A study recently published in Modern Rheumatology demonstrates a higher risk of serious infections for young people with juvenile idiopathic arthritis (JIA) when they are treated with “biologic” therapies, such as Actemra (tocilizumab). These infections can include a form of herpes as well as tuberculosis and a fungal infection known as systemic mycoses. Out of 80 study participants, 27 wound up contracting infections a total of 35 times. Although none of these were fatal, the patients required hospital treatments.
Four other biologic drugs were studied, including Humira (adalimumab), Enbrel (etanercept), Orencia (infliximab) and Remicade (abatacept). Of the five drugs involved in the study, Actemra was associated with the highest rates of opportunistic infections, affecting patients nearly 15 percent of the time. The lowest risk was associated with Remicade; only one patient among subjects treated with that medication developed an infection. Orencia patients also had much lower infection rates.
Overall, the study found that patients who had begun taking these medications at an earlier age or had a previous history of infections prior to starting the therapy were at the highest risk. The research team concluded that their study
“...demonstrated a high rate of serious infections in JIA patients under biologic therapy in a real-life setting, except for ABA [Orencia]. Systemic-onset JIA, lower age at biologic therapy start and history of previous serious infections were important risk factors for these complications.”
Biologic therapy, better known as immunotherapy, is a treatment for disease that works either with or against the immune system. JIA is a form of arthritis that affects approximately 300,000 children and adolescents in the U.S., and is the most common form of the disease among young people.
Arthritis itself is an autoimmune disease that results in inflammation of the joints. The five prescription medications in the Brazilian study work to suppress the immune system in order to reduce the inflammation. Four of the five drugs studied target a protein known as TNF (Tumor Necrosis Factor) Alpha. This protein, or cytokine, is produced by large white blood cells (antibodies), or macrophages that are found in and around connective tissues. Inflammation results when TNF is released; the four drugs associated with lower rates of infection work to suppress the action of TNF.
Actemra, the drug that caused the most infections, is an IL (InterLeukin)-6 inhibitor. IL-6 is another protein that causes an inflammatory response. Arthritis victims tend to have unusually high levels of IL-6. Specifically, Actemra targets the cell's IL-6 receptors, so they are unable to receive signals, thus suppressing inflammatory response. It was the first prescription drug to receive FDA approval for this indication, which was granted in 2011.
In addition to causing serious infections in JIA patients, Actemra has been linked to heart attacks, respiratory disease, stroke, pancreatic inflammation and cerebral hemorrhaging. Currently, the company is facing legal action from patients who have suffered from these side effects, alleging that Swiss-based drug maker Roche and its U.S. subsidiary, Genentech, were aware of these dangers and concealed this information from patients and their physicians.