OUR RESEARCH AND DATA

Understanding the urgency of our mission, we focus our scientific and clinical excellence on developing treatment options that significantly enhance how patients manage their disease.

AUR200: A Highly Potent Immunomodulator Targeting BAFF and APRIL

EULAR 2022: Voclosporin for Lupus Nephritis: Results of the Two-Year AURORA 2 Continuation Study

Voclosporin Is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations

European Renal Association Congress 2022: Early Reductions in Proteinuria with Voclosporin Treatment across Lupus Nephritis Biopsy Classes: Pooled Data from the AURA-LV and AURORA 1 Trials

European Renal Association Congress 2022: Voclosporin for Lupus Nephritis: Results of the Two-year AURORA 2 Continuation Study

Tatsuya Atsumi, Tien-Tsai Cheng, Tuyen Do Gia, Shunsuke Furuta, Harold Michael P. Gomez, Llewellyn T. Hao, Ngoc Phuong Thao Huynh, Michihito Kono, Sandra Navarra, Kajohnsak Noppakun, Kenji Oku, Bernadette Reyes, Bancha Satirapoj: Long-term Safety and Efficacy of Voclosporin in Asian Patients with Lupus Nephritis. APLAR. 2022.

Tagoe KJ, Orujov E, Baker MG, Cipolla L, McLemore J, Leher H: Enlight-LN: A Prospective Observational Registry of Patients Treated with Voclosporin for Lupus Nephritis in the United States. J Am Soc Nephrol 33, 2022.

Link: 2022 ASN Poster

Caster D, Saxena A, Almaani S, Rosales A, Leher H: Long-term Use of Voclosporin in Patients with Class V Lupus Nephritis: Results from the AURORA 2 Continuation Study. J Am Soc Nephrol 33, 2022: Page 498.

Link: 2022 ASN Poster

Parikh S, Arriens C, Hodge L, Mela C, Leher H: Voclosporin for Lupus Nephritis: Assessment of Long-Term Safety and Efficacy Including Renal Outcome Over Three Years of Treatment in the Phase 3 AURORA 1 and AURORA 2 Studies. J Am Soc Nephrol 33, 2022: Page 184.

Link: 2022 ASN Poster

Saxena R, Collins C, Birardi V, Pavlova-Wolf A: Long-Term Safety And Efficacy Of Voclosporin In Patients With Lupus Nephritis and Low eGFR. J Am Soc Nephrol 33, 2022: Page 184.

Afshinnia F, Rehaume LM, Cross JL, Huizinga RB, Pennathur S: Voclosporin Therapy Induces Systemic Lipidomic Alterations: Implications for Lipid Mediators for Remission of Lupus Nephritis. J Am Soc Nephrol 33, 2022: Page 792.

Saxena A, Caster D, Almaani S, Rosales A, Leher H. Long-term Use of Voclosporin in Patients with Class V Lupus Nephritis: Results from the AURORA 2 Continuation Study [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9).

Link: 2022 ACR Poster

Ginzler E, Saxena A, Bal V, Birardi V, Leher H. Long-term Safety and Efficacy of Voclosporin in Hispanic and Latino Patients with Lupus Nephritis [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9).

Link: 2022 ACR Poster

American Society of Nephrology – Kidney Week 2020: Pooled AURA-LV and AURORA. Management of Lupus Nephritis with Voclosporin: An Update from a Pooled Analysis of 534 Patients. Brad H. Rovin, Samir V. Parikh, Robert B. Huizinga, Neil Solomons and Simrat Randhawa for the AURORA Study Group.

American Society of Nephrology – Kidney Week 2020: Linear PK TDM. Use of Therapeutic Drug Monitoring Does Not Add Clinical Value for Voclosporin in Patients with Lupus Nephritis. Teun van Gelder, Robert B. Huizinga, Jan Noukens, Laura Lisk, and Neil Solomons.

European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) 2020 Virtual Congress. AURORA Phase 3 Study Demonstrates Voclosporin Statistical Superiority Over Standard of Care in Lupus Nephritis. Dawn J. Caster, Neil Solomons, Simrat Randhawa, Robert B. Huizinga for the AURORA Study Group.

European e-Congress of Rheumatology (EULAR) 2020. AURORA Phase 3 Study Demonstrates Voclosporin Statistical Superiority Over Standard of Care in Lupus Nephritis. Cristina Arriens, Svetlana Polyakova, Igor Adzerikho, Simrat Randhawa, Neil Solomons for the AURORA Study Group.

NKF 2020 Spring Clinical Meetings: AURORA Phase 3 Results. AURORA Phase 3 Study Demonstrates Voclosporin Statistical Superiority Over Standard of Care in Lupus Nephritis. Keisha Gibson, MD, MPH, Samir Parikh, MD, Amit Saxena, MD, Neil Solomons, MD, Simrat Randhawa, MD, MBA for the AURORA Study Group.

Keystone Symposia 2020 - Islet Biology: From Gene to Cell to Micro-Organ. Tacrolimus, but not voclosporin, significantly inhibits insulin exocytosis from human islets at clinically relevant trough concentrations. Jelena Kolic, Leanne Beet, Evgeniy Panzhinskiy, Peter Overby, Haoning Howard Cen, Jennifer Cross, Robert B. Huizinga, James D. Johnson.

Rehaume Linda M., Cross Jennifer L., Huizinga Robert B, Viel John J. Voclosporin Inhibits Calcineurin and T Cell Activation at Dose Levels Clinically Relevant for the Treatment of Lupus Nephritis. NKF Spring Clinical Meetings 2023.

Waddingham Nicola, Rosales Amber, Cheung Gigi, Potter Blake, Palmen Mary, Collins Christopher. Trial in Progress: Voclosporin in Adolescents with Lupus Nephritis (VOCAL). NKF Spring Clinical Meetings 2023.

Da’Lee Keeley, Tagoe Keith, Bal Victoria, Flauto Ron. Enlight-LN: A Prospective Observational Registry of Patients Treated with Voclosporin for Lupus Nephritis in the United States. NKF Spring Clinical Meetings 2023.

Tatsuya Atsumi, Tien-Tsai Cheng, Tuyen Do Gia, Shunsuke Furuta, Harold Michael P. Gomez, Llewellyn T. Hao, Ngoc Phuong Thao Huynh, Michihito Kono, Sandra Navarra, Kajohnsak Noppakun, Kenji Oku, Bernadette Reyes, Bancha Satirapoj: Long-term Safety and Efficacy of Voclosporin in Asian Patients with Lupus Nephritis. APLAR. 2022.

Menn-Josephy H, Palmen M, Truman M, Leher H: Efficacy and Safety of Voclosporin Over Three Years in Patients with Severe Lupus Nephritis. J Am Soc Nephrol 33, 2022: Page 33.

Link: 2022 ASN Abstract

Tagoe KJ, Orujov E, Baker MG, Cipolla L, McLemore J, Leher H: Enlight-LN: A Prospective Observational Registry of Patients Treated with Voclosporin for Lupus Nephritis in the United States. J Am Soc Nephrol 33, 2022.

Link: 2022 ASN Abstract

Caster D, Saxena A, Almaani S, Rosales A, Leher H: Long-term Use of Voclosporin in Patients with Class V Lupus Nephritis: Results from the AURORA 2 Continuation Study. J Am Soc Nephrol 33, 2022: Page 498.

Link: 2022 ASN Abstract

Parikh S, Arriens C, Hodge L, Mela C, Leher H: Voclosporin for Lupus Nephritis: Assessment of Long-Term Safety and Efficacy Including Renal Outcome Over Three Years of Treatment in the Phase 3 AURORA 1 and AURORA 2 Studies. J Am Soc Nephrol 33, 2022: Page 184.

Link: 2022 ASN Abstract

Saxena R, Collins C, Birardi V, Pavlova-Wolf A: Long-Term Safety And Efficacy Of Voclosporin In Patients With Lupus Nephritis and Low eGFR. J Am Soc Nephrol 33, 2022: Page 184.

Link: 2022 ASN Abstract

Afshinnia F, Rehaume LM, Cross JL, Huizinga RB, Pennathur S: Voclosporin Therapy Induces Systemic Lipidomic Alterations: Implications for Lipid Mediators for Remission of Lupus Nephritis. J Am Soc Nephrol 33, 2022: Page 792.

Link: 2022 ASN Abstract

Morales S, Cross J, Huizinga R. AUR200: An Improved BAFF/APRIL Inhibitor with Increased Potency and Safety for the Treatment of B Cell-Mediated Diseases [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9).

Link: 2022 ACR Abstract

Askanase A, Hodge L, Birardi V, Leher H. EARLY REDUCTIONS IN PROTEINURIA WITH VOCLOSPORIN TREATMENT ACROSS LUPUS NEPHRITIS BIOPSY CLASSES: POOLED DATA FROM THE AURA-LV AND AURORA1 TRIALS. NDT Volume 37 Supplement 1 – Abstracts Book. 2022.

Link here.

Ginzler E, Saxena A, Bal V, Birardi V, Leher H. Long-term Safety and Efficacy of Voclosporin in Hispanic and Latino Patients with Lupus Nephritis [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9).

Link: 2022 ACR Abstract

Slawny N, Pavlova-Wolf A, Collins C, Gluck R, Hodge L, Leher H. Enlight-LN: A Prospective Observational Registry of Patients Treated with Voclosporin for Lupus Nephritis in the United States. CCR West, San Diego, California, October 20 – 23, 2022.

Anders HJ, Federico R, Randhawa S, Leher H. Voclosporin is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations. Annals of the Rheumatic Diseases 2022;81:325.

Link: 2022 EULAR Abstract

Saxena A, Teng YKO, Collins C, England N, Leher H. Voclosporin for Lupus Nephritis: Results of the Two-year AURORA 2 Continuation Study. Annals of the Rheumatic Diseases 2022;81:325.

Link: 2022 EULAR Abstract

Teng YKO, Saxena A, Palmen M, Birardi V, and Lisk L. VOCLOSPORIN FOR LUPUS NEPHRITIS: RESULTS OF THE TWO-YEAR AURORA 2 CONTINUATION STUDY. NDT Volume 37 Supplement 1 – Abstracts Book. 2022.

Menn-Josephy H, Truman M, Palmen M, Mina-Osorio P: Voclosporin is Effective in Achieving Complete Renal Response in Severe Lupus Nephritis [SA-OR31]. J Am Soc Nephrol 32, 2021:48.

Link: 2021 ASN Abstract

Mina-Osorio P, Dahl K, Collins C, Gluck R, Leher H. ENLIGHT-LN: A Prospective Observational Registry of Patients Treated with Voclosporin for Lupus Nephritis in the United States. American Journal of Kidney Diseases, Volume 79, Issue 4, S10.

Link: 2022 NKF Abstract

Diamond B, Truman M, Mina-Osorio P. The Efficacy of Voclosporin in Lupus Nephritis is Independent of Changes in Anti-dsDNA and Complement at Week 52. American Journal of Kidney Diseases, Volume 79, Issue 4, S2.

Link: 2022 NKF Abstract

Jolly M, Truman M, Hodge L, Lisk L. Attainment of Complete Renal Response Results in Significant Improvements in Lupus Impact Tracker in the AURORA 1 Study of Voclosporin in Lupus Nephritis. American Journal of Kidney Diseases, Volume 79, Issue 4, S17.

Link: 2022 NKF Abstract

Rehaume LM, Cross JL, Huizinga RB. Confirmation of the immunosuppressive function of voclosporin at the clinically relevant lupus nephritis dose in lupus-prone mice. American Journal of Kidney Diseases, Volume 79, Issue 4, S41.

Link: 2022 NKF Abstract

Ardoin S, Smoyer W, Cross JL, Hodge L, Leher H. POS-227 LIPID PROFILES OF PATIENTS WITH LUPUS NEPHRITIS IN THE VOCLOSPORIN AURA-LV AND AURORA 1 CLINICAL TRIALS. Kidney International Reports Vol. 7. Issue 2, Supplement S99. Published in issue: February 2022.

Link here.

Palmer B, Tumlin J, Radhakrishnan J, Rehaume LM, Huizinga RB. POS-390 ELECTROLYTE PROFILES OF LUPUS NEPHRITIS PATIENTS TREATED WITH THE NOVEL CALCINEURIN INHIBITOR VOCLOSPORIN. Kidney International Reports Vol. 7. Issue 2, Supplement S175–S176. Published in issue: February 2022.

Link here.

Radhakrishnan J, Palmer B, Tumlin J, Cross JL, Huizinga RB. POS-391 LUPUS NEPHRITIS PATIENTS TREATED WITH VOCLOSPORIN DO NOT SHOW AN INCREASE IN URINARY KIDNEY INJURY AND PRO-FIBROTIC BIOMARKERS. Kidney International Reports Vol. 7. Issue 2, Supplement S176–S177. Published in issue: February 2022.

Link here.

Askanase A, Randhawa S, Lisk L, Mina-Osorio P. Voclosporin Is Effective in Achieving Complete Renal Response Across Lupus Nephritis Biopsy Classes: Pooled Data from the AURA-LV and AURORA 1 Trials [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9).

Mackay M, Truman M, England N, Birardi V, Mina-Osorio P. Efficacy of Voclosporin in Recent Onset Lupus Nephritis [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9).

Link: 2021 ACR Abstract

Askanase A, Randhawa S, Lisk L, Mina-Osorio P. Efficacy of Voclosporin Across Lupus Nephritis Biopsy Classes: Pooled Data from the AURORA and AURA-LV Trials. American Journal of Kidney Diseases. 2021. 77(Issue 4):574.

Abstract available here.

van Gelder T, Huizinga RB, Solomons N, Lisk L. Voclosporin Does Not Decrease Mycophenolic Acid Concentrations in Patients with SLE. 19th International Congress of Therapeutic Drug Monitoring & Clinical Toxicology, 19-22 September 2021.

Link to download abstract book: 2021 IATDMCT Encore Abstract

van Gelder T, Huizinga RB, Lisk L Solomons N. Voclosporin: a novel calcineurin inhibitor with no impact on mycophenolic acid levels in patients with SLE. Nephrol Dial Transplant (2022) 37: 917–922. doi: 10.1093/ndt/gfab022

Link: 2021 Nephrol Dial Transplant Abstract

Rehaume LM, Collins TD, Cross J, Huizinga RB: Chronic Dosing of Voclosporin at Clinically Relevant Exposure Levels Does Not Induce Renal Fibrosis Markers in Rats [PO2021]. J Am Soc Nephrol 32, 2021:621.

Link: 2021 ASN Abstract

Saxena A, Mina-Osorio P, Mela C, Birardi V. Voclosporin for Lupus Nephritis: Interim Analysis of the AURORA 2 Extension Study. Annals of the Rheumatic Diseases. 2021. 80:585-586.

Link: 2021 EULAR Abstract

Dall’era M, Hermes T, Eaddy M, Ogbonnaya A, Farrelly E, Mina-Osorio P. Real-World Economic Implications of Achieving Low Disease Activity in Lupus Nephritis. Ann Rheum Dis 2021;80:595.

Link: 2021 EULAR Abstract

Dall'Era M, Mina-Osorio P, Birardi V, Randhawa S. Voclosporin Increases Renal Response at Commonly Used UPCR Thresholds in Patients with Lupus Nephritis. Nephrology Dialysis Transplantation. 2021. Volume 36, Issue Supplement 1, gfab121.004, https://doi.org/10.1093/ndt/gfab121.004.

Link: 2021 ERA-EDTA Abstract

Caster DJ, Solomons N, Randhawa S, Huizinga RB. AURORA Phase 3 Trial Demonstrates Voclosporin Statistical Superiority Over Standard of Care in Lupus Nephritis. Nephrology Dialysis Transplantation. 35 (suppl 3).

Link to abstract and downloadable .pdf here.

Gibson K, Parikh S, Saxena A, Solomons N, Randhawa S. AURORA Phase 3 Trial Demonstrates Voclosporin Statistical Superiority Over Standard of Care in Lupus Nephritis (LN). American Journal of Kidney Diseases.2020. 75(No. 5):819-819.

Link: 2020 NKF Abstract

Ginzler E, Kaplan J, Lisk L, Federico R, Solomons N, Huizinga R. Integrated Efficacy of the AURORA-1 and AURA-LV Trials Confirms Voclosporin Rapid Proteinuria Reduction in the Presence of Low-Dose Steroids. Arthritis Rheumatology. 2020. 72(suppl 10).

Link: 2020 ACR Abstract

Atsumi T, Navarra S, Randhawa S, Solomons N. Voclosporin Has Demonstrated Efficacy in Asian Patients With Lupus Nephritis. APLAR. 2020.

van Gelder T, Huizinga R, Solomons N, Lisk L. Voclosporin Does Not Decrease Mycophenolic Acid Concentrations in Patients with SLE. Arthritis Rheumatology. 2020. 72(suppl 10).

Link: 2020 ACR Abstract

Arriens C, Polyakova S, Adzerikho I, Randhawa S, Solomons N. AURORA Phase 3 Study Demonstrates Voclosporin Statistical Superiority Over standard of Care in Lupus Nephritis. Annals of the Rheumatic Diseases. 2020. 79(suppl 1): 172‐173.

Link: 2020 EULAR Abstract

Rovin B, Parikh S, Huizinga RB, Solomons N, Randhawa S. Management of Lupus Nephritis (LN) with Voclosporin (VCS): An Update from a Pooled Analysis of 534 Patients. Journal of the American Society of Nephrology. 2020. 31:594.

Link: 2020 ASN Abstract

van Gelder T, Huizinga RB, Noukens J, Lisk L, Solomons N. Use of TDM Does Not Add Clinical Value for Voclosporin in Patients with Lupus Nephritis. Journal of the American Society of Nephrology. 2020. 31:594.

Link: 2020 ASN Abstract

Teng YO, Parikh SV, Saxena A, Solomons N, Huizinga RB. AURORA Phase 3 Study Demonstrates Voclosporin Statistical Superiority Over Standard of Care in Lupus Nephritis (LN). Lupus Science and Medicine. 2020. 7(suppl 1).

Link: 2020 LUPUS Abstract

Saxena A, Ginzler EM, Gibson K, Satirapoj B, Santillán AE, Levchenko O, Navarra S, Atsumi T, Yasuda S, Chavez‐Perez NN, Arriens C. Safety and efficacy of long‐term Voclosporin treatment for lupus nephritis in the phase 3 AURORA 2 clinical trial. Arthritis & Rheumatology (2024);76(1):59-67.

Link: 2024 Manuscript

Wei KY, van Heugten MH, van Megen WH, van Veghel R, Rehaume LM, Cross JL, Viel JJ, van Willigenburg H, Silva PH, Danser AJ, de Baaij JH. Calcineurin inhibitor effects on kidney electrolyte handling and blood pressure: tacrolimus versus voclosporin. Nephrol Dial Transplant (2024); https://doi.org/10.1093/ndt/gfae119.

Link: 2024 Manuscript   

Afshinnia F, Rajendiran TM, Byun J, Arnipalli MS, Rehaume LM, Cross JL, Huizinga RB, Pennathur S. Voclosporin Induces Systemic Lipidomic Alterations: Implications for Lupus Nephritis Remission. Kidney Int Rep (2024); https://doi.org/10.1016/j.ekir.2024.04.069.

Link: 2024 Manuscript

Dall’Era M, Kenneth Kalunian K, Eaddy M, Augustina Ogbonnaya A, Farrelly E, Turowski E, Birardi V, Solomons N, Randhawa S, Mina-Osorio P. Real-world treatment utilization and economic implications of lupus nephritis disease activity in the United States. J Manag Care Spec Pharm. 2022; Oct.

Link: 2022 Manuscript

Arriens C, Teng, YKO, Ginzler EM, Parikh SV, Askanase AD, Saxena A, Gibson K, Caster D, Atsumi T, Lisk L, Randhawa S, Gluck R, Solomons N, Huizinga RB. Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis. Arthritis Care & Research. 2022; Aug 30.

Link: 2022 Manuscript

van Gelder T, Lerma E, Engelke K, Huizinga RB. Voclosporin: A Novel Calcineurin Inhibitor for the Treatment of Lupus Nephritis. Review of Clinical Pharmacology. 2022; Jul 16;1-15.

Link: 2022 Manuscript

Ogando NS, Metscher E, Moes DJAR, Arends EJ, Tas A, Cross J, Snijder EJ, Teng YKO, de Vries APJ, van Hemert MJ. The Cyclophilin-Dependent Calcineurin Inhibitor Voclosporin Inhibits SARS-CoV-2 Replication in Cell Culture. Transpl Int. 2022 Jun 24;35:10369.

Link: 2022 Manuscript

van Gelder T, Huizinga RB, Lisk L Solomons N. Voclosporin: a novel calcineurin inhibitor with no impact on mycophenolic acid levels in patients with SLE. Nephrol Dial Transplant (2022) 37: 917–922.

Link here.

LM, Collins TD, Cross J, Huizinga RB: Chronic Dosing of Voclosporin at Clinically Relevant Exposure Levels Does Not Induce Renal Fibrosis Markers in Rats [PO2021]. J Am Soc Nephrol 32, 2021:621.

Rovin B, Teng YKO, Ginzler EM, Arriens C, Caster DJ, Romero-Diaz J, Gibson K, Kaplan J, Lisk L, Navarra S, Parikh SV, Randhawa S, Solomons N, Huizinga RB. 2021. Efficacy and Safety of Voclosporin Versus Placebo for Lupus Nephritis (AURORA 1): A Double-blind, Randomised, Multicentre, Placebo-controlled, Phase 3 Trial. Lancet. DOI:https://doi.org/10.1016/S0140-6736(21)00578-X.

Link: 2021 Manuscript

van Gelder T, Huizinga RB, Lisk L, Solomons, N. 2021. Voclosporin: a novel calcineurin inhibitor without impact on mycophenolic acid in patients with SLE. Nephrology Dialysis Transplantation. gfab022.

Link: 2021 Manuscript

T, Navarra S, Randhawa S, Solomons N. Voclosporin Has Demonstrated Efficacy in Asian Patients With Lupus Nephritis. APLAR. 2020.

Kolic J, Beet L, Overby P, Cen HH, Panzhinskiy E, Ure DR, Cross JL, Huizinga RB, Johnson JD. 2020. Differential Effects of Voclosporin and Tacrolimus on Insulin Secretion from Human Islets. Endocrinology. 161(11):bqaa162.

Link: 2020 Manuscript

Teng YO, Parikh SV, Saxena A, Solomons N, Huizinga RB. AURORA Phase 3 Study Demonstrates Voclosporin Statistical Superiority Over Standard of Care in Lupus Nephritis (LN). Lupus Science and Medicine. 2020. 7(suppl 1).

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