Title: | Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study |
Author: |
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Date: | 2019-01-08 |
Language: | English |
Scope: | 887-895 |
University/Institute: | Háskóli Íslands University of Iceland |
School: | Heilbrigðisvísindasvið (HÍ) School of Health Sciences (UI) |
Department: | Lyfjafræðideild (HÍ) Faculty of Pharmaceutical Sciences (UI) |
Series: | Drug Safety;42(7) |
ISSN: | 0114-5916 1179-1942 (eISSN) |
DOI: | 10.1007/s40264-018-00789-9 |
Subject: | Toxicology; Depression; mAbs; Autoimmune Diseases; Eiturefnafræði; Sjálfsofnæmissjúkdómar; Þunglyndi; Sjálfsvíg |
URI: | https://hdl.handle.net/20.500.11815/1687 |
Citation:Minnema, L.A., Giezen, T.J., Souverein, P.C. et al. Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study. Drug Safety 42, 887–895 (2019). https://doi.org/10.1007/s40264-018-00789-9
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Abstract:Introduction: Several monoclonal antibodies (mAbs) have been linked to neuropsychiatric adverse efects in patients, including depression and suicidal ideation and behavior.
Objective: The aim of this study was to quantify and characterize spontaneously reported adverse drug reactions (ADRs) of
depression and suicidal ideation and behavior related to mAb users, and to explore a possible association with their mechanism of action.
Methods: We included mAb ADRs that were reported in VigiBase, and identifed those related to depression and suicidal
ideation and behavior. Reporting odds ratios (RORs) were estimated for each mAb (bevacizumab as the reference) and
according to their infuence on the immune system (not directly targeting [reference], stimulating, or suppressing). Those
suppressing the immune system were further divided into their intended indication (auto-immune diseases, cancer).
Results: Overall, 2,924,319 ADRs for 44 mAbs were included; 9455 ADRs were related to depression and 1770 were related
to suicidal ideation and behavior. The association was strongest for natalizumab and belimumab, both for depression (ROR
5.7, 95% confdence interval [CI] 5.0–6.4; and ROR 5.1, 95% CI 4.2–6.2) and suicidal ideation and behavior (ROR 12.0,
95% CI 7.9–18.3; and ROR 20.2, 95% CI 12.4–33.0). Those suppressing the immune system showed higher ROR, i.e. 1.9
(95% CI 1.8–2.0) for depression and 3.6 (95% CI 3.0–4.4) for suicidal ideation and behavior. This fnding was only seen for
mAbs used for treating autoimmune diseases.
Conclusion: Depression and suicidal ideation and behavior are seen in patients using mAbs, particularly mAbs used for
treating autoimmune diseases that suppress the immune system. For interpretation of these data, the indications for use and
other characteristics require further consideration.
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Description:Publisher's version (útgefin grein)
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Rights:Open Access. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
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