Actemra (tocilizumab) significantly slows down damage to joints in patients w/early aggressive RA

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Actemra monotherapy significantly slows down damage to joints in patients

with early aggressive rheumatoid arthritis

http://www.medicalnewstoday.com/medicalnews.php?newsid=33841#

Roche announced the results of the first Phase III study in rheumatoid

arthritis (RA) conducted by Chugai in Japan which are being presented at the

American College of Rheumatology (ACR) Annual Scientific Meeting in San

Diego, USA. These data conclude for the first time that Actemra in

monotherapy shows superiority to conventional disease modifying

anti-rheumatic drugs (DMARDs) in inhibiting radiographic progression of

joint destruction. The data also show Actemra dramatically improves the

painful and disabling symptoms of patients with rheumatoid arthritis.

Actemra (tocilizumab) is a humanized anti-human interleukin-6 (IL-6)

receptor monoclonal antibody that offers a novel mechanism of action and may

become a new therapeutic option for the treatment of RA.

Rheumatoid arthritis is a debilitating autoimmune disease in which the

lining of the joints becomes inflamed causing irreversible joint damage and

destruction. Patients experience pain, stiffness, swelling and ultimately

loss of mobility.

" These data show the progression of patients' joint damage is substantially

reduced over the one year period. Furthermore, the important role of IL-6

blockade is highlighted by the clinical benefits experienced in this Actemra

monotherapy study. Following these impressive results, we look forward to

the outcome of the large phase III programmes currently being run in Europe

and the US with Actemra in combination with other anti-rheumatic drugs "

commented Dr. Eduard Holdener, Head of Global Pharma Development, Roche.

Impressive results achieved with Actemra in patients with early, aggressive

disease

Of the 302 patients evaluated in this monotherapy study, patients in the

Actemra arm showed significantly less radiographic joint destruction

compared to patients in the DMARDs control group as measured by change in

total Sharp score1. Furthermore, Actemra was superior to DMARDs in

preventing both erosion and joint space narrowing. Disease Activity Scores

(DAS) were 6.9 and 6.8 at baseline, Actemra and DMARDs control groups

respectively, indicating very active disease. Following one year of

treatment, DAS in the Actemra arm fell to 2.5 and to 5.7 in the DMARDs

control group. ACR2 response rates in the Actemra arm were significantly

higher than those in the DMARDs control arm: percentages of Actemra patients

achieving ACR20, 50 and 70 were 89%, 70% and 47% respectively compared to

35%, 14% and 6% respectively in the DMARDs group. Results of this magnitude

have not been previously achieved in rheumatoid arthritis patients who have

early aggressive disease.

Actemra generally well tolerated

The overall incidence of adverse events including laboratory abnormalities

was 96% and 87% in the Actemra and DMARDs control arms respectively. While

lipid increases were reported in the Actemra group, the mean cholesterol

level stabilized around the upper limit of normal. No tuberculosis was

observed and Actemra monotherapy was generally well tolerated.

About the study

This phase III clinical trial is a randomized trial in which 306 patients

with active early rheumatoid arthritis of < 5 years' duration were allocated

to receive either Actemra as a monotherapy at 8 mg/kg I.V. every 4 weeks or

conventional DMARDs for 52 weeks. In the control group, the dose, type and

combination of DMARDs could be varied according to disease activity, but

anti-TNF agents and leflunomide were not permitted. The efficacy endpoints

included change from baseline to week 52 in van der Heijde modified Sharp

score, evaluated in blinded manner, and ACR response rates.

About Actemra

Actemra is a first-in-class humanized anti-IL-6 receptor monoclonal antibody

whose novel mechanism of action may provide a new and effective form of

treatment for adult RA. Phase II studies have been completed in Japan and

Europe. Collaborative phase III clinical development in RA has been

completed by Chugai in Japan and is underway outside Japan with more than

4000 patients expected to be enrolled in over 20 countries including several

European countries and the USA.

Roche and Chugai are developing Actemra in collaboration with Osaka

University. This co-development partnership was set up under the first

licensing agreement between the two companies in 2003, where Roche was

granted the right to promote in all countries except Japan, South Korea and

Taiwan, and the parties would co-promote in the UK, France and Germany.

About rheumatoid arthritis

Rheumatoid arthritis is a progressive, systemic autoimmune disease

characterized by inflammation of the membrane lining in joints. This

inflammation causes a loss of joint shape and function, resulting in pain,

stiffness and swelling, ultimately leading to irreversible joint destruction

and disability. Characteristics of RA include redness, swelling, pain, and

movement limitation around joints of the hands, feet, elbows, knees and

neck. In more severe cases of RA the eyes, lungs or blood vessels may be

involved. RA may also shorten life expectancy by affecting major organ

systems and after 10 years, less than 50% of patients can continue to work

or function normally on a day to day basis. RA is one of the most common

forms of autoimmune disease and affects more than 21 million people

worldwide.

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 disease, 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 medicines for cancer and transplantation and a market leader in

virology. In 2004 sales by the Pharmaceuticals Division totaled 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.

References:

1 Total Sharp Score (TSS) is a method by which to evaluate joint destruction

of RA patients, which is calculated based on erosion score and joint space

narrowing from bone x-rays.

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 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.

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