RT Journal Article
SR Electronic
T1 Safety of procuring research tissue during a clinically indicated kidney biopsy from patients with lupus: data from the Accelerating Medicines Partnership RA/SLE Network
JF Lupus Science & Medicine
JO Lupus Sci Med
FD Lupus Foundation of America
SP e000522
DO 10.1136/lupus-2021-000522
VO 8
IS 1
A1 Kristina K Deonaraine
A1 Philip M Carlucci
A1 Andrea Fava
A1 Jessica Li
A1 David Wofsy
A1 Judith A James
A1 Chaim Putterman
A1 Betty Diamond
A1 Anne Davidson
A1 Derek M Fine
A1 Jose Monroy-Trujillo
A1 Mohamed G Atta
A1 Kristin Haag
A1 Deepak A Rao
A1 William Apruzzese
A1 H Michael Belmont
A1 Peter M Izmirly
A1 Ming Wu
A1 Sean Connery
A1 Fernanda Payan-Schober
A1 Richard A Furie
A1 Celine C Berthier
A1 Maria Dall'Era
A1 Kerry Cho
A1 Diane L Kamen
A1 Kenneth Kalunian
A1 Jennifer Anolik
A1 Mariko Ishimori
A1 Michael H Weisman
A1 The Accelerating Medicines Partnership RA/SLE network
A1 Michelle A Petri
A1 Jill P Buyon
YR 2021
UL http://lupus.bmj.com/content/8/1/e000522.abstract
AB 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.All data relevant to the study are included in the article or uploaded as supplementary information.