New Study Shows ACTEMRA(TM) (tocilizumab) Significantly Improves Remission Rates In Patients With Rheumatoid Arthritis

Roche today announced the results
from two Phase III studies and one Phase II study that showed treatment
with the investigational agent tocilizumab -- marketed as ACTEMRA(TM) in
Japan for Castleman's Disease -- consistently improved remission rates in
patients with rheumatoid arthritis (RA) compared to placebo or other
conventional antirheumatic treatments including the current standard of
care methotrexate. The data were presented at the American College of
Rheumatology annual meeting in Washington D.C.



In a one-year, 302-patient study, approximately 40% of the patients in
the ACTEMRA(TM) group experienced a 70% improvement in certain symptoms and
lab parameters (ACR70) at 52 weeks. Approximately 59% of patients achieved
DAS remission (








Using the two standard measurements, researchers evaluated data across
the following three studies:


-- A Phase III study that involved 302 patients randomized to receive
8mg/kg of ACTEMRA(TM) compared to conventional DMARDs (disease modifying
antirheumatic drugs) over a period of 52 weeks.


-- A second Phase III trial with 125 patients who were randomized to
receive 8mg/kg of ACTEMRA(TM) compared with methotrexate, the current
standard of care, for a period of 24 weeks.


-- A Phase II study that enrolled 163 patients who were randomized to
receive either 4 or 8mg/kg of ACTEMRA(TM) or placebo for 12 weeks.



In the combined analysis, consistent disease remission was demonstrated
in treatment with ACTEMRA(TM) compared to placebo and conventional DMARDs
including methotrexate. In the 302-patient study, ACR20 was achieved in
89.2% of ACTEMRA(TM)-treated patients compared to 35.2% of patients
receiving conventional therapy at 52 weeks; ACR70 was achieved in 43.3% of
ACTEMRA(TM)- treated patients compared to 5.5% of patients receiving
conventional therapy at 52 weeks; DAS28 was achieved in 58.6% of patients
compared to 3.4% of patients, respectively.



In the second study, ACR20 was achieved in 80.3% of ACTEMRA(TM)-treated
patients compared to 25.0% of patients receiving methotrexate at 24 weeks;
ACR70 was achieved in 27.9% of ACTEMRA(TM)-treated patients versus 4.7% of
patients receiving methotrexate at 24 weeks, and DAS28 was achieved in 41%
of patients versus 1.6%.



In the third study with 163 patients, ACR20 was achieved in 78.2% of
ACTEMRA(TM)-treated patients (8 mg/kg) compared to 11.3% of patients
receiving placebo at 12 weeks; ACR70 was achieved in 16.4% of
ACTEMRA(TM)-treated patients (8mg/kg) and DAS28 in 18.2% of patients at 12
weeks; no patients achieved ACR70 or DAS28 in the control group by week 12.



The most common adverse events reported in these studies were
infections (primarily aggravated RA infections), anaphylactic reaction and
hypersensitivity. Mild increases in liver function tests and lipid
elevations were experienced; however, most returned to near-baseline within
8 weeks of the last infusion of ACTEMRA(TM).



About ACTEMRA(TM) (tocilizumab)



ACTEMRA(TM) (tocilizumab) is a humanized interleukin-6 (IL-6) receptor
monoclonal antibody with a novel mechanism of action. It is an
investigational agent which aims to become a new therapeutic option for the
treatment of RA, a disease with a high unmet medical need. Roche and Chugai
have initiated a collaborative Phase III clinical development program in RA
that is underway outside Japan with more than 4,000 patients expected to be
enrolled in 41 countries including several European countries and the USA.
The compound is not currently approved in the United States.



About Roche



Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years, the Roche Group has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2005, Roche was named
one of Fortune magazine's Best Companies to Work For in America, one of the
Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to
Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling
Power), and one of AARP's Top Companies for Older Workers. For additional
information about the U.S. pharmaceuticals business, visit our websites:
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