Evidence map›Paper›PMID 25832312›Full record

Trial reportArthritis care & research2015

Impact of Certolizumab Pegol on Patient-Reported Outcomes in Patients With Axial Spondyloarthritis.

J Sieper, A Kivitz, A van Tubergen, A Deodhar, G Coteur, F Woltering, R Landewé

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis care & research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
4.6field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. La Tunisie medicale · 2025
    Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Unmet Needs in Axial Spondyloarthritis.Clinical reviews in allergy & immunology · 2018
    Review
  14. Review
  15. Observational
  16. Review
  17. Article
  18. Patient Burden of Axial Spondyloarthritis.Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2017
    Review
  19. Article
  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

7 authors at 7 institutions in 4 countries.

J SieperUniversity Hospital Charité, Berlin, Germany.
A KivitzAltoona Center for Clinical Research, Duncansville, Pennsylvania.
A van TubergenMaastricht University Medical Center, Maastricht, The Netherlands.
A DeodharOregon Health and Science University, Portland.
G CoteurUCB Pharma, Brussels, Belgium.
F WolteringUCB Pharma, Monheim, Germany.
R LandewéAmsterdam and Atrium Medical Center, Heerlen, The Netherlands.
Altoona Center for Clinical Research · USAtrium Medisch Centrum Parkstad · NLCharité - Universitätsmedizin Berlin · DEMaastricht University · NLOregon Health & Science University · USUCB Pharma (Belgium) · BEUCB Pharma (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePatient-reported outcomes (PROs) provide an opportunity to collect important information relating to patient well-being, which is often difficult for physicians to measure (e.g., quality of life, pain, fatigue, and sleep). Here we evaluate the effects of certolizumab pegol (CZP) on PROs during the 24-week, double-blind phase of the RAPID axial spondyloarthritis (SpA) trial, a phase 3 trial of axial SpA patients, including both ankylosing spondylitis (AS) and nonradiographic axial SpA patients.

methodsA total of 325 patients with active axial SpA were randomized 1:1:1 to placebo, CZP 200 mg every 2 weeks, or CZP 400 mg every 4 weeks. The primary end point was the Assessment of SpondyloArthritis International Society criteria for 20% improvement in disease activity response at week 12, and has been reported previously. PROs included total back pain, nocturnal back pain, a daily pain diary, the Sleep Problems Index II (SPI) domain of the Medical Outcomes Study (MOS) Sleep Scale, fatigue, the Ankylosing Spondylitis Quality of Life (ASQOL) measure, and the Short Form 36-item (SF-36) health survey physical component summary (PCS), mental component summary (MCS), and domains.

resultsPatients treated with CZP reported significant improvements from week 1 for nocturnal back pain (placebo -0.6, CZP 200 mg every 2 weeks -1.9, and CZP 400 mg every 4 weeks -1.6; P < 0.001) and ASQOL (placebo -1.0, CZP 200 mg every 2 weeks -2.3, and CZP 400 mg every 4 weeks -1.9; P < 0.05) compared with placebo, while significant improvements in total back pain were seen from day 2. Patients treated with both CZP dosing regimens also had significantly greater improvements in fatigue, MOS-SPI, SF-36 PCS, MCS, and domains compared with placebo. Improvements were similar in both AS and nonradiographic axial SpA patients.

conclusionBoth CZP dosing schedules rapidly improved patient well-being, as measured by PROs, including pain, fatigue, sleep, SF-36, and ASQOL in both AS and nonradiographic axial SpA patients.

Indexed as

Patient Outcome AssessmentQuality of LifeAdultAntirheumatic AgentsCertolizumab PegolDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansMaleMiddle AgedPain MeasurementPatient SatisfactionProspective StudiesAntirheumatic AgentsCertolizumab Pegol

Identifiers

PMID25832312
PMCPMC5054930
OpenAlexW1924813320

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.