- Design
- Multicentre, randomised, open-label non-inferiority trial, 24 weeks
- Population
- 348 adults with rheumatoid arthritis in sustained low disease activity on b/tsDMARDs
- Primary outcome
- Maintenance of DAS28-ESR low disease activity at week 24
- Effect
- 88.2% vs 89.6%; risk difference −1.43% (95% CI −8.09 to 5.23), non-inferior
In a 24-week, multicentre, open-label non-inferiority trial, 348 people with rheumatoid arthritis who had maintained DAS28-ESR low disease activity for at least six months on a stable biologic or targeted synthetic DMARD were randomised to stepwise dose tapering or continuation.
Low disease activity at week 24 was maintained in 88.2% of the tapering group and 89.6% of the continuation group (risk difference −1.43%, 95% CI −8.09 to 5.23), within the prespecified −10% margin. Most who flared regained low disease activity after protocol-guided re-escalation, without stopping treatment. Some measures — DAS28-CRP at week 12, DAS28-ESR and SDAI at week 24 — favoured continuation. Adverse events were uncommon.
Twenty-four weeks is short, and the open-label design and a 10% margin leave room for a modest loss of control. But a structured taper with a clear re-escalation plan appears safe for patients in sustained low disease activity. Where advanced therapies are paid for out of pocket, as often in India, that matters.
- Consider structured tapering for patients in sustained low disease activity for at least six months on a biologic or JAK inhibitor.
- Taper stepwise — dose reduction or interval extension — rather than stopping outright.
- Agree a re-escalation plan in advance; most flares in this trial were recaptured.
- Monitor disease activity closely during the first months of tapering.
- Discuss tapering as a shared decision, including cost savings and flare risk.
Why it matters
It gives randomised support to tapering, which can reduce drug exposure and cost without losing control for most patients.
Don't overread it
Twenty-four weeks of open-label follow-up; longer-term flare and damage outcomes are not known.
The statistics, in plain English
In a non-inferiority trial the question is whether tapering is not meaningfully worse. The lower limit of the interval (−8.09%) is above the −10% margin, so tapering met that test. A margin of 10% means the trial accepted up to one extra loss of control in ten patients.
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