Spacing of a tumour necrosis factor (TNF) inhibitor or dose reduction of methotrexate vs continued treatment in patients with rheumatoid arthritis in remission or low disease activity: a randomised, controlled trial (SORAIRO trial)
Authors' conclusion
Treatment tapering may not be feasible in patients with low disease activity, whereas both extending the TNF inhibitor interval and reducing the methotrexate dose may be reasonable options for patients in remission.
Study context
- Population
- Patients with RA in remission or low disease activity (Clinical Disease Activity Index (CDAI)) in the preceding phase III trial of ozoralizumabanalysed
- Participants
- 144 patients
- Comparison
- Ozoralizumab spacing or MTX dose reduction vs continued treatment
- Primary endpoint
- Noninferiority of low disease activity maintenance
- Follow-up
- Week 48
Methodological detailsmulticentre, open-label, noninferiority
- Multicentre
- Open-label
- Noninferiority
Primary result
As reported in the abstract
Low disease activity
Each group vs continued treatmentDifference (95% CI)
Ozoralizumab spacing
−21.6(−39.9 to −5.7)
Methotrexate dose reduction
−30.4(−54.0 to −10.5)
Non-inferiority margin −18 as printed, not drawn
Further findings
Remission maintenance in baseline remission subgroup
Remission maintenance in baseline remission subgroup
- Comparable in the 3 groups
Changes in HAQ-DI and mTSS
- No significant differences
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Spacing of a TNF inhibitor or dose reduction of methotrexate vs continued treatment in patients with rheumatoid arthritis in remission or low disease activity: a randomised, controlled trial (SORAIRO trial). Ann Rheum Dis. Published 28 February 2026. doi:10.
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