Actemra Associated With Increased Risk of Infection in JIA Patients
By Sean Lally, Staff Writer
In June of 2017, STAT conducted an investigation into the Rheumatoid Arthritis (RA) drug treatment known as Actemra, which in 2010 was praised as being a saving grace for people suffering throughout the country. That praise, STAT would soon conclude, was misplaced, as nearly 500,000 reports of side-effects showed that the drug was (and continues to be) linked to high rates of heart attacks, strokes, heart failure and a litany of other conditions. What’s worse, the FDA has received 1,128 reports of fatalities potentially linked to the drug. Without the proper resources to investigate those events, the agency has not been able to conclusively determine whether Actemra was the direct cause or simply an unrelated variable having little to do with the fatalities.
Lack of Resources
Perhaps underfunding could explain this extreme lack in follow-up, but it is difficult to understand how certain events were not taken seriously by the agency. On at least two occasions, doctors have asserted that Actemra was the only possible cause of death. In one case, a 73-year old man died of a brain bleed. As the Government Accountability Office put it in a 2016 report: “FDA lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systematic oversight.”
Where’s the Warning?
The FDA’s severe lack of resources is one problem. But another problem is just as concerning: failure to warn. Upon its release, Actemra was lauded as the better, safer drug for RA. But the truth is: the drug is just as safe (if not less safe) than the other RA drugs available on the market. Whereas the other drugs warn of risks of heart failure, stroke and other health problems, Actemra says nothing of such conditions, despite the plain fact that these issues occur with relative frequency. In fact, the drug fails to warn patients about: pancreatitis, heart attacks, heart failure, stroke and respiratory issues. And the drug is linked to cancer, issues with the nervous system, tears in the gastrointestinal system and allergic reactions.
Risk of Infection
And there are even more risks. According to a recent study, published in Modern Rheumatology in February of 2017, patients with juvenile idiopathic arthritis (JIA) who take biologic therapy (like Actemra) may be subject to serious risk of infection. The study, which observed 107 patients at the University of Sao Paulo’s hospital, focused on patients who had undergone treatment for anywhere from .5 to 11.5 years. What Dr. Juliana Barbosa Brunelli (the lead researcher) found was disconcerting. Nearly a quarter of all patients involved in the study suffered from 35 infections, 31 of which were labeled “serious.” The other four were deemed “opportunistic” – meaning they appeared more readily in patients with weak immune systems.
According to the study, the increased risk of infection is linked to biologic therapies, which includes drugs like Enbrel, Humira, Orencia, Remicade and (as mentioned) Actemra. All of these drugs, except Actemra, target a protein known to cause inflammation. That protein, known as the TNF alpha, is also linked to other associated symptoms of arthritis, which include joint pain, stiffness, decreased range of motion and redness, to name a few. RA patients may also experience fatigue, fever or loss of appetite.
Actemra Has Highest Rate
Actemra, by contrast, is designed to interrupt the activity of IL-6, another protein, also thought to be integral to inducing inflammation. Actemra, it should be noted, stood out in the study, having one of the higher rates of infections. With respect to serious and opportunistic infections, the drug yielded a rate of 14.8 per 100 patient-years (py), whereas the other drugs showed rates of 10.9 py and lower. Ultimately, patients who underwent biologic drug treatments at a younger age were found to be more prone to higher infection rates.
Seeing as how JIA affects nearly 300,000 youths throughout the US, this study may be an important stepping stone toward improving the lives of these young people. It is also yet another reason to keep Actemra on the proverbial radar. If you have suffered after taking Actemra, you may be able to obtain compensation for your injuries by consulting an Actemra injury attorney near you.