Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis
Gratacós, Jordi (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Pontes García, Caridad (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Juanola, Xavier (Hospital Universitari de Bellvitge)
Sanz, Jesús (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Torres, Ferran (Universitat Autònoma de Barcelona. Departament de Pediatria, Obstetrícia i Ginecologia i Medicina Preventiva i Salut Pública)
Avendaño Sola, Cristina (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Vallano, Antoni (Hospital Universitari de Bellvitge)
Calvo, Gonzalo (Hospital Clínic i Provincial de Barcelona)
de Miguel, Eugenio (Hospital Universitario La Paz (Madrid))
Sanmartí, Raimon (Hospital Clínic i Provincial de Barcelona)

Data:	2019
Resum:	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.
Ajuts:	Ministerio de Economía y Competitividad PI13/02680
Nota:	Altres ajuts: programa "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)
Drets:	Aquest 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.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Spondyloarthritis ; Dose-tapering ; Non-inferiority ; TNF inhibitors
Publicat a:	Arthritis research & therapy, Vol. 21 (january 2019) , ISSN 1478-6362

Adreça alternativa: https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-018-1772-z
DOI: 10.1186/s13075-018-1772-z
PMID: 30621746

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