Efficacy and safety of Adalimumab in Crohn’s disease.

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M. Serghini
W. Haddad
H. Jeddi
S. Karoui
N. Ben Mustapha
L Kallel
M. Fekih
S. Matri
J. Boubaker
A. Filali

Abstract

Background: Adalimumab is the first subcutaneously selfadministered fully human anti-TNFa.
Aim: To determine efficacy and safety of Adalimumab therapy in Crohn disease.
Methods: Literature review.
Results: Adalimumab has been evaluated for its effect in inducing and maintaining remission and its steroid-sparing effect of refractory Crohn’s disease. In addition, it offers a significant treatment option in patients who have lost response to or become intolerant to Infliximab. Results also suggest efficacy of Adalimumab in fistulising Crohn’s disease but more studies are needed. Adalimumab was well tolerated and studies show that all anti-TNF inhibitors have similar safety profiles

Keywords:

Inflammatory bowel disease, Crohn's disease, anti-TNFa, Adalimumab

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References

  1. Abott laboratories. Monographie Adalimumab. www.rxabbott.com/pdf/humira.pdf
  2. Casinotti A, Ardizzone S. Adalimumab for the treatment of Crohn's disease. Biologics: Targets and Therapy 2008; 2: 763-77.
  3. Calabrese LH. Molecular differences in anticytokine therapies. Clin Exp Rheumatol 2003;21:241-8
  4. Tracey D, Klareskog L, Sasso EH. Tumor necrosis factor antagonist mechanisms of action: A comprehensive review. Pharmacol Ther 2008; 117: 244-79
  5. Shen C, Assche GV, Colpaert S. Adalimumab induces apoptosis of human monocytes: a comparative study with infliximab and etanercept. Aliment Pharmacol Ther 2005 ; 21:251-8
  6. Chadhary R, Butler M, Playford RJ. Anti-TNF antibody induced stimulated T lymphocyte apoptosis depends on the concentration of the antibody and etanercept induces apoptosis at rates equivalent to infliximab and adalimumab at 10 micrograms per ml concentration. Gastroenterology 2006;130:A696
  7. Mitoma H, Horiuchi T, Tsukamoto H. Mechanisms for cytotoxic effects of anti-tumor necrosis factor agents on transmembrane tumor necrosis factor alpha-expressing cells. Arthritis Rheum 2008;58:1248-57
  8. Di Sabatino A, Pender SL, Jackson CL. Functional modulation of Crohn's disease myofibroblasts by anti-tumor necrosis factor antibodies. Gastroenterology 2007;133:137-49
  9. Nestorov I. Clinical pharmacokinetics of TNF antagonists: how do they differ? Semin Arthritis Rheum 2004;34(suppl 1):12-18
  10. Weisman MH, Moreland LW, First DE. Efficacity, pharmacokinetic and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: a pilot study. Clin Ther 2003;25:1700-21
  11. Hanauer SB, Sandborn WJ. Human Anti-Tumor Necrosis Factor Monoclonal Antibody (Adalimumab) in Crohn's Disease: the CLASSIC-I Trial. Gastroenterology 2006;130: 323-33.
  12. Sandborn WJ, Rutgeerts P. Adalimumab induction therapy for Crohn Disease previously treated with infliximab. Ann Intern Med. 2007; 146:829-38.
  13. Sandborn WJ, Hanauer SB. Adalimumab for maintenance treatment of Crohn's disease: results of the CLASSIC II trial. Gut 2007;56; 1232-39.
  14. Colombel JF, Sandborn WJ. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: The CHARM Trial. Gastroenterology 2007; 132:52-65.
  15. Feagan BG, Panaccione R. Effects of Adalimumab therapy on incidence of hospitalization and surgery in Crohn's disease: Results from the CHARM Study. Gastroenterology 2008; 135:1493-1499.
  16. Sandborn WJ, Hanauer S. An 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; 99:1984-9.
  17. Hinojosa J, Gomollon F, Garcia S. Efficacy and safety of shortterm adalimumab treatment in patients with active Crohn's disease who lost response or showed intolerance to infliximab: a prospective, open-label, multicentre trial. Aliment Pharmacol Ther. 2007; 25:409-18.
  18. Peyrin-Biroulet L, Laclotte C, Bigard MA. Adalimumab maintenance therapy for Crohn's disease with intolerance or lost response to infliximab: an open-label study. Aliment Pharmacol Ther 2007; 25:675-80.
  19. Oussalah A, Babouri A, Chevaux JB. Adalimumab for Crohn's disease with intolerance or lost response to infliximab: a 3-year single-centre experience. Aliment Pharmacol Ther 2008;29:416- 23.
  20. Lopez Placios N, Mendoza JL, Taxonera C, Lana R, Fuentes Ferre M, Diaz-Rubio M. Adalimumab induction and maintenance therapy for Crohn's disease: An open label study. Spanish J Gastroenterol 2008;100:676-81.
  21. Panaccione R, Colombel JF, Sandborn WJ et al. Adalimumab sustains clinical remission and overall clinical benefit after 2 years of therapy for Crohn's disease. Aliment Pharmacol Ther 2010; 31: 1296-309.
  22. Scwartz DA. Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR. The natural history of fistulizing Crohn's disease in Olmsted Country. Minnesota. Gastroenterology 2002;122:875-80.
  23. Sands BE, Anderson FH, Bernstein CN. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med 2004;350:876-85.
  24. Colombel JF, Schwartz DA, Sandborn WJ. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Inflamm Bowel Dis 2009; 58:940-48.
  25. Burmester GR, Mease P, Dijkmans BAC. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases. Ann Rheum Dis 2009 ;68 :1863-69
  26. Bongartz T, Sutton AJ, Sweeting MJ. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA 2006;295:2275-85.
  27. Peyrin-Birouet L, Deltenre P, De Suray N, Branche J, Sandborn WJ, Colombel JF. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: Meta-analysis of placebocontrolled trials. Clin Gastroenterol Hepatol 2008; 6:644-53.
  28. Colombel JF, Sandborn WJ, Panaccione R. Adalimumab safety in global clinical trials of patients with Crohn's disease. Inflamm Bowel Dis 2009; 15:1308-19.
  29. Karmiris K, Paintaud G, Noman M. Influence of trough serum levels and immunogenicity on long-term outcome of Adalimumab therapy in Crohn's disease. Gastroenterology 2009;137:1628-40.
  30. West RL, Zelinkova Z. Immunogenicity negatively influences the outcome of adalimumab treatment in Crohn's disease. Aliment Pharmacol Ther 2008; 28: 1122-26.
  31. Ochenrider MG, Patterson DJ. Hepatosplenic T-cell lymphoma in a young man with Crohn's disease: case report and literature review. Clin Lymphoma Myeloma Leuk. 2010;10:144-8.
  32. Theis VS, Rhodes JM. Minimizing tuberculosis during antitumour necrosis factor-alpha treatment of inflammatory bowel disease. Aliment Pharmacol Ther 2008;27: 19-30.
  33. Hoentjen F, Van Bodegraven A. Safety of anti-tumor necrosis factor therapy in inflammatory bowel disease. World J Gastroenterol 2009; 15: 2067-73.