1,022
Views
8
CrossRef citations to date
0
Altmetric
Review

A practical, evidence-based guide to the use of adalimumab in Crohn’s disease

, , &
Pages 1803-1813 | Accepted 08 Jul 2011, Published online: 02 Aug 2011

References

  • Hanauer SG, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn’s disease: the CLASSIC-I trial. Gastroenterology 2006;130:323-33
  • Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomized trial. Lancet 2002;359:1541-9
  • Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology 2007;132:52-65
  • Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor α for Crohn’s disease. N Engl J Med 1997;337:1029-35
  • Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn’s disease previously treated with infliximab. Ann Intern Med 2007;146:829-38
  • Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn’s disease. N Engl J Med 2007;357:228-38
  • Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med 2007;357:239-50
  • Lichtenstein GR, Hanauer SB, Sandborn WJ; Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn’s disease in adults. Am J Gastroenterol 2009;104:465-83
  • Dignass A, Van Assche G, Lindsay JO, et al. The second European evidence-based consensus on the diagnosis and management of Crohn’s disease: current management. J Crohns Colitis 2010;4:28-62
  • Rutgeerts P, Vermeire S, Van Assche G. Mucosal healing in inflammatory bowel disease: impossible ideal or therapeutic target? Gut 2007;56:453-5
  • Frøslie KF, Jahnsen J, Mourn BA, et al. Mucosal healing in inflammatory bowel disease: results from a Norwegian population-based cohort. Gastroenterology 2007;133:412-22
  • Minderhoud IM, Samsom M, Oldenburg B. What predicts mucosal inflammation in Crohn’s disease patients? Inflamm Bowel Dis 2007;13:1567-72
  • Van Assche G, Dignass A, Panes J, et al. The second European evidence-based consensus on the diagnosis and management of Crohn’s disease: definitions and diagnosis. J Crohns Colitis 2010;4:7-27
  • Van Assche G, Vermeire S, Rutgeerts P. Immunosuppression in inflammatory bowel disease: traditional, biological or both? Curr Opin Gastroenterol 2009;25:323-8
  • Jones J, Loftus EV Jr, Panaccione R, et al. Relationships between disease activity and serum and fecal biomarkers in patients with Crohn’s disease. Clin Gastroenterol Hepatol 2008;6:1218-24
  • Cellier C, Sahmoud T, Froguel E, et al. Correlations between clinical activity, endoscopic severity, and biological parameters in colonic or ileocolonic Crohn’s disease: a prospective multicentre study of 121 cases. Gut 1994;35:231-5
  • Rutgeerts P, Diamond RH, Bala M, et al. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn’s disease. Gastrointest Endosc 2006;63:433-42
  • Beaugerie L, Seksik P, Nion-Larmurier I, et al. Predictors of Crohn’s disease. Gastroenterology 2006;130:650-6
  • Loly C, Belaiche J, Louis E. Predictors of severe Crohn’s disease. Scand J Gastroenterol 2008;43:948-54
  • Allez M, Lemann M, Bonnet J, et al. Long term outcome of patients with active Crohn’s disease exhibiting extensive and deep ulcerations at colonoscopy. Am J Gastroenterol 2002;97:947-53
  • Louis E, Michel V, Hugot JP, et al. Early development of stricturing or penetrating pattern in Crohn’s disease is influenced by disease location, number of flares, and smoking but not by NOD2/CARD15 genotype. Gut 2003;52:552-7
  • Thia KT, Sandborn WJ, Harmsen WS, et al. Risk factors associated with progression to intestinal complications of Crohn’s disease in a population-based cohort. Gastroenterology 2010;139:1147-55
  • Panaccione R, Rutgeerts P, Sandborn WJ, et al. Treatment algorithms to maximize remission and minimize corticosteroid dependence in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2008;28:674-88
  • Rutgeerts PJ. Review article: the limitations of corticosteroid therapy in Crohn’s disease. Aliment Pharmacol Ther 2001;15:1515-25
  • Plevy SE. Corticosteroid-sparing treatments in patients with Crohn’s disease. Am J Gastroenterol 2002;97:1607-17
  • Schreiber S, Reinisch W, Colombel JF, et al. Early Crohn’s disease shows high levels of remission to therapy with adalimumab: sub-analysis of CHARM. Gastroenterology 2007;132(Suppl 2):A147
  • Lofberg R, Louis EV, Reinisch W, et al. Adalimumab produces clinical remission and reduces extraintestinal manifestations in Crohn’s disease: results from CARE. Inflamm Bowel Dis 2011; published online 23 February 2011, doi:10.1002/ibd.21663
  • Rutgeerts P, D’Haens GR, Van Assche GA, et al. Adalimumab induces and maintains mucosal healing in patients with moderate to severe ileocolonic Crohn’s disease – first results of the EXTEND trial. Gastroenterology 2009;136(Suppl 1):A-116
  • Sandborn WJ, Panaccione R, Thakkar R, et al. Crohn’s disease mucosal healing in adalimumab-treated patients is affected by disease duration: results from EXTEND. Gastroenterology 2010;138(Suppl 1):S-164
  • HUMIRA [prescribing information]. Abbott Laboratories. 2011. Available at: http://www.rxabbott.com/pdf/humira.pdf [Last accessed 15 June 2011]
  • HUMIRA [summary of product characteristics]. Abbott Biotechnology Deutschland GmbH. 2010. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf [Last accessed 21 March 2011]
  • Ma C, Panaccione R, Heitman SJ, et al. Systematic review: the short-term and long-term efficacy of adalimumab following discontinuation of infliximab. Aliment Pharmacol Ther 2009;30:977-86
  • Kugathasan S, Saubermann LJ, Smith L, et al. Mucosal T-cell immunoregulation varies in early and late inflammatory bowel disease. Gut 2007;56:1696-705
  • Veny M, Esteller M, Ricart E, et al. Late Crohn’s disease patients present an increase in peripheral Th17 cells and cytokine production compared with early patients. Aliment Pharmacol Ther 2010;31:561-72
  • D’Haens GR. Top-down therapy for IBD: rationale and requisite evidence. Nat Rev Gastroenterol Hepatol 2010;7:86-92
  • Burmester GR, Mease P, Dijkmans BA, et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases. Ann Rheum Dis 2009;68:1863-9
  • Colombel JF, Sandborn WJ, Panaccione R, et al. Adalimumab safety in global clinical trials of patients with Crohn’s disease. Inflamm Bowel Dis 2009;15:1308-19
  • Esteve M, Saro C, Gonzalez HR, et al. Chronic hepatitis B reactivation following infliximab therapy in Crohn’s disease patients: need for primary prophylaxis. Gut 2004;53:1363-5
  • Wendling D, Auge B, Bettinger D, et al. Reactivation of a latent precore mutant hepatitis B virus related chronic hepatitis during infliximab treatment for severe spondyloarthropathy. Ann Rheum Dis 2005;64:788-9
  • Matsumoto T, Marusawa H, Dogaki M, et al. Adalimumab-induced lethal hepatitis B virus reactivation in an HbsAg-negative patient with clinically resolved hepatitis B virus infection. Liver Int 2010;30:1241-2
  • Ojiro K, Naganuma M, Ebinuma H, et al. Reactivation of hepatitis B in a patient with Crohn’s disease treated with infliximab. J Gastroenterol 2008; 43:397-401
  • Kotlyar DS, Osterman MT, Diamond RH, et al. A systematic review of factors that contribute to hepatosplenic T-cell lymphoma in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2011;9:36-41
  • Schwartzman S, Morgan GJ Jr. Does route of administration affect the outcome of TNF antagonist therapy? Arthritis Res Ther 2004;6(Suppl 2):S19-23
  • Kivitz A, Cohen S, Dowd JE, et al. Clinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human monoclonal antibody adalimumab: the TOUCH trial. Clin Ther 2006;28:1619-29
  • Lomax KG. Crohn’s disease patients’ preferences for injectable vs. infused medications: results of a patient survey. Presented at the 36th Annual Course of the Society of Gastroenterology Nurses and Associates, Inc.; St Louis, MO, USA, May 15–20, 2009
  • Feagan BG, Panaccione R, Sandborn WJ, et al. Effects of adalimumab therapy on incidence of hospitalization and surgery in Crohn’s disease: results from the CHARM study. Gastroenterology 2008;135:1493-9
  • Lichtenstein GR, Yan S, Bala M, et al. Infliximab maintenance treatment reduces hospitalizations, surgeries, and procedures in fistulizing Crohn’s disease. Gastroenterology 2005;128:862-9
  • Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn’s disease. Gastroenterology 2009;137:1628-40
  • Loftus Jr EV, Pan X, Zurawski P, et al. Adalimumab real-world dosage pattern and predictors of weekly dosing: Patients with Crohn’s disease in the United States. J Crohns Colitis 2011; published online 12 June 2011, doi:10.1016/j.crohns.2011.05.005
  • Rubin D, Sederman R. Patient response to anti-TNF dose escalation in Crohn’s disease using health claims data. Presented at the American College of Gastroenterology Annual Scientific Meeting; San Antonio, TX, USA, October 15–20, 2010
  • Panaccione R, Sandborn W, Colombel JF, et al. Response after 12 weeks of adalimumab therapy in patients with Crohn’s disease who were nonresponders at week 4. Am J Gastroenterol 2008;103(Suppl 1):S379
  • Panaccione R, Colombel JF, Sandborn W, et al. Maintenance of long-term remission in patients with moderately to severely active Crohn’s disease treated for 3 years with adalimumab: results from the open-label ADHERE study. Gastroenterology 2009;136:A-652
  • Loftus EV Jr, Colombel JF, Rutgeerts P, et al. Quality-of-life improvements in patients with Crohn’s disease treated for 3 years with adalimumab in an open-label extension of CHARM. Gastroenterology 2009;136(Suppl 1):A-179
  • Loftus EV Jr, Feagan F, Chen N, et al. Risk of Crohn’s disease-related hospitalization in patients receiving long-term adalimumab therapy: 3-year data from CHARM and ADHERE. J Crohns Colitis 2009;3:S24
  • Kamm MA, Hanauer SB, Panaccione R, et al. Adalimumab sustains steroid-free remission after 3 years of therapy for Crohn’s disease. Aliment Pharmacol Ther 2011;34:306-17
  • Colombel JF, Kamm M, Schwartz D, et al. Long-term adalimumab treatment is associated with sustained fistula healing in patients with moderate to severe Crohn’s disease. Am J Gastroenterol 2008;103(Suppl 1):S417
  • Colombel JF, Sandborn WJ, Reinisch W, et al.; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn’s disease. N Engl J Med 2010;362:1383-95
  • Lichtenstein GR, Diamond RH, Wagner CL, et al. Clinical trial: benefits and risks of immunomodulators and maintenance infliximab for IBD-subgroup analyses across four randomized trials. Aliment Pharmacol Ther 2009;30:210-26
  • Gisbert JP, Bermejo F, Pérez-Calle JL, et al. Fecal calprotectin and lactoferrin for the prediction of inflammatory bowel disease relapse. Inflamm Bowel Dis 2009;15:1190-8
  • Sandborn WJ, Colombel JF, Schreiber S, et al. Dosage adjustment during long-term adalimumab treatment for Crohn’s disease: clinical efficacy and pharmacoeconomics. Inflamm Bowel Dis 2011;17:141-51
  • Rubin DT. Strategies for maximizing and extending response to biologic therapy. Gastroenterol Hepatol 2009;4(Suppl 12):6-8
  • Singh S, Graff LA, Bernstein CN. Do NSAIDs, antibiotics, infections, or stress trigger flares in IBD? Am J Gastroenterol 2009;104:1298-313
  • Takeuchi K, Smale S, Premchand P, et al. Prevalence and mechanism of nonsteroidal anti-inflammatory drug-induced clinical relapse in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2006;4:196-202
  • Shah SB, Hanauer SB. Treatment of diarrhea in patients with inflammatory bowel disease: concepts and cautions. Rev Gastroenterol Disord 2007;7(Suppl 3):S3-10
  • Issa M, Ananthakrishnan AN, Binion DG. Clostridium difficile and inflammatory bowel disease. Inflamm Bowel Dis 2008;14:1432-42
  • Ananthakrishnan AN, Issa M, Binion DG. Clostridium difficile and inflammatory bowel disease. Med Clin N Am 2010;94:135-53
  • Klaus J, Spaniol U, Adler G, et al. Small intestinal bacterial overgrowth mimicking acute flare as a pitfall in patients with Crohn’s disease. BMC Gastroenterol 2009;9:61
  • Binder HJ. Mechanisms of diarrhea in inflammatory bowel diseases. Ann NY Acad Sci 2009;1165:285-93
  • Bernstein CN, Singh S, Graff LA, et al. A prospective population-based study of triggers of symptomatic flares in IBD. Am J Gastroenterol 2010;105:1994-2002
  • Stallmach A, Carstens O. Role of infections in the manifestation or reactivation of inflammatory bowel diseases. Inflamm Bowel Dis 2002;8:213-18
  • Van Assche G, Vermeire S, Rutgeerts P. Optimizing treatment of inflammatory bowel diseases with biologic agents. Curr Gastroenterol Rep 2008;10:591-6
  • Panaccione R, Colombel JF, Sandborn WJ, et al. Long-term maintenance of clinical remission with reduced dosing frequency of adalimumab in patients with moderate to severe Crohn’s disease. Gastroenterology 2010;138(Suppl 1):S468-9
  • Karmiris K, Noman M, Paintaud G, et al. A 3-week course of 80 mg weekly administered adalimumab as a rescue therapy for patients with Crohn’s disease who lost response to 40 mg weekly: relationship with adalimumab trough serum levels. Gastroenterology 2008;134(Suppl 1):A-640
  • Cassani LS, Beaulieu DB, Ananthakrishnan AN, et al. Re-capturing response with micro-reinduction of adalimumab: a tertiary care center experience. Gastroenterology 2010;138(Suppl 1):S-697
  • Bendtzen K, Ainsworth M, Steenholdt C, et al. Individual medicine in inflammatory bowel disease: monitoring bioavailability, pharmacokinetics, and immunogenicity of anti-tumour necrosis factor-alpha antibodies. Scand J Gastroenterol 2009;44:774-81
  • Ainsworth MA, Bendtzen K, Brynskov J. Tumor necrosis factor-alpha binding capacity and anti-infliximab antibodies measured by fluid-phase radioimmunoassay as predictors of clinical efficacy of infliximab in Crohn’s disease. Am J Gastroenterol 2008;103:944-8
  • Afif W, Loftus EV Jr, Faubion WA, et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol 2010;105:1133-9
  • Breedveld FC. Therapeutic monoclonal antibodies. Lancet 2000;355:735-40
  • Sandborn WJ, Hanauer SB, Rutgeerts P, et al. Adalimumab for maintenance treatment of Crohn’s disease: results of the CLASSIC II trial. Gut 2007;56:1232-9

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.