This protocol addresses patients with rheumatoid arthritis who have no contraindication (or only early intolerance) to methotrexate, carry one or more poor prognostic factors, and whose initial advanced therapy did not reach the expected disease activity targets.
Poor prognostic factors are present: RF and/or ACPA positivity (especially at high levels), persistently moderate or high disease activity despite conventional DMARD therapy, high swollen joint count, elevated acute phase reactants, early erosive joint disease, or prior failure of two or more conventional synthetic DMARDs.
The preceding step added a biologic DMARD or a JAK inhibitor to the existing conventional synthetic DMARD. This strategy did not achieve at least 50% improvement in disease activity within 3 months, or did not reach sustained remission or low disease activity by 6 months — meeting the criteria to advance to the current protocol.
The next step involves switching to a different biologic or targeted synthetic DMARD — in some cases to one with a different mechanism of action than the agent that failed. The specific agent selection, sequencing, and supporting therapy are set out in the full structured protocol.
The goal is at least 50% improvement in disease activity within 3 months of the new regimen, and sustained remission — defined by ACR-EULAR Boolean criteria (swollen joint count, tender joint count, CRP, and patient global assessment) — or low disease activity by 6 months.
DOI: 10.1136/ard-2022-223356
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