title: Immunologic tolerability profile of celecoxib.
abstract: Celecoxib is primarily an inhibitor of cyclooxygenase (COX) 2 and, at therapeutic concentrations in humans, does not inhibit the COX-1 isoenzyme. The present meta-analyses explore the incidence of allergic reactions with celecoxib in patients in the North American and international arthritis trials, in patients with a history of hypersensitivity reactions to sulfonamides, and in patients receiving medications containing sulfonamides. Data were obtained from 11,008 patients in 14 double-masked trials of celecoxib in arthritis ranging from 4 to 24 weeks in duration. Results demonstrate that the incidence of allergic reactions with celecoxib was not statistically different from that seen with placebo or active comparators (nonsteroidal anti-inflammatory drugs [NSAIDs]) when data from the entire cohort were analyzed. The subset of patients with a history of sulfonamide hypersensitivity reactions had a 3-fold to 6-fold higher incidence of dermatologic reactions than did the entire arthritis trial cohort. Although dermatologic reactions occurred with greater frequency in patients with a history of sulfonamide hypersensitivity, the trend was consistent across all 3 treatment groups (celecoxib, NSAIDs, and placebo). According to these data and structural and metabolic differences between sulfonamides, the potential for cross-allergenicity between celecoxib and other sulfonamide-containing medications appears comparable to that of placebo and nonsulfonamide-containing NSAIDs. Additionally, the risk of allergic reactions with celecoxib appears comparable to that of placebo and comparator NSAIDs. Prospective trials are needed to confirm these findings.
authors.affiliation: Department of Medicine, Northwestern University, Chicago, Illinois, USA.
authors.forename: R
authors.initials: R
authors.lastname: Patterson
authors.forename: A E
authors.initials: AE
authors.lastname: Bello
authors.forename: J
authors.initials: J
authors.lastname: Lefkowith
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D000068579:Celecoxib; D002986:Clinical Trials as Topic; D003429:Cross Reactions; D051546:Cyclooxygenase 2; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects*; D003875:Drug Eruptions / Q000453:epidemiology; D004342:Drug Hypersensitivity / Q000453:epidemiology*; D004347:Drug Interactions; D006801:Humans; D007527:Isoenzymes; D008565:Membrane Proteins; D011451:Prostaglandin-Endoperoxide Synthases; D011720:Pyrazoles; D012307:Risk Factors; D013449:Sulfonamides / Q000009:adverse effects*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors; D007527:Isoenzymes; D008565:Membrane Proteins; D011720:Pyrazoles; D013449:Sulfonamides; D051546:Cyclooxygenase 2; C496540:PTGS2 protein, human; D011451:Prostaglandin-Endoperoxide Synthases; D000068579:Celecoxib