An open‐label trial of the selective cyclo‐oxygenase‐2 inhibitor, rofecoxib, in inflammatory bowel disease‐associated peripheral arthritis and arthralgia

• Published in: Alimentary pharmacology & therapeutics Vol. 17; no. 11; pp. 1371 - 1380
• Main Authors: Reinisch, W., Miehsler, W., Dejaco, C., Harrer, M., Waldhoer, T., Lichtenberger, C., Vogelsang, H.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01-06-2003; Blackwell
• Subjects: Adult; Aged; Arthralgia - complications; Arthritis - complications; Biological and medical sciences; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors - administration & dosage; Cyclooxygenase Inhibitors - adverse effects; Drug Evaluation; Humans; Inflammatory Bowel Diseases - complications; Inflammatory Bowel Diseases - drug therapy; Isoenzymes - antagonists & inhibitors; Lactones - administration & dosage; Lactones - adverse effects; Medical sciences; Membrane Proteins; Middle Aged; Pain Measurement; Prospective Studies; Prostaglandin-Endoperoxide Synthases; Sulfones; Treatment Outcome
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1046/j.1365-2036.2003.01596.x

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 In three patients (9%), rofecoxib had to be withdrawn after a few days due to gastrointestinal complaints which ceased immediately after drug discontinuation.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.