New Data Reinforce One In Three Rheumatoid Arthritis (RA) Patients Achieve Clinical Remission With Tocilizumab

Main Category: Arthritis / Rheumatology
Also Included In: Bones / Orthopedics
Article Date: 08 Nov 2007 - 1:00 PDT

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Exciting new data from the TOWARD study, at the American College of Rheumatology (ACR) Annual Scientific Meeting in Boston, show that around one in three patients achieved clinical remission in the tocilizumab (Actemra) group, as assessed using DAS28 <2.61 .These results are consistent with the previously presented results of OPTION, another tocilizumab trial, reinforcing the benefit of tackling RA through the inhibition of the IL-6 pathway. This treatment advance may become a crucial new option for clinicians in their quest to 'cure' RA.

This innovative potential new rheumatoid arthritis medicine has been shown to significantly improve the signs and symptoms of rheumatoid arthritis (RA) in patients who failed to achieve an adequate response to traditional disease modifying agents (DMARDs).

In the TOWARD trial in the tocilizumab plus DMARD group:

- 38% of patients achieved a 50% reduction in RA symptoms (ACR50 response) compared with only 9% of patients in the control group
- 61% of patients achieved a 20% reduction in RA symptoms (ACR20response) compared with only 25% of patients in the control group.

"We are very encouraged by the findings of this new TOWARD data which suggest that Actemra plus DMARDs demonstrates significant improvement in RA symptoms compared with DMARDs alone," said Prof Paul Emery, Arthritis Research Campaign (Arc), Professor of Rheumatology at University of Leeds, "These data further establish the efficacy of Actemra and confirm that inhibiting the interleukin-6 (IL-6) receptor is a novel method of reducing RA symptoms."

ACR: 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%, 50% or 70% 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.

DAS28 <2.6:

The Disease Activity Score (DAS)28 is a combined index that measures disease activity in patients with RA. It combines information 28 tender and swollen joints (range0-28), erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. The level of disease activity is interpreted as low (DAS28≤3.2), moderate (3.25.1). DAS28<2.6 corresponds to being in remission.

DMARD: Disease Modifying Anti-Rheumatic Drug

About TOWARD Study

The TOWARD (Tocilizumab in cOmbination With traditional DMARD therapy) trial, a two-arm, double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of Actemra plus DMARDs compared to placebo plus DMARDs in RA patients. Patients were randomized to receive either Actemra intravenously (8mg/kg) every four weeks plus DMARDs weekly or placebo infusions plus DMARDs weekly. The multicentre study treated 1,216 patients at 130 trial sites in 18 countries, including the U.S.

At 24 weeks significantly more patients achieved a 20%, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with Actemra plus DMARDs compared to the control group. The ACR20, ACR50 and ACR70 was achieved in 61%, 38% and 21%, respectively, of Actemra plus DMARDs patients versus 25%, 9% and 3%, respectively, in the placebo plus DMARDs arm. Disease remission was demonstrated in 30% of Actemra patients (DAS28 <2.6) compared with 3 % of patients treated with only DMARDs.

Actemra generally well tolerated in both TOWARD and OPTION

Actemra was generally well tolerated in both studies. The most common adverse events reported more frequently in the Actemra arm were upper respiratory tract infections, headache, nasopharyngitis and hypertension. As with other DMARD's, serious infections have been reported in some patients treated with Actemra.

Other studies

The TOWARD and OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trials are two of five phase III clinical studies designed to evaluate Actemra as a potential new treatment for RA. Findings from the TOWARD and OPTION studies will be part of the application to Regulatory Authorities by the end of the year

Two others, RADIATE and AMBITION- are completed and have met their primary study endpoints. An additional phase III trial is ongoing; the two-year study, called LITHE, and this study is expected to report data later in 2008.All studies are expected to be presented at upcoming medical meetings in 2008.

About Tocilizumab

Tocilizumab is the first humanised interleukin-6 (IL-6) receptor inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA, a disease with a high unmet medical need. This treatment is not yet licenced in the Europe. Roche and Chugai have initiated a collaborative phase III clinical development programme in RA running outside Japan, with more than 4000 patients enrolled in 41 countries including several European countries and the USA. In Japan, tocilizumab was launched in June 2005 as a therapy for Castleman's disease and in April 2006 filed for the additional indications of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis.

About rheumatoid arthritis (RA)

RA is a progressive, systemic autoimmune disease characterized by chronic inflammation of multiple joints and fatigue as well as the possibility of osteoporosis, anaemia, and lung, skin and liver effects. This inflammation causes pain, stiffness and swelling, resulting in loss of joint function due to destruction of the bone and cartilage, often leading to progressive disability. Further, as chronic inflammation continues, there may be shortening of life expectancy as a result of effects on major organ systems. RA is associated with very high costs to society in the UK, both directly and indirectly. The total direct and indirect costs of RA in England alone have most recently been estimated at as much as £1.2 billion per year.2

About Roche in rheumatoid arthritis

Tocilizumab is the result of research collaboration by Roche and Chugai and is being co-developed globally. Roche has prioritised research and development of new treatments for auto-immune diseases, including rheumatoid arthritis.

About Roche in the UK

Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia. Find out more at http://www.rocheuk.com

About Chugai in the UK

Chugai's mission is to dedicate itself to adding exceptional value through the creation of innovative medical products and services for the benefit of the medical community and human health around the world.

All trademarks used or mentioned in this release are protected by law.

References:

1 Genovese, M et al, L15, American College of Rheumatology Annual Conference Boston 2007
2 McIntosh E. The Cost of Rheumatoid Arthritis. Brit J Rheumatol 1996; 35: 781-790

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Roche. "New Data Reinforce One In Three Rheumatoid Arthritis (RA) Patients Achieve Clinical Remission With Tocilizumab." Medical News Today. MediLexicon, Intl., 8 Nov. 2007. Web.
15 Feb. 2012. <http://www.medicalnewstoday.com/releases/88039.php>

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Roche. (2007, November 8). "New Data Reinforce One In Three Rheumatoid Arthritis (RA) Patients Achieve Clinical Remission With Tocilizumab." Medical News Today. Retrieved from
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