Abstract
Background Across all phase 3 studies, treatment with upadacitinib (UPA), a JAK1-selective inhibitor, was associated with significantly higher remission (REM) rates, compared to placebo (PBO) or active comparators, in RA patients (pts) who were methotrexate (MTX)-naive, had inadequate response to conventional synthetic (csDMARD-IR) or had inadequate response or intolerance to biologic DMARDs (bDMARD-IR) Objectives REM definitions are based on composite scores of various individual assessments of disease activity. To determine the response to UPA on REM and component assessments, we assessed the proportions of pts achieving REM using multiple REM definitions, and the improvement in their respective individual components, compared to PBO or active comparators, in 3 different RA pt populations spanning a range of RA pt populations. Methods Three phase 3 studies included pts who were MTX naive (SELECT EARLY, n=945), MTX-IR (SELECT COMPARE, n=1629) and bDMARD-IR (SELECT BEYOND, n=498). The proportion of pts achieving REM at Week (Wk) 12 by 4 definitions (DAS28-CRP Results Pt demographics and disease characteristics have been previously reported. 1-3 At 12 wks, in EARLY and COMPARE, a significantly greater proportion of pts receiving UPA 15 mg or 30 mg QD achieved REM by all 4 definitions vs MTX, PBO or ADA (Table). In BEYOND, (a refractory population many of whom had inadequate response to multiple bDMARDs), a significantly greater proportion of pts receiving UPA 30mg achieved all REM definitions vs PBO within the first 12 wks, with significantly greater proportions on UPA 15mg achieving DAS28-CRP Conclusion Significantly greater proportions of pts receiving UPA 15 or 30mg achieved REM by multiple definitions at 12 wks compared to PBO, MTX or ADA. All disease activity components of each REM definition were significantly improved in pts receiving UPA compared to MTX or PBO, and all Boolean components were significantly improved in pts receiving UPA 15mg compared to ADA.
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