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
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- #TNF inhibitor
- #methotrexate
- #rheumatoid arthritis
- The SORAIRO trial assessed noninferiority of spacing TNF inhibitors or reducing methotrexate dose vs. continued treatment in rheumatoid arthritis patients in remission/low disease activity.
- 144 patients (mean age 58.2, 75% female) were randomized into continued treatment, ozoralizumab spacing, or methotrexate dose reduction groups.
- Primary endpoint: Noninferiority of low disease activity maintenance at week 48 (margin: -18%). Continued treatment showed 97.9% success vs. 79.2% (ozoralizumab spacing) and 72.7% (methotrexate reduction).
- Remission maintenance rates were comparable across groups in the baseline remission subgroup (77.4%, 76.7%, 79.2%).
- No significant differences in Health Assessment Questionnaire Disability Index or modified total Sharp score changes.
- Adverse events occurred in 68.0% (continued treatment), 59.2% (ozoralizumab spacing), and 58.0% (methotrexate reduction).
- Conclusion: Tapering not feasible for low disease activity patients, but spacing TNF inhibitors or reducing methotrexate may be options for those in remission.