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2014 ; 66
(11
): 3096-104
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Treatment of lupus nephritis with abatacept: the Abatacept and Cyclophosphamide
Combination Efficacy and Safety Study
#MMPMID25403681
ä
Arthritis Rheumatol
2014[Nov]; 66
(11
): 3096-104
PMID25403681
show ga
OBJECTIVE: To assess the efficacy and safety of a 24-week course of abatacept in
the treatment of active lupus nephritis and to assess the potential of abatacept
to induce "clinical tolerance," defined as sustained clinical quiescence of lupus
nephritis after discontinuation of immunosuppressive therapy. METHODS: Patients
with active lupus nephritis (n = 134) were enrolled in a randomized, double-blind
phase II add-on trial in which they received either abatacept or placebo in
conjunction with the Euro-Lupus Nephritis Trial regimen of low-dose
cyclophosphamide (CYC) followed by azathioprine (AZA). The primary efficacy
outcome was the frequency of complete response at week 24. Thereafter, patients
who met either complete or partial response criteria continued blinded treatment
through week 52. During this phase of the study, subjects in the abatacept
treatment group in whom a complete response was achieved at week 24 discontinued
immunosuppressive therapy other than prednisone (10 mg/day). RESULTS: There were
no statistically significant differences between groups with respect to the
primary outcome or any of the secondary outcomes, including measures of safety. A
complete response was achieved in 33% of the subjects in the treatment group and
in 31% of the subjects in the control group at week 24. Fifty percent of the
subjects in the treatment group who met complete response criteria and therefore
discontinued immunosuppressive therapy at week 24 maintained their complete
response status through week 52. CONCLUSION: The addition of abatacept to a
regimen of CYC followed by AZA did not improve the outcome of lupus nephritis at
either 24 or 52 weeks. No worrisome safety signals were encountered.
|Abatacept
[MESH]
|Adult
[MESH]
|Antirheumatic Agents/adverse effects/*therapeutic use
[MESH]
|Cyclophosphamide/adverse effects/*therapeutic use
[MESH]
|Dose-Response Relationship, Drug
[MESH]
|Double-Blind Method
[MESH]
|Drug Therapy, Combination
[MESH]
|Female
[MESH]
|Humans
[MESH]
|Immunoconjugates/adverse effects/*therapeutic use
[MESH]