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* = Presenting author

P630 Efficacy of TNF -alpha therapy in Crohn's disease: A 5-year retrospective cohort study in an intermediate sized hospital

C. Quaade Michelsen1, S. Wildt*2, L.K. Munck2

1Koege Hospital, University Hospital of Copenhagen, Department of Medicine, section of gastroenterology, Koege, Denmark, 2Koege Hospital, University Hospital of Copenhagen, Department of medicine, section of gastroenterology, Koege, Denmark

Background

Meta-analysis and randomised controlled trials have demonstrated the efficacy and safety of anti-TNF-alpha antibody therapy (anti-TNF α ), and this has been confirmed in cohort studies from tertiary care centres. Whether these results can be projected to daily clinical practice in smaller primary and secondary centres is not as well described. The aim of this study was to evaluate the effects and side effects of anti-TNF α in a non-selected population of Crohn's patients in a real life clinical setting.

Methods

We conducted a retrospective cohort study in an intermediate sized hospital. All patients with Crohn's disease who initiated treatment with infliximab or adalimumab at Koege Hospital, Denmark, between January 2009 and January 2014 were identified and their files were reviewed. Effect and safety of therapy (response, remission, and side effects) was based on physician's global assessment, symptoms and paraclinical findings in the patient files.

Results

Of the 142 patients included 105 were TNF α naïve. During the study period 37 of the 105 patients reinitiated or switched between infliximab or adalimumab therapy. Patient demographics were: average age 36 years, male 52%, disease duration: 5 years, bowel resection: 36%, concomitant immunosuppressive therapy at inclusion: 66%, a total of 46% did not tolerate thiopurines. The indications for anti-TNF α were luminal disease in 119 patients (84%) and fistulae in 23 (16%). After 6 weeks of treatment (induction) 87% had an initial response or were in remission. 125 patients were still on anti-TNF α after 12 month and 49% of patients were in steroid-free remission. Median time on anti-TNF α was 16 months and median time of follow-up was 25 months. Patients who received infliximab gained and maintained a mean of 3 kilograms during the first months of treatment. Side effects caused discontinuation in 24 % of patients who received infliximab treatment and in 9 % who received adalimumab treatment. Severe infections and anaphylactic reactions were the most frequent severe side effect associated with infliximab, severe infections the most frequent severe side effects associated with adalimumab.

Conclusion

In this real life clinical setting anti-TNF α induced steroid free remission in 50 % of patients with Crohn's disease at 12 month. Discontinuation of anti-TNF α due to side effects was higher than reported in randomised controlled trials.