RT Journal Article
T1 Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis.
A1 Gratacós, Jordi
A1 Pontes, Caridad
A1 Juanola, Xavier
A1 Sanz, Jesús
A1 Torres, Ferran
A1 Avendaño, Cristina
A1 Vallano, Antoni
A1 Calvo, Gonzalo
A1 de Miguel, Eugenio
A1 Sanmartí, Raimon
A1 REDES-TNF investigators, 
K1 Dose-tapering
K1 Non-inferiority
K1 Spondyloarthritis
K1 TNF inhibitors
AB 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 2011-005871-18 and ClinicalTrials.gov, NCT01604629 .
YR 2019
FD 2019-01-08
LK https://hdl.handle.net/10668/25952
UL https://hdl.handle.net/10668/25952
LA en
DS RISalud
RD Apr 12, 2025