Changes to the labeling of etanercept (Enbrel) note the risk of lymphoma associated with its use and discourage concurrent therapy with anakinra (Kineret). Etanercept is indicated for the treatment of rheumatoid arthritis, polyarticulat-course juvenile arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
The change was made because three cases of lymphoma occurred among 4,509 patients receiving etanercept in controlled clinical trials, compared with zero cases in 2,040 patients given placebo. The FDA notes that the risk of lymphoma in patients receiving etanercept is threefold higher than would be expected in the general population.