The warning regarding lymphoma was elevated to a higher level by the FDA for Remicade® so that Remicade now matches the warning on the other TNF inhibitors, Enbrel® and Humira®.
In a recent letter from the makers of Remicade®, physicians were warned that Remicade® has been linked to a higher rate of lymphoma than that found in the general population. Based on data from clinical trials, there was about a threefold higher incidence of lymphoma than for the general population and a sixfold increase among all completed trials. Because rheumatoid arthritis itself is associated with an increased risk of lymphoma, it is unclear how much TNF inhibitors contribute to this increase in malignancies.
However, regardless of the source of risk, physicians should use caution when considering Remicade treatment in patients with a history of malignancy or in those that develop malignancies during treatment.
Drs. Wolf and Michaud reported on a study undertaken to determine the rate and standardized incidence ratio (SIR) for lymphoma in RA patients, and in subsets of patients by treatment group, including TNF inhibitors. In addition, the investigators sought to determine predictors of lymphoma in RA.