Safety of celecoxib and nonselective nonsteroidal anti-inflammatory drugs in juvenile idiopathic arthritis: results of the phase 4 registry

Authors

Rachel E. Sobel
Daniel J. Lovell
Hermine I. Brunner
Jennifer E. Weiss
Paula W. Morris
Beth S. Gottlieb
Elizabeth C. Chalom
Lawrence K. Jung, George Washington University
Karen B. Onel
Lisa Petiniot
Donald P. Goldsmith

Document Type

Journal Article

Publication Date

7-2014

Journal

Pediatric Rheumatology

Volume

Volume 12

Inclusive Pages

Article number 29

Abstract

Background

This study aimed to assess long-term safety and developmental data on juvenile idiopathic arthritis (JIA) patients treated in routine clinical practice with celecoxib or nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs).

Methods

Children aged ≥2 to <18 years with rheumatoid-factor–positive or –negative polyarthritis, persistent or extended oligoarthritis, or systemic arthritis were enrolled into this prospective, observational, multicenter standard-of-care registry. Eligible patients were newly or recently prescribed (≤6 months) an nsNSAID or celecoxib. Enrolled patients were followed to the end of the study, whether they remained on the original NSAID, switched, or discontinued therapy altogether. All adverse events (AEs) regardless of severity were captured in the database.

Results

A total of 274 patients (nsNSAID, n = 219; celecoxib, n = 55) were observed for 410 patient-years of observation. Naproxen, meloxicam, and nabumetone were the most frequently used nsNSAIDs. At baseline, the celecoxib group was older, had a numerically longer median time since diagnosis, and a numerically higher proportion of patients with a history of gastrointestinal-related NSAID intolerance. AEs reported were those frequently observed with NSAID treatment and were similar across groups (nsNSAIDs: 52.0%; celecoxib: 52.9%). Twelve unique patients experienced a total of 18 serious AEs; the most frequent were infections, and none was attributed to NSAID use.

Conclusions

The safety profile of celecoxib and nsNSAIDs appears similar overall. The results from this registry, ongoing pharmacovigilance, and the phase 3 trial that led to the approval of celecoxib for children with JIA provide evidence that the benefit-risk for celecoxib treatment in JIA remains positive.

Comments

Reproduced with permission of BioMed Central Pediatric Rheumatology.

Creative Commons License

This work is licensed under a Creative Commons Attribution 3.0 License.

APA Citation

Sobel, R.E., Lovell, D.J., Brunner, H.I., Weiss, J.E., Morris, P.W. et al. (2014). Safety of celecoxib and nonselective nonsteroidal anti-inflammatory drugs in juvenile idiopathic arthritis: results of the phase 4 registry. Pediatric Rheumatology, 12:29.

Peer Reviewed

1

Open Access

1