Evidence map›Paper›PMID 29544534›Full record

Trial reportArthritis research & therapy2018

Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3).

Peter Nash, Philip J Mease, Iain B McInnes, Proton Rahman, Christopher T Ritchlin, Ricardo Blanco, Eva Dokoupilova, Mats Andersson, Radhika Kajekar, Shephard Mpofu and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis research & therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01989468 (A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Psoriatic Arthritis), which is not on this map. Cited by 91 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 21 pooled it
11.4field-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.

NCT01989468 phase3completednot on this map

A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2018Enrolled414ConditionsPsoriatic ArthritisArmsSecukinumab, Placebo
3 · Its place in the literature

Who cites it

91 citing papers in PubMed, 21 syntheses or guidelines pooled it, 164 citations in OpenAlex.

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  13. Secukinumab Efficacy in Psoriatic Arthritis: Machine Learning and Meta-analysis of Four Phase 3 Trials.Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2021
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31 more citing papers are in PubMed but not listed here.

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 7 institutions in 7 countries.

Peter NashDepartment of Medicine, University of Queensland, Brisbane, Australia. drpnash@tpg.com.au.
Philip J MeaseSwedish Medical Centre and University of Washington, Seattle, WA, USA.
Iain B McInnesUniversity of Glasgow, Glasgow, UK.
Proton RahmanMemorial University of Newfoundland, St. John's, NL, Canada.
Christopher T RitchlinAllergy/Immunology and Rheumatology Division, University of Rochester, Rochester, NY, USA.
Ricardo BlancoHospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.
Eva DokoupilovaMedical Plus, s.r.o., Uherské Hradiště, and University of Veterinary and Pharmaceutical Sciences, Faculty of Pharmacy, Brno, Czech Republic.
Mats AnderssonNovartis Pharma AG, Basel, Switzerland.
Radhika KajekarNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Shephard MpofuNovartis Pharma AG, Basel, Switzerland.
Luminita PricopNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
FUTURE 3 study group
Novartis (Switzerland) · CHMemorial University of Newfoundland · CAThe University of Queensland · AUUniversity of Veterinary Sciences Brno · CZInstituto de Investigación Marqués de Valdecilla · ESNovartis (United States) · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe study aimed to assess 52-week efficacy and safety of secukinumab self-administration by autoinjector in patients with active psoriatic arthritis (PsA) in the FUTURE 3 study ( ClinicalTrials.gov NCT01989468).

methodsPatients (≥ 18 years of age; N = 414) with active PsA were randomized 1:1:1 to subcutaneous (s.c.) secukinumab 300 mg, 150 mg, or placebo at baseline, weeks 1, 2, 3, and 4, and every 4 weeks thereafter. Per clinical response, placebo-treated patients were re-randomized to s.c. secukinumab 300 or 150 mg at week 16 (nonresponders) or week 24 (responders) and stratified at randomization by prior anti-tumor necrosis factor (TNF) therapy (anti-TNF-naïve, 68.1%; intolerant/inadequate response (anti-TNF-IR), 31.9%). The primary endpoint was the proportion of patients achieving at least 20% improvement in American College of Rheumatology response criteria (ACR20) at week 24. Autoinjector usability was evaluated by Self-Injection Assessment Questionnaire (SIAQ).

resultsOverall, 92.1% (300 mg), 91.3% (150 mg), and 93.4% (placebo) of patients completed 24 weeks, and 84.9% (300 mg) and 79.7% (150 mg) completed 52 weeks. In the overall population (combined anti-TNF-naïve and anti-TNF-IR), ACR20 response rate at week 24 was significantly higher in secukinumab groups (300 mg, 48.2% (p < 0.0001); 150 mg, 42% (p < 0.0001); placebo, 16.1%) and was sustained through 52 weeks. SIAQ results showed that more than 93% of patients were satisfied/very satisfied with autoinjector usage. Secukinumab was well tolerated with no new or unexpected safety signals reported.

conclusionsSecukinumab provided sustained improvements in signs and symptoms in active PsA patients through 52 weeks. High acceptability of autoinjector was observed. The safety profile was consistent with that reported previously.

trial registrationClinicalTrials.gov NCT01989468 . Registered 21 November 2013. EudraCT 2013-004002-25 . Registered 17 December 2013.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedArthritis, PsoriaticDouble-Blind MethodDrug Delivery SystemsFemaleHeadacheHumansInjections, SubcutaneousMaleMiddle AgedNasopharyngitisSelf AdministrationTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedsecukinumabAutoinjectorFUTURE 3 studyInterleukin-17aPsoriatic arthritisSecukinumab

Identifiers

PMID29544534
PMCPMC5856314
OpenAlexW2797662273

What OpenQuestion holds

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LicenceCC BY
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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.