Roche's Actemra helps arthritis, side effects okay

BARCELONA, June 15 (Reuters) A drug that fights rheumatoid arthritis in a completely new way has proved as effective as existing treatments, without producing any serious safety concerns, scientists said today.

The first multinational Phase III data on Roche Holding AG's experimental compound Actemra was unveiled at the annual European Congress of Rheumatology in Barcelona.

Lead investigator Josef Smolen, a professor of medicine at the Medical University of Vienna, said the drug marked a ''pivotal advance'' in treating the crippling disease.

Although Actemra, which is given as a monthly infusion, produced similar results to other modern medicines, the fact it targeted a different inflammatory protein - interleukin-6 - gave patients a new treatment option, he said.

Some earlier trials conducted in Japan had suggested Actemra might be better than other therapies, but Smolen said the results in Japanese and Western patients were nonetheless very similar.

A 24-week study found 44 per cent of patients given the higher dose of Actemra, in combination with the older drug methotrexate, experienced a 50 percent improvement in disease symptoms and 22 per cent achieved a 70 improvement.

Currently available drugs that target a protein called tumour necrosis factor, or TNF, have helped revolutionise treatment for rheumatoid arthritis, but up to 40 per cent of patients do not get an adequate response.

TNF blockers can also have significant side effects, including serious infections, tuberculosis and increased cancer risk.

There have been concerns, too, about Actemra's side effects, but Smolen said the problems caused by the drug were not major.

CHOLESTEROL Actemra does increase cholesterol levels, raising the prospect that some patients might be at increased risk of a heart attack. In practice, however, the effect is modest, and researchers found no worrying shift in balance between levels of ''good'' HDL and ''bad'' LDL cholesterol.

''Although the lipid levels increased, the atherogenic index overall did not change ... the HDL/LDL ratios didn't tremendously change,'' Smolen told reporters.

''So, from the point of view of the overall risk, it does not seem that the risk increases.'' As with the TNF blockers, there was also an increase in severe infections, but Smolen said no particular type of infection was dominant, and there were no cases of tuberculosis.

''The safety results were very consistent with everything we saw before in Phase II trials, with no new signals,'' he said.

Roche is planning to file Actemra for regulatory approval in the United States and Europe by the end of 2007, implying it could be launched in major markets next year.

The company hopes it will become a blockbuster, with sales of more than $1 billion a year.

It is already sold in Japan by Roche's majority-owned partner Chugai Pharmaceutical Co Ltd for Castleman's disease, a rare immune disorder, and was filed for Japanese approval in arthritis in April 2006.

The Actemra trial presented in Barcelona, known as OPTION, is one of five Phase III trials that Roche is running on the medicine. Last week, the company announced that another trial had also met its goal.

REUTERS ARB KP1436