Study Shows Actemra Is Superior to Steroids in Treating Blood Vessel Inflammation. Is the Study Trustworthy?
Last week, the New England Journal of Medicine published the results of a Phase 3 clinical trial which demonstrated the superiority of Actemra (tocilizumab) over steroidal medications for the treatment of a condition known as “giant cell arteritis” (GCA). Most commonly affecting white, post-menopausal women, this malady causes a constriction of the blood vessels, which in turn reduces blood flow. It is often associated with another inflammatory disease called polymyalgia rheumatica (PMR).
Approximately 15 percent of patients diagnosed with PMR also develop GCA. Symptoms include severe headaches, vision problems, vertigo, difficulty swallowing and periodic chest pain. It can even cause blindness. In most cases, the standard treatment for GCA is the administration of corticosteroids, hormones that are normally produced by the adrenal gland. However, a Danish study published in the Journal of the American Medical Association in 2013 indicated an association between synthetic corticosteroids and an elevated risk of venous thromboembolism, a condition that can lead to heart attack and stroke.
According to the study's lead author, GCA affects approximately a quarter-million people in the U.S. - most of whom are age 50 and older. Rheumatologist John Stone M.D. of Massachusetts General Hospital said, “This trial is the first to demonstrate beyond any doubt that an alternative to chronic, unending steroid treatment exists,” which he said would “have an immediate, sustained impact on the lives of hundreds of thousands of patients across the world.”
It bears mentioning, however, that the study was funded by none other than the parent company of Roche, which produces Actemra. It should also be pointed out that the study in question comes at the same time that serious questions are being raised about the safety of Actemra. When the prescription drug first came on to the market in 2010, physicians and patients were lead to believe that unlike other rheumatoid arthritis treatments, Actemra did not raise the risk of adverse cardiac events. Since then, however, it has become apparent that the drug actually increases such risks.
The dangerous side effects don't end there. Only a year after Actemra hit the market, the FDA added a warning about “fatal anaphylaxis” to the label after Roche reported two deaths linked to the drug. Since that time, Actemra has been associated with lung disease and pancreatitis. To date, approximately 1,100 deaths have been associated with Actemra – despite several manufacturer-funded studies claiming that the drug is safe.
Patients suffering from GCA may be feeling hopeful over the results of the recent study – but that hope should be tempered with extreme caution, because this is yet another case in which a treatment is proving to be worse than the disease itself.