BASEL, Switzerland Roche and Biogen Idec are suspending trials of a drug for treating autoimmune disorders amid reports that its safety risks may outweigh its benefits, the two drug makers announced Monday.
A review of data from a clinical trial of the monoclonal antibody ocrelizumab in patients with rheumatoid arthritis by an independent data and safety monitoring board found evidence of infections, some of which were fatal. Many drugs for treating autoimmune disorders work by lowering the body’s immune system, and this has been known to raise patients’ risk of infections when taking some of the drugs.
Two studies of ocrelizumab — a study of rheumatoid arthritis patients and a study of lupus patients — were halted due to safety risks. A study of the drug in multiple sclerosis patients is ongoing.
“Patient safety is of the utmost importance in all of our drug-development programs,” Roche chief medical officer and EVP Hal Barron said. “In light of the [data and safety monitoring board] recommendations, we have decided to suspend ocrelizumab treatment in the RA clinical development program.”