Roche announces new study data on rheumatoid arthritis treatment

MANILA, Philippines - Roche recently announced new data from the ACT-RAY study, presented at the European League Against Rheumatism congress.

The results demonstrated that in people with rheumatoid arthritis (RA), tocilizumab alone had comparable clinical efficacy to tocilizumab plus methotrexate (MTX).

Methotrexate, a disease modifying anti-rheumatic drug (DMARD), is widely prescribed for people with RA. However, up to 40 percent of people given MTX do not adequately respond to treatment or experience adverse events and require other drugs to help control their inflammation.

Data from the ACT-RAY study demonstrated that tocilizumab provided clinical benefit, regardless of whether it was given in combination with MTX or as a monotherapy.

“The findings of the ACT-RAY study provide further evidence of the meaningful benefits of tocilizumab monotherapy. Tocilizumab is approved for people with rheumatoid arthritis who do not respond to, or are unable to tolerate the side effects associated with methotrexate, a commonly used treatment for the disease,” said Dr. Hal Barron, head of global development and chief medical officer for Roche.

RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction, and systemic complications such as fatigue and anemia.

Tocilizumab is the first in a new class of treatments for rheumatoid arthritis which target interleukin-6 receptors. It is currently approved in Europe for the treatment of RA in people who have either responded inadequately to, or who were intolerant to, previous therapy with one or more DMARDs or tumor necrosis factor (TNF) inhibitors.

Results from the ACT-RAY study build on a previous Phase III study (AMBITION) which showed that compared to MTX, patients receiving tocilizumab alone achieved a greater reduction of signs and symptoms of RA (e.g. swollen and tender joints) at six months and nearly three times as many patients achieved DAS28 disease remission.

Tocilizumab is the first and only biologic to have demonstrated superiority as monotherapy treatment over MTX.

Tocilizumab is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. It was first approved in Japan, and launched in June 2005 as a therapy for Castleman’s disease.

In April 2008, additional indications for rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and systemic-onset juvenile idiopathic arthritis (sJIA) were also approved in Japan.

It is also approved for use in over 90 other countries, including India, Brazil, Switzerland, and Australia.

It was approved in the United States in January 2010 for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more TNF inhibitors.

In addition, tocilizumab is now approved in the US and Mexico for the treatment of active SJIA in patients aged two and older.

The safety and efficacy of tocilizumab in RA has been established in an extensive clinical development program, including five Phase III clinical studies that enrolled more than 4,000 people with RA in 41 countries, including the US.

The overall safety profile of tocilizumab is consistent across all global clinical studies. The serious adverse events reported in tocilizumab clinical studies include serious infections, gastrointestinal perforations, and hypersensitivity reactions, including anaphylaxis.

Headquartered in Basel, Switzerland, Roche is a leader in research-focused health care with combined strengths in pharmaceuticals and diagnostics.

Roche is the world’s largest biotech company with truly differentiated medicine in oncology, virology, inflammation, metabolism and CNS.

Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management.

Its personalized health care strategy aims at providing medicine and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.