board for Genentech, Sanofi-Genzyme and Alexion. Dr. Rempe has contract research support from Sanofi-Genzyme, Novartis, Celgene, and Genentech. Dr. Elfasi has nothing to disclose. Dr. Rodriguez has nothing to disclose. Dr. Vasquez has nothing to disclose. Dr. Graves has received research support from NMSS, Octave, Biogen, EMD Serono, Novartis, ATARA Biotherapeutics, and ABM. She has served on an advisory board for TG therapeutics and a pediatric clinical trial steering committee for Novartis. She has consulted for Google. Dr Kinkel has received honoraria for non-promotional educational activity from Biogen and received speaker fees from Alexion, Biogen, BMS, Genentech and Sanofi-Genzyme.

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