Premium
An open‐label trial of the selective cyclo‐oxygenase‐2 inhibitor, rofecoxib, in inflammatory bowel disease‐associated peripheral arthritis and arthralgia
Author(s) -
Reinisch W.,
Miehsler W.,
Dejaco C.,
Harrer M.,
Waldhoer T.,
Lichtenberger C.,
Vogelsang H.
Publication year - 2003
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2003.01596.x
Subject(s) - medicine , rofecoxib , inflammatory bowel disease , arthritis , arthropathy , gastroenterology , exacerbation , regimen , prospective cohort study , inflammatory arthritis , surgery , osteoarthritis , disease , pathology , biochemistry , chemistry , alternative medicine , cyclooxygenase , enzyme
Summary Background: Conventional non‐steroidal anti‐inflammatory drugs have been associated with an increased risk of exacerbation of inflammatory bowel disease. Aim: 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 In three patients (9%), rofecoxib had to be withdrawn after a few days due to gastrointestinal complaints which ceased immediately after drug discontinuation.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.