New Data Reveals Tocilizumab Is The First And Only Biologic Drug To Show Superiority Over Current Standard Of Care In Rheumatoid Arthritis

Main Category: Arthritis
Also Included In: Biology / Biochemistry
Article Date: 17 Jun 2008 - 2:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

The innovative rheumatoid arthritis drug tocilizumab has shown superiority over the current standard of care, methotrexate (MTX), by achieving a greater reduction of signs and symptoms at 6 months in patients suffering from rheumatoid arthritis(RA). This new data, presented today at The European League Against Rheumatism (EULAR) meeting in Paris, makes tocilizumab the first and only biologic therapy to have achieved superiority over MTX.

Furthermore, nearly three times as many patients treated with the therapy achieved disease remission (34% vs. 12%) as defined by the globally recognised measure DAS28 <2.6, the ultimate goal of treatment for this incurable and incapacitating condition. The outcome is significant as RA is a debilitating, long-term disease and new treatment options are urgently needed.

The AMBITION study was designed to evaluate the efficacy and safety of tocilizumab (8 mg/kg) compared to MTX in patients with active RA disease. The study showed that significantly more patients receiving tocilizumab achieved a 20% improvement in their symptoms (ACR20: 70% vs. 53%) after 24 weeks of treatment. No previous biologic therapy has demonstrated superiority compared to MTX. In addition, nearly three times as many patients taking tocilizumab as monotherapy achieved remission compared to those taking MTX (34% vs. 12%).

RADIATE Study Shows tocilizumab Effective in Difficult-to-Treat-Patients

Data from a second study, the RADIATE trial, also presented in Paris, revealed that the treatment is also effective in difficult-to-treat patients who have had an inadequate response to a commonly used class of RA drugs known as anti-TNFs (anti-tumour necrosis factor therapy). Thirty percent of patients treated with tocilizumab in combination with MTX achieved disease remission (DAS28 <2.6) compared with 1.6% of patients who were treated with MTX alone. What made this result even more impressive was the fact that 12-18% of the study population had failed to respond to one or more prior anti-TNF therapies, leaving them with little hope of further symptom relief from these traditional treatments.

Presenting the data, Professor Paul Emery, arc Professor of Rheumatology, University of Leeds, and Principal Investigator, said, "These study results are very promising for RA patients who need a variety of treatment options."

Tocilizumab is not yet licenced for use in Europe.

About the AMBITION Study

The Phase III AMBITION (Tocilizumab versus Methotrexate double-Blind Investigative Trial In mONotherapy) trial was a two-arm, randomized, double-blind, placebo-controlled study in 673 patients designed to evaluate the efficacy and safety of tocilizumab (8 mg/kg) compared to MTX in patients with active moderate to severe RA, including a high proportion of patients with early disease.

In the AMBITION study, 70%, 44% and 28% of patients in the tocilizumab (8 mg/kg) monotherapy arm achieved ACR20, ACR50 and ACR70 compared, respectively, with 53%, 34% and 15%, respectively, of patients treated with MTX alone.1 Disease remission (DAS28 <2.6) was demonstrated in 34% of tocilizumab patients compared with 12% of patients in the control group.

About the RADIATE study

The Phase III RADIATE (Research on Tocilizumab Determining effIcacy after Anti-TNF FailurEs) study was a three-arm, randomised, double-blind, placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (8mg/kg or 4mg/kg) in combination with MTX, in patients with moderate to severe active RA who had an inadequate response to at least one anti-TNF therapy. Traditionally this patient group have more refractory disease and prove more difficult to treat. The study involved treating 499 patients randomised across three treatment groups. Each group of patients either received 8mg/kg or 4mg/kg of the treatment, or placebo in addition to 10-25mg MTX weekly.

In the RADIATE study, 50%, 29% and 12% of RA patients treated with tocilizumab (8 mg/kg) plus MTX achieved ACR20, ACR50 and ACR70, respectively, compared with 10%, 4% and 1%, respectively, of patients treated with placebo infusions plus MTX weekly. Furthermore, disease remission (DAS28 <2.6) was demonstrated in 30% compared with 1.6% of patients in the control group.

About Tocilizumab

Tocilizumab is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody co-developed globally as part of a research collaboration between Roche and Chugai Pharma. An extensive clinical development program of five Phase III trials was designed to evaluate clinical findings of tocilizumab and these five studies have met their primary endpoints. Tocilizumab is awaiting approval in the United States and Europe. In Japan, it was launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan.

Tocilizumab is generally well tolerated. Its overall safety profile is consistent across all global clinical studies. The most common, non-serious, adverse events reported are upper respiratory tract infection, nasopharyngitis, headache and hypertension. As with other biological disease modifying anti-rheumatic drugs (DMARDs), serious infections and hypersensitivity reactions including a few cases of anaphylaxis, have been reported in some patients. Increases in liver transaminases (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no hepatic injuries or any observed impact on liver function.

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.therapy failed: The RADIATE study. Presented at EULAR, 13 June 2008.

Roche UK