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-Schober; Richard 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

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

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 journal › Article › peer-review

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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 language	English
Article number	e000522
Journal	Lupus Science and Medicine
Volume	8
Issue number	1
DOIs	https://doi.org/10.1136/lupus-2021-000522
State	Published - 13 Aug 2021
Externally published	Yes

Bibliographical note

Publisher Copyright:
©

Funding

Contributors The study was conceptualised by KD, PC, AF, DW, JAJ, CP, BD, AD, DF, JM-T, MGA, DR, WA, HMB, PI, RAF, MD'E, DLK, KK, MAP and JPB. Data curation was completed by KD, PC, AF, JL, DW, JAJ, CP, KH, WA, PI, MW, SC, FP-S, RAF, MD'E, DLK, MAP and JPB. Formal analysis was completed by KD, PC, AF, JL, DW, JAJ, CP, MAP and JPB. Funding was acquired by AF, DW, JAJ, CP, MAP and JPB. Investigation was performed by KD, PC, AF, DW, JAJ, CP, BD, AD, DF, JM-T, MGA, DR, WA, HMB, PI, CCB, KC, MI, MW, MAP and JPB. Methodology was designed by KD, PC, AF, JL, DW, JAJ, CP, MAP and JPB. Project administration was performed by KD, PC, AF, DW, WA, MAP and JPB. Resources were provided by DW, CP, BD, AD, DF, JM-T, MGA, HMB, PI, MW, RAF, MD'E, DLK, KK, JA, MW, MAP and JPB. Software analysis was performed by JL. Supervision was provided by DW, MAP and JPB. Validation was performed by AF. The original draft of the manuscript was written by KD, PC, MAP and JPB. All authors assisted with review and editing of the final manuscript. Funding This work was supported by the Accelerating Medicines Partnership (AMP) in Rheumatoid Arthritis and Lupus Network. AMP is a public-private partnership (AbbVie Inc., Arthritis Foundation, Bristol-Myers Squibb Company, Foundation for the National Institutes of Health, GlaxoSmithKline, Janssen Research and Development, LLC, Lupus Foundation of America, Lupus Research Alliance, Merck Sharp & Dohme Corp., National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Pfizer Inc., Rheumatology Research Foundation, Sanofi and Takeda Pharmaceuticals International, Inc.) created to develop new ways of identifying and validating promising biological targets for diagnostics and drug development Funding was provided through grants from the National Institutes of Health (UH2-AR067676, UH2-AR067677, UH2-AR067679, UH2-AR067681, UH2-AR067685, UH2-AR067688, UH2-AR067689, UH2-AR067690, UH2-AR067691, UH2-AR067694, and UM2-AR067678).

Funders	Funder number
Foundation
National Institutes of Health
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Arthritis Foundation
Lupus Foundation of America
Bristol-Myers Squibb
Pfizer
GlaxoSmithKline
Sanofi
Rheumatology Research Foundation
AbbVie
Merck Sharp and Dohme
Lupus Research Alliance
Takeda Pharmaceuticals International	UH2-AR067677, UH2-AR067688, UH2-AR067689, UH2-AR067679, UH2-AR067685, UM2-AR067678, UH2-AR067676, UH2-AR067691, UH2-AR067681, UH2-AR067694, UH2-AR067690

Keywords

autoimmunity
lupus erythematosus
lupus nephritis
systemic

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10.1136/lupus-2021-000522

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Deonaraine, K. K., Carlucci, P. M., Fava, A., Li, J., Wofsy, D., James, J. A., Putterman, C., Diamond, B., Davidson, A., Fine, D. M., Monroy-Trujillo, J., Atta, M. G., Haag, K., Rao, D. A., Apruzzese, W., Belmont, H. M., Izmirly, P. M., Wu, M., Connery, S., ... Buyon, J. P. (2021). Safety of procuring research tissue during a clinically indicated kidney biopsy from patients with lupus: Data from the Accelerating Medicines Partnership RA/SLE Network. Lupus Science and Medicine, 8(1), Article e000522. https://doi.org/10.1136/lupus-2021-000522

@article{ae544339e374404181ff5ee724e1a8b8,

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

note = "Publisher Copyright: {\textcopyright} ",

year = "2021",

month = aug,

day = "13",

doi = "10.1136/lupus-2021-000522",

language = "אנגלית",

volume = "8",

journal = "Lupus Science and Medicine",

issn = "2053-8790",

publisher = "BMJ Publishing Group",

number = "1",

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Deonaraine, KK, Carlucci, PM, Fava, A, Li, J, Wofsy, D, James, JA, Putterman, C, Diamond, B, Davidson, A, Fine, DM, Monroy-Trujillo, J, Atta, MG, Haag, K, Rao, DA, Apruzzese, W, Belmont, HM, Izmirly, PM, Wu, M, Connery, S, Payan-Schober, F, Furie, RA, Berthier, CC, Dall'Era, M, Cho, K, Kamen, DL, Kalunian, K, Anolik, J, Ishimori, M, Weisman, MH, Petri, MA & Buyon, JP 2021, 'Safety of procuring research tissue during a clinically indicated kidney biopsy from patients with lupus: Data from the Accelerating Medicines Partnership RA/SLE Network', Lupus Science and Medicine, vol. 8, no. 1, e000522. https://doi.org/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. / Deonaraine, Kristina K.; Carlucci, Philip M.; Fava, Andrea et al.
In: Lupus Science and Medicine, Vol. 8, No. 1, e000522, 13.08.2021.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Safety of procuring research tissue during a clinically indicated kidney biopsy from patients with lupus

T2 - Data from the Accelerating Medicines Partnership RA/SLE Network

AU - Deonaraine, Kristina K.

AU - Carlucci, Philip M.

AU - Fava, Andrea

AU - Li, Jessica

AU - Wofsy, David

AU - James, Judith A.

AU - Putterman, Chaim

AU - Diamond, Betty

AU - Davidson, Anne

AU - Fine, Derek M.

AU - Monroy-Trujillo, Jose

AU - Atta, Mohamed G.

AU - Haag, Kristin

AU - Rao, Deepak A.

AU - Apruzzese, William

AU - Belmont, H. Michael

AU - Izmirly, Peter M.

AU - Wu, Ming

AU - Connery, Sean

AU - Payan-Schober, Fernanda

AU - Furie, Richard A.

AU - Berthier, Celine C.

AU - Dall'Era, Maria

AU - Cho, Kerry

AU - Kamen, Diane L.

AU - Kalunian, Kenneth

AU - Anolik, Jennifer

AU - Ishimori, Mariko

AU - Weisman, Michael H.

AU - Petri, Michelle A.

AU - Buyon, Jill P.

PY - 2021/8/13

Y1 - 2021/8/13

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.

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.

KW - autoimmunity

KW - lupus erythematosus

KW - lupus nephritis

KW - systemic

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U2 - 10.1136/lupus-2021-000522

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AN - SCOPUS:85113185320

SN - 2053-8790

VL - 8

JO - Lupus Science and Medicine

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M1 - e000522

ER -

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

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Keywords

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