A total of 283 patients participated in the phase II study designed to evaluate the safety, optimal dosing and efficacy of LymphoStat-B (belimuma) in patients with active moderate-to-severe rheumatoid arthritis who had failed prior treatment(s).
Patients were randomized to receive one of three different doses of LymphoStat-B or placebo administered intravenously over a 24-week treatment period, in addition to standard-of-care therapy. Efficacy was evaluated according to the American College of Rheumatology (ACR) criteria for defining clinical improvement in rheumatoid arthritis patients.
Patients treated with LymphoStat-B showed statistically significant improvement in the primary efficacy endpoint compared to the placebo group. Results demonstrate that the treatment is safe and well tolerated, biologically active, and reduces rheumatoid arthritis disease activity at a level of statistical significance. Clinically significant infusion reactions were rare.