Disease activity-guided tapering of biologics in patients with inflammatory arthritis: a pragmatic, randomized, open-label, equivalence trial
Authors' conclusion
Disease activity-guided tapering of biologics in patients with inflammatory arthritis enabled one-third to achieve ≥ 50% biologic reduction, while disease activity between groups remained equivalent.
Study context
- Population
- Adults with RA, PsA or axSpA in low disease activity on stable-dose biologics for ≥ 12 months
- Participants
- 95 vs 47
- Comparison
- Disease activity-guided tapering of biologics vs continuation as usual care
- Taperingn = 95
- Controln = 47reference
- Primary endpoint
- Co-primary: superiority in ≥ 50% biologic reduction and equivalence of disease activity (equivalence margins ± 0.5)
- Follow-up
- 18 months
Methodological detailspragmatic, open-label, equivalence, 2:1 randomisation
- Pragmatic
- Open-label
- Equivalence
- 2:1 randomisation
Primary result
As reported in the abstract
≥ 50% biologic reduction
Tapering vs ControlEstimate (95% CI)
Statistically significant
risk difference 35%(24%–45%)
Equivalent (margins ± 0.5)
mean difference (disease activity) 0.05(−0.12-0.29)
Safety
| Outcome | Tapering | Control | Risk difference (95% CI) | |
|---|---|---|---|---|
| FlareStatistically significant | 41% | 21% | 20% (4%–35%) | |
| −2002040Difference (linear scale) |
Persistent flare needing switch to another biologic
Original publication
Disease activity-guided tapering of biologics in patients with inflammatory arthritis: a pragmatic, randomized, open-label, equivalence trial. Scand J Rheumatol. Published 6 February 2023. doi:10.
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