Background/Purpose: Celecoxib, a selective COX-2 inhibitor, was approved by the FDA for the treatment of the signs and symptoms of JIA in children aged 2-17 years in December, 2006.  As a condition of approval, Pfizer conducted a Phase IV study, the Safety in Idiopathic Arthritis: NSAIDs and Celebrex Evaluation Registry (SINCERE), to collect longer-term safety and developmental data on patients with JIA treated in routine clinical practice with celecoxib or non-selective NSAIDs (nsNSAIDs).

Methods: Children aged between 2 and 18 years with RF(+) or RF(-) polyarthritis, persistent or extended oligoarthritis, or systemic juvenile arthritis (without features of extra-articular features for ≥6 months) were enrolled into this prospective, observational, multi-centered, standard-of-care registry.  To be eligible, patients had to be receiving newly or recently prescribed (≤6 months) nsNSAID or celecoxib.  Duration of previous nsNSAID or celecoxib exposure, or use of concomitant DMARD or biologic therapy did not affect eligibility.  Once enrolled, patients were to remain in the study whether they continued on the original NSAID, switched, or discontinued NSAIDs altogether.  Visits were scheduled at 0, 4, 8, 12 months, and at 6 month intervals thereafter for a minimum of 2 years.  All adverse events (AEs) regardless of severity were captured in the SINCERE database. 

Results: A total of 274 patients (219 in the nsNSAID and 55 in the celecoxib group) were observed for 410 patient-years of observation (PYO) at study termination.  Sixty percent of patients in the celecoxib group, and 53% in the nsNSAID group had oligoarthritis.  Naproxen, meloxicam, and nabumetone were the most frequently used nsNSAIDs.  At baseline, the celecoxib group had numerically longer disease duration, was older, and had a higher median weight and height.  This is consistent with the practice of using celecoxib as the second or third NSAID in JIA.  A numerically higher proportion of celecoxib patients had a history of intolerance to nsNSAIDs, mostly due to gastrointestinal side effects.  The analysis of AEs reported during the study showed a similar incidence of AEs across groups (44 and 53/100 PYO for nsNSAID and celecoxib respectively, and 50/100 PYO for those off-NSAID [≥29 days after final dose]).  AEs were those frequently observed with NSAID treatment.  Two patients on nsNSAID and 2 off-NSAID experienced AEs of special interest.  Twelve unique patients experienced a total of 18 serious adverse events (SAEs), the most frequent of which were infections; none were attributed to NSAID.  Incidence rates (95% CI) of SAEs per 100 PYO were 3.4 (1.2, 5.6) and 2.9 (0, 7.0) for the nsNSAID and celecoxib group respectively, and 4.0 (0, 8.6) for the off-NSAID cohort.  Overall, the study results indicate no important difference in the safety profiles between celecoxib and nsNSAIDs.

Conclusion: The total study population of 274 patients followed for a total of 410 PYO is one of the largest JIA NSAID cohorts, and adds substantially to the safety experience of NSAID treatment of JIA.  The safety profile of celecoxib appears similar overall to that of nsNSAIDs and the benefit-risk for celecoxib treatment in JIA remains positive.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-celecoxib-and-non-selective-non-steroidal-anti-inflammatory-drugs-in-juvenile-idiopathic-arthritis/