Safety of procuring research tissue during a clinically indicated kidney biopsy from patients with lupus: Data from the Accelerating Medicines Partnership RA/SLE Network

Kristina K. Deonaraine, Philip M. Carlucci, Andrea Fava, Jessica Li, David Wofsy, Judith A. James, Chaim Putterman, Betty Diamond, Anne Davidson, Derek M. Fine, Jose Monroy-Trujillo, Mohamed G. Atta, Kristin Haag, Deepak A. Rao, William Apruzzese, H. Michael Belmont, Peter M. Izmirly, Ming Wu, Sean Connery, Fernanda Payan-SchoberRichard A. Furie, Celine C. Berthier, Maria Dall'Era, Kerry Cho, Diane L. Kamen, Kenneth Kalunian, Jennifer Anolik, Mariko Ishimori, Michael H. Weisman, Michelle A. Petri, Jill P. Buyon

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Article numbere000522
JournalLupus Science and Medicine
Volume8
Issue number1
DOIs
StatePublished - Aug 13 2021

Keywords

  • autoimmunity
  • lupus erythematosus
  • lupus nephritis
  • systemic

ASJC Scopus subject areas

  • Immunology

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