Safety of procuring research tissue during a clinically indicated kidney biopsy from patients with lupus: data from the Accelerating Medicines Partnership RA/SLE Network
- PMID: 34389634
- PMCID: PMC8354250
- DOI: 10.1136/lupus-2021-000522
Safety of procuring research tissue during a clinically indicated kidney biopsy from patients with lupus: data from the Accelerating Medicines Partnership RA/SLE Network
Abstract
Objectives: In lupus nephritis the pathological diagnosis from tissue retrieved during kidney biopsy drives treatment and management. Despite recent approval of new drugs, complete remission rates remain well under aspirational levels, necessitating identification of new therapeutic targets by greater dissection of the pathways to tissue inflammation and injury. This study assessed the safety of kidney biopsies in patients with SLE enrolled in the Accelerating Medicines Partnership, a consortium formed to molecularly deconstruct nephritis.
Methods: 475 patients with SLE across 15 clinical sites in the USA consented to obtain tissue for research purposes during a clinically indicated kidney biopsy. Adverse events (AEs) were documented for 30 days following the procedure and were determined to be related or unrelated by all site investigators. Serious AEs were defined according to the National Institutes of Health reporting guidelines.
Results: 34 patients (7.2%) experienced a procedure-related AE: 30 with haematoma, 2 with jets, 1 with pain and 1 with an arteriovenous fistula. Eighteen (3.8%) experienced a serious AE requiring hospitalisation; four patients (0.8%) required a blood transfusion related to the kidney biopsy. At one site where the number of cores retrieved during the biopsy was recorded, the mean was 3.4 for those who experienced a related AE (n=9) and 3.07 for those who did not experience any AE (n=140). All related AEs resolved.
Conclusions: Procurement of research tissue should be considered feasible, accompanied by a complication risk likely no greater than that incurred for standard clinical purposes. In the quest for targeted treatments personalised based on molecular findings, enhanced diagnostics beyond histology will likely be required.
Keywords: autoimmunity; lupus erythematosus; lupus nephritis; systemic.
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Conflict of interest statement
Competing interests: None declared.
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- UH2 AR067685/AR/NIAMS NIH HHS/United States
- UM2 AR067678/AR/NIAMS NIH HHS/United States
- UL1 TR003167/TR/NCATS NIH HHS/United States
- T32 HG002295/HG/NHGRI NIH HHS/United States
- UH2 AR067681/AR/NIAMS NIH HHS/United States
- UH2 AR067688/AR/NIAMS NIH HHS/United States
- UH2 AR067689/AR/NIAMS NIH HHS/United States
- UH2 AR067690/AR/NIAMS NIH HHS/United States
- UH2 AR067677/AR/NIAMS NIH HHS/United States
- UH2 AR067694/AR/NIAMS NIH HHS/United States
- R01 AR075423/AR/NIAMS NIH HHS/United States
- UH2 AR067679/AR/NIAMS NIH HHS/United States
- UH2 AR067676/AR/NIAMS NIH HHS/United States
- UH2 AR067691/AR/NIAMS NIH HHS/United States