Biomedical Literature

Abstract

Data from three randomized, double-blind, placebo-controlled studies of REGN-88 in patients with rheumatoid arthritis (RA) showed REGN-88 to be well tolerated and to reduce markers of inflammation after subcutaneous administration. In one trial, patients with well-controlled RA received single ascending doses of REGN-88 (50, 100 or 200 mg) or placebo (N = 15). In a second study, patients with active RA received parallel single doses of REGN-88 (50, 100 or 200 mg) or placebo (N = 32) and in the third trial, patients with well-controlled RA received weekly or biweekly doses of REGN-88 (50, 100, 150 or 200 mg) or placebo for 5 weeks (N = 60). In the three studies, one patient had a serious adverse event of RA flare after administration of 50 mg REGN-88, while three REGN-88-treated subjects withdrew due to adverse events. The most common adverse events were upper respiratory tract infection, alanine aminotransferase elevation and RA flare. A transient decrease in neutrophil count was noted in five patients given REGN-88 during a 16-week exposure and follow-up period, during which time one REGN-88- treated patient had a transient ALT elevation 3-5 times the upper limit of normal (ULN) and one patient given REGN-88 had ALT over 5 times the ULN. In the study conducted in 32 patients with active RA, analysis of biomarkers revealed a dose-dependent reduction in high-sensitivity Creactive protein through day 15 after single-dose administration, and dose-related reductions in serum amyloid A, the erythrocyte sedimentation rate and serum hepcidin were also noted.