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Roche files first rheumatoid arthritis indication for MabThera in Europe

MabThera: a medicine used to treat non-Hodgkin's lymphoma

MabThera delivers significant and sustained relief from symptoms in patients with difficult-to-treat rheumatoid arthritis

This filing follows positive results from the REFLEX study which showed that MabThera is highly effective in relieving symptoms in patients who have had an inadequate response or are intolerant to prior treatment with one or more anti-TNF (biologic) therapies. Most important, the benefits are seen after only a short treatment course of two infusions.

RA is one of the most common forms of autoimmune disease which affects more than 21 million people worldwide, with up to 2 million sufferers in Europe alone. Of the RA patients treated with current biologic therapy, about 30% do not have a satisfactory outcome and at present have few treatment alternatives remaining. There is therefore a high need for novel and effective options for patients whose daily life continues to be impacted by this serious disease.

"MabThera offers a unique new treatment for patients with rheumatoid arthritis in that it selectively targets B cells, providing a fundamentally different approach for managing painful and swollen arthritic joints. A successful regulatory outcome will allow physicians and patients an alternative option for tackling this debilitating disease" commented Eduard Holdener, Head of Global Pharma Development in Roche’s Pharmaceutical Division.

Today’s regulatory filing of MabThera for patients with the most difficult-to-treat RA is to support the first indication of MabThera in rheumatoid arthritis and marks the beginning of a new opportunity for Roche in this therapeutic area. Genentech and Biogen Idec have also recently submitted a US filing for Rituxan (rituximab’s name in the US).

MabThera has a strong heritage in the treatment of a form of lymphatic cancer called non-Hodgkin’s lymphoma (NHL) where over 730,000 patients have been treated with MabThera to date.

About the REFLEX study
The REFLEX study (Randomised Evaluation oF Long-term Efficacy of Rituximab in RA) is a multi-centre, randomized, double-blind, placebo-controlled Phase III study. In this trial, patients who received a single course of only two infusions of MabThera with a stable dose of methotrexate (MTX) displayed a statistically significant improvement in symptoms measured at 24 weeks, compared to those receiving placebo and MTX. A preliminary analysis of the REFLEX data did not reveal any unexpected safety signals and the companies continue to monitor the long-term safety of MabThera in all clinical trials. The results of the REFLEX trial will be presented at the American College of Rheumatology meeting in San Diego in November.

About MabThera
MabThera is a therapeutic antibody that selectively targets B cells without affecting stem, pro-B or plasma cells, therefore allowing continuation of normal protective function. B cells play a key role in the inflammatory cascade of RA and MabThera aims to break this inflammatory cascade - a series of reactions inflaming the synovia and leading to cartilage loss and bone erosion that is characteristic of the disease. MabThera has also been studied in a Phase IIb study, DANCER (Dose-Ranging Assessment iNternational Clinical Evaluation of Rituximab in RA), which was designed to evaluate the efficacy and safety of varying doses of MabThera in combination with MTX in patients with active RA who currently have an inadequate response to MTX.

About Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in joints. This inflammation causes a loss of joint shape and function, resulting in pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. Characteristics of RA include redness, swelling, pain, and movement limitation around joints of the hands, feet, elbows, knees and neck. In more severe cases of RA the eyes, lungs or blood vessels may be involved. RA may also shorten life expectancy by affecting major organ systems and after 10 years, less than 50% of patients can continue to work or function normally on a day to day basis.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet.

All trademarks used or mentioned in this release are legally protected.


Further information
- Genentech
- Biogen Idec


 

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