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. 2024 Feb;14(1):e200241.
doi: 10.1212/CPJ.0000000000200241. Epub 2024 Jan 4.

A Proposed Approach to Screening and Surveillance Labs for Patients With Multiple Sclerosis on Anti-CD20 Therapy

Stephanie Gandelman  1 , Kerry A Lenzi  1 , Clyde Markowitz  1 , Joseph R Berger  1
Affiliations

A Proposed Approach to Screening and Surveillance Labs for Patients With Multiple Sclerosis on Anti-CD20 Therapy

Stephanie Gandelman et al. Neurol Clin Pract. 2024 Feb.

Abstract

Background: Anti-CD20 therapies have proven to be highly effective and safe therapies for multiple sclerosis (MS) and have had rapid uptake in the MS community. However, no clear consensus has arisen regarding an approach to screening or surveillance lab monitoring.

Recent findings: Based on current evidence, for screening labs before anti-CD20 initiation, we propose checking liver function test (LFT), complete blood count with differential (CBC), absolute B-cell count, quantitative immunoglobulins, hepatitis B virus serologies, varicella zoster virus IgG, John Cunningham virus (JCV) status, and age-appropriate vaccination history. For surveillance monitoring in an otherwise asymptomatic individual, we propose biannual LFTs and CBC, quantitative immunoglobulins annually after year 3, absolute B-cell count at month 6 and in the setting of relapse, and JCV only if clinical or radiographic features of progressive multifocal leukoencephalopathy arise. For ublituximab, pregnancy testing is additionally recommended before each infusion.

Implications for practice: We propose evidence-based screening and safety surveillance labs which take into account likelihood of changing management in an otherwise stable or asymptomatic individual.

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Conflict of interest statement

The authors report no relevant disclosures. Full disclosure form information provided by the authors is available with the full text of this article at Neurology.org/cp. TAKE-HOME POINTS → Anti-CD20 therapies have had rapid uptake in the MS community and have proven to be highly effective and safe therapies. However, no clear consensus has arisen regarding an approach to screening and surveillance lab monitoring.→ We propose an evidence-based set of screening and safety surveillance labs for patients with MS on anti-CD20 monotherapy which takes into account likelihood of changing management in an otherwise stable or asymptomatic individual.→ This proposal is aimed for patients who do not have particular individualized risks or “red flag” signs for therapy-related complications, for whom new or concerning symptoms would necessitate broader laboratory evaluation.

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References

    1. Hauser SL, Waubant E, Arnold DL, et al. . B-cell depletion with rituximab in relapsing–remitting multiple sclerosis. New Engl J M. 2008;358(7):676-688. doi:10.1056/NEJMoa0706383 - DOI - PubMed
    1. Ocrevus Full Prescribing Information. 2017. Accessed November 29. 2022. accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf.
    1. Kesimpta Full Prescribing Information. 2020. Accessed December 10, 2022. accessdata.fda.gov/drugsatfda_docs/label/2020/125326s070lbl.pdf.
    1. Wolinsky J, Kappos L, Montalban X, et al. . Routine laboratory measures in the controlled-treatment period of phase III ocrelizumab trials in relapsing and progressive multiple sclerosis (P5.425). Neurology. 2018;90(15 suppl):P5.425. doi:10.1212/wnl.90.15_supplement.p5.425 - DOI
    1. Biolato M, Bianco A, Lucchini M, Gasbarrini A, Mirabella M, Grieco A. The disease-modifying therapies of relapsing-remitting multiple sclerosis and liver injury: a narrative review. CNS Drugs. 2021;35(8):861-880. doi:10.1007/s40263-021-00842-9 - DOI - PMC - PubMed

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