Combined Rituxan and MTX shows efficacy in RA Ph III trial

US firm Genentech, which is majority-owned by Swiss major Roche, and Biogen Idec say that results from the REFLEX study demonstrate that Rituxan (Rituximab), combined with methotrexate reduces joint erosion and narrowing in rheumatoid arthritis patients who have failed prior anti-tumor necrosis factor-based therapy. The announcement was made during a meeting at the European League Against Rheumatism (EULAR) conference in Amsterdam, the Netherlands.

Rituxan, which is marketed as MabThera outside the USA, is a CD20-positive B cell-targeting drug that has been approved for use in a variety of autoimmune disorders, as both a monotherapy and in combination with other agents.

The REFLEX program was a Phase II assessment of Rituxan in combination with MTX in 520 RA patients. Those enrolled were randomized to receive two 1,000mg infusions of the combined therapy on days one and 15, or placebo, followed by a 24 week observation period. After six months, those patients who had demonstrated a response, or had initially received placebo, were eligible for further treatment. The compound's efficacy was assessed via comparison of X-ray images taken at baseline and after 24 weeks, according to the criteria established by the Genant-modified Sharp method.