Safety of intravenous and subcutaneous belimumab in Japanese patients with systemic lupus erythematosus: Final analysis of data from an all-case post-marketing surveillance study.

OBJECTIVES: To assess safety of belimumab in Japanese patients with systemic lupus erythematosus (SLE) in real-world clinical practice. METHODS: This all-case post-marketing surveillance study included patients initiating belimumab between December 2017 and October 2018. To evaluate safety, patients were observed for up to 52 weeks. In main population, baseline risk factors for serious infection were assessed by multivariate analysis. Exploratory risk factor analysis for depression/suicidal ideation/suicide attempt was conducted in expanded population. RESULTS: Among 1177 patients (main population), incidence rates per 100 person-years of serious adverse events (SAEs) and AEs of special interest were: SAEs, 28.4; serious infection, 8.8; depression/suicidal ideation/suicide attempt, 1.3; malignant tumour, 0.7; serious hypersensitivity, 0.7. Male sex, any comorbidity and glucocorticoid dose at baseline were independent risk factors for serious infection. In exploratory analysis, comorbidity of depression/suicidal ideation/suicide attempt at belimumab initiation was an associated characteristic factor for the new occurrence/worsening depression/suicidal ideation/suicide attempt. CONCLUSIONS: No new safety concerns were identified compared with previously reported data and current belimumab labelling. Depression/suicidal ideation/suicide attempt incidence rate was similar to that previously reported for patients with SLE. Patients with risk factors for serious infection and depression/suicidal ideation/suicide attempt should be carefully monitored.Clinicaltrials.gov: NCT03370263.