title: Safety of celecoxib and nonselective nonsteroidal anti-inflammatory drugs in juvenile idiopathic arthritis: results of the Phase 4 registry.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT00688545.
authors: Pfizer Inc, 235 East 42nd St, MS#219-9-1, New York, NY 10017, USA.
authors: Rachel E
authors: RE
authors: Sobel
authors: Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors: Daniel J
authors: DJ
authors: Lovell
authors: Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors: Hermine I
authors: HI
authors: Brunner
authors: Hackensack University Medical Center, Hackensack, NJ, USA.
authors: Jennifer E
authors: JE
authors: Weiss
authors: University of Arkansas for Medical Science, Little Rock, AR, USA.
authors: Paula W
authors: PW
authors: Morris
authors: Cohen Children's Medical Center of New York, New Hyde Park, NY, USA.
authors: Beth S
authors: BS
authors: Gottlieb
authors: St. Barnabas Medical Center, Livingston, NJ, USA.
authors: Elizabeth C
authors: EC
authors: Chalom
authors: Children's National Medical Center, Washington, DC, USA.
authors: Lawrence K
authors: LK
authors: Jung
authors: University of Chicago, Chicago, IL, USA.
authors: Karen B
authors: KB
authors: Onel
authors: Specially for Children, Dell Children's Medical Center, Austin, TX, USA.
authors: Lisa
authors: L
authors: Petiniot
authors: St. Christopher's Hospital for Children/Drexel College of Medicine, Philadelphia, PA, USA.
authors: Donald P
authors: DP
authors: Goldsmith
authors: Rainbow Babies & Children's Hospital, Cleveland, OH, USA ; Current address: Seattle Children's Hospital, Seattle, WA, USA.
authors: Kabita
authors: K
authors: Nanda
authors: Phoenix Children's Hospital, Phoenix, AZ, USA.
authors: Michael
authors: M
authors: Shishov
authors: Pfizer Inc, 235 East 42nd St, MS#219-9-1, New York, NY 10017, USA.
authors: Staci
authors: S
authors: Abramsky
authors: United BioSource Corporation, Ann Arbor, MI, USA.
authors: James P
authors: JP
authors: Young
authors: Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors: Edward H
authors: EH
authors: Giannini
mesh_terms: D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000145:classification; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D000068579:Celecoxib; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D054539:Medication Therapy Management; D061214:Patient Safety; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects*; D012042:Registries; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects*; D013995:Time; D014481:United States
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib
keywords: Celecoxib; Juvenile idiopathic arthritis; NSAIDs; Safety