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Systematic literature review of immunoglobulin trends for anti-CD20 monoclonal antibodies in multiple sclerosis
OBJECTIVE: To exp lore changes in immunoglobulin (Ig) levels for people with relapsing-multiple sclerosis (RMS) treated with ocrelizumab or ofatumumab and the relationship between Ig levels and infections. METHODS: A systematic literature review (SLR) was conducted to identify clinical trials and re...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9843103/ https://www.ncbi.nlm.nih.gov/pubmed/36648561 http://dx.doi.org/10.1007/s10072-022-06582-y |
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author | Saidha, Shiv Bell, Judith Harold, Sydney Belisario, Jose Marcano Hawe, Emma Shao, Qiujun Wyse, Kerri Maiese, Eric M. |
author_facet | Saidha, Shiv Bell, Judith Harold, Sydney Belisario, Jose Marcano Hawe, Emma Shao, Qiujun Wyse, Kerri Maiese, Eric M. |
author_sort | Saidha, Shiv |
collection | PubMed |
description | OBJECTIVE: To exp lore changes in immunoglobulin (Ig) levels for people with relapsing-multiple sclerosis (RMS) treated with ocrelizumab or ofatumumab and the relationship between Ig levels and infections. METHODS: A systematic literature review (SLR) was conducted to identify clinical trials and real-world evidence (RWE) studies on Ig levels over time and studies on associations with infections for ocrelizumab and ofatumumab for people with RMS through 10 September 2021. Searches were conducted in Embase, MEDLINE, Cochrane Library, trial registries, and recent conference abstracts. RESULTS: Of 1,580 articles identified, 30 reporting on 11 trials and 5 RWE studies were included. Ocrelizumab trials (n = 4) had 24–336 weeks of follow-up and reported decreasing Ig G (IgG) levels, while RWE (n = 5) had 52–78 weeks of follow-up and reported IgG to be stable or decrease only slightly. IgG levels were stable in ofatumumab trials (n = 5; 104–168 weeks of follow-up), but no RWE or longer-term studies were identified. No apparent association between decreased Ig levels and infections was observed during ofatumumab treatment (ASCLEPIOS I/II), while for ocrelizumab, the only data on apparent associations between decreased IgG levels and serious infection rates were for a pooled population of people with RMS or primary progressive MS. CONCLUSION: Decreasing IgG levels have been correlated with increased infection risk over time. IgG levels appeared to decrease over time in ocrelizumab trials but remained relatively stable over time in ofatumumab trials. Additional research is needed to understand differences between ocrelizumab and ofatumumab and identify people at risk of decreasing IgG levels and infection. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10072-022-06582-y. |
format | Online Article Text |
id | pubmed-9843103 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-98431032023-01-17 Systematic literature review of immunoglobulin trends for anti-CD20 monoclonal antibodies in multiple sclerosis Saidha, Shiv Bell, Judith Harold, Sydney Belisario, Jose Marcano Hawe, Emma Shao, Qiujun Wyse, Kerri Maiese, Eric M. Neurol Sci Review Article OBJECTIVE: To exp lore changes in immunoglobulin (Ig) levels for people with relapsing-multiple sclerosis (RMS) treated with ocrelizumab or ofatumumab and the relationship between Ig levels and infections. METHODS: A systematic literature review (SLR) was conducted to identify clinical trials and real-world evidence (RWE) studies on Ig levels over time and studies on associations with infections for ocrelizumab and ofatumumab for people with RMS through 10 September 2021. Searches were conducted in Embase, MEDLINE, Cochrane Library, trial registries, and recent conference abstracts. RESULTS: Of 1,580 articles identified, 30 reporting on 11 trials and 5 RWE studies were included. Ocrelizumab trials (n = 4) had 24–336 weeks of follow-up and reported decreasing Ig G (IgG) levels, while RWE (n = 5) had 52–78 weeks of follow-up and reported IgG to be stable or decrease only slightly. IgG levels were stable in ofatumumab trials (n = 5; 104–168 weeks of follow-up), but no RWE or longer-term studies were identified. No apparent association between decreased Ig levels and infections was observed during ofatumumab treatment (ASCLEPIOS I/II), while for ocrelizumab, the only data on apparent associations between decreased IgG levels and serious infection rates were for a pooled population of people with RMS or primary progressive MS. CONCLUSION: Decreasing IgG levels have been correlated with increased infection risk over time. IgG levels appeared to decrease over time in ocrelizumab trials but remained relatively stable over time in ofatumumab trials. Additional research is needed to understand differences between ocrelizumab and ofatumumab and identify people at risk of decreasing IgG levels and infection. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10072-022-06582-y. Springer International Publishing 2023-01-17 2023 /pmc/articles/PMC9843103/ /pubmed/36648561 http://dx.doi.org/10.1007/s10072-022-06582-y Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Review Article Saidha, Shiv Bell, Judith Harold, Sydney Belisario, Jose Marcano Hawe, Emma Shao, Qiujun Wyse, Kerri Maiese, Eric M. Systematic literature review of immunoglobulin trends for anti-CD20 monoclonal antibodies in multiple sclerosis |
title | Systematic literature review of immunoglobulin trends for anti-CD20 monoclonal antibodies in multiple sclerosis |
title_full | Systematic literature review of immunoglobulin trends for anti-CD20 monoclonal antibodies in multiple sclerosis |
title_fullStr | Systematic literature review of immunoglobulin trends for anti-CD20 monoclonal antibodies in multiple sclerosis |
title_full_unstemmed | Systematic literature review of immunoglobulin trends for anti-CD20 monoclonal antibodies in multiple sclerosis |
title_short | Systematic literature review of immunoglobulin trends for anti-CD20 monoclonal antibodies in multiple sclerosis |
title_sort | systematic literature review of immunoglobulin trends for anti-cd20 monoclonal antibodies in multiple sclerosis |
topic | Review Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9843103/ https://www.ncbi.nlm.nih.gov/pubmed/36648561 http://dx.doi.org/10.1007/s10072-022-06582-y |
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