607 Impact of anifrolumab on neuropsychiatric manifestations of depression and suicidality in patients with systemic lupus erythematosus

BackgroundNeuropsychiatric (NP) disease is more common in patients with systemic lupus erythematosus (SLE) than in the general population.1 Increased incidence of NP events (depression and suicidality) has been reported with biologic therapies, including SLE therapies.2 Depression and suicidality were evaluated in patients with SLE treated with anifrolumab, a type I interferon receptor antibody, in the TULIP-1 and TULIP-2 trials.3,4 This analysis aims to understand the impact of anifrolumab treatment on NP manifestations (depression and suicidality) in patients with SLE relative to standard therapy using pooled data from the TULIP trials.MethodsTULIP-1/-2 were randomized, placebo-controlled, 52-week trials of intravenous anifrolumab every 4 weeks in patients with moderate to severe SLE despite standard therapy.3,4Patients with active severe or unstable NP SLE were excluded. Patients who received ≥1 dose of anifrolumab 300 mg or placebo were analyzed for depression and suicidality .3,4 The Personal Health Questionnaire Depression Scale-8 (PHQ-8) and Columbia Suicide Severity Rating Scale (C-SSRS) were used to assess clinical depression and suicidal ideation and behavior, respectively. Incidence of adverse events (AEs) within the standardized Medical Dictionary for Regulatory Activities query of depression (excluding suicide and self-injury) and antidepressant use at baseline and during the study were also assessed.ResultsIn the TULIP pooled analysis, 360 patients received anifrolumab and 365 received placebo. Mean PHQ-8 scores were in the mild range (≥5 to