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

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Show simple item record Gratacós, Jordi Pontes, Caridad Juanola, Xavier Sanz, Jesús Torres, Ferran Avendaño, Cristina Vallano, Antoni Calvo, Gonzalo De Miguel, Eugenio Sanmartí, Raimon Almirall, Miriam Aparicio, Maria Sellas, Agustí Vives, Roser Albiñana, Nestor Moreno, Mireia Clavaguera, Teresa Torre-Alonso, Juan Carlos Veroz, Raúl Rodríguez-Lozano, Carlos Linares, Luís Francisco Urruticoechea, Ana Collantes, Eduardo Morlà, Rosa María Reina, Dèlia Cuende, Eduardo Zarco, Pedro Fernández-Espartero, Maria Cruz García-Vicuña, Rosario Montilla, Carlos Alberto Villalba, Alejandro Pascual, Dora Campos, Cristina Juan, Antonio Ariza, Rafael Díaz-Miguel, Consuelo Maqueda, Manuel Fernández-Dapica, Maria Pilar Fernández-Prada, Manuel Batlle, Enrique González-Fernández, Carlos Queiro, Rubén
dc.contributor.other UAM. Departamento de Medicina es_ES 2019-09-13T11:59:05Z 2019-09-13T11:59:05Z 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.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, 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 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 Reconocimiento es_ES
dc.rights.accessRights openAccess en
dc.authorUAM De Miguel Mendieta, Eugenio (262770)

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