- Design
- Multicentre, randomised, open-label, non-inferiority trial, 24 weeks
- Population
- 348 adults with RA in sustained low disease activity on b/tsDMARDs, Korea
- Primary outcome
- Maintenance of DAS28-ESR low disease activity at week 24
- Effect
- 88.2% vs 89.6%; risk difference -1.43% (-8.09 to 5.23)
This 24-week, multicentre, open-label, non-inferiority trial in Korea randomised 348 patients with rheumatoid arthritis who had held DAS28-ESR low disease activity for at least six months on a stable biologic or targeted synthetic DMARD. Patients either continued the full dose or followed a stepwise taper.
Low disease activity 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), meeting the -10% non-inferiority margin. Most patients who worsened regained low disease activity after protocol-guided re-escalation. Some secondary measures favoured continuation, including DAS28-ESR and SDAI at 24 weeks. Adverse events were uncommon.
For Indian patients who pay for biologics and JAK inhibitors themselves, a structured taper in sustained low disease activity is a reasonable way to cut cost and exposure. Twenty-four weeks is short, and the open-label design and the secondary scores favouring continuation argue for close monitoring and a ready plan to step back up.
- Consider a stepwise taper after at least six months of sustained low disease activity on a biologic or JAK inhibitor.
- Agree in advance the flare criteria and the plan for re-escalation.
- Review disease activity at least every three months during tapering.
- Do not taper patients with recent flares, erosive progression or only borderline control.
Why it matters
Most patients stay on full-dose advanced therapy indefinitely, and this supports doing otherwise for selected patients.
Don't overread it
Only 24 weeks of follow-up in an open-label trial; longer-term flare and damage risk are not addressed.
The statistics, in plain English
Non-inferiority means tapering was not worse than continuation by more than 10 percentage points. The lower bound of the interval (-8.09%) stayed inside that margin, but a loss of control in up to 8 more patients per 100 cannot be excluded.
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