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P608. Azathioprine versus mesalazine for prevention of post-operative clinical recurrence in Crohn's disease patients with endoscopic recurrence: follow-up data of a randomised, double-blind, double-dummy, 1-year, multicentre trial

W. Reinisch1, S. Angelberger1, W. Petritsch2, O. Shonova3, M. Lukas4, R. Greinwald5, R. Mueller5, E.F. Stange6, K. Herrlinger7, 1Allgemeines Krankenhaus Wien, Klinische Abt. für Gastroenterologie und Hepatologie, Vienna, Austria, 2Medizinische Universitätsklinik Graz, Klinische Abt. für Gastroenterologie, Graz, Austria, 3Nemocnice Ceske Budejovice, Gastroenterologicke oddeleni, Ceske Budejovice, Czech Republic, 4Klinické centrum Iscare Lighthouse, Prague, Czech Republic, 5Dr Falk Pharma GmbH, Dept. of Clinical Research & Development, Freiburg, Germany, 6Robert Bosch Krankenhaus, Internal Medicine I, Stuttgart, Germany, 7Asklepios Klinik Nord – Standort Heidberg, Innere Medizin I, Hamburg, Germany

Background

After curative intestinal surgery, a substantial proportion of Crohn's disease (CD) patients experience endoscopic recurrence at the site of the neoterminal ileum and the ileocolonic anastomosis. A moderate or severe endoscopic recurrence of i2–4 according to Rutgeerts et al. has been described as a predictor for clinical relapse.

This follow-up survey aimed to evaluate the long-term efficacy of mesalamine and azathioprine in CD patients with postoperative moderate or severe endoscopic recurrence [1].

Methods

This was a follow-up survey in CD patients who participated in a recently conducted double-blind, double-dummy, randomized, controlled post-operative trial for prevention of clinical relapse. In the double-blind treatment phase patients were randomized to a 52-weeks treatment with 4g mesalamine (Salofalk® tablets) or 2.0–2.5 mg/kg/BW azathioprine (Azafalk®) per day. The primary outcome in the follow-up period was clinical recurrence.

Results

46 of the originally 78 randomized patients could be included into the follow-up. The median follow-up period was approximately 4 years in both groups. Medical treatment during follow-up was comparable between the groups.

Within 24 months after the 1-year treatment with mesalamine or azathioprine, clinical recurrence was observed in 9/25 patients (36.0%) treated with azathioprine and 5/20 patients (25.0%) treated with mesalamine in the double-blind phase irrespective of the treatment during follow. Kaplan–Meier analysis did not show any significant difference in the time to clinical recurrence (p = 0.5346, 2-sided Log-Rank test, see figure).

Figure: The LIFETEST procedure.

Conclusion

The prognostic value of a 1-year treatment with high dose Eudragit-L coated mesalamine was not different to that of treatment with azathioprine for long-term prevention of clinical recurrence in post-operative CD.

Supported by Dr. Falk Pharma GmbH, Freiburg, Germany

1. Reinisch et al. Azathioprine versus mesalazine for prevention of postoperative clinical recurrence in patients with Crohn's disease with endoscopic recurrence: efficacy and safety results of a randomised, double-blind, double-dummy, multicentre trial Gut 2010;59:752–759.