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
Author
Gratacós, Jordi; Pontes, Caridad; Juanola, Xavier; Sanz, Jesús; Torres, Ferran; Avendaño Solá, 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 de Vicuña Pinedo, María del 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, RubénEntity
UAM. Departamento de MedicinaPublisher
BMC (part of Springer Nature)Date
2019-01-08Citation
10.1186/s13075-018-1772-z
Arthritis Research and Therapy 21.1 (2019): 11
ISSN
1478-6354 (print); 1478-6362 (online)DOI
10.1186/s13075-018-1772-zFunded by
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).Project
Gobierno de España: EC11–229; Gobierno de España. PI13/02680Editor's Version
https://doi.org/10.1186/s13075-018-1772-zSubjects
Dose-tapering; Non-inferiority; Spondyloarthritis; TNF inhibitors; MedicinaRights
© 2019 The Author(s)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.
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Google Scholar:Gratacós, Jordi
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Pontes, Caridad
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Juanola, Xavier
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Sanz, Jesús
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Torres, Ferran
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Avendaño Solá, Cristina
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Vallano, Antoni
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Calvo, Gonzalo
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De Miguel, Eugenio
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Sanmartí, Raimon
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Almirall, Miriam
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Aparicio, Maria
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Sellas, Agustí
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Vives, Roser
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Albiñana, Nestor
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Moreno, Mireia
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Clavaguera, Teresa
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Torre-Alonso, Juan Carlos
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Veroz, Raúl
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Rodríguez-Lozano, Carlos
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Linares, Luís Francisco
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Urruticoechea, Ana
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Collantes, Eduardo
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Morlà, Rosa María
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Reina, Dèlia
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Cuende, Eduardo
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Zarco, Pedro
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Fernández-Espartero, Maria Cruz
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García de Vicuña Pinedo, María del Rosario
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Montilla, Carlos Alberto
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Villalba, Alejandro
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Pascual, Dora
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Campos, Cristina
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Juan, Antonio
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Ariza, Rafael
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Díaz-Miguel, Consuelo
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Maqueda, Manuel
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Fernández-Dapica, Maria Pilar
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Fernández-Prada, Manuel
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Batlle, Enrique
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González-Fernández, Carlos
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Queiro, Rubén