MabThera highly effective in treating rheumatoid arthritis

Jun 9 2005

Results from the DANCER study presented today revealed that MabThera significantly improves symptoms in heavily treated patients who are affected by moderate-to-severe rheumatoid arthritis (RA), a painful and debilitating disease of the joints.

MabThera, a potential first-in-class targeted B cell therapy for RA, provided relief to almost twice as many patients as compared to placebo. An even more profound difference was noted between the MabThera and placebo groups at the hard-to-achieve goals of 50% or 70% improvement in symptoms.

In this study, a single treatment course of just two doses of MabThera given two weeks apart provided patients with significant symptom relief. These excellent effects support the data from earlier studies where symptom relief was maintained for at least six months. In addition, MabThera's unique dosing regimen offered patients a high level of convenience, helping them to better cope with this disabling disease.

Professor Paul Emery, University of Leeds, UK, one of the lead investigators commented: "These data are significant because they confirm the ability of MabThera to provide substantial relief of symptoms following just a short course of therapy. The results again demonstrate the benefits of a novel way of treating RA by targeting B cells and show MabThera to be effective in a broad rheumatoid arthritis population, including those who have received previous biologic therapy."

MabThera has also recently proven beneficial in an ongoing pivotal Phase III trial, REFLEX, in patients with the most difficult-to-treat RA who had an inadequate response or were intolerant to prior treatment with anti-TNF alpha therapy. Results from this study will be presented at a medical meeting later in the year.

Rheumatoid arthritis is an autoimmune disease characterised by inflammation which leads to painful, stiff and swollen joints. Current treatments include disease-modifying drugs (DMARDS) and biologic therapy such as the anti-TNF alpha (tumour necrosis factor) drugs.

MabThera is a first-in-class monoclonal antibody that selectively targets B cells, which are believed to play a key role in the inflammatory cascade of rheumatoid arthritis. By doing so, MabThera aims to break the inflammatory cascade of RA - a series of reactions inflaming the synovia and leading to the cartilage loss and bone erosion that is characteristic of the disease. MabThera has a strong heritage in the treatment of a form of lymphatic cancer called non-Hodgkin's lymphoma (NHL) where over 500 000 patients have been treated with MabThera to date.

DANCER (Dose-Ranging Assessment iNternational Clinical Evaluation of Rituximab in RA) is a Phase IIb study evaluating the efficacy and safety of varying doses of MabThera and glucocorticoids in combination with methotrexate in patients who had failed prior treatment with one or more disease-modifying anti-rheumatic drugs (DMARDs), including biologics, and were inadequately responding to methotrexate (MTX). DANCER included various combinations of MabThera (placebo; 2x500mg; 2x1000mg, two weeks apart) and glucocorticoids (placebo; i.v. 200mg; and i.v. 200mg + p.o. 570mg). DANCER is the largest study of rituximab in rheumatoid arthritis to date and the results being presented today are the 24-week analysis with the study continuing out to 2 years.

MabThera has also been successfully studied in an ongoing trial, REFLEX (Randomised Evaluation oF Long-term Efficacy rituXimab in RA), a pivotal Phase III study which met its primary endpoint in patients with the most difficult-to-treat RA. These patients had an inadequate response or were intolerant to prior treatment with one or more anti-TNF alpha (tumour necrosis factor) therapies. Results from this study will be presented at a medical meeting later in the year.