Treatment of systemic lupus erythematosus with LJP 394.
OBJECTIVE
LJP 394 is a novel therapy under development for the treatment of systemic lupus erythematosus (SLE). We investigated the optimal LJP 394 dosing regimen required to maximally reduce serum dsDNA antibodies. We also evaluated the safety and tolerability of repeated doses of LJP 394 as well as the effects of therapy on SLE related disease activity and health related quality of life.


METHODS
This was a multicenter, partially randomized, placebo controlled, double blind, dose-ranging trial. Study drug or placebo was administered at weekly, biweekly, or monthly intervals for a total of 17, 9, or 5 doses, respectively. Fifty-eight patients were randomly assigned to receive 1, 10, or 50 mg LJP 394 or placebo. After a 2 month pretreatment period, dosing visits continued for 16 weeks, after which there was a 2 month posttreatment period.


RESULTS
The greatest reductions in mean dsDNA antibody titers were observed in the group of patients who received 50 mg LJP 394 weekly (38.1% and 37.1 % at Weeks 16 and 24, respectively). A reduction (29.3%) in dsDNA antibody titers was also observed at Week 24 in the group of patients who received 10 mg LJP 394 weekly. The frequencies of adverse events were comparable in the placebo and active treatment groups.


CONCLUSIONS
This clinical trial, in which a large number of patients with SLE were treated with LJP 394, expanded the safety profile of LJP 394 and demonstrated its capacity to reduce dsDNA antibodies.
Division of Rheumatology and Allergy--Clinical Immunology North Shore University Hospital--NYU School of Medicine, Manhasset, NY 11030, USA. furie@nshs.edu
R A
RA
Furie
J M
JM
Cash
M E
ME
Cronin
R S
RS
Katz
M H
MH
Weisman
C
C
Aranow
M R
MR
Liebling
N P
NP
Hudson
C M
CM
Berner
S
S
Coutts
H A
HA
de Haan
D000293:Adolescent; D000328:Adult; D000368:Aged; D000906:Antibodies / Q000097:blood; D004247:DNA / Q000276:immunology; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009841:Oligonucleotides / Q000008:administration & dosage* / Q000009:adverse effects*; D011788:Quality of Life; D011795:Surveys and Questionnaires
D000906:Antibodies; D009841:Oligonucleotides; D004247:DNA; C094104:abetimus