A randomized, controlled double-blind study comparing the efficacy and safety of dose-ranging voclosporin with placebo in achieving remission in patients with active lupus nephritis

Calcineurin inhibitors added to standard-of-care induction therapy for lupus nephritis (LN) may increase complete renal remission (CRR) rates. The AURA-LV study tested the novel calcineurin inhibitor voclosporin for efficacy and safety in active LN. AURA-LV was a Phase 2, multicenter, randomized, do...

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Published inKidney international Vol. 95; no. 1; pp. 219 - 231
Main Authors Rovin, Brad H., Solomons, Neil, Pendergraft, William F., Dooley, Mary Anne, Tumlin, James, Romero-Diaz, Juanita, Lysenko, Lidia, Navarra, Sandra V., Huizinga, Robert B., Adzerikho, Ihar, Mikhailova, Elena, Mitkovskaya, Natalya, Pimanov, Sergey, Soroka, Nikolay, Bogov, Boris Iliev, Deliyska, Boriana, Ikonomov, Valentin, Tilkiyan, Eduard, Almeida, Ruth, Jimenez, Fernando, Teran, Faud, Tchokhonelidze, Irma, Tsiskarishvili, Nino, Herrera Mendez, Maynor, Loaeza, Arturo Reyes, Gutierrez Urena, Sergio Ramon, Araiza Casillas, Rodolfo, Madero Rovalo, Magdalena, Niemczyk, Stanislaw, Sokalski, Antoni, Wiecek, Andrzej, Klinger, Marian, Bugrova, Olga V., Chernykh, Tatiana M., Kameneva, Tatiana R., Lysenko, Lidia V., Raskina, Tatiana A., ReshEtko, Olga V., Vezikova, Natalia N., Kropotina, Tatiana V., Maksudova, Adelya N., Marasaev, Vyacheslav, Gordeev, Ivan, EssAian, Ashot M., Frolov, Alexey, Jelacic, Rosa, Jovanovic, Dragan, Mitic, Branka, Pekovic, Gordana, Radovic, Milan, Radunovic, Goran, Carreira, Patricia, Diaz Gonzalez, Federico, Fulladosa, Xavier, Herath, Chula, Hewageegana, Anura, Nazar, Abdul Latiff Mohamed, Wazil, A.W.M., Dudar, Iryna, Godlevska, Olga, Korneyeva, Svitlana, Vasylets, ViktoriIa, Sydor, Nataliya, Kolesnyk, Mykola, Parikh, Samir V., Ginzler, Ellen M., Tumlin, James A., Saxena, Amit, Saxena, Ramesh, Lafayette, Richard Alan, Pendergraft, William Franklin, Podoll, Amber S., Arrey-Mensah, Annie A., Bubb, Michael, Grossman, Jennifer, Oporta, Alejandro I., Nami, Alireza, Rahman, Md. Mujibur, Haq, Syed Atiqul, Chan, Tak Mao Daniel, Temy, Mok Mo Yin, Gomez, Harold Michael P., Bermas, James, Reyes, Bernadette Heizel, Hao, Llewellyn T., Roberto, Linda Charmaine, Amante, Eric, Lanzon, Allan E., Choe, Jung-Yoon, Kang, Tae Young, Kim, Yon Su, Lee, Seung-Geun, Lee, Ji Soo, Jun, Jason Choo Chon, Vasudevan, Archana, Luo, Shue-Fen, Cheng, Tien-Tsai, Satirapoj, Bancha, Noppakun, Kajohnsak
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 01.01.2019
Subjects
Adult
calcineurin inhibitors
Calcineurin Inhibitors - administration & dosage
Calcineurin Inhibitors - adverse effects
Cyclosporine - administration & dosage
Cyclosporine - adverse effects
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination - adverse effects
Drug Therapy, Combination - methods
Female
glomerulonephritis
Glucocorticoids - administration & dosage
Glucocorticoids - adverse effects
Humans
Immunosuppressive Agents - administration & dosage
Immunosuppressive Agents - adverse effects
kidney biopsy
Lupus Nephritis - drug therapy
Lupus Nephritis - mortality
Male
Mycophenolic Acid - administration & dosage
Mycophenolic Acid - adverse effects
proteinuria
Remission Induction - methods
systemic lupus erythematosus
Treatment Outcome
Young Adult
systemic lupus erythematosus
kidney biopsy
glomerulonephritis
proteinuria
calcineurin inhibitors
Online AccessGet full text
ISSN0085-2538
1523-1755
1523-1755
DOI10.1016/j.kint.2018.08.025

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Abstract Calcineurin inhibitors added to standard-of-care induction therapy for lupus nephritis (LN) may increase complete renal remission (CRR) rates. The AURA-LV study tested the novel calcineurin inhibitor voclosporin for efficacy and safety in active LN. AURA-LV was a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial of two doses of voclosporin (23.7 mg or 39.5 mg, each twice daily) versus placebo in combination with mycophenolate mofetil (2 g/d) and rapidly tapered low-dose oral corticosteroids for induction of remission in LN. The primary endpoint was CRR at 24 weeks; the secondary endpoint was CRR at 48 weeks. Two hundred sixty-five subjects from 79 centers in 20 countries were recruited and randomized to treatment for 48 weeks. CRR at week 24 was achieved by 29 (32.6%) subjects in the low-dose voclosporin group, 24 (27.3%) subjects in the high-dose voclosporin group, and 17 (19.3%) subjects in the placebo group (OR=2.03 for low-dose voclosporin versus placebo). The significantly greater CRR rate in the low-dose voclosporin group persisted at 48 weeks, and CRRs were also significantly more common in the high-dose voclosporin group compared to placebo at 48 weeks. There were more serious adverse events in both voclosporin groups, and more deaths in the low-dose group compared to placebo and high-dose voclosporin groups (11.2%, 1.1%, and 2.3%, respectively). These results suggest that the addition of low-dose voclosporin to mycophenolate mofetil and corticosteroids for induction therapy of active LN results in a superior renal response compared to mycophenolate mofetil and corticosteroids alone, but higher rates of adverse events including death were observed. [Display omitted]
AbstractList Calcineurin inhibitors added to standard-of-care induction therapy for lupus nephritis (LN) may increase complete renal remission (CRR) rates. The AURA-LV study tested the novel calcineurin inhibitor voclosporin for efficacy and safety in active LN. AURA-LV was a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial of two doses of voclosporin (23.7 mg or 39.5 mg, each twice daily) versus placebo in combination with mycophenolate mofetil (2 g/d) and rapidly tapered low-dose oral corticosteroids for induction of remission in LN. The primary endpoint was CRR at 24 weeks; the secondary endpoint was CRR at 48 weeks. Two hundred sixty-five subjects from 79 centers in 20 countries were recruited and randomized to treatment for 48 weeks. CRR at week 24 was achieved by 29 (32.6%) subjects in the low-dose voclosporin group, 24 (27.3%) subjects in the high-dose voclosporin group, and 17 (19.3%) subjects in the placebo group (OR=2.03 for low-dose voclosporin versus placebo). The significantly greater CRR rate in the low-dose voclosporin group persisted at 48 weeks, and CRRs were also significantly more common in the high-dose voclosporin group compared to placebo at 48 weeks. There were more serious adverse events in both voclosporin groups, and more deaths in the low-dose group compared to placebo and high-dose voclosporin groups (11.2%, 1.1%, and 2.3%, respectively). These results suggest that the addition of low-dose voclosporin to mycophenolate mofetil and corticosteroids for induction therapy of active LN results in a superior renal response compared to mycophenolate mofetil and corticosteroids alone, but higher rates of adverse events including death were observed. [Display omitted]
Calcineurin inhibitors added to standard-of-care induction therapy for lupus nephritis (LN) may increase complete renal remission (CRR) rates. The AURA-LV study tested the novel calcineurin inhibitor voclosporin for efficacy and safety in active LN. AURA-LV was a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial of two doses of voclosporin (23.7 mg or 39.5 mg, each twice daily) versus placebo in combination with mycophenolate mofetil (2 g/d) and rapidly tapered low-dose oral corticosteroids for induction of remission in LN. The primary endpoint was CRR at 24 weeks; the secondary endpoint was CRR at 48 weeks. Two hundred sixty-five subjects from 79 centers in 20 countries were recruited and randomized to treatment for 48 weeks. CRR at week 24 was achieved by 29 (32.6%) subjects in the low-dose voclosporin group, 24 (27.3%) subjects in the high-dose voclosporin group, and 17 (19.3%) subjects in the placebo group (OR=2.03 for low-dose voclosporin versus placebo). The significantly greater CRR rate in the low-dose voclosporin group persisted at 48 weeks, and CRRs were also significantly more common in the high-dose voclosporin group compared to placebo at 48 weeks. There were more serious adverse events in both voclosporin groups, and more deaths in the low-dose group compared to placebo and high-dose voclosporin groups (11.2%, 1.1%, and 2.3%, respectively). These results suggest that the addition of low-dose voclosporin to mycophenolate mofetil and corticosteroids for induction therapy of active LN results in a superior renal response compared to mycophenolate mofetil and corticosteroids alone, but higher rates of adverse events including death were observed.
Calcineurin inhibitors added to standard-of-care induction therapy for lupus nephritis (LN) may increase complete renal remission (CRR) rates. The AURA-LV study tested the novel calcineurin inhibitor voclosporin for efficacy and safety in active LN. AURA-LV was a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial of two doses of voclosporin (23.7 mg or 39.5 mg, each twice daily) versus placebo in combination with mycophenolate mofetil (2 g/d) and rapidly tapered low-dose oral corticosteroids for induction of remission in LN. The primary endpoint was CRR at 24 weeks; the secondary endpoint was CRR at 48 weeks. Two hundred sixty-five subjects from 79 centers in 20 countries were recruited and randomized to treatment for 48 weeks. CRR at week 24 was achieved by 29 (32.6%) subjects in the low-dose voclosporin group, 24 (27.3%) subjects in the high-dose voclosporin group, and 17 (19.3%) subjects in the placebo group (OR=2.03 for low-dose voclosporin versus placebo). The significantly greater CRR rate in the low-dose voclosporin group persisted at 48 weeks, and CRRs were also significantly more common in the high-dose voclosporin group compared to placebo at 48 weeks. There were more serious adverse events in both voclosporin groups, and more deaths in the low-dose group compared to placebo and high-dose voclosporin groups (11.2%, 1.1%, and 2.3%, respectively). These results suggest that the addition of low-dose voclosporin to mycophenolate mofetil and corticosteroids for induction therapy of active LN results in a superior renal response compared to mycophenolate mofetil and corticosteroids alone, but higher rates of adverse events including death were observed.Calcineurin inhibitors added to standard-of-care induction therapy for lupus nephritis (LN) may increase complete renal remission (CRR) rates. The AURA-LV study tested the novel calcineurin inhibitor voclosporin for efficacy and safety in active LN. AURA-LV was a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial of two doses of voclosporin (23.7 mg or 39.5 mg, each twice daily) versus placebo in combination with mycophenolate mofetil (2 g/d) and rapidly tapered low-dose oral corticosteroids for induction of remission in LN. The primary endpoint was CRR at 24 weeks; the secondary endpoint was CRR at 48 weeks. Two hundred sixty-five subjects from 79 centers in 20 countries were recruited and randomized to treatment for 48 weeks. CRR at week 24 was achieved by 29 (32.6%) subjects in the low-dose voclosporin group, 24 (27.3%) subjects in the high-dose voclosporin group, and 17 (19.3%) subjects in the placebo group (OR=2.03 for low-dose voclosporin versus placebo). The significantly greater CRR rate in the low-dose voclosporin group persisted at 48 weeks, and CRRs were also significantly more common in the high-dose voclosporin group compared to placebo at 48 weeks. There were more serious adverse events in both voclosporin groups, and more deaths in the low-dose group compared to placebo and high-dose voclosporin groups (11.2%, 1.1%, and 2.3%, respectively). These results suggest that the addition of low-dose voclosporin to mycophenolate mofetil and corticosteroids for induction therapy of active LN results in a superior renal response compared to mycophenolate mofetil and corticosteroids alone, but higher rates of adverse events including death were observed.
Author Kolesnyk, Mykola
Luo, Shue-Fen
Noppakun, Kajohnsak
Jovanovic, Dragan
Korneyeva, Svitlana
Navarra, Sandra V.
Lee, Seung-Geun
Madero Rovalo, Magdalena
Tsiskarishvili, Nino
Bubb, Michael
Lysenko, Lidia
Dobronravov, Vladimir A.
Kim, Yon Su
ReshEtko, Olga V.
Oporta, Alejandro I.
Maksudova, Adelya N.
Radovic, Milan
Adzerikho, Ihar
Olsen, Nancy
Chernykh, Tatiana M.
Vasylets, ViktoriIa
Niemczyk, Stanislaw
Nami, Alireza
Klinger, Marian
De Silva, Shamila
Teran, Faud
Almeida, Ruth
Frolov, Alexey
Loaeza, Arturo Reyes
EssAian, Ashot M.
Jimenez, Fernando
Herrera Mendez, Maynor
Dudar, Iryna
Sokalski, Antoni
Jun, Jason Choo Chon
Ucar, Eduardo
Kameneva, Tatiana R.
Romero Diaz, Juanita
Podoll, Amber S.
Huizinga, Robert B.
Lanzon, Allan E.
Pendergraft, William F.
Kropotina, Tatiana V.
Pekovic, Gordana
Mikhailova, Elena
Mitic, Branka
Lafayette, Richard Alan
Solomons, Neil
Bogov, Boris Iliev
Godlevska, Olga
Marasaev, Vyacheslav
Sydor, Nataliya
Saxena, Ramesh
Bugrova, Olga V.
Wazil, A.W.M.
Soroka, Nikolay
Diaz Gonzalez, Federico
Nazar, Abdul Latiff Mohamed
Arrey-M
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/30420324$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Contributor Kolesnyk, Mykola
Luo, Shue-Fen
Noppakun, Kajohnsak
Jovanovic, Dragan
Korneyeva, Svitlana
Lee, Seung-Geun
Madero Rovalo, Magdalena
Hao, Llewellyn T
Tsiskarishvili, Nino
Bubb, Michael
Vezikova, Natalia N
Kim, Yon Su
Arrey-Mensah, Annie A
Parikh, Samir V
Radovic, Milan
Adzerikho, Ihar
Olsen, Nancy
Vasylets, ViktoriIa
Niemczyk, Stanislaw
Nami, Alireza
Klinger, Marian
De Silva, Shamila
Teran, Faud
Almeida, Ruth
Frolov, Alexey
Loaeza, Arturo Reyes
Rahman, Md Mujibur
Jimenez, Fernando
Herrera Mendez, Maynor
Dudar, Iryna
Sokalski, Antoni
Jun, Jason Choo Chon
Tumlin, James A
Lysenko, Lidia V
Ucar, Eduardo
Romero Diaz, Juanita
Bugrova, Olga V
Kropotina, Tatiana V
Pekovic, Gordana
Mikhailova, Elena
Mitic, Branka
Lafayette, Richard Alan
EssAian, Ashot M
Bogov, Boris Iliev
Godlevska, Olga
Marasaev, Vyacheslav
Sydor, Nataliya
Saxena, Ramesh
Navarra, Sandra V
Soroka, Nikolay
Diaz Gonzalez, Federico
Ginzler, Ellen M
Nazar, Abdul Latiff Mohamed
Deliyska, Boriana
Hewageegana, Anura
Chan, Tak Mao Daniel
Wiecek, Andrzej
Saxena, Amit
Radunovic, Goran
Chavez Perez,
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Copyright 2018 International Society of Nephrology
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Issue 1
Keywords systemic lupus erythematosus
kidney biopsy
glomerulonephritis
proteinuria
calcineurin inhibitors
Language English
License Copyright © 2018 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.
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Snippet Calcineurin inhibitors added to standard-of-care induction therapy for lupus nephritis (LN) may increase complete renal remission (CRR) rates. The AURA-LV...
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SubjectTerms Adult
calcineurin inhibitors
Calcineurin Inhibitors - administration & dosage
Calcineurin Inhibitors - adverse effects
Cyclosporine - administration & dosage
Cyclosporine - adverse effects
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination - adverse effects
Drug Therapy, Combination - methods
Female
glomerulonephritis
Glucocorticoids - administration & dosage
Glucocorticoids - adverse effects
Humans
Immunosuppressive Agents - administration & dosage
Immunosuppressive Agents - adverse effects
kidney biopsy
Lupus Nephritis - drug therapy
Lupus Nephritis - mortality
Male
Mycophenolic Acid - administration & dosage
Mycophenolic Acid - adverse effects
proteinuria
Remission Induction - methods
systemic lupus erythematosus
Treatment Outcome
Young Adult
Title A randomized, controlled double-blind study comparing the efficacy and safety of dose-ranging voclosporin with placebo in achieving remission in patients with active lupus nephritis
URI https://dx.doi.org/10.1016/j.kint.2018.08.025
https://www.ncbi.nlm.nih.gov/pubmed/30420324
https://www.proquest.com/docview/2132736469
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