Roche arthritis drug effective in late-stage trial

By Toni Clarke

BOSTON, Nov. 7 (Reuters) - Swiss drugmaker Roche Holding AG (ROG.VX) said on Wednesday that its experimental rheumatoid arthritis drug, Actemra, was effective in the second of five late-stage clinical trials.

In a 24-week study known as TOWARD, 61 percent of patients who took Actemra plus one or more older disease modifying drugs, or DMARDs, achieved a 20 percent improvement in symptoms compared with 25 percent of patients who took DMARDs plus a placebo, according to data presented at the annual scientific meeting of the American College of Rheumatology in Boston.

About 30 percent of Actemra patients in the 1,216-person trial achieved disease remission, defined as a patient having no visible sign of inflammation or symptoms, such as tender or swollen joints. That compared with 3.4 percent of patients treated with DMARDs plus placebo.

Actemra is the first of a new class of drugs that target an inflammatory protein called interleukin-6 that could compete with a popular class of drugs known as TNF-inhibitors.

Anti-TNF drugs include Abbott Laboratories' (ABT.N) Humira, Amgen Inc's (AMGN.O) Enbrel and Johnson & Johnson's (JNJ.N) Remicade. Together they generated sales of nearly $10 billion in 2006.

The market for rheumatoid arthritis drugs is becoming increasingly crowded. There are already several medicines approved for patients who have failed to be helped by anti-TNF drugs, including Bristol-Myers Squibb Co's (BMY.N) Orencia and a drug marketed by Genentech Inc DNA.N and Biogen Idec Inc(BIIB.O) called Rituxan.

Virginia Valenze, a spokeswoman for Roche, said Actemra would likely first be used in people for whom TNF-inhibitors have failed. But the company hopes it will be eventually used as a first option treatment.

Investigators said Actemra appears to have a relatively benign safety profile. However, 16.1 percent of patients experienced a rise in LDL, or "bad" cholesterol, compared with 3.4 percent of patients in the placebo arm.

On the other hand, 15 percent of patients saw their HDL, or "good" cholesterol rise, compared with 6 percent in the placebo group. Total cholesterol increases were seen in 22.9 percent of patients taking Actemra in the study.

While the specific percentage cholesterol increases were not immediately available, the study's lead investigator, Dr. Mark Genovese, said they were not "significant."

He also said an indicator of heart risk was unchanged.

Even so, Genovese, an associate professor at Stanford University School of Medicine, said it remains to be seen whether the cholesterol changes will have a clinical impact later.

"At this point we can't say one way or another what the cardiovascular implications are," he said. "It does highlight the importance of continuing to look at these markers over time."

Results from the trial are consistent with a previous trial of the drug, he said.

Roche previously reported results from a 623-person trial known as OPTION that showed 59 percent of patients who took Actemra in combination with an older drug, methotrexate, had a 20 percent reduction in symptoms compared with 27 percent of patients in who took methotrexate plus placebo, at 24 weeks.

Other side effects in the TOWARD trial included hypertension, which affected 5 percent of patients in the Actemra group compared with 2.7 percent in the control group, and serious infections, which were reported in 2.7 percent of Actemra patients versus 1.9 percent in the control arm.

The two studies are part of a broader clinical program involving more than 4,000 patients. Three other trials are due to report full data in 2008, the company said.

Roche plans to file for regulatory approval for the drug in the United States and Europe by the end of 2007.

It is already sold in Japan by Roche's majority-owned partner Chugai Pharmaceutical Co. Ltd. (4519.T) for Castleman's disease, a rare immune disorder.

(Reporting by Toni Clarke, editing by Bill Berkrot/Gary Hill)

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