Identifier to cite or link to this item: http://hdl.handle.net/20.500.13003/15936
Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis
Identifiers
ISSN: 1478-6354
eISSN: 1478-6362
WOS ID: 000455329300002
Scopus EID: 2-s2.0-85059766002
PMID: 30621746
Embase PUI: L625827318
Share
Statistics
Item usage statisticsMetadata
Show Dublin Core item recordAuthor
Gratacos, Jordi; Pontes, Caridad; Juanola, Xavier; Sanz, Jesus; Torres, Ferran; Avendano, Cristina; Vallano, Antoni; Calvo, Gonzalo; de Miguel, Eugenio; Sanmarti, Raimon; Almirall, Miriam; Aparicio, Maria; Sellas, Agusti; Vives, Roser; Albinana, Nestor; Moreno, Mireia; Clavaguera, Teresa; Carlos Torre-Alonso, Juan; Veroz, Raul; Rodriguez-Lozano, Carlos; Francisco Linares, Luis; Urruticoechea, Ana; Collantes, Eduardo; Maria Morla, Rosa; Reina, Delia; Cuende, Eduardo; Zarco, Pedro; Cruz Fernandez-Espartero, Maria; Garcia-Vicuna, Rosario; Alberto Montilla, Carlos; Villalba, Alejandro; Pascual, Dora; Campos, Cristina; Juan Mas, Antonio
Publication date
2019-01-08Document type
research articleCitation
Gratacos J, Pontes C, Juanola X, Sanz J, Torres F, Avendano C, et al. Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis. Arthritis Res Ther. 2019 Jan 08;21:11.Abstract
ObjectiveThe 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.MethodsRandomized, parallel, non-inferiority, open-label multicentre clinical trial. Patients were eligible if they had axial spondyloarthritis and had been in clinical remission for 6months 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 1year. Serious adverse reactions or infections were recorded.ResultsThe 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 1year (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).ConclusionIn patients with ankylosing spondylitis in clinical remission for at least 6months, dose reduction is non-inferior to full TNF inhibitor doses to maintain LDA after 1year. Serious adverse events may be less frequent with reduced doses.Trial registrationEU Clinical Trials Registry, EudraCT 2011-005871-18 and ClinicalTrials.gov, NCT01604629.
Publisher version
https://dx.doi.org/10.1186/s13075-018-1772-zMeSH
AdalimumabEtanercept
Dose-Response Relationship, Drug
Adult
Antibodies, Monoclonal
Humans
Spondylarthritis
Middle Aged
Male
Prospective Studies
Tumor Necrosis Factor Inhibitors
Tumor Necrosis Factor-alpha
Female
Infliximab
DeCS
Inhibidores del Factor de Necrosis TumoralFemenino
Infliximab
Factor de Necrosis Tumoral alfa
Masculino
Espondiloartritis
Adalimumab
Relación Dosis-Respuesta a Droga
Humanos
Persona de Mediana Edad
Estudios Prospectivos
Etanercept
Adulto
Anticuerpos Monoclonales
This item appears in following Docusalut collections
Área de Salud de Ibiza y Formentera - ASEF > Comunicación científicaHospital Universitario Son Llàtzer - HUSLL > Comunicación científica