Evidence map›Paper›PMID 25057265›Full record

Observational studyPediatric rheumatology online journal2014

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

Rachel E Sobel, Daniel J Lovell, Hermine I Brunner, Jennifer E Weiss, Paula W Morris, Beth S Gottlieb, Elizabeth C Chalom, Lawrence K Jung, Karen B Onel, Lisa Petiniot and 7 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Pediatric rheumatology online journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00688545 (SINCERE™), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00688545 terminatednot on this map

SINCERE™: Safety in Idiopathic Arthritis: NSAIDs and Celebrex Evaluation Registry A Prospective Observational Registry Of Patients With Juvenile Idiopathic Arthritis (JIA) Treated With NSAIDs

TypeobservationalSponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.Ran2009 to 2012Enrolled275ConditionsArthritis, Juvenile RheumatoidArmsCelecoxib, nsNSAIDs
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. New Insights on Juvenile Psoriatic Arthritis.Frontiers in pediatrics · 2022
    Review
  10. Article
  11. Review
  12. Review
  13. The molecular biology of pelvi-ureteric junction obstruction.Pediatric nephrology (Berlin, Germany) · 2018
    Review
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 1 country.

Rachel E SobelPfizer Inc, 235 East 42nd St, MS#219-9-1, New York, NY 10017, USA.
Daniel J LovellCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Hermine I BrunnerCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Jennifer E WeissHackensack University Medical Center, Hackensack, NJ, USA.
Paula W MorrisUniversity of Arkansas for Medical Science, Little Rock, AR, USA.
Beth S GottliebCohen Children's Medical Center of New York, New Hyde Park, NY, USA.
Elizabeth C ChalomSt. Barnabas Medical Center, Livingston, NJ, USA.
Lawrence K JungChildren's National Medical Center, Washington, DC, USA.
Karen B OnelUniversity of Chicago, Chicago, IL, USA.
Lisa PetiniotSpecially for Children, Dell Children's Medical Center, Austin, TX, USA.
Donald P GoldsmithSt. Christopher's Hospital for Children/Drexel College of Medicine, Philadelphia, PA, USA.
Kabita NandaRainbow Babies & Children's Hospital, Cleveland, OH, USA ; Current address: Seattle Children's Hospital, Seattle, WA, USA.
Michael ShishovPhoenix Children's Hospital, Phoenix, AZ, USA.
Staci AbramskyPfizer Inc, 235 East 42nd St, MS#219-9-1, New York, NY 10017, USA.
James P YoungUnited BioSource Corporation, Ann Arbor, MI, USA.
Edward H GianniniCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Pediatric Rheumatology Collaborative Study Group
Cincinnati Children's Hospital Medical Center · USPfizer (United States) · USSaint Barnabas Medical Center · USChildren's National · USCohen Children's Medical Center · USDell Children's Medical Center of Central Texas · USHackensack University Medical Center · USPhoenix Children's Hospital · USSeattle Children's Hospital · USUniversity of Illinois Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis 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).

methodsChildren 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.

resultsA 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.

conclusionsThe 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 registrationClinicalTrials.gov identifier NCT00688545.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalDrug-Related Side Effects and Adverse ReactionsAdolescentArthritis, JuvenileCelecoxibChildChild, PreschoolFemaleHumansMaleMedication Therapy ManagementPatient SafetyPyrazolesRegistriesSulfonamidesTimeAnti-Inflammatory Agents, Non-SteroidalCelecoxibPyrazolesSulfonamidesCelecoxibJuvenile idiopathic arthritisNSAIDsSafety

Identifiers

PMID25057265
PMCPMC4107597
OpenAlexW2120729861

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.