BOSTON (Reuters) - Swiss drugmaker Roche Holding AG 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' Humira, Amgen Inc's Enbrel and Johnson & Johnson's 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 Orencia and a drug marketed by Genentech Inc and Biogen Idec Inc 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.
