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Increased incidence of malignancy in adults treated with tumor necrosis factor α (TNF-α) antagonists is reasonably well established, albeit confounded by increased background rates of cancer associated with the underlying diseases. An association with increased lymphoma incidence is apparent in adult recipients, even after adjustment for underlying disease and concomitant use of other immunomodulatory agents. In 2008, the FDA mandated a label change for infliximab in children with Crohn disease after multiple reports of a link to an unusual hepatosplenic lymphoma, which occurred almost exclusively in patients receiving concomitant 6-mercaptopurine or azathioprine.
To identify malignancies associated with the use of infliximab, etanercept, an…