학술논문
Safety of procuring research tissue during a clinically indicated kidney biopsy from patients with lupus: data from the Accelerating Medicines Partnership RA/SLE Network
Document Type
article
Author
Andrew Filer; Michael H Weisman; Judith A James; Kenneth Kalunian; Michelle A Petri; Chaim Putterman; H Michael Belmont; Ilfita Sahbudin; Karim Raza; Maria Dall'Era; Jill P Buyon; Diane L Kamen; Karen Salomon-Escoto; Kazuyoshi Ishigaki; Patrick Dunn; David Wofsy; Michele Bombardieri; Vivian Bykerk; Myles Lewis; Ming Wu; Soumya Raychaudhuri; Hemant Suryawanshi; Thomas Tuschl; Christopher Ritchlin; Maureen McMahon; Jennifer Grossman; Philip M Carlucci; Alessandra Nerviani; Peter M Izmirly; Fan Zhang; Felice Rivellese; Joan Bathon; Zhu Zhu; Qian Xiao; Jessica Li; Holden Maecker; Nir Hacohen; Rong Mao; Jennifer Anolik; Javier Rangel-Moreno; Nida Meednu; Susan Goodman; Lindsy Forbess; Mariko Ishimori; Kevin Deane; David Hildeman; Yuhong Li; Laura Hughes; Robert Clancy; ANNE DAVIDSON; Matthias Kretzler; Larry Moreland; Harris Perlman; Peter Gregersen; Celine C Berthier; Andrea Fava; David Boyle; Derek M Fine; Ami Ben-Artzi; P J Utz; Melanie Smith; Beatrice Goilav; Carla Cuda; Andrew McDavid; Deepak A Rao; Joshua Keegan; Ilya Korsunsky; Joel Guthridge; Kevin Wei; Arnon Arazi; Thomas Eisenhaure; Michael Brenner; Susan Macwana; Pavel Morozov; Manjunath Kustagi; Gerald Watts; Kristina K Deonaraine; Jose Monroy-Trujillo; Mohamed G Atta; Kristin Haag; William Apruzzese; Sean Connery; Fernanda Payan-Schober; Kerry Cho; Jennifer Goff; Aparna Nathan; Joseph Mears; Nghia Millard; Kathryn Weinand; Saori Sakaue; Bill Robinson; Wade DeJager; Louis Bridges; Laura Donlin; Edward DiCarlo; Amit Lakhanpal; Heather Sherman; Anvita Singaraju; Lorien Shakib; Brendan Boyce; Darren Tabechian; Jen Albrecht; James Lederer; A Helena Jonsson; Daimon Simmons; Gregory Keras; Adam Chicoine; Zhihan Jian Li; Mandy McGeachy; Gary Firestein; Arnold Ceponis; Diane Horowitz; Salina Dominguez; Arthur Mandelin; Anjali Thakrar; Mike Holers; Jennifer Seifert; Constanino Pitzalis; Ellen Gravallese; Jennifer Barnas; Raymond Hsu; Steven Woodle; Paul Hoover; Michael Peters; Tony Jones; David Lieb; Jeffrey Hodgin; Raji Menon
Source
Lupus Science and Medicine, Vol 8, Iss 1 (2021)
Subject
Language
English
ISSN
2053-8790
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.