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See Latest ArticlesAbetimus sodium for renal flare in systemic lupus erythematosus: Results of a randomized, controlled phase III trial
Arthritis & Rheumatism, 08/11/08
Cardiel MH et al. – Abetimus at 100 mg/week significantly reduced anti-dsDNA antibody levels but did not prolong time to renal flare when compared with placebo. Multiple positive trends in renal end points were observed in the abetimus treatment group.
Methods- Study to investigate whether treatment with abetimus delays renal flare in pts with lupus nephritis
- Evaluation of the effect of abetimus on C3 levels, anti-dsDNA ab levels, use of high-dose corticosteroids and/or cyclophosphamide, and major SLE flare were also determined
- 317 pts with a history of renal flare and anti-dsDNA levels >15 IU/ml were enrolled
- Pts were randomized to a treatment group (158 abetimus, 159 placebo)
- 94% were enrolled in the intent-to-treat (ITT) population (145 abetimus, 153 placebo)
- Abetimus did not 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
- Abetimus treatment decreased anti-dsDNA ab levels; associated with increases in C3 levels
- More pts in the abetimus group experienced ≥50% reductions in proteinuria at 1 yr
- Trends toward reduced rates of renal flare and major SLE flare were noted in treated pts who had impaired renal function at baseline
- Treatment with abetimus for up to 22 mos was well tolerated
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