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MabThera meets study primary endpoint in improving disease symptoms when used as first biologic therapy in patients with rheumatoid arthritis


First Phase III study demonstrating the potential of MabThera when used earlier in the course of treatment

Roche announced today that their innovative drug MabThera (rituximab) can be used effectively and safely as first-line biologic therapy to improve the debilitating symptoms of rheumatoid arthritis (RA).

The pivotal study, SERENE1, investigated patients suffering from RA who had an inadequate response to methotrexate (MTX) therapy, a commonly used RA drug. The study successfully met its primary endpoint2 by showing that significantly more patients treated with MabThera in combination with MTX achieved an improvement in disease signs and symptoms compared to patients treated with MTX alone.

MabThera is the first and only selective B cell therapy licensed for the treatment of patients suffering from RA. It has already demonstrated significant clinical benefits when used later in the treatment cycle but this is the first phase III study to investigate its benefits when used as first-line biologic therapy.

“These data support the potential for MabThera to be used earlier in the course of treatment for RA. The results are encouraging and show that MabThera represents a promising alternative to current treatment options in patients who have an inadequate response to traditional therapy”, said William M. Burns, CEO Pharmaceuticals Division of Roche.
MabThera is currently licensed in patients with more advanced disease who have had an inadequate response or intolerance to tumour necrosis factor (TNF) inhibitors. Data from this trial will be submitted for presentation at upcoming international scientific meetings.

RA is one of the most common autoimmune diseases, affecting more than 21 million people worldwide, with as many as three million sufferers in Europe alone. It is twice as common in women as in men and also impacts on the average life expectancy, shortening it by three to seven years.
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1) SERENE refers to Study Evaluating Rituximab’s Efficacy in methotrexate iNadequate rEsponders
2) The proportion of patients who achieved ACR20 at week 24. 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%, 50% or 70% level of reduction (the percentage of reduction of RA symptoms) is represented as ACR20, ACR50 or ACR70.
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