FRI0310 Achievement of low disease activity in lupus patients treated with belimumab is independent of serologic status at baseline: a real-life observational study

Abstract

BackgroundLow disease activity is a validated target of systemic lupus erythematosus (SLE) therapy.Objectivesτo assess the ability of belimumab to induce low disease activity states in real-life setting.MethodsMulticentre prospective observational study of SLE patients receiving belimumab due to active disease, refractory to at least one conventional immunosuppressant. Disease activity, including attainment of lupus low disease activity state (LLDAS) and remission-on-glucocorticoids (GC) (clinical SLEDAI-2K=0 with prednisone ≤5 mg/day), accrual of organ damage, flares and side effects were documented.ResultsNinety-one patients were included [94.5% women, mean (SD) age 45.9 (12.5) years]. Most frequent manifestations were arthritis (76.7%), rash (72.5%), serologic activity (low C3/C4 and/or high anti-dsDNA; 54.9%), hair loss (47.2%) and mucosal ulcers (27.5%). Median (range) duration of treatment was 10.5 (3.0–42.1) months. Belimumab decreased average SLEDAI-2K, physician global assessment and daily prednisone dose over time, as early as 3 months after initiation. Complete withdrawal of GC was achieved in 17.8%, 22.5%, 31.7% and 23.3% at 3, 6, 9 and 12 months, respectively. The number of flares and severe flares was reduced by 62% and 50%, respectively, during the first year of treatment. Although reduction in clinical SLEDAI-2K was more pronounced in patients who were serologically active (from 8 to 1.5 at 12 months) compared to serologically inactive (from 6 to 4) at baseline, attainment of low disease activity states (LLDAS or remission) did not differ between groups and was reached by more than 40% of completers after 9–12 months (figure 1). Twenty patients (22.0%) discontinued treatment due to inadequate response and two due to side effects potentially related to the drug.ConclusionsBelimumab is efficacious in achieving low disease activity in over 40% of active SLE patients, accompanied by complete GC discontinuation in more than 20%. Serologically active and inactive patients respond equally to the drug.References[1] Franklyn K, et al. Definition and initial validation of a Lupus Low Disease Activity State (LLDAS). Ann Rheum Dis. 2016;75(9):1615–21.[2] Zen M, et al. Prolonged remission in Caucasian patients with SLE: prevalence and outcomes. Ann Rheum Dis. 2015;74(12):2117–22.Disclosure of InterestNone declared