Repeat treatment with MabThera provides continuous improvement of quality of life in RA patients

Benefit of B cell therapy confirmed in patients who respond inadequately to one or more TNF inhibitors

Washington, U.S. -- Data presented at this year's American College of Rheumatology Congress (ACR) show that patients receiving repeat treatment with MabThera/Rituxan (rituximab) achieved continued improvement in both physical and mental aspects of quality of life measures. In addition, a higher proportion of patients achieved a significant improvement in disease symptoms with a second course of MabThera, compared to the first course they received.

Commenting on the findings, Professor Keystone, University of Toronto, Canada said; "With further analyses, we are able to evaluate just what MabThera can deliver with subsequent treatment courses for patients who have an inadequate response or intolerance to one or more TNF inhibitors. Patients are telling us they feel better and their quality of life has improved significantly; this is supported by clinical outcomes."

RA is one of the most common forms of autoimmune disease which affects more than 21 million people worldwide, with as many as 3 million sufferers in Europe alone. Currently up to 40 per cent of people with RA who are treated with biologic therapies such as TNF inhibitors, do not have satisfactory outcomes.

Study results: patient reported outcomes In 156 patients with an inadequate response to treatment with TNF inhibitors:

  • Patients reported an improvement in the mental component of quality of life measures after the first course of MabThera with further improvement following a second course (SF-363 scores increased from 4.8 to 8.7, following the first and second courses respectively)
  • The physical component of quality of life measures also increased following a second course of treatment, suggesting patients physical ability continues to improve with repeated treatment (SF-363 increased from 6.4 to 7.8 at 24 weeks following the first and second treatment courses respectively)
  • Patient questionnaires showed that repeated treatment allowed them to better perform daily tasks (more than two thirds of patients reported a decrease in HAQ-DI4 score after each treatment course)
All comparisons of change were made relative to patients' baseline values prior to treatment with MabThera.

Study results: efficacy Data presented from an ongoing extension study in patients with prior exposure to one or more TNF inhibitors demonstrated the long-term efficacy of repeated courses of MabThera. At 24 weeks following a subsequent course of treatment with MabThera, patients continued to show clinical improvements in their RA symptoms, measured using the standard ACR assessment, compared to outcomes after their first course of treatment:

  • 72 percent achieved ACR20 after a subsequent course, versus 65 percent after the first course
  • 42 percent achieved ACR50 after a subsequent course, versus 33 percent after the first course and
  • 21 percent achieved ACR70 after a subsequent course, versus 12 percent after the first course

Furthermore, a greater number of patients achieved low disease activity (25% vs 13%) and remission2 (13% vs 6%), after a subsequent treatment course of MabThera.

Inhibition of joint structural damage Further analyses of the 56 week radiographic data presented previously, have confirmed the positive impact of MabThera treatment in inhibiting structural damage to joints. Damage to the structure of the joints ultimately causes joint destruction and contributes to joint deformity and loss of mobility. MabThera provides the first evidence of inhibition of radiographic progression in rheumatoid arthritis patients with an inadequate response1 to one or more TNF inhibitors.

The extensive MabThera data presented at the American College of Rheumatology this year provides the opportunity for optimising therapy for patients who have previously not achieved satisfactory outcomes in managing their disease.

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Editor's Notes

About Rheumatoid Arthritis and MabThera
Rheumatoid arthritis is an autoimmune disease characterised by inflammation that leads to stiff, swollen and painful joints. Current treatments include disease-modifying drugs (DMARDS) and biologic therapy such as the TNF inhibitor drugs.

MabThera is a first-in-class therapy that selectively targets B cells early in the inflammatory cascade of rheumatoid arthritis. B cells are known to play a key role in the inflammation associated with rheumatoid arthritis and MabThera breaks 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, and may provide an innovative new treatment even in patients with severe and long-standing disease. MabThera has a strong heritage in the treatment of a form of lymphatic cancer called non-Hodgkin's lymphoma (NHL) and the safety profile of MabThera has now been established in more than 960,000 patient exposures over the last 8 years in oncology and autoimmune disease.

About Long-term Safety
Other results presented at the congress added to the wealth of data contributing to MabThera's safety profile with 1669 patient-years of follow-up now collected. The latest analysis showed no new safety signals when subsequent courses of MabThera are administered, beyond those reported in the randomised clinical trials. In fact, the rate of any adverse events and infusion reactions decreased with subsequent courses.

About the REFLEX study
REFLEX (Randomised Evaluation oF Long-term Efficacy of MabThera in RA) is a pivotal Phase III study evaluating the efficacy and safety of MabThera in combination with methotrexate (MTX) in patients with long-standing, severe disease who have had an inadequate response of are intolerant to TNF inhibitor therapy. A total of 520 patients were randomised in this multi-centre, double-blind, placebo-controlled trial. 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 MTX and a two-week course of glucocorticoids. The study was conducted as part of the overall development programme in RA.

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 (www.roche.com).

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

For a selection of broadcast footage clips relating to MabThera and rheumatoid arthritis please visit www.thenewsmarket.com/roche To view and download high resolution stills and media materials please visit the Virtual Press Office at www.mabthera-ra.com

For further information, please contact:

Roche Cohn & Wolfe Jennifer Wilson (on site) Emily Goodenough (on site): Tel: +44 7980 663851 International Communications Manager Tel: + 41 79 619 1765

1The 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% level of reduction (the percentage of reduction of RA symptoms) is represented as ACR20, ACR50 or ACR70. An ACR70 response is exceptional for existing treatments and represents a significant improvement in a patient's condition. Disease activity is measured by a Disease Activity Score (DAS), where low disease activity is defined as DAS28 = 3.2 and remission is defined as DAS28 = 2.6 3SF-36 is the Short Form-36 which is used to assess quality of life 4HAQ-DI score refers to the Health Assessment Questionnaire Disability Index and it is used to assess physical function


Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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