FDA Clears Actemra for Juvenile Arthritis, Despite Side Effects Concerns

Published on September 28, 2018 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) has approved use of the subcutaneous form of Actemra to treat juvenile arthritis, despite reports linking the medication to heart problems and other potentially-deadly side effects.

Actemra (tocilizumab) was developed by Genentech and initially approved by the FDA in 2010 as a second-line treatment for severe rheumatoid arthritis (RA) that hasn’t responded to other therapies. Its other indications include:

• Adults with giant cell arteritis (GCA).
• People with active polyarticular juvenile idiopathic arthritis (PJIA) ages 2 and above.
• People with active systemic juvenile idiopathic arthritis (SJIA) ages 2 and above.
• Severe or life-threatening cytokine release syndrome (CRS), caused by CAR T-cell therapy.

The FDA’s latest decision on Actemra was announced on September 13^th.

Actemra Side Effects Reports Raise Safety Concerns

Actemra is a blockbuster medication, generating annual sales of some $1.6 billion.  Those sales may have been driven by the belief on the part of some physicians that Actemra was safer than other RA drugs, including Humira, Remicade, and Enbrel.

However, in June 2017, STAT reported that its own review of the FDA’s adverse event database revealed 13,000 reports involving Actemra, including cases of interstitial lung disease, heart attack, heart failure, stroke, and pancreatitis. The reports also linked Actemra to more than 1,100 deaths.

While the labels for many other RA treatments, such as Humira, Remicade and Enbrel, include warnings for some of these side effects, Actemra’s does not.

Prior to its initial approval in 2010, the FDA’s own reviewers voiced concerns about clinical data that suggested  Actemra could increase blood lipid levels, potentially resulting in an elevated risk of heart attacks and other cardiovascular events. The FDA only cleared Actemra on the condition that its manufacturers conduct long-term studies of its potential side effects.

STAT noted that the FDA has reviewed the safety of Actemra several times. However, the agency has so far ignored the recommendations of some of its own experts that the Actemra label should be modified to list other potential side effects and complications.