The primary endpoint of the study was the proportion of patients who achieved either a Major Clinical Response (MCR) or Partial Clinical Response (PCR) using the Bilag instrument at 52 weeks. The study also did not meet any of the six secondary endpoints. Genentech and Biogen Idec will continue to analyze the study results.
This is the first of two studies evaluating the safety and efficacy of Rituxan in patients with lupus. The second, an ongoing Phase III trial (Lunar) is evaluating Rituxan in patients with active lupus nephritis with results expected in first quarter of 2009.
Hal Barron, Genentech’s senior vice president, development and chief medical officer, said: “We are disappointed in the results of this Phase II/III study, but we understood from the outset the significant challenges in developing treatments for systemic lupus erythematosus. We believe the ongoing Phase III trial in lupus nephritis (Lunar) remains an important study as it evaluates the potential of Rituxan in a different patient population.”