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New Evidence Shows MabThera(R) is More Effective Than a Second TNF Inhibitor in Rheumatoid Arthritis Patients who Have Interrupted Anti-TNF Therapy Due to Lack of Efficacy

Basel, Switzerland (ots/PRNewswire)

- New Data Also Proves MabThera's Inhibition of Joint Damage is
Maintained Over Two Years
A recent study(1) has called into question the practice of
putting rheumatoid arthritis (RA) patients onto a second tumour
necrosis factor (TNF) inhibitor therapy, a commonly used class of RA
drugs, when they do not respond to the first TNF inhibitor.
The study, presented at the EULAR annual meeting (European League
Against Rheumatism) in Paris, revealed that when RA patients do not
respond to a TNF inhibitor, it is more effective to treat them with
MabThera (rituximab), an RA drug with a different mode of action,
than to use a second TNF inhibitor therapy.(1)
The study was conducted among 300 patients who had previously not
responded to TNF inhibitor therapy. It analyzed the improvement in
the disease activity score (DAS28)(2) of patients receiving MabThera
compared to patients receiving an alternative TNF inhibitor. Data at
six months showed that MabThera achieved a significantly larger
reduction in disease activity (DAS28) than a subsequent TNF inhibitor
in patients who had interrupted TNF inhibitor therapy due to lack of
efficacy (reduction in DAS28 by 1.55 versus 1.03)(1).
"These findings are significant because they confirm the benefit
of switching to an alternative biological agent, such as rituximab,
in the subset of RA patients who don't respond to a first anti-TNF
agent", said Dr Axel Finckh, Rheumatology Division, University of
Geneva, Switzerland, presenting the results."In patients with
persistent active disease despite anti-TNF therapy, our data suggest
that switching to rituximab is more effective than switching to an
alternative anti-TNF agent."
Inhibition of joint damage
New data from another study, REFLEX(3), also presented at EULAR,
demonstrate that MabThera continues to significantly inhibit the
progression of joint damage caused by RA over a period of two years
in those patients who do not respond to TNF inhibitor therapy(4).
X-ray evidence at two years  showed that the narrowing of joint
spaces and appearance of new bone  erosions were reduced by more than
50% in patients receiving MabThera and  methotrexate (a commonly used
RA drug) compared to patients receiving  methotrexate alone
(Genant-modified Sharp Score increase of 1.14 versus  2.81
respectively, p<0.0001)(5). MabThera consistently inhibited
progression  of joint damage since 89% of MabThera-treated patients
who did not show  progression the first year had no progression the
second year.
Damage to the structure of joints ultimately causes joint
destruction and contributes to joint deformity and loss of mobility.
The inhibition of joint structural damage is therefore a major goal
of treatment. In patients who do not respond to TNF inhibitor therapy
MabThera is the first and only therapy to have demonstrated a
reduction in joint structural damage.
Reporting on the significance of these data, Professor Edward
Keystone, Rheumatology Department at the University of Toronto,
Canada, said, "We know that many patients suffer the debilitating
effects of joint damage and it is extremely promising to see that
MabThera continues to inhibit the progression of this damage over
time, therefore improving the quality of life of our patients. This
was a very important study since MabThera is the only agent that has
ever been evaluated and shown to inhibit radiographic progression
among patients who have not responded to TNF inhibitor therapy."
Patient preference
Additional data presented at EULAR identified that RA patients
prefer treatments with infrequent administration. Based on a range of
treatment preferences and key drivers of choice, the study found that
patients favour a treatment like MabThera which offers symptom
control with extended interval time between treatment
administrations, therefore providing minimum disruption to a
patient's life(6).
Notes to Editors
About rheumatoid arthritis and MabThera
Rheumatoid arthritis (RA) is an autoimmune disease characterized
by inflammation that leads to stiff, swollen and painful joints. This
ultimately results in irreversible joint damage and disability.
MabThera selectively targets B cells and represents a new highly
effective therapeutic approach for RA in addition to existing
treatments such as disease-modifying anti-rheumatic drugs (DMARDs)
and tumour necrosis factor (TNF) inhibitors.
B cells are known to play a key role in the inflammation
associated with RA. As the first and only selective B cell therapy
available for the treatment of RA, MabThera represents a proven and
truly different alternative for patients who have inadequate response
or are not able to tolerate TNF inhibitor therapy. MabThera is the
only RA treatment that has demonstrated the ability to preserve joint
structure in this patient group and offers an unprecedented duration
of response of at least six months with each course. Each course of
MabThera also provides the opportunity of sustained or improved
relief for patients from the signs and symptoms of their disease.
MabThera is marketed in the US by Genentech and Biogen Idec under
the brand name Rituxan(R).
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 MabThera Virtual Press Office at
http://www.mabthera-ra.com
All trademarks used or mentioned in this release are legally
protected.
References
(1)Finckh, A et al. Which subgroup of rheumatoid arthritis
patients benefit most from switching to rituximab versus alternative
anti-TNF agents after previous failure to anti-TNF agent? Abstract
OP-0249, EULAR 2008
(2)DAS28 is a measurement score used to assess whether a patient
shows an improvement in disease activity. DAS28 provides a number on
a scale from 0 to 10 which indicates the current activity of the
disease.
(3)A Randomised Evaluation oF Long-term Efficacy of rituXimab in
RA
(4)Cohen, S et al. Continued inhibition of structural damage in
rheumatoid arthritis patients treated with rituximab at 2 tears:
REFLEX  study. Abstract THU0167, EULAR 2008
(5)As measured by the mean increase from baseline in the total
Genant-modified Sharp Score, an x-ray measurement of change in joint
damage
(6)Ostor, AJK et al. Patient preference for rituximab as a
treatment for rheumatoid arthritis: a study using discrete choice
analysis. Abstract AB0375, EULAR 2008

Contact:

For further information, please contact: Roche, Federico Maiardi (on
site), Associate International Communications Manager, Tel:
+41-79-264-3978; Cohn & Wolfe, Rebecca Hibble (on site), Tel:
+44-781-309-6161, Huong Nguyen (UK), Tel: +44-207-331-5332

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