MabThera inhibits the destruction of joints in patients with early rheumatoid arthritis

Phase III study in patients not previously treated with methotrexate meets primary endpoint

Roche announced today that MabThera (rituximab) can significantly inhibit structural damage to joints in patients with early rheumatoid arthritis (RA) who have not been treated with methotrexate (MTX), the current standard of care for RA treatment.

Results from the IMAGE1 study showed that at one year initiating treatment with MabThera in combination with MTX exhibited a significant reduction in the rate of progressive joint damage2, compared to initiating treatment with MTX alone. The trial was conducted in patients not previously treated with MTX and studied MabThera infusions of either the currently approved 1000mg dose or low dose 500mg in combination with MTX. Patients in each MabThera dosing group were compared to patients receiving MTX alone. Only the standard, currently approved 1000mg MabThera dose showed ability to significantly inhibit structural joint damage.

Damage to the structure of joints ultimately contributes to joint deformity and loss of mobility. As a result, prevention of structural joint damage, particularly in early disease, is a major goal of treatment in RA.

The study also showed that both doses of MabThera in combination with MTX were superior to MTX alone in relieving the signs and symptoms of RA (ACR scores3). Relieving the debilitating symptoms of the disease is another very important objective of RA therapy.

“The results of IMAGE show that MabThera has the potential to alter the course of rheumatoid arthritis by preventing the early damage to joints which ultimately causes deformity and disability. These pivotal findings add support for the early use of MabThera in the treatment of rheumatoid arthritis to allow patients to maintain a life as normal as possible,” said William M. Burns, CEO Pharmaceuticals Division of Roche.

MabThera is the first and only selective B cell therapy available for the treatment of RA. It has already demonstrated significant clinical and radiographic benefits when used later in the RA treatment pathway. It is currently licensed for patients with severe disease who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) inhibitors.

Data from the IMAGE study will be submitted for presentation at upcoming international scientific meetings. Roche plans to file the IMAGE data together with data from two other studies with the European health authorities in 2009 to extend the current label for MabThera.

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. Seventy per cent of people with rheumatoid arthritis have signs of permanent joint damage within two years of the start of their disease.