Evidence map›Paper›PMID 34330846›Full record

Trial reportRMD open2021

Secukinumab provides sustained improvement in signs and symptoms and low radiographic progression in patients with psoriatic arthritis: 2-year (end-of-study) results from the FUTURE 5 study.

Philip J Mease, Robert Landewé, Proton Rahman, Hasan Tahir, Atul Singhal, Elke Boettcher, Sandra Navarra, Aimee Readie, Shephard Mpofu, Eumorphia Maria Delicha and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in RMD open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02404350 (A Phase III, Randomized, Double-blind, Placebo Controlled Multi-center Study of Subcutaneous Secukinumab), which is not on this map. Cited by 25 papers, 2 of them syntheses that pooled it.

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

NCT02404350 phase3completednot on this map

A Phase III, Randomized, Double-blind, Placebo Controlled Multi-center Study of Subcutaneous Secukinumab (150 mg and 300 mg) in Prefilled Syringe to Demonstrate Efficacy (Including Inhibition of Structural Damage), Safety, and Tolerability up to 2 Years in Subjects With Active Psoriatic Arthritis (FUTURE 5)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2019Enrolled997ConditionsPsoriatic ArthritisArmsSecukinumab
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  20. Biologic and Small-Molecule Therapies for Moderate-to-Severe Psoriasis: Focus on Psoriasis Comorbidities.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    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.

Philip J MeaseRheumatology Research Division, Providence St. Joseph Health and University of Washington, Swedish Medical Center, Seattle, Washington, USA pmease@philipmease.com.ORCID 0000-0002-6620-0457
Robert LandewéDepartment of Rheumatology, University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0002-0577-6620
Proton RahmanFaculty of Medicine, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
Hasan TahirRheumatology, Whipps Cross University Hospital, London, UK.
Atul SinghalSouthwest Rheumatology, Dallas, Texas, USA.
Elke BoettcherRheumazentrum, Favoriten Hospital, Vienna, Austria.
Sandra NavarraSection of Rheumatology, University of Santo Tomas Hospital, Manila, Philippines.
Aimee ReadieRheumatology, Novartis Pharmaceuticals Corp, East Hanover, New Jersey, USA.
Shephard MpofuRheumatology, Novartis AG, Basel, Basel-Stadt, Switzerland.
Eumorphia Maria DelichaRheumatology, Novartis AG, Basel, Basel-Stadt, Switzerland.
Luminita PricopRheumatology, Novartis Pharmaceuticals Corp, East Hanover, New Jersey, USA.
Desirée van der HeijdeRheumatology, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-5781-158X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveSecukinumab provided sustained efficacy, low radiographic progression and consistent safety over 52 weeks in patients with psoriatic arthritis (PsA) in the FUTURE 5 study. Here, we report 2-year (end-of-study) results from this study.

methodsAdults with active PsA were randomised 2:2:2:3 to receive subcutaneous secukinumab 300 mg load (300 mg), 150 mg load (150 mg), 150 mg no load or placebo at baseline; weeks 1, 2, 3 and 4; and every 4 weeks thereafter. Secukinumab could be escalated from 150 mg to 300 mg starting at week 52, if active signs of disease were observed based on physician's assessment. Assessments at week 104 (2 years) included clinical end points and radiographic damage (mean change in van der Heijde-modified total Sharp score (vdH-mTSS)). Safety analysis included all patients who received ≥1 dose of study medication.

resultsOf the 996 patients randomised, 783 patients (78.6%) completed 2 years of treatment. Improvement in clinical end points was sustained through 2 years. The vdH-mTSS (mean change (SD)) was 0.10 (1.74; 300 mg), 0.52 (2.66; 150 mg) and 0.41 (2.20; 150 mg no load) at 2 years. The proportion of patients with no radiographic progression (change from baseline in vdH-mTSS ≤0.5) at 2 years was 89.5% (300 mg), 82.3% (150 mg) and 81.1% (150 mg no load).

conclusionSecukinumab with and without loading regimen provided sustained clinical efficacy and low radiographic progression through 2 years in patients with PsA. No new safety findings were reported. TRIAL REGISTRATION NUMBER: NCT02404350.

Indexed as

Arthritis, PsoriaticAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDisease ProgressionDouble-Blind MethodHumansAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedsecukinumabarthritisbiological therapycytokinesinflammationpsoriatic

Identifiers

PMID34330846
PMCPMC8327842

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.