Evidence map›Paper›PMID 23740231›Full record

Trial reportAnnals of the rheumatic diseases2014

Maintenance of biologic-free remission with naproxen or no treatment in patients with early, active axial spondyloarthritis: results from a 6-month, randomised, open-label follow-up study, INFAST Part 2.

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 readMulticenter StudyRandomized Controlled Trial
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 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
7.8field-weighted citation impact, top 2% 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

25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 64 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Pooled it
  4. Review
  5. Review
  6. Article
  7. Article
  8. A glance into the future of diagnosis and treatment of spondyloarthritis.Therapeutic advances in musculoskeletal disease · 2022
    Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. New evidence on the management of spondyloarthritis.Nature reviews. Rheumatology · 2016
    Review
  19. Review
  20. Review
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

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

objectiveTo investigate whether biologic-free remission can be achieved in patients with early, active axial spondyloarthritis (SpA) who were in partial remission after 28 weeks of infliximab (IFX)+naproxen (NPX) or placebo (PBO)+NPX treatment and whether treatment with NPX was superior to no treatment to maintain disease control.

methodInfliximab as First-Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial (INFAST) Part 1 was a double-blind, randomised, controlled trial in biologic-naïve patients with early, active, moderate-to-severe axial SpA treated with either IFX 5 mg/kg+NPX 1000 mg/d or PBO+NPX 1000 mg/d for 28 weeks. Patients achieving Assessment of SpondyloArthritis international Society (ASAS) partial remission at week 28 continued to Part 2 and were randomised (1:1) to NPX or no treatment until week 52. Treatment group differences in ASAS partial remission and other efficacy variables were assessed through week 52 with Fisher exact tests.

resultsAt week 52, similar percentages of patients in the NPX group (47.5%, 19/40) and the no-treatment group (40.0%, 16/40) maintained partial remission, p=0.65. Median duration of partial remission was 23 weeks in the NPX group and 12.6 weeks in the no-treatment group (p=0.38). Mean Bath Ankylosing Spondylitis Disease Activity Index scores were low at week 28, the start of follow-up treatment (NPX, 0.7; no treatment, 0.6), and remained low at week 52 (NPX, 1.2; no treatment, 1.7).

conclusionsIn axial SpA patients who reached partial remission after treatment with either IFX+NPX or NPX alone, disease activity remained low, and about half of patients remained in remission during 6 months in which NPX was continued or all treatments were stopped.

Indexed as

AdolescentAdultAnti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodEarly DiagnosisFemaleFollow-Up StudiesHumansMaleMiddle AgedNaproxenPlacebosRemission InductionSpondylarthritisSpondylitis, AnkylosingTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalNaproxenPlacebosNSAIDsSpondyloarthritisTNF-alpha

Identifiers

PMID23740231
PMCPMC3888608
OpenAlexW2165871178

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.