Latest Data Show MabThera(R) Provides Significant and Sustained Relief From Signs and Symptoms of Rheumatoid Arthritis

    -  Patients Experience Consistent Safety Profile With Subsequent Courses
       of Therapy
    -  As Released Earlier Today

    BARCELONA, June 13 /CNW/ - New data presented at the EULAR meeting
(European League Against Rheumatism) demonstrate that MabThera's (rituximab)
effectiveness in relieving patients of the distressing symptoms of rheumatoid
arthritis (RA) is sustained or further improved with subsequent courses of
treatment, as is the number of patients achieving remission(1). Importantly,
the safety profile of MabThera remained unchanged in patients who had received
as many as seven courses of treatment at 6-12 month intervals.
    Commenting on the findings, Professor Keystone, Rheumatology Department
at the University of Toronto, Canada, said: "As physicians gain experience
with MabThera and the long-term efficacy and safety data are collected, we are
able to make treatment decisions with confidence for the ultimate benefit of
our patients".

    Results following subsequent courses of therapy

    A total of 1053 RA patients was treated with MabThera with almost 70% of
patients followed up for more than two years and 11% for more than three
years. The study was conducted in patients who had an inadequate response to
treatment with either tumour necrosis factor (TNF) inhibitors or
disease-modifying anti-rheumatic drugs (DMARDs), both of which are commonly
used classes of RA drugs. All study patients received multiple courses of
MabThera (2 x1000mg infusion, 2 weeks apart) based on disease activity.
    The data showed that after three courses of MabThera in patients who had
an inadequate response to TNF inhibitors:

    -  The number of patients achieving the hard-to-reach goal of a 70%
       improvement in disease signs and symptoms (ACR70 response(2)) almost
       tripled from 11% to 25%

    -  The number of patients achieving remission improved from 6% to 12%

    Equally, in patients with an inadequate response or intolerance to
DMARDs, the remission rate increased almost threefold from 5% to 14%
confirming the benefit of providing subsequent courses to responding patients.

    Long-term safety of MabThera

    Further pooled data examining the safety of MabThera when used long-term
revealed that the safety profile of MabThera remained consistent with a low,
unchanging rate of serious infections in 1053 patients, receiving up to seven
treatment courses. These results add to the wealth of data contributing to
MabThera's safety profile with 2438 patient-years of follow-up now collected.

    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 nine years in oncology and
autoimmune disease.

    About Roche in Rheumatoid Arthritis

    One of the most important drivers for growth at Roche over the next few
years is expected to be the company's emerging franchise in autoimmune
diseases with rheumatoid arthritis as the first indication. Following the
launch of MabThera, there are a number of projects in development, potentially
allowing Roche to build on further opportunities. MabThera is the first and
only selective B cell therapy for RA, providing a fundamentally different
treatment approach by targeting B cells, one of the key players in the
pathogenesis of RA. Actemra is Roche's second novel medicine and is a
humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, inhibiting
the activity of IL-6, a protein that plays a major role in the RA inflammation
process. Actemra is the result of research collaboration by Chugai and is
being co-developed globally with Chugai. Additional projects creating a rich
pipeline include compounds in Phase I, II and III clinical trials. Notably,
ocrelizumab, a fully humanised anti-CD20 antibody, is just entering phase III
development for 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 the world's biggest biotech company and an innovator of
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 the world leader in
in-vitro diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as autoimmune
diseases, inflammation, metabolism and central nervous system. In 2006 sales
by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the
Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs
approximately 75,000 worldwide 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 at

    All trademarks used or mentioned in this release are protected by law.

    For a selection of broadcast footage clips relating to MabThera and
rheumatoid arthritis please visit
    To view and download high resolution stills and media materials please
visit the MabThera Virtual Press Office at


    (1) Disease activity is measured by a Disease Activity Score (DAS), where
        low disease activity is defined as DAS 28 less than or equal to 3.2
        and remission is defined as DAS 28 less than or equal to 2.6

    (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). 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 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.

For further information:

For further information: Roche, Jennifer Wilson (on site), International
Communications Manager, Tel: +41-79-619-1765; Cohn & Wolfe, Lucy Heaton (on
site), Tel: +44-7931-929003; Lynn Huynh (UK), Tel : +44-207-331-5332

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