POS0028 DEFINING THE PREVALENCE OF UNMET NEED IN SLE: DATA FROM A LARGE MULTINATIONAL LONGITUDINAL SLE COHORT

Rangi Kandane‐Rathnayake ,J Cho,Shue‐Fen Luo ,Z Zhang ,Tsutomu Takeuchi ,Vera Golder ,Shereen Oon ,Yanjie Hao ,Chak Sing Lau ,Yoshiya Tanaka ,Leonid Zamora ,Ya‐Fen Wu ,A Hoi ,Y H Chen ,Jun Kikuchi ,Laniyati Hamijoyo ,Madelynn Chan ,Kathryn A Gibson ,Sang Cheol Bae ,Fiona Goldblatt ,Z Li ,Aisha Lateef ,Sean O’neill ,Worawit Louthrenoo ,Mandana Nikpour ,S Navarra ,Nicola Tugnet ,Masayoshi Harigai ,Kristine Ng ,Sunil Kumar ,Yi An ,Sargunan Sockalingam ,B M P K Dheemantha Basnayake ,Yasuhiro Katsumata ,Eric F Morand

doi:10.1136/annrheumdis-2021-eular.938

Abstract

Background:The recent prospectively validated definition of the lupus low disease activity state (LLDAS) allows characterisation of patients not achieving a treatment goal, providing impetus for an analysis of unmet needs in SLE using formal definitions. Other recently described definitions of high disease burden include disease activity over time, high disease activity status (HDAS) episodes, and the combination of high disease activity, serological activity and glucocorticoid (GC) use (HDAS+SA+GC).Objectives:To determine the prevalence of formal categories of unmet need, and the association of these with adverse outcomes, in SLE.Methods:Data from a 13-country longitudinal SLE cohort (ACR/SLICC criteria) were collected between 2013 and 19 using standard templates. Unmet need was defined as (i) patients never attaining LLDAS defined as in Golder et al., 2019 [1], (ii) having persistently active disease (time adjusted mean SLEDAI-2K (AMS) > 4), (iii) ever exhibiting high disease activity status (HDAS; SLEDAI-2K ≥10[2]), or (iv) ever exhibiting all of SLEDAI≥10, serological activity, and glucocorticoid use (HDAS+SA+GC)[3]. Health-related quality of life (HRQoL) was assessed using SF36 (v2) surveys and damage accrual using SLE Damage Index (SDI).Results:3,384 SLE patients were followed for 30,313 visits over median [IQR] 2.4 [0.4, 4.3] years. 53% of all visits were not in LLDAS; 813 patients (24%) never achieved LLDAS during observation. Median AMS was 3.0 [1.4, 4.9] and 34% of patients had AMS > 4 throughout the study. 25% of patients had at least one episode of HDAS, representing 8% of visits. 702 patients (21%) had at least one episode of HDAS+SA+GC, representing 8% of visits. Each of never-LLDAS, AMS>4, ever-HDAS, and ever-HDAS+SA+GC were associated with significantly greater number of physician visits, higher mean glucocorticoid dose, lower HRQoL and higher mortality. 31%, 58% and 83% of never-LLDAS, AMS>4, and ever-HDAS patients respectively were also HDAS+SA+GC on at least one occasion.Conclusion:Data from a multinational longitudinal SLE cohort indicate that unmet need, defined by LLDAS-never, AMS>4, HDAS, or HDAS+SA+GC, is prevalent in SLE, and that these definitions are associated with poor outcomes.

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