Safety of etoricoxib, a specific cyclooxygenase-2 inhibitor, in asthmatic patients with aspirin-exacerbated respiratory disease.

BACKGROUND: Treatment of rheumatic conditions is limited in patients with asthma owing to concerns of nonsteroidal anti-inflammatory drugs potentially provoking asthma. Cross-sensitivity to all anti-inflammatory drugs that inhibit cyclooxygenase enzymes occurs in these individuals.

OBJECTIVES: To study the safety of etoricoxib, a specific cyclooxygenase-2 inhibitor, and to determine whether it cross-reacts with asthma in patients with aspirin-exacerbated respiratory disease (AERD).

METHODS: This study included 77 patients who had experienced asthma induced by aspirin and at least 1 other nonsteroidal anti-inflammatory drug. Baseline evaluation included blood pressure measurement, nasal examination, spirometry, and peak expiratory flow rate measurement. Patients were given placebo the first day and then were challenged with once-daily etoricoxib in 3 different doses: 60 mg on day 2, 90 mg on day 3, and 120 mg on day 4. If no evidence of intolerance was seen, each patient was rechallenged with 60 or 90 mg of etoricoxib once daily (according to the rheumatic condition) 7 days later. Reassessment of the baseline measurements was performed daily from day 1 to day 4 after the initial challenge, on day 7 after rechallenge, and after 1 month of drug intake. If the patient developed any mucosal or skin reaction, hypotension, upper or lower airway obstruction, conjunctival reaction, or laryngeal edema during the challenge test, it was considered a positive response.

RESULTS: Etoricoxib was well tolerated, without any signs of immediate or delayed hypersensitivity in aspirin- and nonsteroidal anti-inflammatory drug-induced asthmatic patients. None of 77 study patients experienced any symptoms or developed dyspnea, change in nasal examination, significant variation in peak expiratory flow rate greater than 20%, or decline in forced expiratory volume in 1 second greater than 15% during etoricoxib challenge. The exact 1-sided confidence interval for the probability of etoricoxib inducing cross-reactions in patients with AERD was 0% to 2%.

CONCLUSIONS: These results confirm the lack of cross-reactivity between specific cyclooxygenase-2 inhibitors and aspirin in AERD. Etoricoxib was safe for treating inflammation in patients with AERD.