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Best-Practice Igm- and Iga-Enriched Immunoglobulin Use in Patients with Sepsis

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Best-Practice Igm- and Iga-Enriched Immunoglobulin Use in Patients with Sepsis Nierhaus et al. Ann. Intensive Care (2020) 10:132 https://doi.org/10.1186/s13613-020-00740-1 REVIEW Open Access Best-practice IgM- and IgA-enriched immunoglobulin use in patients with sepsis Axel Nierhaus1,2* , Giorgio Berlot3, Detlef Kindgen‑Milles4, Eckhard Müller5 and Massimo Girardis6 Abstract Background: Sepsis is a life‑threatening organ dysfunction caused by a dysregulated host response to infection. Despite treatment being in line with current guidelines, mortality remains high in those with septic shock. Intrave‑ nous immunoglobulins represent a promising therapy to modulate both the pro‑ and anti‑infammatory processes and can contribute to the elimination of pathogens. In this context, there is evidence of the benefts of immuno‑ globulin M (IgM)‑ and immunoglobulin A (IgA)‑enriched immunoglobulin therapy for sepsis. This manuscript aims to summarize current relevant data to provide expert opinions on best practice for the use of an IgM‑ and IgA‑enriched immunoglobulin (Pentaglobin) in adult patients with sepsis. Main text: Sepsis patients with hyperinfammation and patients with immunosuppression may beneft most from treatment with IgM‑ and IgA‑enriched immunoglobulin (Pentaglobin). Patients with hyperinfammation present with phenotypes that manifest throughout the body, whilst the clinical characteristics of immunosuppression are less clear. Potential biomarkers for hyperinfammation include elevated procalcitonin, interleukin‑6, endotoxin activity and C‑reactive protein, although thresholds for these are not well‑defned. Convenient biomarkers for identifying patients in a stage of immune‑paralysis are still matter of debate, though human leukocyte antigen–antigen D related expression on monocytes, lymphocyte count and viral reactivation have been proposed. The timing of treatment is potentially more critical for treatment efcacy in patients with hyperinfammation compared with patients who are in an immunosuppressed stage. Due to the lack of evidence, defnitive dosage recommendations for either population cannot be made, though we suggest that patients with hyperinfammation should receive an initial bolus at a rate of up to 0.6 mL (30 mg)/kg/h for 6 h followed by a continuous maintenance rate of 0.2 mL (10 mg)/kg/hour for 72 h (total dose 0.9 g/kg). For immunosuppressed patients, dosage is more conservative (0.2 mL [10 mg]/kg/h) for≥ 72 h, without an≥ initial bolus (total dose 0.72 g/kg). ≥ ≥ Conclusions: Two distinct populations that may beneft most from Pentaglobin therapy are described in this review. However, further clinical evidence is required to strengthen support for the recommendations given here regarding timing, duration and dosage of treatment. Keywords: Immunoglobulin, IgM‑ and IgA‑enriched immunoglobulin, Sepsis, Pentaglobin, Hyperinfammation, Immunosuppression Background Sepsis is a global issue which afects an estimated 49 mil- lion people every year, potentially leading to 11 million deaths [1]. It is a clinical syndrome in which profound physiological and biochemical changes often lead to a *Correspondence: [email protected] fatal outcome of an infection; the Tird International 2 Dep. of Intensive Care Medicine, University Medical Center Hamburg‑ Consensus (Sepsis-3) defned sepsis as a life-threaten- Eppendorf, Martinistr. 52, 20246 Hamburg, Germany Full list of author information is available at the end of the article ing organ dysfunction caused by a dysregulated host © The Author(s) 2020. This 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://creat iveco mmons .org/licen ses/by/4.0/. Nierhaus et al. Ann. Intensive Care (2020) 10:132 Page 2 of 19 response to infection. Even after many years of intensive of sepsis, patients often present with multiple features clinical and laboratory research, there is still no specifc of immunological alterations including systemic infam- therapy for sepsis. A subset of sepsis known as septic matory responses, complement consumption, defects in shock is characterized by profound circulatory, cellular neutrophil-mediated immunity and decreased serum lev- and metabolic abnormalities that are associated with a els of immunoglobulins fnally causing immunosuppres- greater risk of mortality than sepsis alone; with hospital sion (Fig. 1) [5, 6]. mortality rates > 50% [2, 3]. Immune pathophysiology of sepsis Early stage hypercytokinemia Sepsis is diferentiated from uncomplicated infection Activation of the TLRs on macrophages such as mono- due to a dysregulated host response to infection. Te cytes and neutrophils induces signal transduction clinical syndrome of sepsis is initiated by the activation and translocation of nuclear factor kappa-light-chain- of multiple signaling pathways following the recognition enhancer of activated B cells (NF-κB) to the nucleus. of pathogen-derived molecules [pathogen-associated NF-κB induces the expression of early activation genes, molecular patterns (PAMPs) e.g. endo- and exotoxins, including infammatory cytokines such as tumor necro- DNA, lipids] and endogenous host-derived danger sig- sis factor α (TNF-α), interleukin (IL)-1, IL-12, IL-18 nals (damage-associated molecular patterns [DAMPs]) and interferons (IFNs), which further initiate a cascade by specifc cell-surface receptors on macrophages [toll- of other infammatory cytokines (including IL-6, IL-8, like receptors (TLRs)] [4]. Consequently, this leads to the IFN-γ), as well as the suppression of adaptive immunity expression of genes involved in infammation, adaptive components [5]. Terefore, in the early stages of sepsis, immunity, and cellular metabolism [5]. During the course an increase in the presence of both proinfammatory and Fig. 1 Immune pathophysiology of sepsis. DAMP damage‑associated molecular pattern, DC dendritic cell, HLA human leukocyte antigen, IgM/G/A immunoglobulin M/G/A, IL interleukin, MDSC myeloid‑derived suppressor cell, NET neutrophil extracellular trap, NF-kB nuclear factor kappa‑light‑chain‑enhancer of activated B cells, PAMP pathogen‑associated molecular pattern, PD-1 programmed death protein 1, PD-L1 programmed death ligand 1, ROS reactive oxygen species, TGF-β transforming growth factor β, TLR toll‑like receptor, TNF-α tumor necrosis factor α, Treg regulatory T cell Nierhaus et al. Ann. Intensive Care (2020) 10:132 Page 3 of 19 anti-infammatory cytokines is observed at diagnosis apoptotic decrease in antigen-presenting dendritic cells [7–9]. and monocytes has been observed, along with a loss of their proinfammatory cytokine production [29–33]. Efects of complement activation and neutrophil‑mediated Human leukocyte antigen–antigen D related (HLA- immunity DR) expression on monocytes and dendritic cells is also In sepsis, there is considerable evidence of complement downregulated, which decreases responsiveness, and the activation, as refected by the appearance of complement failure of monocytes to recover HLA-DR levels predicts a activation products (anaphylatoxins such as C3a, C4a, poor outcome from sepsis [34]. C5a) in plasma [10]. Normally, C5a has a benefcial efect Natural killer-cell, B- and T-lymphocyte depletion and is linked to the recruitment of neutrophils to the can also be observed in peripheral blood along with an site of infection. C5a binding to the C5a receptor (C5aR) increase in apoptosis of dendritic cells (antigen-pre- transforms the neutrophil into a migratory cell able to senting cells [APCs]) and stromal cells [35–40]. In the invade infammatory tissue sites and clear pathogens and course of sepsis, inhibitory immune checkpoint mole- debris [11]. PAMPs and DAMPs induce oxidative burst cules, including programmed death protein 1 (PD-1), are leading to the release of reactive oxygen species and gran- upregulated on T cells, APCs or peripheral tissue epithe- ular enzymes, and release neutrophil extracellular traps lial cells. Tese molecules regulate leukocyte functions, (NETs). Excessive activation of C5a in the development leading to immune cell apoptosis (contributing to T cell of sepsis is linked to several processes including apopto- exhaustion), APC dysfunction and expansion of regula- sis of lymphocytes, aggravation of systemic infammation tory T (Treg) cells [5, 39, 41–44]. Although cell death in and neutrophil dysfunction [12]. Excessive C5a leads to innate and adaptive immunity is initially benefcial to the down-regulation of C5aR during sepsis and can have det- host, by downregulating the infammatory responses in rimental efects resulting in homing of neutrophils to the sepsis, the extensive loss of immune cells may compro- microvasculature, infammation, tissue damage, throm- mise the ability of the host to further eliminate invading bosis and multiple organ failure. Blockage of C5a or C5aR pathogens. It has been shown that preventing immune inhibits the development of sepsis in mouse models,
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