Structured tapering of biologic and targeted DMARDs was noninferior for 24 weeks in stable rheumatoid arthritis

Design

Multicentre, randomised, open-label, noninferiority trial, 24 weeks

Population

348 patients with rheumatoid arthritis in sustained low disease activity on stable biologic or targeted synthetic DMARDs

Primary outcome

Maintenance of DAS28-ESR low disease activity at week 24

Effect

88.2% (tapering) vs 89.6% (continuation); difference -1.43% (95% CI -8.09 to 5.23), margin -10%

Evidence for tapering biologic or targeted synthetic DMARDs in rheumatoid arthritis with sustained low disease activity is limited. This multicentre, open-label, noninferiority trial randomised 348 patients who had been on stable doses and in low disease activity by DAS28-ESR for at least six months to stepwise dose tapering (n = 171) or continuation (n = 177). The primary endpoint was maintained low disease activity at week 24, with a prespecified noninferiority margin of -10%.

In the per-protocol population, low disease activity was kept in 89.6% on continuation and 88.2% on tapering (risk difference -1.43%, 95% CI -8.09 to 5.23), meeting noninferiority. Full-analysis results were similar. Most patients whose disease worsened regained low disease activity after protocol-guided re-escalation without permanent discontinuation. Some measures favoured continuation, namely DAS28-CRP at week 12 and DAS28-ESR and the Simplified Disease Activity Index at week 24. Adverse events were uncommon in both groups.

Follow-up was 24 weeks, open-label, and tapering was stepwise with planned re-escalation, so it speaks to short-term disease control. Whether radiographic progression or later flares differ is unknown. Tapering remains a shared decision for patients in sustained low disease activity or remission, with a plan to restore dose if disease worsens.

• Low disease activity was kept in 88.2% with tapering and 89.6% with continuation (difference -1.43%, 95% CI -8.09 to 5.23).
• Most patients who flared regained control on re-escalation.
• Some disease activity measures, such as DAS28-ESR at week 24, favoured continuation.
• Taper stepwise with a pre-agreed plan to restore the dose.
• Follow-up was 24 weeks; radiographic and long-term effects are unknown.

Why it matters

Dose reduction can lower cost and exposure, which matters in settings where access to biologics is limited.

Don't overread it

The trial lasted 24 weeks and was open-label, so it does not show sustained control, radiographic safety or drug-free remission.

The statistics, in plain English

Noninferiority here means the lower end of the confidence interval for the difference (-8.09%) stayed above the -10% margin, so tapering was not worse by more than 10 percentage points. The margin itself is a judgement, and a 24-week open-label design cannot exclude later differences.

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