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P337. TNF-alpha as induction therapy for Crohn's disease: a comparison of adalimumab and infliximab - a prospective observational study in Germany

B. Bokemeyer1, U. Helwig2, N. Teich3, C. Schmidt4, T. Krummenerl5, A.-K. Rupf6, H. Hartmann7, M. Bläker8, A. Krummenerl9, M. Düffelmeyer10, R. Hinrichs11, P. Hartmann12, S. Nikolaus13, D. Hüppe7, S. Schreiber13, 1Gastroenterology Practice Minden, University Hospital Schleswig-Holstein, Department of General Internal Medicine I, Kiel, Germany, Minden, Germany, 2Gastroenterology Practice, Gastroenterology, Oldenburg, Germany, 3Gastroenterology Practice Leipzig, Gastroenterology, Leipzig, Germany, 4University of Jena, Gastroenterology Department, Jena, Germany, 5Gastroenterology Practice, Gastroenterology, Münster, Germany, 6Frierichshafen Hospital, Department of General Internal Medicine I, Friedrichhafen, Germany, 7Gastroenterology Practice Herne, Gastroenterology, Herne, Germany, 8Gastroenterology Practice Hamburg, Gastroenterology, Hamburg, Germany, 9Hospital Matha-Maria Halle-Dölau, Department of General Internal Medicine I, Hall (Saale), Germany, 10IOMTech GmbH, Software FORGA UG, Berlin, Germany, 11Competence Network on IBD, Germany, Kiel, Germany, 12Gastroenterology Practice Minden, Gastroenterology, Minden, Germany, 13Christian-Albrechts-Universität, University Hospital Schleswig-Holstein, Department of General Internal Medicine I, Kiel, Germany

Background

The nationwide BioCrohn Registry (Biological Registry with Crohn's Disease Patients in Germany) of the German Competence-Network IBD is a five-year prospective registry of about 1.500 patients with Crohn's disease (CD) in Germany. This is a sub-study of the BioCrohn Registry reporting the induction therapy steroid-free remission rates in 393 anti-TNF-naïve CD-patients with adalimumab (ADA) or infliximab (IFX).

Methods

Within the framework of this non-interventional prospective online documentation, data on the course of disease, on psychosocial burden of disease, on health economics and on the genetic profile were examined. End of 2012 the recruitment was stopped having 1.525 CD-patients included by 59 different gastroenterology practices and hospitals with IBD-experience. All patients have a 5 year follow-up period. The databank for baseline and 6-months data has been closed in 07/2013 and after databank cleansing now we have the finalized data including the 6-months visit. Results after 6 months are calculated only on the basis of an interim analysis.

Results

392 TNF-naive CD-patients (ADA: n = 263; IFX: n = 128) have been analysed (average age: 36 years; female: 52%; smokers 34%; disease duration: 9.4 years; bowel resection: 33%; prior immunosuppressive therapy: 75%). Baseline characteristics were in the two groups. The IBD-therapy followed an accelerated step-up management. The indication for TNF-therapy has been steroid-dependent or steroid-refractory course of disease or patients haven't responded or were intolerant to an immunosuppressive therapy. Immunosuppressants were used in 19% at 6 months, in 23% after 12 months and 17% after 24 months. Accordingly to the TNF therapy, the use of systemic glucocorticoids dropped over time (baseline until 6 and 12 months) from 22.3% to 6.3% and 9.2%, respectively (p < 0.001). The remission rate (PGA) at 6 months was 70.7% and 70.1% after 12 months. In spite of the TNF-induced clinical remission (>70%) the psychosocial impairments with anxiety/depression (EQ-5D) show only minor improvement and remain on a relatively high level (baseline: 37%, 6 months: 31%, 12 months: 29%). In the induction therapy with TNF we found a steroid-free remission (HBI <5) in 66.7% at 6 months. Evaluating the efficacy of ADA vs. IFX as an induction therapy we do not find any difference in steroid-free remission rates at month 6 (ADA: 67.5%; IFX: 65.2%; p = n.s.).

Conclusion

In this real life setting anti-TNF therapy could induce steroid-free remission in about 70% with the relatively early escalation of therapy in IBD-experienced centres. In comparison there is no difference in steroid-free remission between ADA vs. IFX.