Repeat Treatment with MabThera Provides Continuous Improvement of Quality of Life in Rheumatoid Arthritis Patients

Repeat Treatment with MabThera Provides Continuous Improvement of Quality of Life in Rheumatoid Arthritis Patients

November 13, 2006

Benefit of B Cell Therapy Confirmed in Patients Who Respond Inadequately to One or More TNF Inhibitors

 
    WASHINGTON, Nov. 13 /Xinhua-PRNewswire/ -- 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-36(3) 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-DI(4) 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[1] 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(2) (25% vs 13%) and remission(2) (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 response(1) 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.

    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 (
http://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
http://www.thenewsmarket.com/roche 

    To view and download high resolution stills and media
materials please visit the Virtual Press Office at
http://www.mabthera-ra.com 

    1) 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% 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.

    2) Disease activity is measured by a Disease Activity
Score (DAS), where low disease activity is defined as DAS28
less than or equal to 3.2 and remission is defined as DAS28
less than or equal to 2.6

    3) SF-36 is the Short Form-36 which is used to assess
quality of life

    4) HAQ-DI score refers to the Health Assessment
Questionnaire Disability Index and it is used to assess
physical function

    For more information, please contact:

     Roche, Jennifer Wilson (on site)
     International Communications Manager
     Tel: [phone]

     Cohn & Wolfe, Emily Goodenough (on site)
     Tel: [phone]

     Rebecca Hibble (UK)
     Tel: [phone]

SOURCE  Roche Pharmaceuticals