TY - JOUR 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 DO - 10.1136/lupus-2021-000522 VL - 8 IS - 1 SP - e000522 AU - Kristina K Deonaraine AU - Philip M Carlucci AU - Andrea Fava AU - Jessica Li AU - David Wofsy AU - Judith A James AU - Chaim Putterman AU - Betty Diamond AU - Anne Davidson AU - Derek M Fine AU - Jose Monroy-Trujillo AU - Mohamed G Atta AU - Kristin Haag AU - Deepak A Rao AU - William Apruzzese AU - H Michael Belmont AU - Peter M Izmirly AU - Ming Wu AU - Sean Connery AU - Fernanda Payan-Schober AU - Richard A Furie AU - Celine C Berthier AU - Maria Dall'Era AU - Kerry Cho AU - Diane L Kamen AU - Kenneth Kalunian AU - Jennifer Anolik AU - Mariko Ishimori AU - Michael H Weisman AU - The Accelerating Medicines Partnership RA/SLE network AU - Michelle A Petri AU - Jill P Buyon Y1 - 2021/08/01 UR - http://lupus.bmj.com/content/8/1/e000522.abstract N2 - 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. ER -