The long-awaited results of the pivotal phase 3 trial of denosumab proved to be good news for Amgen: The bone drug produced statistically significant reductions in the incidence of vertebral, nonvertebral, and hip fractures compared with placebo. Moreover, Amgen reported no major side-effect concerns in the treatment cohort — a departure from smaller studies that suggested an elevated risk of serious infections, such as tuberculosis, or cancer. More than 7,800 women with osteoporosis took part in the 3-year international study.
The positive news for Amgen came on the heels of a British study of its best-selling TNF-α inhibitor, etanercept (Enbrel), that documented prompt remission of rheumatoid arthritis when it is given early in the course of the disease. A regimen of etanercept and methotrexate in patients whose RA had been classified as moderate to severe for less than 2 years led to remission in about half of the 542 people studied. After 1 year, disease progression stopped in 8 of 10 people who received the combination therapy, compared with about 6 of 10 patients who were treated with methotrexate alone.
Hoping to make its own inroads in the RA market, Roche released more positive data from two phase 3 trials of its interleukin 6 receptor blocker, tocilizumab (Actemra). One of the studies, published in Annals of Rheumatic Diseases, evaluated difficult-to-treat patients with moderate to severe RA who had failed previous anti-TNF-α therapies. Half of those receiving tocilizumab achieved ACR20.