Adalimumab in patients with Crohn's disease - Safety and efficacy in an open-label single centre study

Alimentary Pharmacology and Therapeutics

Volumn 25, Issue 7, 2007, Pages 787-796

  Seiderer, J ^a   Brand, S ^a   Dambacher, J ^a   Pfennig, S ^a   Jurgens M ^a   Goke B ^a   Ochsenkuhn T ^a  

^a LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ANTIFUNGAL AGENT; C REACTIVE PROTEIN; CASPASE RECRUITMENT DOMAIN PROTEIN 15; DERMATOLOGICAL AGENT; INFLIXIMAB; TUMOR NECROSIS FACTOR ALPHA ANTIBODY;

ADULT; AGED; ARTICLE; AUTOIMMUNE DISEASE; CANDIDIASIS; CARDIOVASCULAR DISEASE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROHN DISEASE; DISEASE ACTIVITY; DRUG EFFICACY; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG INDUCED CANCER; DRUG SAFETY; DRUG TOLERABILITY; DRY SKIN; ECZEMA; FEMALE; GENETIC POLYMORPHISM; GENOTYPE; HUMAN; INJECTION SITE DISCOMFORT; LABORATORY TEST; LEUKOCYTE COUNT; MALE; NEUROLOGIC DISEASE; OPEN STUDY; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; REMISSION; SCORING SYSTEM; TOPICAL TREATMENT; TREATMENT OUTCOME;

ADMINISTRATION, CUTANEOUS; ADULT; AGED; ANTI-INFLAMMATORY AGENTS; ANTIBODIES, MONOCLONAL; CROHN DISEASE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG RESISTANCE; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 33947218020     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2007.03253.x     Document Type: Article

References (53)

1. Podolsky DK. Inflammatory bowel disease. N Engl J Med 2002; 347: 417-29.
2. Plevy SE, Landers CS, Prehn J, et al. A role for TNF alpha and mucosal T helper-1 cytokines in the pathogenesis of Crohn's disease. J Immunol 1997; 159: 6276.
3. Reimund JM, Dumont S, Muller CD, et al. Increased production of tumor necrosis factor-α, interleukin-β and interleukin-6 by morphologically normal intestinal biopsies from patients with Crohn's disease. Gut 1996; 39: 684-9.
4. Scallon BJ, Moore MA, Trinh H, et al. Chimeric Anti-TNF-alpha monoclonal Antibody cA2 binds recombinant transmembrane TNF-alpha and activates immune effector functions. Cytokine 1995; 7: 251-9.
5. Papadakis KA, Targan SR. Tumor necrosis factor: biology and therapeutic inhibitors. Gastroenterology 2000; 119: 1148-57.
6. Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohńs disease. Crohńs Disease cA2 Study Group. N Engl J Med 1997; 337: 1029-35.
7. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohńs disease: the ACCENT I randomised trial. Lancet 2002; 359: 1541-9.
8. Ten Hove T, van Montfrans C, Peppelenbosch MP, van Deventer SJH. Infliximab treatment induces apoptosis of lamina propria T lymphocytes in Crohn's disease. Gut 2002; 50: 206-11.
9. Present DH, Rutgeerts P, Targan S, et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med 1999; 340: 1398-405.
10. Ochsenkühn T, Sackmann M, Göke B. Infliximab for acute moderate or severe ulcerative colitis as first line therapy: a randomized pilot study. Eur J Gastroenterol Hepatol 2004; 16: 1167-71.
11. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005; 353: 2462-76.
12. Hanauer SB. Immunogenicity of infliximab in Crohńs disease. N Engl J Med 2003; 348: 2155-6.
13. Baert F, Noman M, Vermeire S, et al. Influence of the immunogenicity on the long-term efficacy of infliximab in Crohńs disease. N Engl J Med 2003; 348: 601.
14. Colombel JF, Loftus EV Jr, Tremaine WJ, et al. The safety profile of infliximab in patients with Crohn' s disease: The Mayo clinic experience in 500 patients. Gastroenterology 2004; 126: 19-31.
15. Seiderer J, Göke B, Ochsenkühn T. Safety aspects of infliximab in IBD patients - a retrospective cohort study in 100 patients of a German university hospital. Digestion 2004; 70: 3-9.
16. Mease PJ, Gladman DD, Ritchlin CT, et al. Adalimumab Effectiveness in Psoriatic Arthritis Trial Study Group. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005; 52: 3279-89.
17. Navarro-Sarabia F, Ariza-Ariza R, Hernandez-Cruz B, Villanueva I. Adalimumab for treating rheumatoid arthritis. J Rheumatol 2006; 33: 1075-81.
18. van der Heijde D, Kivitz A, Schiff MH, et al. ATLAS Study Group. Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2006; 54: 2136-46.
19. Barthel HR, Gille T, Halbsguth A, Kramer M. Successful treatment with adalimumab in infliximab-resistant Crohn's disease. J Gastroenterol Hepatol 2005; 20: 1464-5.
20. Papadakis KA, Shaye OA, Vasiliauskas EA, et al. Safety and efficacy of adalimumab (D2E7) in Crohn's disease patients with an attenuated response to infliximab. Am J Gastroenterol 2005; 100: 75-9.
21. Youdim A, Vasiliauskas EA, Targan SR, et al. A pilot study of adalimumab in infliximab-allergic patients. Inflamm Bowel Dis 2004; 10: 333-8.
22. Sandborn WJ, Hanauer S, Loftus EV Jr, et al.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.
23. Hanauer SB, 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.
24. 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.
25. Lennard-Jones JE. Classification of inflammatory bowel disease. Scand J Gastroenterol Suppl 1989; 170: 2-6.
26. Gasche C, Brynskov J, D'Haens G, et al. A simple classification of Crohn's disease: report of the Working Party for the World Congresses of Gastroenterology, Vienna 1998. Inflamm Bowel Dis 2000; 6: 8-15.
27. Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology 1976; 70: 439-44.
28. Schnitzler F, Brand S, Staudinger T, et al. Eight novel CARD15 variants detected by DNA sequence analysis of the CARD15 gene in 111 patients with inflammatory bowel disease. Immunogenetics 2005; 58: 99-106.
29. Thalmaier D, Dambacher J, Seiderer J, et al. The +1059G/C polymorphism in the C-reactive protein (CRP) gene is associated with involvement of the terminal ileum and decreased serum CRP levels in patients with Crohn's disease. Aliment Pharmacol Ther 2006; 24: 1105-15.
30. Chang JT, Lichtenstein GR. Drug insight: antagonists of tumor-necrosis factor-alpha in the treatment of inflammatory bowel disease. Nat Clin Pract Gastroenterol Hepatol 2006; 3: 220-8.
31. Schreiber S, Rutgeerts P, Fedorak RN, et al. CDP870 Crohn's Disease Study Group. A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease. Gastroenterology 2005; 129: 807-18.
32. Sandborn WJ, Hanauer SB, Katz S, et al. Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trial. Gastroenterology 2001; 121: 1088-94.
33. Rutgeerts P, Sandborn WJ, Fedorak RN, et al. Onercept Study Group. Onercept for moderate-to-severe Crohn's disease: a randomized, double-blind, placebo-controlled trial. Clin Gastroenterol Hepatol 2006; 4: 888-93.
34. Feagan BG, Sandborn WJ, Lichtenstein G, Radford-Smith G, Patel J, Innes A. CDP571, a humanized monoclonal antibody to tumour necrosis factor-alpha, for steroid-dependent Crohn's disease: a randomized, double-blind, placebo-controlled trial. Aliment Pharmacol Ther 2006; 23: 617-28.
35. Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 2001; 11: 345.
36. Scheinfeld N. Adalimumab: a review of side effects. Expert Opin Drug Saf 2005; 4: 637-41.
37. Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. 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.
38. Schiff MH, Burmester GR, Kent JD, et al. Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis 2006; 65: 889-94.
39. Giles JT, Bartlett SJ, Gelber AC, et al. Tumor necrosis factor inhibitor therapy and risk of serious postoperative orthopedic infection in rheumatoid arthritis. Arthritis Rheum 2006; 55: 333-7.
40. Bassetti M, Pizzorni C, Gradoni L, Del Bono V, Cutolo M, Viscoli C. Visceral leishmaniasis infection in a rheumatoid arthritis patient treated with adalimumab. Rheumatology 2006; 45: 1446-8.
41. Gutierrez-Macias A, Lizarralde-Palacios E, Martinez-Odriozola P, Miguel-de la Villa F. Tuberculous peritonitis in a patient with rheumatoid arthritis treated with adalimumab. Clin Rheumatol 2006; 11: 1-2.
42. Chung JH, Van Stavern GP, Frohman LP, Turbin RE. Adalimumab-associated optic neuritis. J Neurol Sci 2006; 244: 133-6.
43. Beuthien W, Mellinghoff H, von Kempis J. Skin reaction to adalimumab. Arthritis Rheum 2004; 50: 1690-2.
44. Orpin SD, Majmudar VB, Soon C, Azam NA, Salim A. Adalimumab causing vasculitis. Br J Dermatol 2006; 154: 998-9.
45. Huggett MT, Armstrong R. Adalimumab-associated pulmonary fibrosis. Rheumatology 2006; 45: 1312-3.
46. Allanore Y, Devos-Francois G, Caramella C, Boumier P, Jounieaux V, Kahan A. Fatal exacerbation of fibrosing alveolitis associated with systemic sclerosis in a patient treated with adalimumab. Ann Rheum Dis 2006; 65: 834-5.
47. Biancone L, Orlando A, Kohn A, et al. Infliximab and newly diagnosed neoplasia in Crohn's disease: a multicentre matched pair study. Gut 2006; 55: 228-33.
48. Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab, a fully human antitumor necrosis factor a monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003; 48: 35-45.
49. Seiderer J, Brand S, Herrmann KA, et al. Predictive value of the CARD15 variant 1007 fs for the diagnosis of intestinal stenoses and the need for surgery in Crohn's disease in clinical practice: results of a prospective study. Inflamm Bowel Dis 2006; 12: 1114-21.
50. Seiderer J, Schnitzler F, Brand S, et al. Homozygosity for the CARD15 frame-shift mutation 1007 fs is predictive of early onset of Crohn's disease with ileal stenosis, entero-enteral fistulas, and frequent need for surgical intervention with high risk of re-stenosis. Scand J Gastroenterol 2006; 41: 1421-32.
51. Louis E, Vermeire S, Rutgeerts P, et al. A positive response to infliximab in Crohn disease: association with a higher systemic inflammation before treatment but not with -308 TNF gene polymorphism. Scand J Gastroenterol 2002; 37: 818-24.
52. Sandborn WJ, Feagan BG, Radford-Smith G, et al. CDP571, a humanised monoclonal antibody to tumour necrosis factor alpha, for moderate to severe Crohn's disease: a randomised, double blind, placebo controlled trial. Gut 2004; 53: 1485-93.
53. Willot S, Vermeire S, Ohresser M, et al. No association between C-reactive protein gene polymorphisms and decrease of C-reactive protein serum concentration after infliximab treatment in Crohn's disease. Pharmacogenet Genomics 2006; 16: 37-42.