Z Gastroenterol 2010; 48 - A35
DOI: 10.1055/s-0030-1254773

Endoscopic outcome of medium term adalimumab therapy in patients with Crohn's disease. National data from Hungary

L Kiss 6, Z Czegledi 1, P Miheller 2, T Molnar 3, L Lakatos 4, K Palatka 5, K Farkas 3, T Szamosi 1, J Banai 1, Z Tulassay 2, M Papp 5, I Altojay 5, F Nagy 3, J Papp 6 P Lakatos 6,
  • 1Department of Gastroenterology, State Health Centre, Budapest, Hungary
  • 22nd Department of Medicine, Semmelweis University, Budapest, Hungary
  • 31st Department of Medicine, Szeged University, Szeged, Hungary
  • 41st Department of Medicine Csolnoky F. County Hospital, Veszprem, Hungary
  • 52nd Depastrment of Medicine, University of Debrecen, Debrecen, Hungary
  • 61st Department of Medicine, Semmelweis University, Budapest, Hungary

Background/Aims: Adalimumab (ADA) is a fully human monoclonal antibody targeting tumor necrosis factor with proven efficacy in the treatment of Crohn's disease in clinical trials. In Hungary, regular long-term ADA therapy became available on an outpatient basis in December 2008 (since September 2008 as donation). In the present study our aim was to analyse the endoscopic outcome during 1-year ADA therapy in patients with Crohn's disease in specialized centers approved for biological therapy in Hungary until the 1st of November 2009.

Methods: Data of 139 CD patients were analyzed. (male/female: 61/78, mean age: 34.4 years, duration: 10.5 years). Indication for biologic therapy was active luminal disease in 81 (58.3%) and fistulizing disease in 58 (41.7%) patients. Previous infliximab therapy was given in 68 (48.9%) patients. Concomitant immunosuppression was given to all patients at induction therapy (steroid 56 (40.3%), azathioprine: 101 (72.7%) or combined: 38 (37.7%)). Medical records were captured prospectively and analyzed retrospectively. Complete mucosal healing was defined as a Simple Endoscopic Score (SES-CD) of 0, meaning no signs of active inflammation in any colonic segment or in the terminal ileum

Results: After 52 weeks of ADA therapy overall clinical response rate was 59.6 (n=89), while 41.6% patients achieved clinical remission. In addition to the presence or absence of fistulizing complication, inflammation during endoscopy was moderate-to-severe according to the most affected segment by SES-CD in 88/106 (83.1%) prior to the biological therapy. At 52 weeks complete mucosal healing was observed during endoscopy in 11/57 (19.2%) of the patients with available endoscopy or dropout due to clinical deterioration/surgery.

Conclusion: Complete mucosal healing was achieved in almost one fifth of CD patients.