TNF inhibitor tapering non-inferior to non-tapering for LDA maintenance in PsA, axial SpA
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A treat-to-target strategy in which TNF inhibitors are tapered is non-inferior to a regimen without tapering for maintaining low disease activity in patients with psoriatic arthritis or axial spondyloarthritis, according to data.
“TNF inhibitors still carry some disadvantages, such as higher patient burden — injections — higher infection rate and costs,” Celia Michielsens, MD, of the rheumatology department at Sint Maartenskliniek, in the Netherlands, told Healio. “A way to alleviate these disadvantages would be the introduction of treat-to-target tapering strategies.
“Up to now, evidence on treat-to-target tapering strategies in psoriatic arthritis and axial spondyloarthritis are scarce and these strategies are often informally used,” Michielsens added. “In rheumatoid arthritis, however, these strategies are already implemented and widely used.”
To investigate the impact of tapering in treat-to-target strategies employing TNF inhibitors in patients with PsA or axial SpA, Michielsens and colleagues conducted an open-label, single-center, randomized, controlled non-inferiority trial. Patients were included if they were aged 16 years or older and had stable, low disease activity for at least 6 months prior to the study.
Patients were randomized on a 2:1 basis into a treat-to-target strategy with and without tapering, stratified by diagnosis and concomitant conventional synthetic disease-modifying antirheumatic drugs. Participants were treated following prespecified protocol, including direction on tapering, medication and flare treatment. Physicians could deviate if part of a shared decision-making process with their patients. Patients in the tapering group were reduced from 100% at baseline to 66%, 50% and so on until discontinuation as long as low disease activity was maintained.
Low disease activity was measured at every appointment and defined separately for patients with PsA and axial SpA, by way of either the Psoriatic Arthritis Disease Activity Score (PASDAS) or the Ankylosing Spondylitis Disease Activity Score (ASDAS) scales. Adverse events and serious adverse events were collected and graded. Additionally, quality of life was routinely measured using the EuroQol five-dimension scale.
The primary outcome was the difference in proportion of patients with low disease activity between the tapering and non-tapering groups at 12 months. Secondary outcomes included the differences between TNF inhibitor use between groups at 3, 6, 9 and 12 months. In patients with PsA, joint damage was also assessed at 12 months.
A total of 122 participants were evaluated, including 64 with PsA and 58 with axial SpA. There were 81 patients in tapering group and 41 patients in non-tapering group. At 12 months, 69% of patients in the tapering group demonstrated low disease activity, compared with 73% in the non-tapering group. The average percentage of daily defined dose at month 12 was 53% for the tapering group and 91% for the non-tapering group.
“The main takeaway would be that we delivered the highest quality of evidence that disease activity-guided dose personalization can, and in fact should, be used in clinical practice,” Michielsens said. “Our pragmatic treat-to-target tapering strategy is feasible in daily clinical care, although treat-to-target using PASDAS and ASDAS, which are disease composite indices, needs some implementation. We believe this to be beneficial for patients that the same disease activity can be maintained while achieving a substantial dose reduction with reduction of costs and injection burden.”
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