Elevated polyreactive immunoglobulin G in immune mediated liver injuries with the need for immunosuppressive therapy
crossref(2024)
摘要
Background and aim The distinction of drug-induced liver injury (DILI), drug-induced autoimmune-like hepatitis (DI-ALH) and autoimmune hepatitis (AIH) can be challenging due to overlapping clinical characteristics. Recently, polyreactive immunoglobulin G (pIgG) was identified as a novel biomarker with a higher accuracy for the diagnose of AIH than conventional autoantibodies. This retrospective multicenter study aimed to evaluate the diagnostic accuracy of pIgG to distinguish between AIH, DI-ALH and DILI and thus identify patients in need of immunosuppression.
Methods Samples from 116 patients (AIH=81, DI-ALH=12, DILI=23) were recruited and compared to a control group (non-AIH-non-DILI-LD= 596) from existing biorepositories.
Results No patient in the DILI-group but 98% in the AIH-and 92% in the DI-ALH-group received immunosuppressive treatment. pIgG levels were significantly higher in the AIH-group (1.9 normalized arbitrary units (nAU) compared to DILI (1.1 nAU, p<0.001) and non-AIH-non-DILI-LD (1.0 nAU, p<0.001). Median pIgG concentrations of the DI-ALH-group (1.7 nAU) were between AIH (p=.634) and DILI (p=.052). Patients that needed immunosuppressive therapy for remission induction had significantly higher pIgG concentrations compared to those with spontaneous recovery of liver injury (1.8 nAU vs. 1.1 nAU, p<.001). The overall accuracy of pIgG >1.27nAU to distinguish AIH from DILI (74%) and liver injuries with and without the need for immunosuppression (74%) was similar to that of ANA (71/74%) and SMA (74/70%) at cut-offs of ≥1/40.
Conclusion Polyreactive IgG can be used to predict AIH in comparison to DILI and indicate the need for immunosuppressive therapy in the work-up of immune mediated or drug-induced liver injuries.
### Competing Interest Statement
Richard Taubert and Elmar Jaeckel are inventors of the patent application for the use of anti-HIP1R/BSA for the diagnosis of AIH (granted patent: EP3701264 B1; running patent application: 16/754,006). EUROIMMUN Medizinische Labordiagnostika AG and Inova Diagnostics Inc. provided ELISAs free of charge for other projects of Richard Taubert and Bastian Engel. Ye H Oo thanks the Sir Jules Thorn Charitable Trust and Whitney Wood Fellowship. All other authors have nothing to disclose with regard to this paper.
### Funding Statement
Bastian Engel was supported by the PRACTIS Clinician Scientist Programme of Hannover Medical School, funded by the German Research Foundation (DFG, ME 3696/3).
### Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Written informed consent was obtained from all patients at respective centers. Use of material and data from all patients in this multicenter study was approved by the respective local ethical committees. The study was approved by the local Ethics Committee (Number 5582 with last Update from 2018, Hannover Medical School Ethics Committee, Hannover Medical School, Hannover, Germany). The study conforms to the ethical guidelines of the 1975 Declaration of Helsinki.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
* AIH
: Autoimmune hepatitis
AMA
: anti-mitochondrial antibody
ANA
: antinuclear antibody
DI-ALH
: Drug-induced autoimmune-like hepatitis
DILI
: Drug-induced liver injury
LKM
: Liver kidney microsomal antibodies
Non-AIH-non-DILI-LD
: non-autoimmune hepatitis non-drug-induced liver injury - liver disease
pIgG
: polyreactive immunoglobulin G
SMA
: smooth-muscle antigen
SLA
: soluble liver antigens
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