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Multicenter Study
. 2025 Jan:93:106191.
doi: 10.1016/j.msard.2024.106191. Epub 2024 Nov 24.

Hypogammaglobulinemia and severe infections in Multiple Sclerosis patients on anti-CD20 agents: A multicentre study

K Smolik  1 , F Camilli  2 , I Panzera  2 , A Fiore  3 , A Franceschini  3 , M Foschi  4 , A Surcinelli  5 , I Pesci  6 , C Ferri  7 , V Bazzurri  8 , L Mancinelli  9 , C Zini  10 , A M Simone  11 , A Lugaresi  12 , F Falzone  13 , F Granella  14 , M G Piscaglia  5 , A Guareschi  6 , E Baldi  7 , P Immovilli  8 , S Montepietra  9 , M Santangelo  10 , N Poma  1 , M Cardi  1 , G De Napoli  1 , F Vitetta  15 , D Ferraro  16
Affiliations
Free article
Multicenter Study

Hypogammaglobulinemia and severe infections in Multiple Sclerosis patients on anti-CD20 agents: A multicentre study

K Smolik et al. Mult Scler Relat Disord. 2025 Jan.
Free article

Abstract

Background: Hypogammaglobulinemia (HG) is a known side effect of treatment with anti-CD20 monoclonal antibodies, and it is associated with the risk of infections.

Objectives: Aim of this retrospective multicentre study was to assess the frequency of HG in Multiple Sclerosis (MS) and Neuromyelitis Optica Spectrum Disorder patients treated with Ocrelizumab or Rituximab and its association with the occurrence of severe infections (SI). Furthermore, predictors of HG and SI were sought.

Methods: We included 556 patients (190M, 366F, mean age: 47 years) with a mean follow-up of 28 months (range 12-90 months).

Results: IgG HG occurred in 20% and IgM HG in 34% of patients. At multivariable analysis, the risk of IgG HG was influenced by an older age (≥50 years) (OR 1.64, 95%CI: 1.06-2.54, p=0.027), and by the number of treatment cycles (OR: 1.20, 95%CI: 1.09-1.33, p<0.001). A total of 25 SI occurred (100 person-years rate: 1.8), with a disease phenotype other than relapsing-remitting (OR 1.50, 95%CI: 1.02-2.20; p=0.039) and IgG HG (OR 2.65, 95%CI: 1.15-6.12; p=0.022) increasing its risk.

Conclusions: IgG and IgM HG occurred in a considerable proportion of patients. IgG HG increased the risk of SI, which were, nevertheless, relatively infrequent. Our results highlight the importance of monitoring immunoglobulin levels during treatment with anti-CD20 agents, to personalize treatment strategies.

Keywords: Anti-CD20; Hypogammaglobulinemia; Infections; Multiple sclerosis; Ocrelizumab; Rituximab.

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Conflict of interest statement

Declaration of competing interest K. Smolik: nothing to disclose, F. Camilli: nothing to disclose, I. Panzera: nothing to disclose, A. Fiore: nothing to disclose, A. Franceschini: nothing to disclose, M. Foschi has received travel and meeting support from Novartis, Roche, Biogen, Sanofi-Genzyme and Merck., A. Surcinelli nothing to disclose, I. Pesci nothing to disclose, C. Ferri: has received travel or speaker honoraria from Biogen Idec, Merck Serono, Novartis, Sanofi Genzyme, Roche, and Bristol Meyer Squibb, V. Bazzurri nothing to disclose, L. Mancinelli nothing to disclose, C. Zini nothing to disclose, A.M. Simone nothing to disclose, A. Lugaresi has served as a Biogen, Bristol Myers Squibb, Horizon, Janssen, Merck Serono, Novartis, Roche, Sanofi/Genzyme Advisory Board Member. She received congress and travel/accommodation expense compensations or speaker honoraria from Alexion, Biogen, Merck Serono, Novartis, Roche, Sanofi/Genzyme, and Fondazione Italiana Sclerosi Multipla (FISM). Her institutions received research grants from Novartis and Sanofi/Genzyme., F. Falzone nothing to disclose, F. Granella has received research funding from Roche; fees for advisory boards and speaker honoraria from Biogen, Merck Serono, Novartis, Roche, and Sanofi Genzyme; travel funding from Biogen, Sanofi Genzyme, and BMS., M.G. Piscaglia nothing to disclose, A. Guareschi nothing to disclose, E. Baldi has received a grant for the organization of a scientific congress from Biogen Idec and has received travel or speaker honoraria from Biogen Idec, Sanofi Genzyme, Merck Serono, and Teva Neurosciences., P. Immovilli, S. Montepietra, M. Santangelo: nothing to disclose, N. Poma: nothing to disclose, M. Cardi: nothing to disclose, G. De Napoli: nothing to disclose, F. Vitetta has received travel grants and/or speaker/advisory board honoraria from Merck, Novartis, Sanofi, Biogen and Roche. D. Ferraro has received travel grants and/or speaker/advisory board honoraria from Biogen, Merck, Sanofi, Novartis and Roche.

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