Amid recent concerns that Actemra may increase the risk of heart problems, lung disease, pancreatitis and other complications, new research suggests that some users of the rheumatoid arthritis drug may be more likely to experience infections.
Actemra (tocilizumab) was introduced in 2010 by Roche as an immunosuppresive drug approved to treat rheumatoid arthritis. It is a second-line drug used to treat severe cases that may not have responded to other drugs.
The drug has become a blockbuster treatment for Roche, generating over $1.6 billion in annual sales, since it was widely thought by many doctors that it does not carry some of the same health risks associated with competing rheumatoid arthritis drugs. However, concerns have emerged in recent weeks about the potential side effects of Actemra, after an independent review of adverse event reports submitted to the FDA identified a higher-than-expected number of severe injuries, including heart attacks, strokes, heart failure, interstitial lung disease and pancreatitis. In addition, the drug has been linked to at least 1,128 deaths since 2010.
Adding to the Actemra problems for Roche, a study published last week in the medical journal Rheumatology found that individuals with a specific type of rheumatoid arthritis (RA), known as anti-citrullinated protein antibody (ACPA) negative, face a higher risk of infections than those with ACPA-positive rheumatoid arthritis.
Rheumatoid arthritis is an autoimmune disorder that causes inflammation of the joints. It affects about 1% of the population. Most drugs that are used to treat the condition suppress the autoimmune system to some degree. The ailment costs the global health market $14 billion annually.
Infection risks are common among immunosuppressant drugs, due to the weakening of the immune system of individuals with rheumatoid arthritis, which would usually fight off such infections. However, this latest study found some inconsistencies in Actemra infection risks, which the researchers set out to explain.
The study looked at data on nearly 1,500 patients with rheumatoid arthritis gleaned from a French registry. The researchers analyzed the incident rate of first serious infections after Actemra treatment was started.
According to the findings, 125 serious infections occurred in 122 patients, an incidence rate of 4.7 serious infections per 100 patient years. Researchers found that patients with ACPA positivity had a 56% lower risk of infection than those who were ACPA-negative. They also found that concomitant Leflunomide (LEF) treatment, absoulte neutrophil count (ANC), and the activeness of the arthritis symptoms were also factors.
“The rate of first serious infections in current practice is similar to that reported in clinical trials,” the researchers concluded. “High ANC, negative ACPA and concomitant therapy with LEF are predictive factors of serious infection, requiring in this case a tighter surveillance.”
The findings come only weeks after an independent investigation by the publication STATNews.com highlighted alarming information about the risk of life-threatening health problems with Actemra, which are not currently indicated on the drug’s warning label.
While other rheumatoid arthritis drugs, such as Enbrel, Humira and Remicade, contain warnings about the risk of heart attacks, lung disease and other health problems, Actemra was introduced without that information on the label. As a result, many doctors and patients were led to believe the medication was safer. However, after analyzing post-marketing adverse event reports submitted since Actemra was introduced in 2010, STAT indicated that there was “clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs.”
A number of product liability lawyers are now reviewing the potential for Actemra lawsuits for individuals who have experienced problems, pursuing financial compensation from Roche for failing to provide appropriate warnings.