title: Adalimumab - an effective and promising treatment for patients with fistulizing Crohn's disease: a case series.
abstract: BACKGROUND
  Crohn's disease is a chronic inflammatory bowel disease of unknown etiology which may affect any part of the bowel. Fistulas are a common and often serious complication of Crohn's disease. The treatment for fistulizing Crohn's disease can be medical, surgical or a combination of the two. Recently, adalimumab, a fully human anti-tumor necrosis factor monoclonal antibody, has been suggested as a safe and effective treatment for the induction and maintenance of remission in adult patients with moderate to severe Crohn's disease, who are refractory to conventional therapy or intolerant to infliximab. However, large studies focusing on evaluating the efficacy of adalimumab in fistulizing Crohn's disease have not yet been published.
  
  
  METHODS
  We report the cases of three patients, of European Caucasian ethnicity and Greek nationality, with active luminal and fistulizing Crohn's disease. All of the cases were treated successfully with adalimumab. Patient 1 (a 44-year-old man) and patient 2 (an 18-year-old woman) developed early post-surgical enterocutaneous fistulas, while patient 3 (a 20-year-old woman) had peri-anal fistulizing Crohn's disease. Adalimumab treatment (160 mg subcutaneously at week zero, 80 mg at week two, and 40 mg every other week) was used for three different indications: (1) after the failure of other conservative medical treatments for Crohn's disease (patient 1); (2) as a monotherapy in treating a naive patient (patient 2); (3) after an intolerance to infliximab (patient 3). A remission of the active luminal and fistulizing disease was achieved soon after the initiation of adalimumab and sustained thereafter with maintenance doses. No further surgical intervention was required and no adverse effects were observed in any of the cases.
  
  
  CONCLUSIONS
  Fistulizing Crohn's disease remains a challenge in clinical practice. Adalimumab seems to be an effective, well-tolerated and safe treatment option for the induction and maintenance of remission in patients with moderate to severe peri-anal fistulizing Crohn's disease. Furthermore, adalimumab seems to be a promising treatment option for patients with moderate to severe fistulizing Crohn's disease with enterocutaneous fistulas. However, this clinical observation needs to be investigated in further clinical trials.
authors.affiliation: 1st Surgical Department, Medical School, Democritus University of Thrace, University Hospital of Alexandroupolis, University Campus, Dragana 681 00, Alexandroupolis, Greece. eeffraem@med.duth.gr.
authors.forename: George
authors.initials: G
authors.lastname: Kouklakis
authors.forename: Eleni I
authors.initials: EI
authors.lastname: Efremidou
authors.forename: Peter
authors.initials: P
authors.lastname: Zezos
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Liratzopoulos
authors.forename: Vassilios D
authors.initials: VD
authors.lastname: Souftas
authors.forename: Anthia
authors.initials: A
authors.lastname: Gatopoulou
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Simopoulos
authors.forename: Konstantinos J
authors.initials: KJ
authors.lastname: Manolas