NEWS
MEDIA ALERT • DATA PUBLISHED • MEDIA
ALERT
Lasting Clinical Success Achieved with MabThera in
Patients with Active Rheumatoid Arthritis
Pivotal MabThera data published in Arthritis
& Rheumatism
Following the EMEA approval in July 2006 of MabThera (rituximab),
the key MabThera data from the REFLEX1 study is to be published
in the leading journal – Arthritis & Rheumatism later
this month (on-line version now available).
REFLEX demonstrates that MabThera significantly improved all
efficacy measures of rheumatoid arthritis (RA) for six months
following a single course of just two administrations and provided
relief to almost three times as many patients compared to placebo.
Currently up to 40 per cent of people with RA who are treated
with biologic therapies such as TNF inhibitors, do not have
satisfactory outcomes2.
The results of the six-month analysis show that MabThera in
combination with methotrexate (MTX), a standard RA treatment,
was highly effective. At week 24, significantly more (p<0.0001)
MabThera plus MTX-treated patients than MTX alone-treated patients
demonstrated an ACR20 (51% vs. 18%), ACR 50 (27% vs 5%), ACR70
(12% vs. 1%), and moderate-good EULAR responses (65% vs. 22%).
All ACR core parameters were significantly improved in MabThera
plus MTX-treated patients, who also reported clinically meaningful
improvements in fatigue, disability, and health-related quality
of life markers, and showed a trend toward less progression
in radiographic endpoints. These are the first data indicating
the possible inhibition of joint structural damage in a population
of patients who have had an inadequate response to one or more
TNF inhibitors.
The approval of MabThera is based on the impressive efficacy
data from the REFLEX trial where MabThera in combination with
methotrexate, was shown to be a highly effective therapy for
controlling symptoms and improving the physical and mental health
of patients with RA. FDA approval was received in the US earlier
this year.
References:
1 Cohen et al. The REFLEX study (Randomised Evaluation oF Long-term
Efficacy of Rituximab in RA) Manuscript. Arthritis & Rheumatism.
September 2006.
2 Moreland, L.W. Targeted Biologic Therapies for Rheumatoid
Arthritis (last accessed on: 14.08.06)
http://video.medscape.com/pi/editorial/cmecircle/2004/3415/flash/
moreland/transcript.html
Arthritis & Rheumatism:
http://www.rheumatology.org/publications/ar/index.asp?aud=mem
To arrange an interview with a lead investigator from one of
the studies please contact:
Cohn & Wolfe (London) AND / OR Insert
local Roche contact details
Rebecca Hibble
Tel: + 44 207 331 5336
Email: rebecca_hibble@uk.cohnwolfe.com
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