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Edratide produces mixed results following phase 2 trial in patients with SLE
Results from a phase 2 trial of edratide in patients with systemic lupus erythematosus showed tolerability and clinically significant effects in some patients but failed to meet its primary endpoints, according to a recently published report.
Researchers studied 340 patients with mild-to-moderate systemic lupus erythematosus (SLE) enrolled in the PRELUDE study. The study was a phase 2, randomized, multicenter, double-blind, placebo-controlled study designed to assess the safety, efficacy and tolerability of edratide (hCDR1, Teva).
Patients were 94.1% women located in Canada, France, Germany, Holland, Hungary, Israel, Italy, Mexico, Russia, Spain, the U.K. and U.S. Eligible patients had a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score between 6 and 12 and received stable concomitant medications, including NSAIDs, prednisone and antimalarials for at least 1 month before study entry.
Patients were evenly randomized to one of three treatment groups or placebo. Three groups received either 0.5-mg, 1-mg or 2.5-mg edratide. Patients underwent 8 weeks of combined steroids and edratide followed by 18 weeks of a tapered steroid withdrawal.
Patient improvements did not meet the primary endpoint criteria of a significant reduction in SLEDAI-2K scores, but a statistically significant difference between patients who received 0.5-mg edratide and placebo was seen according to the British Isles Lupus Assessment Group (BILAG) Responder Index in 40% of patients. The significance was not evident in the 1-mg and 2.5-mg treatment arms.
Patients who were seropositive with anti-dsDNA antibodies and treated with edratide showed greater improvements compared to seropositive patients in the placebo arm. Compared to 29% of patients who received placebo, 17% of patients treated with edratide presented disease flare.
Serious adverse events were similar between treatment groups and placebo.
The authors concluded that the study was designed with the expectation that efficacy results would be evident at 6 months, but that a 1-year expectation may be more realistic, and that future studies should be designed for a longer term. – by Shirley Pulawski
Disclosure: All three authors report that they are paid consultants for XTL Biopharmaceuticals which is involved in potential commercial development of edratide.