Adalimumab Monotherapy Is Not Associated with Increased Cancer Risk

Summary and Comment |
April 17, 2014

Adalimumab Monotherapy Is Not Associated with Increased Cancer Risk

  1. Douglas K. Rex, MD

However, combination therapy of adalimumab and a thiopurine did carry a greater risk for nonmelanoma skin cancer and other cancers than did adalimumab use alone.

  1. Douglas K. Rex, MD

Mounting evidence suggests that thiopurine use for treatment of Crohn disease is associated with increased risks for nonmelanoma skin cancer (NMSC) and lymphoma. Evidence is less clear on whether use of tumor necrosis factor blockers by themselves increases these risks, although results of individual studies have shown elevated rates of melanoma (NEJM JW Gastroenterol Aug 24 2012) and NMSC (Clin Gastroenterol Hepatol 2010; 8:268) associated with their use.

In the current study, investigators assessed the risks for NMSC and other cancers using pooled data on 1594 patients with Crohn disease participating in clinical trials of adalimumab. Compared with the general population, patients receiving adalimumab monotherapy did not have a greater than expected incidence of NMSC or cancers other than NMSC. Compared with patients receiving adalimumab monotherapy, those receiving combination therapy with adalimumab and a thiopurine had increased risks for NMSC (relative risk, 3.46) and cancers other than NMSC (relative risk, 2.82). The incident cancers did not follow a specific pattern, however (2 cases each of lymphoma, breast cancer, lung cancer, and thyroid cancer).


These findings support evidence to date suggesting that immunomodulators (thiopurines and methotrexate) pose significantly greater malignancy risk in patients with inflammatory bowel disease than do tumor necrosis factor blockers.

Editor Disclosures at Time of Publication

  • Disclosures for Douglas K. Rex, MD at time of publication Consultant / Advisory board Given Imaging; Olympus Corporation America; Exact Sciences; Endo Aid Speaker’s bureau Boston Scientific; Braintree Laboratories; Ferring Pharmaceuticals; Olympus America Grant / Research support CDC; Olympus America; Boston Medical Center Editorial boards World Journal of Gastroenterology; The Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; Gastroenterology & Hepatology; Expert Review of Gastroenterology & Hepatology; Medscape Gastroenterology; World Journal of Gastrointestinal Pharmacology and Therapeutics; Annals of Gastroenterology & Hepatology; World Journal of Gastrointestinal Oncology; Comparative Effectiveness Research; Journal of Anesthesia & Clinical Research; Gastroenterology; World Journal of Gastrointestinal Pathophysiology; Gastroenterology Research and Practice; GI & Hepatology News; Gastroenterology Report; Clinical Epidemiology Reviews; JSM Gastroenterology and Hepatology Leadership positions in professional societies American Society for Gastrointestinal Endoscopy (Councilor); US Multi-Society Task Forces (AGA, ACG, ASGE) (Chair)


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