Evidence map›Paper›PMID 31228101›Full record

ArticleRheumatology and therapy2019

Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study.

Alan J Kivitz, Peter Nash, Hasan Tahir, Andrea Everding, Heřman Mann, Andrzej Kaszuba, Pascale Pellet, Albert Widmer, Luminita Pricop, Ken Abrams

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02294227 (A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab), which is not on this map. Cited by 43 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 10 pooled it
6.4field-weighted citation impact, top 3% 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.

NCT02294227 phase3completednot on this map

A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2017Enrolled341ConditionsArthritis, PsoriaticArmsSecukinumab, Placebo
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 10 syntheses or guidelines pooled it, 80 citations in OpenAlex.

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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

10 authors at 6 institutions in 5 countries.

Alan J KivitzAltoona Centre for Clinical Research, Duncansville, PA, USA. ajkivitz@yahoo.com.
Peter NashUniversity of Queensland, Brisbane, Australia.
Hasan TahirBarts Health NHS Trust, London, UK.
Andrea EverdingHamburger Rheuma Forschungszentrum II, Hamburg, Germany.
Heřman MannInstitute of Rheumatology and Department of Rheumatology, Charles University, Prague, Czech Republic.
Andrzej KaszubaSpecjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba, Lodz, Poland.
Pascale PelletNovartis Pharma AG, Basel, Switzerland.
Albert WidmerNovartis Pharma AG, Basel, Switzerland.
Luminita PricopNovartis Pharmaceutical Corporation, East Hanover, NJ, USA.
Ken AbramsNovartis Pharmaceutical Corporation, East Hanover, NJ, USA.
Novartis (Switzerland) · CHNovartis (United States) · USAltoona Center for Clinical Research · USBarts Health NHS Trust · GBInstitute of Rheumatology · CZUniversity of Queensland · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo assess the efficacy and safety of the subcutaneous (s.c.) secukinumab 150 mg with loading (150 mg) or without loading (150 mg no-load) regimen through 104 weeks in patients with active psoriatic arthritis (PsA) in the FUTURE 4 (NCT02294227) study.

methodsPatients with PsA (N = 341) were randomized to s.c. secukinumab 150 mg, 150 mg no-load or placebo at baseline, weeks 1, 2, 3 and every 4 weeks thereafter. All placebo patients were reassigned to secukinumab 150 mg no-load at either week 16 (non-responders) or week 24 (responders). The primary end point was ACR20 at week 16. Patients could have their dose escalated from 150 to 300 mg based on their physician's decision starting at week 36. Pre- and post-escalation ACR and PASI responses were also assessed.

resultsA total of 95.6% (326/341), 84.5% (288/341) and 79.8% (272/341) patients completed 16, 52 and 104 weeks of treatment, respectively. The primary end point was met; ACR20 response rate at week 16 was 41.2% and 39.8% with the 150 mg and 150 mg no-load groups, respectively, versus placebo (18.4%; adjusted P value = 0.0003 for both treatment arms). Efficacy responses observed at week 16 in both treatment regimens were sustained up to week 52 and 104, with many patients continuing to show improvements up to week 104. After dose escalation to 300 mg, the proportion of patients with non-/low-level ACR/PASI response decreased with increasing proportions of patients having higher ACR/PASI responses. No new or unexpected safety signals were reported.

conclusionThe secukinumab 150 mg or 150 mg no-load regimen demonstrated significant and sustained improvements in the signs and symptoms of psoriatic arthritis through 104 weeks; the loading regimen was associated with numerically higher and earlier responses for some high-hurdle end points. Improved efficacy was observed upon dose escalation from 150 to 300 mg. The safety profile was consistent with previous reports.

trial registrationClinicalTrials.gov identifier, NCT02294227.

fundingNovartis Pharma AG, Basel, Switzerland.

Indexed as

BiologicsEfficacyInflammationInterleukinsPsoriatic arthritisSafety

Identifiers

PMID31228101
PMCPMC6702584
OpenAlexW2953083416

What OpenQuestion holds

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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.