Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis 11 Medical and Health Sciences 1117 Public Health and Health Services 11 Medical and Health Sciences 1103 Clinical Sciences

Biblos-e Archivo/Manakin Repository

Show simple item record

dc.contributor.author Gratacós, Jordi
dc.contributor.author Pontes, Caridad
dc.contributor.author Juanola, Xavier
dc.contributor.author Sanz, Jesús
dc.contributor.author Torres, Ferran
dc.contributor.author Avendaño, Cristina
dc.contributor.author Vallano, Antoni
dc.contributor.author Calvo, Gonzalo
dc.contributor.author De Miguel, Eugenio
dc.contributor.author Sanmartí, Raimon
dc.contributor.author Almirall, Miriam
dc.contributor.author Aparicio, Maria
dc.contributor.author Sellas, Agustí
dc.contributor.author Vives, Roser
dc.contributor.author Albiñana, Nestor
dc.contributor.author Moreno, Mireia
dc.contributor.author Clavaguera, Teresa
dc.contributor.author Torre-Alonso, Juan Carlos
dc.contributor.author Veroz, Raúl
dc.contributor.author Rodríguez-Lozano, Carlos
dc.contributor.author Linares, Luís Francisco
dc.contributor.author Urruticoechea, Ana
dc.contributor.author Collantes, Eduardo
dc.contributor.author Morlà, Rosa María
dc.contributor.author Reina, Dèlia
dc.contributor.author Cuende, Eduardo
dc.contributor.author Zarco, Pedro
dc.contributor.author Fernández-Espartero, Maria Cruz
dc.contributor.author García-Vicuña, Rosario
dc.contributor.author Montilla, Carlos Alberto
dc.contributor.author Villalba, Alejandro
dc.contributor.author Pascual, Dora
dc.contributor.author Campos, Cristina
dc.contributor.author Juan, Antonio
dc.contributor.author Ariza, Rafael
dc.contributor.author Díaz-Miguel, Consuelo
dc.contributor.author Maqueda, Manuel
dc.contributor.author Fernández-Dapica, Maria Pilar
dc.contributor.author Fernández-Prada, Manuel
dc.contributor.author Batlle, Enrique
dc.contributor.author González-Fernández, Carlos
dc.contributor.author Queiro, Rubén
dc.contributor.other UAM. Departamento de Medicina es_ES
dc.date.accessioned 2019-09-13T11:59:05Z
dc.date.available 2019-09-13T11:59:05Z
dc.date.issued 2019-01-08
dc.identifier.citation Arthritis Research and Therapy 21.1 (2019): 11 en_US
dc.identifier.issn 1478-6354 (print) es_ES
dc.identifier.issn 1478-6362 (online) es_ES
dc.identifier.uri http://hdl.handle.net/10486/688583
dc.description.abstract Objective: The objective was to determine if dose reduction is non-inferior to full-dose TNFi to maintain low disease activity (LDA) in patients already in remission with TNFi, in axial spondyloarthritis. Methods: Randomized, parallel, non-inferiority, open-label multicentre clinical trial. Patients were eligible if they had axial spondyloarthritis and had been in clinical remission for ≥ 6 months with any available TNFi (adalimumab, etanercept, infliximab, golimumab) at the dose recommended by product labelling. Patients were randomized by automated central allocation to continue the same TNFi dose schedule, or to reduce the dose by roughly half according to the protocol. The main outcome was the proportion of subjects with LDA after 1 year. Serious adverse reactions or infections were recorded. Results: The trial stopped due to end of the funding period, after 126 patients were randomized; 113 patients (84.1% male, mean age (SD) 45.6 (13.0) years) were included in the main per-protocol subset. Non-inferiority was concluded for LDA at 1 year (47/55 (83.8%) patients in the full-dose and 48/58 (81.3%) patients in the reduced-dose arm, adjusted difference (95% CI) - 2.5% (- 16.6% to 11.7%)). Serious adverse reactions or infections were reported in 7/62 patients (11.3%) assigned to full dose and 2/61 patients (3.3%) assigned to reduced dose (p value = 0.164). Conclusion: In patients with ankylosing spondylitis in clinical remission for at least 6 months, dose reduction is non-inferior to full TNF inhibitor doses to maintain LDA after 1 year. Serious adverse events may be less frequent with reduced doses. Trial registration: EU Clinical Trials Registry, EudraCT 2011-005871-18 and ClinicalTrials.gov, NCT01604629. en_US
dc.description.sponsorship The study was fully funded by grants from the Spanish Ministry of Health within the programme “Ayudas para el fomento de la investigación clínica independiente del Ministerio de Salud, Política Social e Igualdad - Orden SPI/ 2885/2011, de 20 de octubre” (project ID: EC11–229) and from the Ministerio de Economía y Consumo (MINECO)-Instituto de Salud Carlos III-Subdirección General de Evaluación and the European Fund for Regional Development (Project ID: PI13/02680). en_US
dc.format.extent 10 pag. es_ES
dc.format.mimetype application/pdf en
dc.language.iso eng en
dc.publisher BMC (part of Springer Nature) en_US
dc.relation.ispartof Arthritis Research and Therapy en_US
dc.rights © 2019 The Author(s) en_US
dc.subject.other Dose-tapering en_US
dc.subject.other Non-inferiority en_US
dc.subject.other Spondyloarthritis es_ES
dc.subject.other TNF inhibitors en_US
dc.title Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis 11 Medical and Health Sciences 1117 Public Health and Health Services 11 Medical and Health Sciences 1103 Clinical Sciences en_US
dc.type article en
dc.subject.eciencia Medicina es_ES
dc.relation.publisherversion https://doi.org/10.1186/s13075-018-1772-z es_ES
dc.identifier.doi 10.1186/s13075-018-1772-z es_ES
dc.identifier.publicationfirstpage 11-1 es_ES
dc.identifier.publicationissue 1 es_ES
dc.identifier.publicationlastpage 11-10 es_ES
dc.identifier.publicationvolume 21 es_ES
dc.relation.projectID Gobierno de España: EC11–229 es_ES
dc.relation.projectID Gobierno de España. PI13/02680 es_ES
dc.type.version info:eu-repo/semantics/publishedVersion en
dc.rights.cc Reconocimiento es_ES
dc.rights.accessRights openAccess en
dc.authorUAM De Miguel Mendieta, Eugenio (262770)


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record