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Immunologic tolerability profile of celecoxib
R Patterson1, A E Bello, J Lefkowith
1Department of Medicine, Northwestern University, Chicago, Illinois, USA.
Clinical Therapeutics
|January 25, 2000
Summary
Celecoxib, a cyclooxygenase-2 inhibitor, showed no increased allergic reactions compared to placebo or NSAIDs in arthritis trials. Patients with sulfonamide hypersensitivity had more skin reactions, but this risk was similar across treatment groups.
Area of Science:
- Pharmacology
- Clinical Immunology
- Rheumatology
Background:
- Celecoxib selectively inhibits cyclooxygenase-2 (COX-2).
- Concerns exist regarding potential allergic reactions, particularly cross-reactivity with sulfonamides.
Purpose of the Study:
- To evaluate the incidence of allergic reactions to celecoxib.
- To assess celecoxib's safety in patients with sulfonamide hypersensitivity.
- To compare celecoxib's allergic reaction profile with placebo and NSAIDs.
Main Methods:
- Meta-analysis of 14 double-masked arthritis trials involving 11,008 patients.
- Analysis of allergic reactions in the overall cohort and a subset with sulfonamide hypersensitivity history.
- Comparison of celecoxib with placebo and non-sulfonamide NSAIDs.
Main Results:
- Overall incidence of allergic reactions with celecoxib did not differ statistically from placebo or NSAIDs.
- Patients with a history of sulfonamide hypersensitivity showed a 3-to-6-fold higher incidence of dermatologic reactions.
- Dermatologic reaction trends were consistent across celecoxib, NSAID, and placebo groups in the hypersensitive subset.
Conclusions:
- Celecoxib's risk of allergic reactions appears comparable to placebo and comparator NSAIDs.
- The potential for cross-allergenicity between celecoxib and sulfonamides is low and similar to placebo.
- Further prospective trials are recommended to confirm these findings on celecoxib safety.