title: An open-label trial of the selective cyclo-oxygenase-2 inhibitor, rofecoxib, in inflammatory bowel disease-associated peripheral arthritis and arthralgia.
abstract: BACKGROUND
  Conventional non-steroidal anti-inflammatory drugs have been associated with an increased risk of exacerbation of inflammatory bowel disease.
  
  
  OBJECTIVE
  To evaluate, in a prospective, open-label study, the safety and efficacy of a 20-day regimen of the selective cyclo-oxygenase-2 inhibitor, rofecoxib, 12.5-25 mg/day, in inflammatory bowel disease patients with associated peripheral arthropathy and/or arthritis.
  
  
  METHODS
  Patients with clinically inactive to mild inflammatory bowel disease and a joint pain score of at least two points on a scale ranging from zero (none) to four (very poor) were eligible. Response was defined by a decrease of at least two points in the arthralgia score.
  
  
  RESULTS
  Of the 32 patients included, 26 (81%) were treated with rofecoxib, 25 mg/day, and six (19%) with rofecoxib, 12.5 mg/day. In three patients (9%), rofecoxib had to be withdrawn after a few days due to gastrointestinal complaints which ceased immediately after drug discontinuation. No flare of inflammatory bowel disease occurred. Thirteen of the 32 patients (41%) were responders and, overall, the arthralgia score decreased from two to one (P = 0.0001).
  
  
  CONCLUSIONS
  This is the first prospective study on the use of a selective cyclo-oxygenase-2 inhibitor in inflammatory bowel disease patients with peripheral arthropathy and/or arthralgia. The promising safety and efficacy profile warrants further evaluation in controlled trials.
authors.affiliation: Department of Internal Medicine IV, Division of Gastroenterology and Hepatology, University of Vienna, Vienna, Austria.
authors.forename: W
authors.initials: W
authors.lastname: Reinisch
authors.forename: W
authors.initials: W
authors.lastname: Miehsler
authors.forename: C
authors.initials: C
authors.lastname: Dejaco
authors.forename: M
authors.initials: M
authors.lastname: Harrer
authors.forename: T
authors.initials: T
authors.lastname: Waldhoer
authors.forename: C
authors.initials: C
authors.lastname: Lichtenberger
authors.forename: H
authors.initials: H
authors.lastname: Vogelsang
mesh_terms: D000328:Adult; D000368:Aged; D018771:Arthralgia / Q000150:complications*; D001168:Arthritis / Q000150:complications*; D051546:Cyclooxygenase 2; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004341:Drug Evaluation; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000150:complications / Q000188:drug therapy*; D007527:Isoenzymes / Q000037:antagonists & inhibitors*; D007783:Lactones / Q000008:administration & dosage* / Q000009:adverse effects; D008565:Membrane Proteins; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D011451:Prostaglandin-Endoperoxide Synthases; D013450:Sulfones; D016896:Treatment Outcome
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors; D007527:Isoenzymes; D007783:Lactones; D008565:Membrane Proteins; D013450:Sulfones; C116926:rofecoxib; D051546:Cyclooxygenase 2; C496540:PTGS2 protein, human; D011451:Prostaglandin-Endoperoxide Synthases