| Summary: | <p><strong>Objective:</strong> To determine whether early changes in disease activity predict later achievement of low disease activity (LDA) or remission in patients treated with baricitinib 4 mg in global phase 3 studies.</p>
<p><strong>Methods:</strong> This analysis examined 487 patients and 159 patients randomized to baricitinib 4 mg in RA-BEAM and RA-BEGIN, respectively. Early response was predefined as Clinical Disease Activity Index (CDAI) improvement from baseline to Week 4 of ≥6.0. LDA and remission were based on Simplified Disease Activity Index at Weeks 12 and 24.</p>
<p><strong>Results:</strong> At Week 4, the majority of baricitinib-treated patients had CDAI improvement ≥ 6.0 in RA-BEAM (86%) and RA-BEGIN (85%), with high LDA/remission rates at Weeks 12 and 24. Negative predictive values (NPVs) based on CDAI improvement < 6 from baseline to Week 4 exceeded 90% for remission at Week 24. In comparison, NPVs for LDA at Week 24 were lower (RA-BEAM, 80%; RA-BEGIN, 58%).</p>
<p><strong>Conclusion:</strong> CDAI improvement ≥ 6.0 at Week 4 was associated with improved clinical outcomes at Weeks 12 and 24 whereas patients who were early non-responders were unlikely to achieve remission at these time points.</p>
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