Z Gastroenterol 2009; 47 - A11
DOI: 10.1055/s-0029-1223990

Early efficacy and safety of adalimumab therapy in patients with Crohn's disease

Z Czegledi 1, P Miheller 2, T Szamosi 1, J Banai 1, Z Tulassay 2, O Gemela 3, J Papp 3, P Lakatos 3
  • 1Department of Gastroenterology, State Health Centre, Budapest, Hungary
  • 22nd Department of Medicine, Semmelweis University, Budapest, Hungary
  • 31st Department of Medicine, Semmelweis University, Budapest, Hungary

Aims: Adalimumab is a fully human monoclonal antibody targeting tumor necrosis factor. We assess the early efficacy and frequency of side effects during induction and maintenance adalimumab therapy in patients with Crohn's disease.

Methods: 54 CD patients were analyzed. (male/female: 34/20, mean age: 31.3 years, duration: 8.7 years). Indication for biologic therapy was steroid dependency and/or steroid refractory disease in 29 (53.7%) and fistulizing disease in 25 (46.3%) patients. Previous infliximab therapy was given in 20 (37%) patients. Concomitant immunosuppression was given to all patients (steroid 43 (79.6%), azathioprine: 46 (85.2%), combined: 36 (66.7%)). Medical records were retrospectively analyzed.

Results: After induction therapy (at week 4) only 3 patients were considered primary non-responders. At 12-weeks the overall response rate was 68.5% (n=37), while 24 (44.4%) patients achieved remission. Complications: four abscesses, two herpes zooster infections and one CMV colitis occurred during the therapy. Two patients had a skin reaction and two needed dilatation because of a stricture of the rectum. One urgent surgery was performed because of ileus of the small intestine.

Conclusion: The 12-week efficacy of adalimumab treatment in this referral population highly exposed to infliximab was comparable to results in clinical trials. Early infectious complications were relatively frequent probably due to the high percentage of triple therapy with immunosupressives.