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

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 infec

SUBMITTER: Gratacos J 

PROVIDER: S-EPMC6323809 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature