title: Adalimumab in budesonide and methotrexate refractory collagenous colitis.
abstract: BACKGROUND
  We described three patients with collagenous colitis (CC) who developed side effects or were refractory to both budesonide and methotrexate and were given adalimumab (ADA) as a third-line treatment.
  
  
  METHODS
  Three patients (two women, mean age 45 years and one man, 74 years old) were included. Mean bowel movements per day per week were calculated and stool weight/24 h registered prior to and following ADA treatment. ADA was given in doses 160 mg s.c. (baseline), 80 mg (week 2) and 40 mg (week 4). Sigmoidoscopies with biopsies were performed at baseline and after 6 weeks to examine changes in histology. The Psychological General Well-Being Index (PGWBI) and Short Health Scale (SHS) were used at baseline and after 6 weeks.
  
  
  RESULTS
  The two female patients tolerated the treatment well. The male patient developed, despite clinical response, side effects (vomiting, abdominal pain) after 80 mg of ADA and the treatment was stopped as side effects reoccurred after rechallenge. The two women were in clinical remission at week 6 and the mean stool frequency per day decreased from mean 11 to 2. Mean stool weight/24 h changed from 600 to 185 g. The quality of life improved drastically in all patients. There were no consistent changes in histology.
  
  
  CONCLUSIONS
  ADA seems effective in budesonide and methotrexate refractory CC and can be administrated to selected patients to achieve clinical remission, improve quality of life and possibly avoid colectomy. Further studies for induction and maintenance treatment should be conducted to confirm efficacy and examine safety issues, even in long term.
authors.affiliation: Linköping University Hospital, Clinic of Endocrinology and Gastroenterology, Linköping, Sweden. andreas.munch@lio.se
authors.forename: Andreas
authors.initials: A
authors.lastname: Münch
authors.forename: Simone
authors.initials: S
authors.lastname: Ignatova
authors.forename: Magnus
authors.initials: M
authors.lastname: Ström
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D001706:Biopsy; D019819:Budesonide; D046729:Colitis, Collagenous / Q000188:drug therapy* / Q000473:pathology* / Q000503:physiopathology; D003672:Defecation; D004351:Drug Resistance; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate; D008875:Middle Aged; D011788:Quality of Life; D012812:Sigmoidoscopy; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D019819:Budesonide; D000068879:Adalimumab; D008727:Methotrexate