AB0461 Long-term use of adalimumab as monotherapy following attainment of low-disease activity: Subanalysis of the open-label extension of premier

Background There has been increased interest in understanding whether biologics can be safely withdrawn from patients (pts) receiving combination therapy with MTX once a clinical target has been achieved. The ability of the biologic to maintain the target as monotherapy has received less consideration. Objectives To evaluate long-term clinical and radiographic outcomes in pts treated with open-label (OL) adalimumab (ADA) as monotherapy following attainment of low-disease activity (LDA). Methods PREMIER was a 2-year (yr), phase 3, randomized, controlled trial (RCT) in MTX-naïve pts with early RA who were randomized to MTX, ADA (40 mg every other week), or ADA+MTX.1 Pts completing the RCT were eligible to receive OL ADA for up to an additional 8 yrs (this trial is ongoing); MTX could be added at the investigator’s discretion. This post hoc analysis included data from pts who were in an LDA state [defined as DAS28(CRP)