Download PDF
Z Gastroenterol 2013; 51(09): 1101-1109
DOI: 10.1055/s-0033-1350165
Übersicht
© Georg Thieme Verlag KG Stuttgart · New York

Adalimumab in der Behandlung des adulten Morbus Crohn – Update eines Konsensus der Arbeitsgruppe Chronisch Entzündliche Darmerkrankungen der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie

Adalimumab for the Treatment of Adult Crohn’s Disease – Update of a Consensus Report by the Working Group Inflammatory Bowel Disease of the Austrian Society of Gastroenterology and Hepatology
G. Novacek
1   Klinische Abteilung für Gastroenterologie und Hepatologie, Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Österreich
,
T. Haas
2   Paracelsus Medizinische Privatuniversität, Universitätsklinik für Innere Medizin I, Salzburg, Österreich
,
P. Knoflach
3   1. Interne Abteilung, Klinikum Wels, Österreich
,
W. Petritsch
4   Klinische Abteilung für Gastroenterologie und Hepatologie, Universitätsklinik für Innere Medizin, Medizinische Universität Graz, Österreich
,
H. Tilg
5   Universitätsklinik für Innere Medizin I, Medizinische Universität Innsbruck, Österreich
,
H. Vogelsang
1   Klinische Abteilung für Gastroenterologie und Hepatologie, Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Österreich
,
W. Reinisch
1   Klinische Abteilung für Gastroenterologie und Hepatologie, Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Österreich
› Author Affiliations
Further Information

Publication History

20 March 2013

26 June 2013

Publication Date:
30 August 2013 (online)

Also available at
    Permissions and Reprints

Corrected by:

Adalimumab in der Behandlung des adulten Morbus Crohn – Update eines Konsensus der Arbeitsgruppe Chronisch Entzündliche Darmerkrankungen der Österreichischen Gesellschaft für Gastroenterologie und HepatologieZ Gastroenterol 2013; 51(09): E2-E2
DOI: 10.1055/s-0033-1355802

Zusammenfassung

TNF-alpha-Antikörper haben den Verlauf von Morbus Crohn mit moderatem bis schwerem Verlauf wesentlich verbessert. Adalimumab ist der erste vollständig humane, monoklonale TNF-alpha-Antikörper, den Patienten selbst subkutan applizieren können. Adalimumab ist seit August 2012 zur Behandlung des mittelschweren bis schwergradigen, aktiven Morbus Crohn bei Patienten zugelassen, bei denen mit einer adäquaten Therapie mit einem Glukokortikoid und/oder einem Immunsuppressivum kein ausreichendes Ansprechen erzielt werden konnte, und/oder die eine entsprechende Unverträglichkeit aufweisen oder bei denen diese Therapien kontraindiziert sind. Mit Adalimumab können bei Patienten mit moderatem bis schwerem Morbus Crohn gegenüber Placebo signifikant höhere Raten an steroidfreier Remission und mukosaler Heilung erreicht, die Zahl der Morbus Crohn bedingten Krankenhausaufenthalte und Operationen verringert sowie die gesundheitsbezogene Lebensqualität verbessert werden. Adalimumab wirkt sowohl bei mit TNF-alpha-Antikörper vorbehandelten wie auch nicht vorbehandelten Patienten. Der Wirkungseintritt erfolgt innerhalb weniger Tage. Eine anhaltende Wirksamkeit ist bis zu 3 Jahren belegt. Die Sicherheitsdaten von Adalimumab entsprechen weitgehend jenen anderer TNF-alpha-Blocker. Allergische Reaktionen sind aufgrund der geringen Immunogenität von Adalimumab selten. Das vorliegende Update eines früheren Konsensus der Arbeitsgruppe Chronisch Entzündliche Darmerkrankungen der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie (ÖGGH) fasst die aktuelle Datenlage zu Adalimumab in der Behandlung des Morbus Crohn zusammen und soll als praktischer Leitfaden für die Anwendung von Adalimumab bei Patienten mit Morbus Crohn dienen.

Abstract

TNF alpha antibodies have clearly improved the outcome of moderate to severe Crohn’s disease. Adalimumab is the first fully human, monoclonal TNF alpha antibody, which can be self-administered subcutaneously. Since August 2012 adalimumab is approved for the treatment of moderately to severely active Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant or who are intolerant to or have medical contraindications for such therapies. Compared to placebo adalimumab can induce significantly more often steroid-free remission and mucosal healing in patients with moderate to severe Crohn’s disease, reduce the rate of Crohn’s disease-related hospitalisations and surgery and improve health-related quality of life. Adalimumab is clinically efficacious both in patients with Crohn’s disease naïve to previous exposure to TNF-alpha antibodies and in those previously exposed with a rapid onset of action within days and confirmed maintenance performance over 3 years. The safety profile of adalimumab is comparable to those of other TNF alpha inhibitors. Due to its low immunogenicity allergic reactions are rare. The update of a consensus report by the Working Group Inflammatory Bowel Disease of the Austrian Society of Gastroenterology and Hepatology presents the existing evidence on adalimumab for the treatment of Crohn’s disease and is aimed to assist as a code of practice in its applications.

Schlüsselwörter

chronisch entzündliche Darmerkrankung - Morbus Crohn - TNF-alpha-Blocker

Key words

chronic inflammatory bowel disease - Crohn’s disease - TNF alpha blocker
 

  • Literatur

  • 1 Humira® Fachinformation. AbbVie GmbH. Stand November 2012
    PubMed
  • 2 Sandborn WJ, Colombel JF, Castillo MM. et al. Induction of remission with adalimumab in patients with moderate Crohn’s disease: subanalysis of CLASSIC I. Gut 2011; 60 (Suppl. 03) A195
    PubMedSearch in Google Scholar
  • 3 Colombel JF, Sandborn WJ, Castillo MM. et al. Efficacy and safety of adalimumab in moderate compared with severe Crohn’s disease: pooled data from the CHARM and EXTEND trials. Gut 2011; 60 (Suppl. 03) A298
    CrossrefPubMedSearch in Google Scholar
  • 4 Löfberg R, Louis E, Reinisch W. et al. Clinical outcomes in patients with moderate versus severe Crohn’s disease at baseline: analysis from CARE. J Crohns Colitis 2012; 6 (Suppl. 01) S94
    PubMedSearch in Google Scholar
  • 5 Reinisch W, Haas T, Kaser A. et al. Adalimumab in der Behandlung des Morbus Crohn – ein Konsensus der Arbeitsgruppe Chronisch Entzündliche Darmerkrankungen der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie (Adalimumab for the treatment of Crohn’s disease – consensus paper of the Working Group “Chronic Inflammatory Bowel Diseases” of the Austrian Society for Gastroenterology and Hepatology). Z Gastroenterol 2009; 47: 372-380
    Thieme ConnectPubMedSearch in Google Scholar
  • 6 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: 323-333
    CrossrefPubMedSearch in Google Scholar
  • 7 Colombel JF, Rutgeerts PJ, Sandborn WJ. et al. Impact of induction dosing on maintenance outcome with adalimumab in Crohn’s disease. Gut 2012; 61 (Suppl. 02) A401 (PWE-254)
    CrossrefPubMedSearch in Google Scholar
  • 8 Panaccione R, Sandborn WJ, Pollack PF. et al. 12-week response to adalimumab among initial week-4 nonresponders in patients with Crohn’s disease. Gut 2008; 57: A259
    CrossrefPubMedSearch in Google Scholar
  • 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
    CrossrefPubMedSearch in Google Scholar
  • 10 Sandborn WJ, Rutgeerts P, Enns R. et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med 2007; 146: 829-838
    CrossrefPubMedSearch in Google Scholar
  • 11 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: 306-317
    CrossrefPubMedSearch in Google Scholar
  • 12 Reenaers C, Louis E, Belaiche J. et al. Does co-treatment with immunosuppressors improve outcome in patients with Crohn’s disease treated with adalimumab. Aliment Pharmacol Ther 2012; 36: 1040-1048
    CrossrefPubMedSearch in Google Scholar
  • 13 Peyrin-Biroulet L, Ferrante M, Magro F. et al. Results from the 2nd Scientific Workshop of the ECCO. I: impact of mucosal healing on the course of inflammatory bowel disease. J Crohns Colitis 2011; 5: 477-483
    CrossrefPubMedSearch in Google Scholar
  • 14 Rutgeerts P, Van Assche G, Sandborn WJ. et al. Adalimumab induces and maintains mucosal healing in patients with Crohn’s disease: data from the EXTEND trial. Gastroenterology 2012; 142: 1102-1111.e2
    CrossrefPubMedSearch in Google Scholar
  • 15 Colombel JF, Schreiber S, Rutgeerts P. et al. Effect of disease duration on “deep remission”: Results from the EXTEND Trial. Gut 2010; 59 (Suppl. 03) A188
    PubMedSearch in Google Scholar
  • 16 Schreiber S, Reinisch W, Colombel JF. et al. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn’s disease. J Crohns Colitis 2013; 7: 213-221
    CrossrefPubMedSearch in Google Scholar
  • 17 Sandborn WJ, Panaccione R, Thakkar R. et al. Duration of Crohn’s disease affects mucosal healing in adalimumab-treated patients: results from EXTEND. J Crohns Colitis 2010; 4 (Suppl. 01) S36
    PubMedSearch in Google Scholar
  • 18 Hommes D, Colombel JF, Emery P. et al. Changing Crohn’s disease management: Need for new goals and indices to prevent disability and improve quality of life. J Crohns Colitis 2012; 6 (Suppl. 02) S224-S234
    CrossrefPubMedSearch in Google Scholar
  • 19 http://efcca-solutions.net/european.php
    PubMed
  • 20 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: 1232-1239
    CrossrefPubMedSearch in Google Scholar
  • 21 Loftus EV, Feagan BG, Colombel JF. et al. Effects of adalimumab maintenance therapy on health-related quality of life with Crohn’s disease: patient-reported outcomes of the CHARM trial. Am J Gastroenterol 2008; 103: 3132-3141
    CrossrefPubMedSearch in Google Scholar
  • 22 Louis E, Löfberg R, Reinisch W. et al. Adalimumab improves patient-reported outcomes and reduces indirect costs in patients with moderate to severe Crohn’s disease: results from the CARE trial. J Crohns Colitis 2013; 7: 34-43
    CrossrefPubMedSearch in Google Scholar
  • 23 Lichtiger S, Binion DG, Wolf DC. et al. The CHOICE trial: adalimumab demonstrates safety, fistula healing, improves quality of life and increased work productivity in patients with Crohn’s disease who failed prior infliximab therapy. Aliment Pharmacol Ther 2010; 32: 1228-1239
    CrossrefPubMedSearch in Google Scholar
  • 24 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: 1493-1499
    CrossrefPubMedSearch in Google Scholar
  • 25 Loftus EV, Feagan B, 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 (Suppl. 01) S24
    PubMedSearch in Google Scholar
  • 26 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: 141-151
    CrossrefPubMedSearch in Google Scholar
  • 27 Baert F, Glorieus E, Reenaers C. et al. Adalimumab dose escalation and dose de-escalation success rate and predictors in a large national cohort of Crohn’s patients. J Crohns Colitis 2013; 7: 154-160
    CrossrefPubMedSearch in Google Scholar
  • 28 Reinisch W. “How to Manage Loss of Response to Anti-TNF in Crohn’s Disease?”. Current Drug Targets 2010; 11: 152-155
    CrossrefPubMedSearch in Google Scholar
  • 29 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
    CrossrefPubMedSearch in Google Scholar
  • 30 Panaccione R, Sandborn WJ, D’Haens G. et al. Adalimumab maintains long-term remission in moderately to severely active Crohn’s disease after infliximab failure: 1-year follow-up of Gain Trial. Gastroenterology 2008; 134 (Suppl. 01) A133
    PubMedSearch in Google Scholar
  • 31 Burmester GR, Panaccione R, Gordon KB. et al. Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn’s disease. Ann Rheum Dis 2013; 72: 517-524
    CrossrefPubMedSearch in Google Scholar
  • 32 http://www.oeggh.at/images/stories/pdf2 / checkliste_antitnfalpha_antikoerper2011.pdf
    PubMed
  • 33 Burmester GR, Mease P, Dijkmans BAC. et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases. Ann Rheum Dis 2009; 68: 1863-1869
    CrossrefPubMedSearch in Google Scholar
  • 34 Loftus Jr EV, Johnson SJ, Wang ST. et al. Risk-benefit analysis of adalimumab versus traditional non-biologic therapies for patients with Crohn’s disease. Inflamm Bowel Dis 2011; 17: 127-140
    CrossrefPubMedSearch in Google Scholar
  • 35 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: 1308-1319
    CrossrefPubMedSearch in Google Scholar
  • 36 Rahier JF, Buche S, Peyrin-Biroulet L. et al. Severe skin lesions cause patients with inflammatory bowel disease to discontinue anti-tumor necrosis factor therapy. Clin Gastroenterol and Hepatol 2010; 8: 1048-1055
    CrossrefPubMedSearch in Google Scholar
  • 37 Ko JM, Gottlieb AB, Kerbleski JF. Induction and exacerbation of psoriasis with TNF-blockade therapy: a review and analysis of 127 cases. J Dermatolog Treat 2009; 20: 100-108
    CrossrefPubMedSearch in Google Scholar
  • 38 D’Haens G, Reinisch W, Satsangi J. et al. PYRAMID Registry: an observational study of adalimumab in Crohn’s disease: results at year 3. Gut 2011; 60 (Suppl. 03) A33
    PubMedSearch in Google Scholar
  • 39 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.e1
    CrossrefPubMedSearch in Google Scholar