Alexion's eculizumab shows mixed results for RA but promise for PNH

Alexion Pharmaceuticals of the USA has reported mixed preliminary results from a Phase IIb trial evaluating its eculizumab as a potential therapy for rheumatoid arthritis.

The double-blind, randomized, placebo-controlled study involved around 350 patients with chronic RA undergoing treatment with methotrexate or leflunomide. Subjects were given either eculizumab biweekly or monthly or placebo over a six-month period. The primary efficacy endpoint of the trial was a 20% improvement in the American College of Rheumatology score at the end of the trial.

Results released showed that monthly administration of eculizumab, following an induction period, was associated with a statistically-significant, moderate improvement in the ACR20 score versus placebo at six months. Furthermore, the monthly therapy was associated with evidence of a long-term anti-inflammatory effect, with a significant reduction in an important pre-specified objective measure of disease activity, erythrocyte sedimentation rate, at six months.