PMID- 25057265
OWN - NLM
STAT- MEDLINE
DCOM- 20151116
LR  - 20231110
IS  - 1546-0096 (Print)
IS  - 1546-0096 (Electronic)
IS  - 1546-0096 (Linking)
VI  - 12
DP  - 2014
TI  - Safety of celecoxib and nonselective nonsteroidal anti-inflammatory drugs in 
      juvenile idiopathic arthritis: results of the Phase 4 registry.
PG  - 29
LID - 10.1186/1546-0096-12-29 [doi]
AB  - 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. 
      TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00688545.
FAU - Sobel, Rachel E
AU  - Sobel RE
AD  - Pfizer Inc, 235 East 42nd St, MS#219-9-1, New York, NY 10017, USA.
FAU - Lovell, Daniel J
AU  - Lovell DJ
AD  - Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
FAU - Brunner, Hermine I
AU  - Brunner HI
AD  - Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
FAU - Weiss, Jennifer E
AU  - Weiss JE
AD  - Hackensack University Medical Center, Hackensack, NJ, USA.
FAU - Morris, Paula W
AU  - Morris PW
AD  - University of Arkansas for Medical Science, Little Rock, AR, USA.
FAU - Gottlieb, Beth S
AU  - Gottlieb BS
AD  - Cohen Children's Medical Center of New York, New Hyde Park, NY, USA.
FAU - Chalom, Elizabeth C
AU  - Chalom EC
AD  - St. Barnabas Medical Center, Livingston, NJ, USA.
FAU - Jung, Lawrence K
AU  - Jung LK
AD  - Children's National Medical Center, Washington, DC, USA.
FAU - Onel, Karen B
AU  - Onel KB
AD  - University of Chicago, Chicago, IL, USA.
FAU - Petiniot, Lisa
AU  - Petiniot L
AD  - Specially for Children, Dell Children's Medical Center, Austin, TX, USA.
FAU - Goldsmith, Donald P
AU  - Goldsmith DP
AD  - St. Christopher's Hospital for Children/Drexel College of Medicine, Philadelphia, 
      PA, USA.
FAU - Nanda, Kabita
AU  - Nanda K
AD  - Rainbow Babies & Children's Hospital, Cleveland, OH, USA ; Current address: 
      Seattle Children's Hospital, Seattle, WA, USA.
FAU - Shishov, Michael
AU  - Shishov M
AD  - Phoenix Children's Hospital, Phoenix, AZ, USA.
FAU - Abramsky, Staci
AU  - Abramsky S
AD  - Pfizer Inc, 235 East 42nd St, MS#219-9-1, New York, NY 10017, USA.
FAU - Young, James P
AU  - Young JP
AD  - United BioSource Corporation, Ann Arbor, MI, USA.
FAU - Giannini, Edward H
AU  - Giannini EH
AD  - Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
CN  - Pediatric Rheumatology Collaborative Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT00688545
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140716
PL  - England
TA  - Pediatr Rheumatol Online J
JT  - Pediatric rheumatology online journal
JID - 101248897
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Pyrazoles)
RN  - 0 (Sulfonamides)
RN  - JCX84Q7J1L (Celecoxib)
SB  - IM
MH  - Adolescent
MH  - *Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse 
      effects/classification
MH  - Arthritis, Juvenile/*drug therapy
MH  - Celecoxib
MH  - Child
MH  - Child, Preschool
MH  - *Drug-Related Side Effects and Adverse Reactions/diagnosis/epidemiology/etiology
MH  - Female
MH  - Humans
MH  - Male
MH  - Medication Therapy Management
MH  - Patient Safety
MH  - Pyrazoles/administration & dosage/*adverse effects
MH  - Registries
MH  - Sulfonamides/administration & dosage/*adverse effects
MH  - Time
MH  - United States
PMC - PMC4107597
OTO - NOTNLM
OT  - Celecoxib
OT  - Juvenile idiopathic arthritis
OT  - NSAIDs
OT  - Safety
FIR - Rabinovich, C Egla
IR  - Rabinovich CE
FIR - Dewitt, Esi Morgan
IR  - Dewitt EM
FIR - Klein-Gitelman, S
IR  - Klein-Gitelman S
FIR - Singer, Nora G
IR  - Singer NG
FIR - Kahn, Philip J
IR  - Kahn PJ
FIR - Ruth, Natasha
IR  - Ruth N
FIR - Graham, Thomas
IR  - Graham T
FIR - Reinhardt, Adam
IR  - Reinhardt A
FIR - Graham, Tameika
IR  - Graham T
FIR - Petranick, Kimberly
IR  - Petranick K
FIR - Sherrard, Tina
IR  - Sherrard T
FIR - Srivastava, Shweta
IR  - Srivastava S
FIR - Mallen, Sharon
IR  - Mallen S
FIR - Upadhyay, Sameer
IR  - Upadhyay S
FIR - Essex, Margaret Noyes
IR  - Essex MN
FIR - Reynolds, Robert
IR  - Reynolds R
EDAT- 2014/07/25 06:00
MHDA- 2014/07/25 06:01
PMCR- 2014/07/16
CRDT- 2014/07/25 06:00
PHST- 2014/05/14 00:00 [received]
PHST- 2014/07/09 00:00 [accepted]
PHST- 2014/07/25 06:00 [entrez]
PHST- 2014/07/25 06:00 [pubmed]
PHST- 2014/07/25 06:01 [medline]
PHST- 2014/07/16 00:00 [pmc-release]
AID - 1546-0096-12-29 [pii]
AID - 10.1186/1546-0096-12-29 [doi]
PST - epublish
SO  - Pediatr Rheumatol Online J. 2014 Jul 16;12:29. doi: 10.1186/1546-0096-12-29. 
      eCollection 2014.