Low Disease Activity Maintained Long Term With TNF Tapering
A tapering strategy for TNF inhibitors maintained low disease activity in patients with psoriatic arthritis (PsA) and those with axial spondyloarthritis (AxSpA) over 24 months. Protocol-driven tapering achieved a greater reduction in the mean dose of TNF inhibitors than routine care tapering, with both methods equally effective for disease control.
METHODOLOGY:
Previous 12-month results from an open-label, noninferiority, pragmatic trial (January 2019 to July 2020) conducted in the Netherlands showed that tapering of TNF inhibitors was noninferior to continued dosing for maintaining low disease activity in patients with PsA or AxSpA.
Participants in the original trial (aged 16 years or older with stable low disease activity for 6 or more months) were randomly assigned to either a treat-to-target tapering strategy (intervention) or a continuation of the original dose of TNF inhibitors (control). Tapering involved extending the interval between doses, leading to doses equivalent to 100%, 66%, 50%, 33%, or 0% of the defined daily dose.
This observational extension of the original trial included 114 patients (mean age, 50 years; 79 from the intervention group and 35 from the control group) with PsA (n = 58) and AxSpA (n = 56), where the intervention group continued the tapering strategy, whereas the control group could attempt tapering (routine care tapering), with treatment decisions made collaboratively by physicians and patients.
The primary outcome was the difference in the proportion of patients with low disease activity at 24 months between the intervention and control groups compared against a prespecified noninferiority margin of 20%.
Secondary outcomes included differences in efficacy between the intervention and control groups determined using disease activity scores at 18 and 24 months, as well as the cumulative incidence of disease flare over 24 months.
TAKEAWAY:
At 24 months, 67% of patients in the intervention group and 72% in the control group maintained low disease activity (adjusted difference, 5%; P = .64). Over 24 months, 89% of patients attempted tapering, with no significant differences in adverse events between groups.
No difference was noted in the percentage of patients achieving low disease activity between the intervention group with protocol-driven tapering at 12 months and the control group with routine care tapering at 24 months. The cumulative incidence of disease flare was 90% over 24 months.
The mean dose of TNF inhibitors increased in the intervention group from 52% to 66% of the defined daily dose from 12 months to 24 months (difference, 14%; P < .0001).
However, the mean dose was lower with protocol-driven tapering in the intervention group at 12 months than with routine care tapering in the control group at 24 months (P = .0001) and lower with routine care tapering vs no tapering in the control group (P = .0007).
IN PRACTICE:
'[T]hese data indicate that a taper-to-target strategy is effective and leads to substantial TNF inhibitor dose reduction, but optimal execution of such a strategy in routine care is more challenging than in the context of a clinical trial,' the authors of the study wrote. 'Considering the risks and benefits of tapering, we suggest that disease activity-guided tapering could enable more optimized and personalized treatment in patients with psoriatic arthritis and axial spondyloarthritis.'
SOURCE:
The study was led by Amy C.D. Peeters, MD, and Celia A.J. Michielsens, MD, PhD, Sint Maartenskliniek in Nijmegen, the Netherlands. It was published online on July 24, 2025, in The Lancet Rheumatology.
LIMITATIONS:
Measurements for disease activity were missing at 18 and 24 months. The absence of validated flare criteria until 2022 may have led to an overestimation of flare incidence. Radiographic progression was not assessed at the 24-month follow-up. Allowing tapering in the control group during the extension phase reduced the difference between groups.
DISCLOSURES:
The study was funded by ReumaNederland. Some authors reported receiving grants from multiple companies including Novartis, Eli Lilly and Company, and AbbVie to their institution. One author reported receiving support for attending meetings and/or travel from Pfizer, Novartis, and UCB.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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