3. Anti-TNF in patients with an early course of Crohn's disease – a prospective observational study in Germany
B. Bokemeyer1, U. Helwig2, A. Stallmach3, N. Teich4, R. Halle5, M. Bläker6, A.-K. Rupf7, T. Krummenerl8, D. Hüppe9, A. Krummenerl10, M. Düffelmeyer11, S. Nikolaus12, S. Schreiber12, 1Gastroenterology Practice Minden, University Hospital of Schleswig-Holstein, Department of General Medicine, Kiel, Minden, 2Gastroenterology Practice, Oldenburg, 3University of Jena, Gastroenterology Department, Jena, 4Internistische Gemeinschaftspraxis, Leipzig, 5Gastroenterologische Gemeinschaftspraxis, Hameln, 6Gastroenterology Practice, Hamburg, 7University Hospital Mannheim, Mannheim, 8Gastroenterology Practice Minden, Münster, 9Gastroenterology Practice, Herne, 10Städtisches Krankenhaus Martha Maria, Klinik für Innere Medizin I, Halle, 11IOMTech GmbH, Berlin, 12University Hospital of Schleswig-Holstein, Department of General Medicine, Kiel, Germany
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 patients suffering from Crohn's disease (CD) in Germany. Up to October 2012, about 1,400 patients were included by 58 different gastroenterology practices and hospitals with IBD-experience. This 24 months follow-up interim analysis reports in particular the anti-TNF data of 620 early disease CD-patients.
Within the framework of this non-interventional prospective online documentation, data on the course of disease, on psychosocial disease burden, on health economics and on the genetic profile will be examined. Until the end of 2012 the registry aims at including 1,500 patients with 5 years of follow-up.
620 early disease CD-patients (course of disease: <3 years) were analyzed (average age: 33 years; female: 55%). The following therapies were observed. The use of immunosuppressants and/or anti-TNF increased in the 24-months course up to 73.9% (6 months), 78.9% (12 months) and 82.8% after two years (34.5% anti-TNF after 24 months). Accordingly the use of systemic glucocorticoids dropped over time (baseline until 6, 12, 18 and 24 months) from 24.7% to 8.4%, 7.4%, 5.6% and 1.7%, respectively (p < 0.001). The remission rate (PGA) was 72.3% after 12 months and 73.3% after 24 months and CRP (baseline: 9.2 mg/l, 24 months: 4.2 mg/l) normalized over the time. Within this group the early disease CD-patients with an anti-TNF therapy in the first 12 months after baseline (n = 82; time since first diagnosis 1.4 years) and a slightly decreasing use of azathioprine in this subgroup (baseline: 31.1% and 24 months 25.8%) showed despite their complex disease a relatively favourable course (24 months: 63.3% in remission and HBI 2.5). Additionally we found a significant decrease in active smokers in the early disease TNF-group with 30% at baseline and only 14% after 24 months.
These 24 months real life setting follow-up data show that the group of early disease CD-patients suffer from a large burden of disease and improve considerably with the relatively early escalation of therapy consistent along current CD-guidelines in IBD-experienced centres with only minor usage of systemic glucocorticoids in the maintenance therapy. Especially the early disease CD-patients with anti-TNF show in spite of their complex disease a relatively favourable course.