Evidence map›Paper›PMID 32352653›Full record

ArticleACR open rheumatology2020

Incidence of Uveitis in Secukinumab-treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies.

Atul A Deodhar, Corine Miceli-Richard, Xenofon Baraliakos, Helena Marzo-Ortega, Dafna D Gladman, Ricardo Blanco, Ayan Das Gupta, Ruvie Martin, Jorge Safi, Brian Porter and 2 more

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in ACR open rheumatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
7.0field-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.

NCT01358175 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2011 to 2014Enrolled371ConditionsAnkylosing SpondylitisArmsSecukinumab (75 mg), Secukinumab (150 mg), Placebo
NCT01649375 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing Spondylitis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2018Enrolled219ConditionsAnklyosing SpondylitisArmsSecukinumab (75 mg), Placebo, Secukinumab (150 mg)
NCT02008916 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing Spondylitis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2017Enrolled226ConditionsSpondylitis, AnkylosingArmsSecukinumab, Placebo secukinumab
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 60 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. A Review of the Safety of Interleukin-17A Inhibitor Secukinumab.Pharmaceuticals (Basel, Switzerland) · 2022
    Review
  16. Review
  17. Review
  18. Review
  19. Article
  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

12 authors at 10 institutions in 8 countries.

Atul A DeodharOregon Health & Science University, Portland.ORCID https://orcid.org/0000-0002-2130-1246
Corine Miceli-RichardParis Descartes University, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, and European League Against Rheumatism Center of Excellence, Paris, France.
Xenofon BaraliakosRuhr-University Bochum, Bochum, Germany.
Helena Marzo-OrtegaLeeds Teaching Hospitals NHS Trust and University of Leeds, Leeds, UK.
Dafna D GladmanToronto Western Hospital, Toronto, Canada.
Ricardo BlancoHospital Universitario Marqués de Valdecilla, Santander, Spain.
Ayan Das GuptaNovartis Healthcare Private Limited, Hyderabad, India.
Ruvie MartinNovartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Jorge SafiNovartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Brian PorterNovartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Abhijit SheteNovartis Pharma AG, Basel, Switzerland.
James T RosenbaumOregon Health & Science University and Legacy Devers Eye Institute, Portland.ORCID https://orcid.org/0000-0002-8452-2441
Novartis (United States) · USLegacy Health · USMarqués de Valdecilla University Hospital · ESNovartis (India) · INNovartis (Switzerland) · CHOregon Health & Science University · USRuhr University Bochum · DEToronto Western Hospital · CAUniversité Paris Cité · FRUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe objective of this study was to report the incidence of uveitis in secukinumab-treated patients with ankylosing spondylitis (AS) in a pooled analysis of three phase 3 trials (MEASURE 1-3 [ClinicalTrials.gov identifiers NCT01358175, NCT01649375, NCT02008916]).

methodsAnalysis included pooled patient-level data from all patients (N = 794) who received any dose (one or more) of secukinumab up to the last patient attending the week 156 study visit in MEASURE 1 and up to the week 156 visit in MEASURE 2 and the week 104 visit in MEASURE 3 for each patient. Postmarketing data were from the periodic safety update report. Incidence of uveitis is reported as the exposure-adjusted incidence rate (EAIR) per 100 patient-years of secukinumab exposure.

resultsOverall, 135 (17%) patients reported preexisting (but not active or ongoing) uveitis at baseline, and 589 (74.2%) patients were HLA antigen B27 positive. The EAIR for uveitis was 1.4 per 100 patient-years over the entire treatment period. Among all cases of uveitis (n = 26), 14 (54%) were flares. The exposure-adjusted reporting rate of uveitis in the postmarketing data (which included patients across the three approved indications of psoriasis, psoriatic arthritis, and AS) was 0.03 per 100 patient-years based on cumulative secukinumab exposure of 96 054 patient-years.

conclusionThe incidence rate of uveitis in secukinumab-treated patients with active AS does not suggest an increased risk with secukinumab treatment.

Identifiers

PMID32352653
PMCPMC7231512
OpenAlexW3022095567

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.