This article was published online on May 11, 2009. An error was subsequently identified. This notice is included in the online and print versions to indicate that both have been corrected May 29, 2009.
Adalimumab safety in global clinical trials of patients with Crohn's disease†
Article first published online: 11 MAY 2009
Copyright © 2009 Crohn's & Colitis Foundation of America, Inc.
Inflammatory Bowel Diseases
Volume 15, Issue 9, pages 1308–1319, September 2009
How to Cite
Colombel, J.-F., Sandborn, W. J., Panaccione, R., Robinson, A. M., Lau, W., Li, J. and Cardoso, A. T. (2009), Adalimumab safety in global clinical trials of patients with Crohn's disease. Inflamm Bowel Dis, 15: 1308–1319. doi: 10.1002/ibd.20956
- Issue published online: 19 AUG 2009
- Article first published online: 11 MAY 2009
- Manuscript Accepted: 17 MAR 2009
- Manuscript Received: 16 MAR 2009
- 12Remicade [prescribing information]. Malvern, PA: Centocor; 2008.
- 13Humira [prescribing information]. North Chicago, IL: Abbott Laboratories; 2008.
- 14Cimzia [prescribing information]. Smyrna, GA: UCB; 2008.
- 15SONIC: a randomized, double-blind, controlled trial comparing infliximab and infliximab plus azathioprine in patients with Crohn's disease naïve to immunomodulators and biologic therapy. Am J Gastroenterol. 2008; (suppl 1): S436. Presented at: American College of Gastroenterology Scientific Meeting; October 3–8, 2008; Orlando, FL., , , et al.
- 17Efficacy and safety of adalimumab for the treatment of Japanese patients with moderately to severely active Crohn's disease: results from a randomized controlled trial. Am J Gastroenterol. 2008; 103( suppl 1): S414– S415., , , et al.
- 18Adalimumab effectiveness in TNF-antagonist-naïve patients and in infliximab nonresponders with Crohn's disease: results from the CARE study. Am J Gastroenterol. 2008; 103( suppl 1): S418., , , et al.
- 19Adalimumab safety in patients with Crohn's disease and previous exposure to infliximab: CHOICE trial. Gastroenterology. 2008; 134( 4 suppl 1): A-489., , , et al.
- 20Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guideline for industry-clinical safety data management: definitions and standards for expedited reporting. FDA Center for Drug Evaluation and Research. Available at: http://www.fda.gov/cder/guidance/iche2a.pdf. Accessed April 9, 2009.
- 21Statistical methods in cancer research: vol II. The design and analysis of cohort studies. International Agency for Research on Cancer. New York: Oxford University Press; 1987: 1– 406., .
- 22Surveillance Epidemiology and End Results [database online]. Bethesda, MD: National Cancer Institute; 2007.
- 23Incidence of non-melanoma skin cancer in the United States. US Department of Health and Human Services, Public Health Service, NIH, NCI, Pub No (NIH) 82-2433; Bethesda, MD: 1981., , .
- 24Mortality Database [database online]. Geneva, Switzerland: World Health Organization; 2006.
- 26Adalimumab safety and mortality rates from trials of six immune mediated inflammatory diseases. Ann Rheum Dis. doi:10.1136/ard.2008.102103., , , et al.
- 27Crohn's disease. In: Feldman et al, eds. Sleisenger & Fordtran's gastrointestinal and liver disease, 8th ed, vol 2. Philadelphia: Saunders Elsevier; 2006: 2459– 2498..
- 32Humira [summary of product characteristics]. Kent, UK: Abbott Laboratories. Available at: http://www.emea.europa.eu/humandocs/PDFs/EPAR/humira/H-481-PI-en.pdf. Accessed April 9, 2009.
- 38Early Crohn's disease shows high levels of remission to therapy with adalimumab: sub-analysis of CHARM. Gastroenterolory. 2007; 132(4 Suppl 2): A-147. Presented at: Digestive Disease Week; May 19–24, 2007; Washington, DC., , , et al.
- 40Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut. doi:10.1136/gut.2008.159251., , , et al.
- 41An open-label study of the human anti-TNF monoclonal antibody adalimumab in subjects with prior loss of response or intolerance to infliximab for Crohn's disease. Am J Gastroenterol. 2004; 99: 1984– 1989., , , et al.Direct Link:
- 45Safety and efficacy of adalimumab (D2E7) in Crohn's disease patients with an attenuated response to infliximab. Am J Gastroenterol. 2005; 100: 75– 79., , , et al.Direct Link: