Treat-to-target dose reduction effective in spondyloarthritis

Many patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) need long-term treatment with biologics, which causes considerable costs and might be responsible for an elevated risk of infection. In an open-label, randomised, non-inferiority trial, tapering TNF blockers in patients that achieved remission or at least low disease activity led to a similar proportion of patients still in low disease activity after a year and a 46% lower risk of grade 3 and 4 infections.

“What makes our trial relevant? First, we focused on stepwise tapering instead of fixed-dose tapering. Secondly, we used disease-specific targets,” explained Dr Celia Michielsens (Sint Maartenskliniek, the Netherlands). Together with her team, she investigated whether a treat-to-target (T2T) strategy with tapering is non-inferior (with a pre-specified non-inferiority margin of 20%) compared with a T2T strategy without tapering in a randomised, controlled, open-label, non-inferiority trial [1]. All participants used TNF inhibitors and had stable low disease activity for ≥6 months. They were randomised (2:1) to a T2T tapering or no-tapering strategy and were followed for 12 months. Low disease activity was defined as a Psoriatic Arthritis Disease Activity Score (PASDAS) ≤3.2 for PsA, and/or Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1, and/or judgement of physician and patient.

Of the 81 participants in the tapering group, 52% had PsA and the rest had axSpA. Of the 41 participants in the non-tapering group, 54% had PsA and the rest axSpA. At 12 months, 73% in the non-tapering group and 69% in the tapering group achieved low disease activity. This difference was well below the inferiority margin, thus confirming non-inferiority. At 12 months, 58 (72%) participants of the tapering group were successfully tapered. The only disadvantage of this approach was an increase in the use of other medications in the tapering group, a difference that was statistically significant regarding non-steroidal anti-inflammatory drug use (54% vs 24%; P=0.002). However, the risk of grade 3/4 infections was 46% lower, and the risk of injection site reactions was 23% lower in the tapering compared with the non-tapering group.

Taken together, there was no significant difference between a tapering and a non-tapering approach regarding disease activity. “This might have been because we used not a fixed but an individualised tapering approach,” Dr Michielsen said. Moreover, tapering led to a substantial reduction in TNF inhibitor use.

1. Michielsens C, et al. Treat-to-target dose reduction and withdrawal strategy of TNF inhibitors in psoriatic arthritis and axial spondyloarthritis: a randomized controlled non-inferiority trial. OP0261, EULAR 2022 Congress, 1–4 June, Copenhagen, Denmark.

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Posted on 21 July 202217 May 2024