Evidence map›Paper›PMID 31943974›Full record

ArticleACR open rheumatology2020

Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study.

Philip J Mease, Arthur Kavanaugh, Andreas Reimold, Hasan Tahir, Juergen Rech, Stephen Hall, Piet Geusens, Pascale Pellet, Eumorphia Maria Delicha, Luminita Pricop and 2 more

Registry-linked trialOpen 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 trial NCT01392326 (A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis), which is not on this map. Cited by 31 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 4 pooled it
5.0field-weighted citation impact, top 4% 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.

NCT01392326 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2011 to 2014Enrolled606ConditionsPsoriatic ArthritisArmsSecukinumab (75 mg), Secukinumab (150 mg), Placebo Comparator
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 4 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. 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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  18. Consensus on targeted drug therapy for spondyloarthritis.Rheumatology and immunology research · 2023
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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 8 institutions in 6 countries.

Philip J MeaseSwedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.ORCID https://orcid.org/0000-0002-6620-0457
Arthur KavanaughUniversity of California San Diego, San Diego, California, USA.
Andreas ReimoldDallas VA and University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Hasan TahirWhipps Cross University Hospital, Barts Health NHS Trust, London, UK.
Juergen RechFriedrich-Alexander-University Erlangen-Nürnberg (FAU), Universitätsklinikum Erlangen, Erlangen, Germany.ORCID https://orcid.org/0000-0002-2569-2029
Stephen HallMonash University, Melbourne, Australia.
Piet GeusensUniversity of Hasselt, Hasselt, Belgium, and Maastricht University Hospital, Maastricht, Belgium.
Pascale PelletNovartis Pharma AG, Basel, Switzerland.
Eumorphia Maria DelichaNovartis Pharma AG, Basel, Switzerland.
Luminita PricopNovartis Pharmaceuticals Corporation, East Hannover, New Jersey, USA.
Shephard MpofuNovartis Pharma AG, Basel, Switzerland.
FUTURE 1 study group
Novartis (Switzerland) · CHBarts Health NHS Trust · GBFriedrich-Alexander-Universität Erlangen-Nürnberg · DEHasselt University · BEMonash University · AUSouthwestern Medical Center · USUniversity of California San Diego · USUniversity of Washington · US

Funding

Novartis
6 · The paper itself

Abstract

objectiveTo report the 5-year efficacy and safety of secukinumab in the treatment of patients with psoriatic arthritis (PsA) in the FUTURE 1 study (NCT01392326).

methodsFollowing the 2-year core trial, eligible patients receiving subcutaneous secukinumab entered a 3-year extension phase. Results are presented for key efficacy endpoints for the secukinumab 150-mg group (n = 236), including patients who escalated from 150 to 300 mg (approved doses) starting at week 156. Safety is reported for all patients (n = 587) who received 1 dose or more of study treatment.

resultsOverall, 81.8%% (193 of 236) of patients in the secukinumab 150-mg group completed 5 years of treatment, of which 36.4% (86 of 236) had dose escalation from 150 to 300 mg. Sustained improvements were achieved with secukinumab across all key efficacy endpoints through 5 years. Overall, 71.0%/51.8%/36.3% of patients achieved American College of Rheumatology (ACR) 20/50/70 responses at 5 years. Efficacy improved in patients requiring dose escalation from 150 to 300 mg and was comparable with those who did not require dose escalation. Exposure-adjusted incidence rates for selected adverse events per 100 patient-years for any secukinumab dose were serious infections (1.8), Crohn's disease (0.2), Candida infection (0.9), and major adverse cardiac events (0.5).

conclusionSecukinumab provided sustained improvements in the signs and symptoms in the major clinical domains of PsA. Efficacy improved for patients requiring dose escalation from 150 to 300 mg during the study. Secukinumab was well tolerated with no new safety signals.

Identifiers

PMID31943974
PMCPMC6957920
OpenAlexW2985236937

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.