RESEARCH - Abetimus sodium for renal flare in SLE: Results of a randomized, controlled phase III trial.

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Arthritis Rheum. 2008 Jul 30;58(8):2470-2480.

Abetimus sodium for renal flare in systemic lupus erythematosus:

Results of a randomized, controlled phase III trial.

Cardiel MH, Tumlin JA, Furie RA, Wallace DJ, Joh T, Linnik MD; LJP

394©\90©\09 Investigator Consortium.

Hospital General " Dr. Silva, " Morelia, Michoac¨¢n, Mexico.

OBJECTIVE: To investigate whether treatment with abetimus delays renal

flare in patients with lupus nephritis. Secondary objectives included

evaluation of the effect of abetimus on C3 levels,

anti-double-stranded DNA (anti-dsDNA) antibody levels, use of

high-dose corticosteroids and/or cyclophosphamide, and major systemic

lupus erythematosus (SLE) flare. METHODS: We conducted a randomized,

placebo-controlled study of treatment with abetimus at 100 mg/week for

up to 22 months in SLE patients. Three hundred seventeen patients with

a history of renal flare and anti-dsDNA levels >15 IU/ml were

randomized to a treatment group (158 abetimus, 159 placebo); 298 (94%)

were enrolled in the intent-to-treat (ITT) population (145 abetimus,

153 placebo), based on the presence of high-affinity antibodies for

the oligonucleotide epitope of abetimus at baseline screening.

RESULTS: Abetimus did not significantly prolong time to renal flare,

time to initiation of high-dose corticosteroid and/or cyclophosphamide

treatment, or time to major SLE flare. However, there were 25% fewer

renal flares in the abetimus group compared with the placebo group (17

of 145 abetimus-treated patients [12%] versus 24 of 153

placebo-treated patients [16%]). Abetimus treatment decreased

anti-dsDNA antibody levels (P < 0.0001), and reductions in anti-dsDNA

levels were associated with increases in C3 levels (P < 0.0001). More

patients in the abetimus group experienced >/=50% reductions in

proteinuria at 1 year, compared with the placebo group (nominal P =

0.047). Trends toward reduced rates of renal flare and major SLE flare

were noted in patients treated with abetimus who had impaired renal

function at baseline. Treatment with abetimus for up to 22 months was

well tolerated.

CONCLUSION: Abetimus at 100 mg/week significantly reduced anti-dsDNA

antibody levels but did not significantly prolong time to renal flare

when compared with placebo. Multiple positive trends in renal end

points were observed in the abetimus treatment group.

PMID: 18668592

http://www.ncbi.nlm.nih.gov/pubmed/18668592

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