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Basel, 6 April 2005

MabThera significantly improves symptoms in patients with rheumatoid arthritis who inadequately responded to anti-TNFα therapies

Third large randomised trial to evaluate efficacy and safety of MabThera in RA

Roche, Genentech and Biogen Idec announced today that REFLEX1, a pivotal Phase III study of MabThera (rituximab), successfully met its primary endpoint in the group of patients with the most difficult-to-treat rheumatoid arthritis (RA). These patients had an inadequate response or were intolerant to prior treatment with one or more anti-TNFα (biologic) therapies. The study showed that a greater proportion of MabThera treated RA patients achieved a significant improvement of disease symptoms (ACR202 response) after 24 weeks, compared to placebo.

“These data suggest that MabThera may offer new hope to patients who have explored all existing therapies. We are pleased that MabThera’s value has now been demonstrated in this group of patients with the most difficult-to-treat rheumatoid arthritis and for whom there are currently no adequate treatment alternatives”, commented William M. Burns, CEO of Roche’s Pharmaceutical Division.

The REFLEX data also complement the excellent results from earlier Phase II studies in less refractory patients, supporting the belief that MabThera has the potential to play a major role for a broad population in the future treatment of rheumatoid arthritis. These data will be presented to the health authorities in due course.

About the REFLEX study
The REFLEX study (Randomised Evaluation oF Long-term Efficacy of Rituximab in RA) was conducted in Canada, Europe and the United States and involved 520 adult patients with active rheumatoid arthritis. In this multi-centre, double–blind, placebo controlled study, patients received either a single treatment course of just two infusions of MabThera two weeks apart (1000mg i.v. on days 1 and 15), or placebo infusions, in combination with continuing methotrexate (MTX) and a two week course of glucocorticoids. Patients in the MabThera and MTX group had a statistically significant improvement in symptoms compared to patients who received placebo infusions and MTX. A preliminary analysis of the data did not reveal any unexpected safety signals. The most common side effects in the MabThera arm included headache, upper respiratory tract infection and nasopharyngitis. The reported rate of serious adverse events was comparable across the two treatment arms. Patients will continue to be followed to gather longer term safety data.

About MabThera
MabThera is a therapeutic antibody that selectively targets B cells, which play a key role in the inflammatory cascade of RA. By doing so, MabThera aims to break the inflammatory cascade of RA – 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.

MabThera is Roche’s leading cancer medicine and has been used for over 7 years for the treatment of a form of lymphatic cancer called non-Hodgkin’s lymphoma (NHL) with over 380,000 patients treated to date worldwide.

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. RA is one of the most common forms of autoimmune disease and affects more than 6 million people worldwide, up to 2 million of who are in Europe.

ACR improvements
The ACR response is a standard assessment used to measure patients’ responses to anti-rheumatic therapies, devised by the American College of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms and measures of their disease. For example, a 20 or 50 percent level of reduction (the percentage of reduction of RA symptoms) is represented as ACR20, ACR50. ACR20 indicates a 20 percent improvement in the number of swollen and tender joints, as well as a 20 percent improvement in three of five categories: patient assessment, physician assessment, pain scale, Health Assessment Questionnaire, and acute phase reactants (erythrocyte sedimentation rate or C-reactive protein).

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 disease, 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 medicines 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.

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

References:
1 Randomised Evaluation oF Long-term Efficacy of Rituximab in RA
2 The ACR response is a standard assessment used to measure patients’ responses to anti-rheumatic therapies, devised by the American College of Rheumatology (ACR). ACR20 indicates a 20 percent improvement in the number of swollen and tender joints, as well as a 20 percent improvement in three of five categories: patient assessment, physician assessment, pain scale, Health Assessment Questionnaire, and acute phase reactants (erythrocyte sedimentation rate or C-reactive protein)

Further information:
- About Roche: www.roche.com
- About Genentech: www.gene.com
- About Biogen Idec: www.biogenidec.com

 

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