Evidence map›Paper›PMID 33351179›Full record

ArticleRheumatology and therapy2021

Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies.

Xenofon Baraliakos, Filip Van den Bosch, Pedro M Machado, Lianne S Gensler, Helena Marzo-Ortega, Bintu Sherif, Erhard Quebe-Fehling, Brian Porter, Corine Gaillez, Atul Deodhar

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

Article in Rheumatology and therapy, 2021. 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 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.1field-weighted citation impact, top 12% 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)
NCT01863732 phase3completednot on this map

An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2013 to 2018Enrolled274ConditionsSpondylitis, AnkylosingArmsSecukinumab, Placebo (Pbo)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Article
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  6. Article
  7. Article
  8. Article
  9. Review
  10. Secukinumab in axial spondyloarthritis: a narrative review of clinical evidence.Therapeutic advances in musculoskeletal disease · 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

10 authors at 9 institutions in 5 countries.

Xenofon BaraliakosRheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany. xenofon.baraliakos@elisabethgruppe.de.
Filip Van den BoschDepartment of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.
Pedro M MachadoDepartment of Rheumatology, University College London Hospitals NHS Foundation Trust, London, UK.
Lianne S GenslerDepartment of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, USA.
Helena Marzo-OrtegaNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Bintu SherifRTI Health Solutions, Research Triangle Park, NC, USA.
Erhard Quebe-FehlingNovartis Pharma AG, Basel, Switzerland.
Brian PorterNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Corine GaillezNovartis Pharma AG, Basel, Switzerland.
Atul DeodharOregon Health and Science University, Portland, OR, USA.
Novartis (Switzerland) · CHGhent University Hospital · BENIHR Leeds Musculoskeletal Biomedical Research Unit · GBNovartis (United States) · USOregon Health & Science University · USRTI Health Solutions · USRuhr University Bochum · DEUniversity College London · GBUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionClinical remission in patients with ankylosing spondylitis (AS) has been determined using composite indices such as the AS Disease Activity Score inactive disease (ASDAS-ID), Assessment of SpondyloArthritis international Society criteria partial remission (ASAS-PR), and low Bath AS Disease Activity Index (BASDAI) scores. The objective of this exploratory analysis was to evaluate the proportion of secukinumab-treated patients with AS achieving remission defined based on the ASDAS-ID (score < 1.3), ASAS-PR or BASDAI score ≤  2.

methodsThe analysis pooled data from the MEASURE 1 and 2 studies over 3 years. The proportion of patients who achieved ASDAS-ID, ASAS-PR, or BASDAI ≤ 2 with secukinumab was compared with placebo at week 16; results for secukinumab-treated patients were summarized through week 156. Sustainability of each criterion was assessed from week 16 to 156 using shift analysis. The association between each of these criteria and specific patient-reported outcomes (PROs), such as health-related quality of life, function, fatigue, and work impairment, was also explored.

resultsAt week 16, a higher proportion of secukinumab-treated patients versus placebo achieved ASDAS-ID (17.6 vs. 3.5%), ASAS-PR (15.4 vs. 4.1%), or BASDAI ≤ 2 (22.3 vs. 6.4%) criteria (all P < 0.0001), which were sustained through 156 weeks. Shift analysis showed that the majority of secukinumab-treated patients achieving remission at week 16 maintained their status at week 156 (ASDAS-ID, 57.1%; ASAS-PR, 68.0% and BASDAI ≤ 2, 74.3%). Remission was also associated with improved PROs over 156 weeks.

conclusionsSecukinumab-treated patients maintained ASDAS-ID, ASAS-PR, or BASDAI ≤ 2 from week 16 up to 3 years. Patients who achieved at least one of the three responses/states, reported improvement in PROs, which suggests an association of clinical remission/ID with PROs in patients with active AS.

trial registrationClinicalTrials.gov: NCT01358175, NCT01863732, and NCT01649375.

Indexed as

Ankylosing spondylitisAxial spondyloarthritisBiologicsInterleukin-17Low disease activityPatient-reported outcomesRemissionSecukinumab

Identifiers

PMID33351179
PMCPMC7991028
OpenAlexW3116658877

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.