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P386 Anti-TNF alpha as induction and maintenance therapy in ulcerative colitis patients in the BioColitis Registry in Germany

B. Bokemeyer*1, T. Krummenerl2, C. Maaser3, J. Büning4, R. Atreya5, A. Lügering6, U. Helwig7, P. Jessen8, P. Hartmann9, S. Schreiber10

1Gastroenterology Practice Minden, University Hospital Schleswig-Holstein, Department of General Internal Medicine I, Kiel, Germany, Minden, Germany, 2Gastroenterology Practice, Gastroenterology, Münster, Germany, 3University Teaching Hospital Lüneburg, IBD Outpatient Clinic and Department of Geriatric Medicine, Lüneburg, Germany, 4University Hospital Schleswig-Holstein, Campus Lübeck, Medical Department I, Gastroenterology, Lübeck, Germany, 5University of Erlangen-Nuremberg, Department of Medicine 1, Erlangen, Germany, 6Gastroenterology Practice Münster, Münster, Germany, 7Gastroenterology Practice Oldenburg, Oldenburg, Germany, 8Gastroenterology Practice, Gastroenterology, Altenholz, Germany, 9Gastroenterology Practice, Minden, Germany, 10Christian-Albrechts-Universität, University Hospital Schleswig-Holstein, Department of General Internal Medicine I, Kiel, Germany

Background

The BioColitis Registry (Biological Registry with ulcerative colitis [UC] Patients in Germany) of the Competence-Network IBD is a 5-year prospective registration of UC patients with an early disease and/or a newly introduced biological therapy in Germany. At the end of 2015, about 650 patients from 38 gastroenterology practices and hospitals had been included in the ‘BioColitis-Study’. Further recruitment will be continued until the end of 2016. The following interim analysis of 249 newly introduced biological therapies reports the clinical 6-months follow-up data of the sub-group with 149 anti-TNF-naïve UC patients with the first anti-TNF as an induction and maintenance therapy.

Methods

Within the framework of this prospective non-interventional study with an online documentation of data on the course of the disease, drug therapy, psychosocial burden, and health economics, the patients’ genetic profile will be examined additionally. Until the end of 2016, the registry aims at including 1 000 patients with a 5-year follow-up.

Results

In the study, 149 anti-TNF-naïve UC patients in therapy were available for the interim analysis (average age 43 years; female 46%; pancolitis 46%; course of disease 9.3 years). In total, 103 patients had a 6-months follow-up: mean pMayo 1.3 and remission (pMayo < 2) 60.3%. The following therapies were observed at the 6-month follow-up: 5-ASA 38%; steroids 27%; immunosuppressants 33%; biologicals 98%. Further, 78% went active employment and 35% of the patients suffered from sub-depression/depression.

Conclusion

About 60% of these anti-TNF-naïve UC patients were in clinical remission at 6-months of follow-up. These anti-TNF UC patients showed an unexpectedly high (co)morbidity with unmet needs, indicating a reduced health state already in these anti-TNF-naïve UC patients.