Evidence map›Paper›PMID 40715761›Full record

ArticleRheumatology and therapy2025

The Impact of Sex on the Pattern and Clinical Response of Early Psoriatic Arthritis: Real-life Data from the Italian Prospective SIRENA Study.

Ennio G Favalli, Michele M Luchetti Gentiloni, Carlo Selmi, Roberta Ramonda, Rosa D Grembiale, Lorenzo Dagna, Salvatore D'Angelo, Roberto Gerli, Rosario Foti, Francesco Ciccia and 8 more

Registry-linked trialAbstract read
In one paragraph

Article in Rheumatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03131661 (A Prospective, Observational Study, in Patients With a Newly Confirmed Diagnosis of Spondyloarthritis), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT03131661 completednot on this map

A Prospective, Observational Study, in Patients With a Newly Confirmed Diagnosis of Spondyloarthritis (SpA) According to ASAS Criteria, naïve to Conventional (cDMARDs), Targeted (tsDMARDs) and Biological DMARDs (bDMARDs) - SIRENA Study (Spondyloarthritis Italian Registry: Evidence From a National Pathway)

TypeobservationalSponsorJanssen-Cilag S.p.A.Ran2017 to 2021Enrolled351ConditionsSpondyloarthritis, Axial and Peripheral
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

18 authors.

Ennio G FavalliDepartment of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Via Gaetano Pini, 9, 20122, Milan, Italy. ennio.favalli@unimi.it.ORCID http://orcid.org/0000-0003-1471-6467
Michele M Luchetti GentiloniClinica Medica, Dipartimento di Scienze Cliniche e Molecolari, Università Politecnica delle Marche, Ancona, Italy.
Carlo SelmiDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Roberta RamondaRheumatology Unit, Department of Medicine-DIMED, University of Padova, Padua, Italy.
Rosa D GrembialeRheumatology Research Unit, Department of Health Sciences, Università "Magna Graecia", Catanzaro, Italy.
Lorenzo DagnaUnit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Milan, Italy.
Salvatore D'AngeloDepartment of Health Sciences - University of Basilicata, Rheumatology Department of Lucania, San Carlo Hospital of Potenza, Potenza, Italy.
Roberto GerliRheumatology Unit, Department of Medicine & Surgery, University of Perugia, Perugia, Italy.
Rosario FotiDivision of Rheumatology, A.O.U. Policlinico-San Marco, Catania, Italy.
Francesco CicciaRheumatology Unit, Department of Precision Medicine, Università degli Studi della Campania "Luigi Vanvitelli", Naples, Italy.
Giuliana GugginoRheumatology Unit, PROMISE Department, University of Palermo, Palermo, Italy.
Franco FranceschiniDepartment of Clinical and Experimental Sciences, University of Brescia-Unit for Rheumatology and Clinical Immunology-ASST Spedali Civili of Brescia, Brescia, Italy.
Maria S ChimentiRheumatology, Allergology and Clinical Immunology, Università di Roma "Tor Vergata", Rome, Italy.
Maurizio RossiniRheumatology Unit, Department of Medicine, University of Verona, Verona, Italy.
Ennio LubranoAcademic Rheumatology Unit, Dipartimento di Medicina e Scienze per la Salute "Vincenzo Tiberio", University of Molise, Campobasso, Italy.
Bruno FredianiDepartment of Medicine, Surgery and Neurosciences, Azienda Universitaria Ospedaliera Le Scotte, Siena, Italy.
Silvia MarelliMedical Affairs Department, Johnson & Johnson, Immunology, Milan, Italy.
Alen ZabottiRheumatology Clinic, Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), University of Udine, Udine, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLimited data are available on sex differences in the disease characteristics, burden and treatment outcomes of early psoriatic arthritis (PsA). The "Spondyloarthritis Italian Registry: Evidence from a National Pathway" (SIRENA) study is a prospective, observational, Italian study conducted in 23 Rheumatology sites on patients with recent diagnosis of spondyloarthritis and naïve to any disease-modifying antirheumatic drugs (DMARDs).

methodsThe study included 203 patients with early PsA, observed per clinical practice, who were studied regarding the influence of sex on the disease presentation and the likelihood of achieving minimal disease activity (MDA). Clinical and patient-reported outcome (PRO) measures were collected at both study entry and each follow-up visit until 24 months. Treatment was assigned by the treating rheumatologist based on standard clinical practice.

resultsAt baseline, 87% of patients with PsA received systemic treatment, mainly with conventional (49%) or biological (25%) DMARDs. Twenty-three of 158 (15%) patients were already in MDA status at study entry: this percentage increased to 55% (n = 83/150) at 6 months and 75% (n = 73/97) at 24 months. MDA was more frequent in males at baseline (20.0% vs. 8.2% in females, p = 0.036) and throughout the study. Significant improvements in clinical measures and PROs were reported in both sexes at all follow-up visits, but PRO scores were significantly worse in females at baseline and at most endpoints. Increasing age, male sex, new PsA diagnosis, mono-/oligoarticular involvement, low (≤ 14) Disease Activity index for PSoriatic Arthritis (DAPSA) and low Health Assessment Questionnaire Disability Index (HAQ-DI) values showed potential associations with MDA achievement at 6 months in univariate analysis, but this was not significant in the multivariate model.

conclusionIn patients with PsA naïve to DMARDs, sex considerably influences the clinical characteristics and outcomes. TRIAL REGISTRATION NUMBER: NCT03131661.

Indexed as

Prospective studyPsoriatic arthritisReal-world evidenceSexSystemic treatment

Identifiers

PMID40715761
PMCPMC12450140

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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.