Drug updates May 2007

Taken from NRAS magazine, Spring 2007

Actemra promising in multinational trials

Actemra (tocilizumab), a novel antirheumatic being developed by Roche, has shown promise in its first multinational Phase III trial outside of Japan. In the study, which involved 623 patients with moderate to severe rheumatoid arthritis in 17 countries, patients who had received tocilizumab intravenously every four weeks plus methotrexate weekly had a significant reduction in the signs and symptoms of their disease compared to patients who received methotrexate alone .

Tocilizumab is called an anti-interleukin-6 receptor monoclonal antibody. Data on this treatment has been submitted to the authorities in Japan for rheumatoid arthritis and systemic onset juvenile arthritis. European and American authorities are expected to receive information later this year.

Data from the trial will be presented at upcoming international scientific meetings. In addition, four other Phase III trials are ongoing with three scheduled to report this year.

Remicade® receives approval in European Union for shortened infusion time in patients

The European Commission (EC) has approved a shortened infusion time for Remicade^® (infliximab) in patients with rheumatoid arthritis (RA). The shortened infusion time will allow carefully selected patients with RA who have tolerated three initial two-hour infusions of Remicade to be administered subsequent infusions over one hour, halving the infusion time. Shortened infusions at doses greater than 6mg/kg have not been studied.

"Being able to give Remicade over a shorter time is good news. The one hour infusion will be much more convenient for patients, allowing them to spend less time in hospital.” said Dr Christopher Edwards, Consultant Rheumatologist, Southampton General Hospital. “It will also mean that units giving this therapy will have more time to treat other patients.”

Two-year data for abatacept demonstrates sustained efficacy

At the American College of Rheumatology (ACR) Annual Meeting, two-year data from three trials demonstrated the long-term efficacy of abatacept in adults with moderate to severe rheumatoid arthritis, who had had an inadequate response to methotrexate or anti-TNF therapies. Abatacept is a selective co-stimulation modulator whose mechanism of action selectively inhibits the activation of T-cells, which is integral to the development of RA.

The data also demonstrated that abatacept provided clinically meaningful improvements in multiple aspects of health-related quality of life and physical function, sustained improvements in pain and had a consistent safety and tolerability profile through two years of treatment. A marketing authorisation application for abatacept has been submitted to the European Medicines Agency (EMEA).

“These data are encouraging and add to the body of evidence demonstrating that abatacept is an effective option providing durable response for patients who have not benefited from previous treatment with disease-modifying anti-rheumatic drugs, ” said Mark Genovese, MD, associate professor of medicine at Stanford University School of Medicine, California, who presented data at the ACR congress.

Cimzia ( certolizumab pegol) shows positive results in two new studies

In December UCB announced positive top-line results from two new studies for Cimzia (certolizumab pegol), the first Fab' fragment anti-TNF which is not yet licensed, in the treatment of rheumatoid arthritis. In both studies Cimzia, in combination with methotrexate, demonstrated superiority to placebo, and a statistically significant improvement in the signs and symptoms of rheumatoid arthritis as measured by all American College of Rheumatology (ACR) scores: ACR20, 50, and 70.

" We have absolute confidence in both the efficacy and tolerability profile of Cimzia and in gaining US approval " said Melanie Lee, Executive Vice President R&D for UCB