Study Suggests Some RA Patients at Increased Risk for Actemra Infections

A new study published in the scientific journal Rheumatology indicates that certain patients with rheumatoid arthritis (RA) who take Actemra (tocilizumab) to treat their symptoms may be at an increased risk for dangerous infections than others.
Actemra, manufactured by Roche and subsidiary Genentech, is a drug that works by inhibiting parts of the immune system that cause inflammation. Patients treated with Actemra are at increased risk for developing dangerous infections because it decreases the body’s ability to fight infections. This new study suggests that some patients who are taking Actemra (and other similar drugs) may be at an even higher risk than previously understood.
This information adds to the concerns about the drug.  Initial concerns were raised back in June 2017, when a STAT News report indicated that Actemra may be linked to heart attacks and strokes—risks that are not mentioned on the product’s warning label.

ACPA-Negative RA Patients at Greater Risk for Actemra Infections

In the new Rheumatology study, researchers analyzed approximately 1,500 RA patients to determine the rate of first serious infections after beginning treatment with Actemra (tocilizumab). The average age of the participants was 56.6 years. During the study period, a total of 122 patients developed infections.
The results showed that those who had anti-citrullinated protein antibody (ACPA)-negative RA, had a higher risk of infections than those with ACPA-positive RA. Those who were taking Arava (leflunomide), another RA medication, at the same time as Actemra, also had a higher risk of infection.
The results suggest that Actemra manufacturers should tell doctors and patients of this increased risk of infection.  Providing this important information will allow patients with ACPA-negative RA and their doctors to make more informed medical decisions regarding whether or not to use Actemra based on its risks and benefits.

Difference Between ACPA-Positive and ACPA-Negative

RA causes chronic inflammation in the joints. But patients with ACPA proteins in the blood are more likely to have an aggressive form of the disease. These proteins can build up outside the joint area. They can also be found in the blood several years before RA’s onset. About two-thirds of patients with RA are ACPA-positive. These patients are more at risk for inflammation and lung damage associated with RA.
People who are ACPA-negative don’t have these proteins and usually, their disease progresses more slowly.

Actemra May Create More Risks Than It Warns About

Actemra contains no warning specifically for ACPA-negative patients about a potential increased risk of infections. It also contains no warning about the potential risk of heart attacks and strokes. Other similar biologic RA medications do warn about heart attacks and strokes.  Notably, Actemra manufacturer Roche and subsidiary Genentech have marketed Actemra being “different” from other RA drugs because it works by inhibiting the chemical signal interleukin-6 (IL-6), which affects different parts of the immune system that other available RA drugs.
According to the STAT News report, however, 1,128 people have died after using the drug since it was released in 2010. Investigators found evidence in these and other injury reports that Actemra created risks for cardiovascular problems similar to other RA drugs. It called for the FDA to require new warnings on the drug label.