Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis

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. Randomized, parallel, non-inferiority, open-label multicentre clinical trial. Patients were eligible if th...

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Autores: Gratacós, Jordi|||0000-0003-4007-4103, Pontes García, Caridad|||0000-0002-3274-6048, Juanola, Xavier|||0000-0001-5998-6300, Sanz, Jesús, Torres, Ferran|||0000-0002-7355-7913, Avendaño Sola, Cristina|||0000-0001-5437-7215, Vallano, Antoni|||0000-0002-3648-3492, Calvo Rojas, Gonzalo|||0000-0001-8860-6653, de Miguel, Eugenio|||0000-0001-5146-1964, Sanmartí, Raimon|||0000-0002-8864-3806
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:226296
Acceso en línea:https://ddd.uab.cat/record/226296
https://dx.doi.org/urn:doi:10.1186/s13075-018-1772-z
Access Level:acceso abierto
Palabra clave:Spondyloarthritis
Dose-tapering
Non-inferiority
TNF inhibitors
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spelling Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritisGratacós, Jordi|||0000-0003-4007-4103Pontes García, Caridad|||0000-0002-3274-6048Juanola, Xavier|||0000-0001-5998-6300Sanz, JesúsTorres, Ferran|||0000-0002-7355-7913Avendaño Sola, Cristina|||0000-0001-5437-7215Vallano, Antoni|||0000-0002-3648-3492Calvo Rojas, Gonzalo|||0000-0001-8860-6653de Miguel, Eugenio|||0000-0001-5146-1964Sanmartí, Raimon|||0000-0002-8864-3806SpondyloarthritisDose-taperingNon-inferiorityTNF inhibitorsThe 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. 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. 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). 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. EU Clinical Trials Registry, EudraCT and ClinicalTrials.gov, . The online version of this article (10.1186/s13075-018-1772-z) contains supplementary material, which is available to authorized users. 22019-01-0120192019-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/226296https://dx.doi.org/urn:doi:10.1186/s13075-018-1772-zreponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengMinisterio de Economía y Competitividad https://doi.org/10.13039/501100003329 PI13/02680open accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2262962026-06-06T12:50:31Z
dc.title.none.fl_str_mv Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis
title Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis
spellingShingle Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis
Gratacós, Jordi|||0000-0003-4007-4103
Spondyloarthritis
Dose-tapering
Non-inferiority
TNF inhibitors
title_short Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis
title_full Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis
title_fullStr Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis
title_full_unstemmed Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis
title_sort Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis
dc.creator.none.fl_str_mv Gratacós, Jordi|||0000-0003-4007-4103
Pontes García, Caridad|||0000-0002-3274-6048
Juanola, Xavier|||0000-0001-5998-6300
Sanz, Jesús
Torres, Ferran|||0000-0002-7355-7913
Avendaño Sola, Cristina|||0000-0001-5437-7215
Vallano, Antoni|||0000-0002-3648-3492
Calvo Rojas, Gonzalo|||0000-0001-8860-6653
de Miguel, Eugenio|||0000-0001-5146-1964
Sanmartí, Raimon|||0000-0002-8864-3806
author Gratacós, Jordi|||0000-0003-4007-4103
author_facet Gratacós, Jordi|||0000-0003-4007-4103
Pontes García, Caridad|||0000-0002-3274-6048
Juanola, Xavier|||0000-0001-5998-6300
Sanz, Jesús
Torres, Ferran|||0000-0002-7355-7913
Avendaño Sola, Cristina|||0000-0001-5437-7215
Vallano, Antoni|||0000-0002-3648-3492
Calvo Rojas, Gonzalo|||0000-0001-8860-6653
de Miguel, Eugenio|||0000-0001-5146-1964
Sanmartí, Raimon|||0000-0002-8864-3806
author_role author
author2 Pontes García, Caridad|||0000-0002-3274-6048
Juanola, Xavier|||0000-0001-5998-6300
Sanz, Jesús
Torres, Ferran|||0000-0002-7355-7913
Avendaño Sola, Cristina|||0000-0001-5437-7215
Vallano, Antoni|||0000-0002-3648-3492
Calvo Rojas, Gonzalo|||0000-0001-8860-6653
de Miguel, Eugenio|||0000-0001-5146-1964
Sanmartí, Raimon|||0000-0002-8864-3806
author2_role author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Spondyloarthritis
Dose-tapering
Non-inferiority
TNF inhibitors
topic Spondyloarthritis
Dose-tapering
Non-inferiority
TNF inhibitors
description 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. 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. 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). 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. EU Clinical Trials Registry, EudraCT and ClinicalTrials.gov, . The online version of this article (10.1186/s13075-018-1772-z) contains supplementary material, which is available to authorized users.
publishDate 2019
dc.date.none.fl_str_mv 2
2019-01-01
2019
2019-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/226296
https://dx.doi.org/urn:doi:10.1186/s13075-018-1772-z
url https://ddd.uab.cat/record/226296
https://dx.doi.org/urn:doi:10.1186/s13075-018-1772-z
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.relation.none.fl_str_mv Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 PI13/02680
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
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