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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Ann+Rheum+Dis
2015 ; 74
(11
): 2006-15
Nephropedia Template TP
gab.com Text
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English Wikipedia
Efficacy and safety of atacicept for prevention of flares in patients with
moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE
randomised trial)
#MMPMID24951103
Isenberg D
; Gordon C
; Licu D
; Copt S
; Rossi CP
; Wofsy D
Ann Rheum Dis
2015[Nov]; 74
(11
): 2006-15
PMID24951103
show ga
OBJECTIVES: Despite advances in systemic lupus erythematosus (SLE) treatment,
many patients suffer from the disease and side effects. Atacicept is a fusion
protein that blocks B-lymphocyte stimulator and a proliferation-inducing ligand,
which are increased in patients with SLE. METHODS: In this double-blind,
placebo-controlled study, patients with moderate-to-severe SLE were randomised to
atacicept 75?mg or atacicept 150?mg administered subcutaneously, or placebo
twice-weekly for 4?weeks, then weekly for 48?weeks. Primary and secondary
efficacy measures were the proportion of patients experiencing at least one flare
of British Isles Lupus Assessment Group A or B, and time to first flare,
respectively. RESULTS: Enrolment in the atacicept 150?mg arm was discontinued
prematurely due to two deaths. In the intention-to-treat population (n=461),
there was no difference in flare rates or time to first flare between atacicept
75?mg and placebo. Analysis of patients treated with atacicept 150?mg suggested
beneficial effect versus placebo in flare rates (OR: 0.48, p=0.002) and time to
first flare (HR: 0.56, p=0.009). Both atacicept doses were associated with
reductions in total Ig levels and anti-dsDNA antibodies, and increases in C3 and
C4 levels. Most treatment-emergent adverse events were mild or moderate.
CONCLUSIONS: There was no difference between atacicept 75?mg and placebo for
flare rate or time to first flare. Analysis of atacicept 150?mg suggested
benefit. TRIAL REGISTRATION NUMBER: EudraCT: 2007-003698-13; NCT00624338.
|Adolescent
[MESH]
|Adult
[MESH]
|Aged
[MESH]
|Antibodies, Antinuclear/immunology
[MESH]
|Antirheumatic Agents/*administration & dosage/therapeutic use
[MESH]
|Complement C3/immunology
[MESH]
|Complement C4/immunology
[MESH]
|Disease Progression
[MESH]
|Double-Blind Method
[MESH]
|Early Termination of Clinical Trials
[MESH]
|Female
[MESH]
|Humans
[MESH]
|Immunoglobulins/immunology
[MESH]
|Lupus Erythematosus, Systemic/drug therapy/immunology/*prevention & control
[MESH]
|Male
[MESH]
|Middle Aged
[MESH]
|Recombinant Fusion Proteins/*administration & dosage/therapeutic use
[MESH]