Evidence map›Paper›PMID 26815944›Full record

Trial reportArthritis care & research2016

Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis.

M Rudwaleit, J T Rosenbaum, R Landewé, H Marzo-Ortega, J Sieper, D van der Heijde, O Davies, H Bartz, B Hoepken, T Nurminen and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis care & research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01087762 (Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis), which is not on this map. Cited by 39 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 4 pooled it
11.1field-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.

NCT01087762 phase3completednot on this map

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

TypeinterventionalSponsorUCB BIOSCIENCES GmbHRan2010 to 2015Enrolled325ConditionsSpondyloarthropathiesArmsCZP 200 mg Q2W, CZP 400 mg Q4W, Placebo
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 4 syntheses or guidelines pooled it, 112 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Trial
  6. Trial
  7. Article
  8. Biosimilars in Adult and Pediatric Noninfectious Uveitis.Clinical ophthalmology (Auckland, N.Z.) · 2026
    Review
  9. Uveitis in Psoriatic Arthritis: A Comprehensive Review.European journal of rheumatology · 2025
    Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Ocular Manifestations of Spondyloarthritis.Mediterranean journal of rheumatology · 2023
    Review
  17. Article
  18. Review
  19. Review
  20. Clinical Manifestations and Diagnosis of Axial Spondyloarthritis.Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2021
    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

11 authors at 9 institutions in 4 countries.

M RudwaleitKlinikum Bielefeld, Bielefeld, Germany.
J T RosenbaumDevers Eye Institute, Legacy Health System, Portland, Oregon, and Oregon Health & Science University, Portland.
R LandewéAcademic Medical Center, Amsterdam and Atrium Medical Center, Heerlen, the Netherlands.
H Marzo-OrtegaLeeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
J SieperUniversity Hospital Charité, Berlin, Germany.
D van der HeijdeLeiden University Medical Centre, Leiden, the Netherlands.
O DaviesUCB Pharma, Slough, UK.
H BartzUCB Pharma, Monheim, Germany.
B HoepkenUCB Pharma, Monheim, Germany.
T NurminenUCB Pharma, Monheim, Germany.
A DeodharOregon Health & Science University, Portland.
UCB Pharma (Germany) · DEAcademic Medical Center · NLCharité - Universitätsmedizin Berlin · DEKlinikum Bielefeld · DELeeds Teaching Hospitals NHS Trust · GBLegacy Health · USLeiden University Medical Center · NLOregon Health & Science University · USUCB Pharma (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAxial spondyloarthritis (axial SpA) is characterized by inflammation of the spine and sacroiliac joints and can also affect extraarticular sites, with the most common manifestation being uveitis. Here we report the incidence of uveitis flares in axial SpA patients from the RAPID-axSpA trial, including ankylosing spondylitis (AS) and nonradiographic (nr) axial SpA.

methodsThe RAPID-axSpA (NCT01087762) trial is double-blind and placebo-controlled to week 24, dose-blind to week 48, and open-label to week 204. Patients were randomized to certolizumab pegol (CZP) or placebo. Placebo patients entering the dose-blind phase were re-randomized to CZP. Uveitis events were recorded on extraarticular manifestation or adverse event forms. Events were analyzed in patients with/without history of uveitis, and rates reported per 100 patient-years.

resultsAt baseline, 38 of 218 CZP-randomized patients (17.4%) and 31 of 107 placebo-randomized patients (29.0%) had past uveitis history. During the 24-week double-blind phase, the rate of uveitis flares was lower in CZP (3.0 [95% confidence interval (95% CI) 0.6-8.8] per 100 patient-years) than in placebo (10.3 [95% CI 2.8-26.3] per 100 patient-years). All cases observed during the 24-week double-blind phase were in patients with a history of uveitis; in these patients, rates were similarly lower for CZP (17.1 [95% CI 3.5-50.1] per 100 patient-years) than placebo (38.5 [95% CI 10.5-98.5] per 100 patient-years). Rates of uveitis flares remained low up to week 96 (4.9 [95% CI 3.2-7.4] per 100 patient-years) and were similar between AS (4.4 [95% CI 2.3-7.7] per 100 patient-years) and nr-axial SpA (5.6 [95% CI 2.9-9.8] per 100 patient-years).

conclusionThe rate of uveitis flares was lower for axial SpA patients treated with CZP than placebo during the randomized controlled phase. Incidence of uveitis flares remained low to week 96 and was comparable to rates reported for AS patients receiving other anti-tumor necrosis factor antibodies.

Indexed as

AdultCertolizumab PegolDouble-Blind MethodFemaleHumansImmunosuppressive AgentsIncidenceMaleMiddle AgedSpondylarthritisUveitisCertolizumab PegolImmunosuppressive Agents

Identifiers

PMID26815944
PMCPMC5089650
OpenAlexW2287850211

What OpenQuestion holds

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LicenceCC BY
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.