AB0778 ASSOCIATION BETWEEN PATIENT-REPORTED OUTCOMES AND DISEASE ACTIVITY IN BIMEKIZUMAB-TREATED PATIENTS WITH PSORIATIC ARTHRITIS

Abstract

Background:Bimekizumab (BKZ) is a humanised IgG1 monoclonal antibody, which selectively neutralises interleukin (IL)-17A and IL-17F. There is support for the BKZ mechanism of action as a novel therapeutic approach for psoriatic arthritis (PsA).1-3The phase 2b dose-ranging BE ACTIVE study assessed the efficacy and safety of BKZ in patients (pts) with PsA; data are reported elsewhere.4Patient-reported outcomes (PROs) are increasingly recognised as important endpoints in clinical trials.5The Psoriatic Arthritis Impact of Disease-9 (PsAID-9) questionnaire was specifically developed to assess health-related quality of life (QoL) in pts with PsA5and its validity in clinical practice has been demonstrated.5-6Objectives:To report the association between PsAID-9 score (a PRO) and disease activity response (very low disease activity [VLDA], minimal disease activity [MDA] or Disease Activity Index for Psoriatic Arthritis [DAPSA] remission) during 48 weeks’ (wks’) BKZ treatment.Methods:Details of the study design (NCT02969525) are reported elsewhere.4Here, we report the proportion of pts who achieved a PsAID-9 score ≤3, and the association between PsAID-9 score at Wk 48 (range 0–10, where 10 corresponds to worst QoL) and VLDA/MDA (binary states of disease control) or DAPSA (range 0–>28 where 0–4 is remission, 5–14 is low, 15–28 is moderate, and >28 is high disease activity) at Wk 12.Results:Across 206 randomised pts at baseline, 66.5% had psoriasis body surface area (BSA) ≥3%, 18.9% had prior tumour necrosis factor inhibitor (TNFi) exposure, and 63.6% received concomitant methotrexate. A substantial proportion of pts achieved MDA and/or DAPSA remission by Wk 12, which generally increased through to Wk 24 and 48 (Table 1). The 160 mg BKZ group saw the highest Wk 48 rates of MDA response (60.0%) and DAPSA remission (45.0%) (Table 1). The proportion of pts achieving a PsAID-9 score ≤3 was consistently high across all active treatment arms (Figure 1). PsAID-9 score was consistently lower (indicating better QoL) for pts with VLDA or MDA, and those in DAPSA remission (Figure 2), indicating that low disease activity was associated with improved PROs.Conclusion:In BKZ-treated pts, improvements in PsAID-9 were associated with achievement of VLDA/MDA response and DAPSA remission. These results suggest that pts achieving higher disease control have improved QoL.