Evidence map›Paper›PMID 35850974›Full record

Trial reportRMD open2022

Predictors of response to secukinumab in patients with psoriatic arthritis and axial manifestations: a post-hoc analysis of the MAXIMISE trial.

Xenofon Baraliakos, Effie Pournara, Laure Gossec, Philip J Mease, Roisin White, Eamonn O'Brien, Barbara Schulz, Helena Marzo-Ortega, Laura C Coates

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

Trial report in RMD open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02721966 (MAXIMISE), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 30% 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.

NCT02721966 phase3completednot on this map

MAXIMISE (Managing AXIal Manifestations in PsorIatic Arthritis With SEcukinumab), a Randomized, Double-blind, Placebo-controlled, Multicenter, 52-week Study to Assess the Efficacy and Safety of Secukinumab 150 mg or 300 mg s.c. in Participants With Active Psoriatic Arthritis and Axial Skeleton Involvement Who Have Inadequate Response to Non-steroidal Anti-inflammatory Drugs (NSAIDs)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2016 to 2019Enrolled503ConditionsAxial Psoratic ArthritisArmsSecukinumab, Secukinumab and Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. 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

9 authors at 7 institutions in 6 countries.

Xenofon BaraliakosRheumazentrum Ruhrgebiet, Ruhr University Bochum, Bochum, Germany Xenofon.Baraliakos@elisabethgruppe.de.ORCID 0000-0002-9475-9362
Effie PournaraImmunology, Hepatology and Dermatology, Novartis Pharma AG, Basel, Basel-Stadt, Switzerland.
Laure GossecInstitut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.
Philip J MeaseRheumatology Research, Swedish Medical Center, Providence St Joseph Health and University of Washington, Seattle, Washington, USA.ORCID 0000-0002-6620-0457
Roisin WhiteNovartis Ireland Limited, Dublin, Ireland.
Eamonn O'BrienNovartis Ireland Limited, Dublin, Ireland.
Barbara SchulzImmunology, Hepatology and Dermatology, Novartis Pharma AG, Basel, Basel-Stadt, Switzerland.
Helena Marzo-OrtegaSection of Musculoskeletal Disease, NIHR Leeds Biomedical Research Centre, LTHT and LIRMM, University of Leeds, Leeds, UK.
Laura C CoatesNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID 0000-0002-4756-663X
Novartis (Ireland) · IENovartis (Switzerland) · CHNuffield Orthopaedic Centre · GBRheumazentrum Ruhrgebiet · DESorbonne Université · FRUniversity of Leeds · GBUniversity of Washington · US

Funding

Department of Health
6 · The paper itself

Abstract

objectivesTo investigate patient characteristics predictive of response to secukinumab in patients with psoriatic arthritis (PsA) with axial manifestations.

methodsIn a post-hoc analysis from the MAXIMISE trial (NCT02721966) in patients with PsA and axial manifestations, we tested the hypothesis that the OR of the effect of treatment on the primary endpoint of the trial (Assessment of SpondyloArthritis international Society (ASAS) 20 responder status at week 12) would be different depending on 12 prespecified predictor variables. We applied a two-model logistic regression approach, a main effects and an interaction model.

resultsThe OR (95% CI) for ASAS20 response for the presence of nail dystrophy was 3.2 (95% CI 0.93 to 10.99) in the secukinumab 150 mg group and 5.0 (95% CI 1.47 to 17.19) in the secukinumab 300 mg group compared with the placebo group (p=0.029). Odds of being a responder were similar in men and women in the secukinumab groups, though men fared worse than women in the placebo group (p=0.039). Current smokers were less likely to be ASAS20 responders compared with never smokers regardless of the treatment group (p=0.589).

conclusionNail dystrophy was identified as a predictor of response to secukinumab in patients with PsA with axial manifestations in the MAXIMISE trial. These findings may be explained by the nail-entheseal concept as part of the axial phenotype in PsA .

Indexed as

Antibodies, Monoclonal, HumanizedArthritis, PsoriaticFemaleHumansMaleAntibodies, Monoclonal, Humanizedsecukinumabarthritis, psoriaticbiological therapyspondylitis, ankylosing

Identifiers

PMID35850974
PMCPMC9297227
OpenAlexW4285807495

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.