041 Efficacy with continuous dosing, down-titration, or treatment withdrawal after successful treatment with baricitinib in patients with moderate-to-severe atopic dermatitis

Abstract

Baricitinib (BARI), an oral, selective Janus kinase (JAK)1/2 inhibitor, demonstrated long-term efficacy in moderate-to-severe atopic dermatitis (AD) in an ongoing, double-blind, phase 3 long-term extension study, BREEZE-AD3 (NCT03334435). We describe a substudy on the efficacy of down titration and withdrawal; it included patients (pts, N=526) treated with BARI 4mg or 2mg at entry into BREEZE-AD3 who achieved a vIGA-AD™ score of 0 (clear)/1 (almost clear)/2 (mild) at Week (wk) 52. BARI 4mg pts were rerandomized to BARI 4mg, BARI 2mg, or placebo (PBO) (BARI 4mg cohort), and BARI 2mg pts were rerandomized to BARI 2mg, BARI 1mg, or PBO (BARI 2mg cohort). After 16 wks, we assessed the proportion of pts with vIGA-AD 0/1, vIGA-AD 0/1/2, vIGA-AD ≥3 (retreatment criteria) and retreated pts recapturing vIGA-AD 0/1/2. In the BARI 4mg cohort, for BARI 4mg, BARI 2mg, and PBO, respectively, the proportions were 51%, 45% and 30% for vIGA-AD 0/1 (P<.001, PBO vs BARI 4mg); 87%, 61% and 50% for vIGA-AD 0/1/2 (P<.001, 2mg and PBO vs 4mg); 39% (continuous 4mg), 49% and 56% of pts were retreated and of these, 67%, 78% and 83% recaptured efficacy. In the BARI 2mg cohort, for BARI 2mg, BARI 1mg, and PBO, respectively, the proportions were 48%, 42%, and 25% for vIGA-AD 0/1 (P<.001, PBO vs BARI 2mg); 92%, 71%, and 45% for vIGA-AD 0/1/2 (P<.001, BARI 1mg and PBO vs 2mg); 41% (continuous 2mg), 41%, and 64% of pts were retreated and of these, 63%, 51%, and 80% recaptured efficacy. BARI allows for pts to down titrate or stop treatment, with many pts maintaining clinically relevant efficacy levels after 16 wks and most pts regaining efficacy on retreatment.