Evidence map›Paper›PMID 23696633›Full record

Trial reportAnnals of the rheumatic diseases2014

Efficacy and safety of infliximab plus naproxen versus naproxen alone in patients with early, active axial spondyloarthritis: results from the double-blind, placebo-controlled INFAST study, Part 1.

J Sieper, J Lenaerts, J Wollenhaupt, M Rudwaleit, V I Mazurov, L Myasoutova, S Park, Y Song, R Yao, D Chitkara and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00844805 (Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial), which is not on this map. Cited by 83 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 7 pooled it
15.1field-weighted citation impact, top 1% 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.

NCT00844805 phase3completednot on this map

Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2009 to 2011Enrolled158ConditionsAnkylosing Spondylitis, Axial SpondyloarthritisArmsInfliximab, Placebo, Naproxen
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 7 syntheses or guidelines pooled it, 212 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Guideline
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. Observational
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. Review

23 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 5 countries.

J SieperMedical Department I, Rheumatology, Charité Campus Benjamin Franklin, , Berlin, Germany.
J Lenaerts
J Wollenhaupt
M Rudwaleit
V I Mazurov
L Myasoutova
S Park
Y Song
R Yao
D Chitkara
N Vastesaeger
All INFAST Investigators
Charité - Universitätsmedizin Berlin · DEMerck & Co., Inc., Rahway, NJ, USA (United States) · USCatholic University of Korea · KRKazan State Medical University · RUMSD (Belgium) · BESaint Petersburg State Pediatric Medical University · RUSeoul National University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess whether combination therapy with infliximab (IFX) plus nonsteroidal anti-inflammatory drugs (NSAIDs) is superior to NSAID monotherapy for reaching Assessment of SpondyloArthritis international Society (ASAS) partial remission in patients with early, active axial spondyloarthritis (SpA) who were naïve to NSAIDs or received a submaximal dose of NSAIDs.

methodsPatients were randomised (2 : 1 ratio) to receive naproxen (NPX) 1000 mg daily plus either IFX 5 mg/kg or placebo (PBO) at weeks 0, 2, 6, 12, 18 and 24. The primary efficacy measure was the percentage of patients who met ASAS partial remission criteria at week 28. Several other measures of disease activity, clinical symptoms and patient-rated outcomes were evaluated. Treatment group differences were analysed with Fisher exact tests or analysis of covariance.

resultsA greater percentage of patients achieved ASAS partial remission in the IFX+NPX group (61.9%; 65/105) than in the PBO+NPX group (35.3%; 18/51) at week 28 (p=0.002) and at all other visits (p<0.05, all comparisons). Results of most other disease activity and patient-reported endpoints (including Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, multiple quality of life measures and pain measures) showed greater improvement in the IFX+NPX group than the PBO+NPX group, with several measures demonstrating early and consistent improvement over 28 weeks of treatment.

conclusionsPatients with early, active axial SpA who received IFX+NPX combination treatment were twice as likely to achieve clinical remission as patients who received NPX alone. NPX alone led to clinical remission in a third of patients.

Indexed as

AdolescentAdultAntibodies, MonoclonalAnti-Inflammatory Agents, Non-SteroidalAntirheumatic AgentsDouble-Blind MethodDrug Therapy, CombinationEarly DiagnosisFemaleHumansInfliximabMaleMiddle AgedNaproxenPlacebosSpondylarthritisAntibodies, MonoclonalAnti-Inflammatory Agents, Non-SteroidalAntirheumatic AgentsInfliximabNaproxenPlacebos

Identifiers

PMID23696633
PMCPMC3888606
OpenAlexW2099312926

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.