Efficacy and Safety of Abatacept in Lupus Nephritis: A Twelve‐Month, Randomized, Double‐Blind Study
Objective To compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for the treatment of active class III or IV lupus nephritis, when used on a background of mycophenolate mofetil and glucocorticoids. Methods This was a 12‐month, ran...
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| Vydané v: | Arthritis & rheumatology (Hoboken, N.J.) Ročník 66; číslo 2; s. 379 - 389 |
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| Hlavní autori: | , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
| Vydavateľské údaje: |
United States
Wiley Subscription Services, Inc
01.02.2014
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| Predmet: | |
| ISSN: | 2326-5191, 2326-5205, 2326-5205 |
| On-line prístup: | Získať plný text |
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| Abstract | Objective
To compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for the treatment of active class III or IV lupus nephritis, when used on a background of mycophenolate mofetil and glucocorticoids.
Methods
This was a 12‐month, randomized, phase II/III, multicenter, international, double‐blind study. A total of 298 patients were treated in 1 of 3 IV treatment arms: placebo, abatacept at the standard weight‐tiered dose (approximating 10 mg/kg), or abatacept at 30 mg/kg for 3 months, followed by the standard weight‐tiered dose (abatacept 30/10). The primary end point, time to confirmed complete response, was a composite measure that required maintenance of glomerular filtration rate, minimal proteinuria, and inactive urinary sediment over the 52‐week treatment period.
Results
There were no differences among treatment arms in the time to confirmed complete response or in the proportion of subjects with confirmed complete response following 52 weeks of treatment. Treatment with abatacept was associated with greater improvements from baseline in anti–double‐stranded DNA antibody, C3, and C4 levels. Among 122 patients with nephrotic‐range proteinuria, treatment with abatacept resulted in an ∼20–30% greater reduction in mean urinary protein‐to‐creatinine ratio compared with placebo. Abatacept was well tolerated; rates of deaths, serious adverse events, and serious infections were similar across treatment arms. Gastroenteritis and herpes zoster occurred more frequently with abatacept treatment.
Conclusion
Although the primary end point was not met, abatacept showed evidence of biologic activity and was well tolerated in patients with active class III or IV lupus nephritis. |
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| AbstractList | To compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for the treatment of active class III or IV lupus nephritis, when used on a background of mycophenolate mofetil and glucocorticoids.OBJECTIVETo compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for the treatment of active class III or IV lupus nephritis, when used on a background of mycophenolate mofetil and glucocorticoids.This was a 12-month, randomized, phase II/III, multicenter, international, double-blind study. A total of 298 patients were treated in 1 of 3 IV treatment arms: placebo, abatacept at the standard weight-tiered dose (approximating 10 mg/kg), or abatacept at 30 mg/kg for 3 months, followed by the standard weight-tiered dose (abatacept 30/10). The primary end point, time to confirmed complete response, was a composite measure that required maintenance of glomerular filtration rate, minimal proteinuria, and inactive urinary sediment over the 52-week treatment period.METHODSThis was a 12-month, randomized, phase II/III, multicenter, international, double-blind study. A total of 298 patients were treated in 1 of 3 IV treatment arms: placebo, abatacept at the standard weight-tiered dose (approximating 10 mg/kg), or abatacept at 30 mg/kg for 3 months, followed by the standard weight-tiered dose (abatacept 30/10). The primary end point, time to confirmed complete response, was a composite measure that required maintenance of glomerular filtration rate, minimal proteinuria, and inactive urinary sediment over the 52-week treatment period.There were no differences among treatment arms in the time to confirmed complete response or in the proportion of subjects with confirmed complete response following 52 weeks of treatment. Treatment with abatacept was associated with greater improvements from baseline in anti-double-stranded DNA antibody, C3, and C4 levels. Among 122 patients with nephrotic-range proteinuria, treatment with abatacept resulted in an ∼20-30% greater reduction in mean urinary protein-to-creatinine ratio compared with placebo. Abatacept was well tolerated; rates of deaths, serious adverse events, and serious infections were similar across treatment arms. Gastroenteritis and herpes zoster occurred more frequently with abatacept treatment.RESULTSThere were no differences among treatment arms in the time to confirmed complete response or in the proportion of subjects with confirmed complete response following 52 weeks of treatment. Treatment with abatacept was associated with greater improvements from baseline in anti-double-stranded DNA antibody, C3, and C4 levels. Among 122 patients with nephrotic-range proteinuria, treatment with abatacept resulted in an ∼20-30% greater reduction in mean urinary protein-to-creatinine ratio compared with placebo. Abatacept was well tolerated; rates of deaths, serious adverse events, and serious infections were similar across treatment arms. Gastroenteritis and herpes zoster occurred more frequently with abatacept treatment.Although the primary end point was not met, abatacept showed evidence of biologic activity and was well tolerated in patients with active class III or IV lupus nephritis.CONCLUSIONAlthough the primary end point was not met, abatacept showed evidence of biologic activity and was well tolerated in patients with active class III or IV lupus nephritis. To compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for the treatment of active class III or IV lupus nephritis, when used on a background of mycophenolate mofetil and glucocorticoids. This was a 12-month, randomized, phase II/III, multicenter, international, double-blind study. A total of 298 patients were treated in 1 of 3 IV treatment arms: placebo, abatacept at the standard weight-tiered dose (approximating 10 mg/kg), or abatacept at 30 mg/kg for 3 months, followed by the standard weight-tiered dose (abatacept 30/10). The primary end point, time to confirmed complete response, was a composite measure that required maintenance of glomerular filtration rate, minimal proteinuria, and inactive urinary sediment over the 52-week treatment period. There were no differences among treatment arms in the time to confirmed complete response or in the proportion of subjects with confirmed complete response following 52 weeks of treatment. Treatment with abatacept was associated with greater improvements from baseline in anti-double-stranded DNA antibody, C3, and C4 levels. Among 122 patients with nephrotic-range proteinuria, treatment with abatacept resulted in an ∼20-30% greater reduction in mean urinary protein-to-creatinine ratio compared with placebo. Abatacept was well tolerated; rates of deaths, serious adverse events, and serious infections were similar across treatment arms. Gastroenteritis and herpes zoster occurred more frequently with abatacept treatment. Although the primary end point was not met, abatacept showed evidence of biologic activity and was well tolerated in patients with active class III or IV lupus nephritis. Objective To compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for the treatment of active class III or IV lupus nephritis, when used on a background of mycophenolate mofetil and glucocorticoids. Methods This was a 12-month, randomized, phase II/III, multicenter, international, double-blind study. A total of 298 patients were treated in 1 of 3 IV treatment arms: placebo, abatacept at the standard weight-tiered dose (approximating 10 mg/kg), or abatacept at 30 mg/kg for 3 months, followed by the standard weight-tiered dose (abatacept 30/10). The primary end point, time to confirmed complete response, was a composite measure that required maintenance of glomerular filtration rate, minimal proteinuria, and inactive urinary sediment over the 52-week treatment period. Results There were no differences among treatment arms in the time to confirmed complete response or in the proportion of subjects with confirmed complete response following 52 weeks of treatment. Treatment with abatacept was associated with greater improvements from baseline in anti-double-stranded DNA antibody, C3, and C4 levels. Among 122 patients with nephrotic-range proteinuria, treatment with abatacept resulted in an 20-30% greater reduction in mean urinary protein-to-creatinine ratio compared with placebo. Abatacept was well tolerated; rates of deaths, serious adverse events, and serious infections were similar across treatment arms. Gastroenteritis and herpes zoster occurred more frequently with abatacept treatment. Conclusion Although the primary end point was not met, abatacept showed evidence of biologic activity and was well tolerated in patients with active class III or IV lupus nephritis. Objective To compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for the treatment of active class III or IV lupus nephritis, when used on a background of mycophenolate mofetil and glucocorticoids. Methods This was a 12‐month, randomized, phase II/III, multicenter, international, double‐blind study. A total of 298 patients were treated in 1 of 3 IV treatment arms: placebo, abatacept at the standard weight‐tiered dose (approximating 10 mg/kg), or abatacept at 30 mg/kg for 3 months, followed by the standard weight‐tiered dose (abatacept 30/10). The primary end point, time to confirmed complete response, was a composite measure that required maintenance of glomerular filtration rate, minimal proteinuria, and inactive urinary sediment over the 52‐week treatment period. Results There were no differences among treatment arms in the time to confirmed complete response or in the proportion of subjects with confirmed complete response following 52 weeks of treatment. Treatment with abatacept was associated with greater improvements from baseline in anti–double‐stranded DNA antibody, C3, and C4 levels. Among 122 patients with nephrotic‐range proteinuria, treatment with abatacept resulted in an ∼20–30% greater reduction in mean urinary protein‐to‐creatinine ratio compared with placebo. Abatacept was well tolerated; rates of deaths, serious adverse events, and serious infections were similar across treatment arms. Gastroenteritis and herpes zoster occurred more frequently with abatacept treatment. Conclusion Although the primary end point was not met, abatacept showed evidence of biologic activity and was well tolerated in patients with active class III or IV lupus nephritis. |
| Author | Burgos‐Vargas, Ruben Kinaszczuk, Michael Furie, Richard Nicholls, Kathy Chen, Shun‐Le Merrill, Joan T. Cheng, Tien‐Tsai Houssiau, Frederic Hillson, Jan L. Meadows‐Shropshire, Stephanie |
| Author_xml | – sequence: 1 givenname: Richard surname: Furie fullname: Furie, Richard organization: North Shore–LIJ Health System – sequence: 2 givenname: Kathy surname: Nicholls fullname: Nicholls, Kathy organization: Royal Melbourne Hospital and University of Melbourne – sequence: 3 givenname: Tien‐Tsai surname: Cheng fullname: Cheng, Tien‐Tsai organization: Chang Gung Memorial Hospital–Kaohsiung Medical Center and Chang Gung University – sequence: 4 givenname: Frederic surname: Houssiau fullname: Houssiau, Frederic organization: Cliniques Universitaires Saint‐Luc, Université Catholique de Louvain – sequence: 5 givenname: Ruben surname: Burgos‐Vargas fullname: Burgos‐Vargas, Ruben organization: Hospital General de México and Universidad Nacional Autonoma de México – sequence: 6 givenname: Shun‐Le surname: Chen fullname: Chen, Shun‐Le organization: Shanghai Jiao Tong University School of Medicine – sequence: 7 givenname: Jan L. surname: Hillson fullname: Hillson, Jan L. organization: Bristol‐Myers Squibb – sequence: 8 givenname: Stephanie surname: Meadows‐Shropshire fullname: Meadows‐Shropshire, Stephanie organization: Bristol‐Myers Squibb – sequence: 9 givenname: Michael surname: Kinaszczuk fullname: Kinaszczuk, Michael organization: Bristol‐Myers Squibb – sequence: 10 givenname: Joan T. surname: Merrill fullname: Merrill, Joan T. organization: Oklahoma Medical Research Foundation |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/24504810$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | 2014 The Authors. Arthritis & Rheumatology is published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology. Copyright © 2014 by the American College of Rheumatology |
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| Notes | Dr. Houssiau has received consulting fees, speaking fees, and/or honoraria from Human Genome Sciences, GlaxoSmithKline, and UCB (less than $10,000 each). Dr. Burgos‐Vargas has received consulting fees, speaking fees, and/or honoraria from Abbvie, Bristol‐Myers Squibb, Jannsen, Pfizer, Roche, and UCB (less than $10,000 each). ClinicalTrials.gov identifier: NCT00430677. Dr. Merrill has received consulting fees, speaking fees, and/or honoraria from Bristol‐Myers Squibb (less than $10,000). Dr. Hillson, Ms. Meadows‐Shropshire, and Mr. Kinaszczuk own stock or stock options in Bristol‐Myers Squibb. Dr. Furie has received consulting fees from Bristol‐Myers Squibb (less than $10,000). ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3 |
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To compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for the treatment of... To compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for the treatment of active class... Objective To compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for the treatment of... |
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| SubjectTerms | Abatacept Adult Dose-Response Relationship, Drug Double-Blind Method Female Humans Immunoconjugates - therapeutic use Immunosuppressive Agents - therapeutic use Internationality Longitudinal Studies Lupus Lupus Nephritis - drug therapy Male Severity of Illness Index Treatment Outcome |
| Title | Efficacy and Safety of Abatacept in Lupus Nephritis: A Twelve‐Month, Randomized, Double‐Blind Study |
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