Incidence of serious infections, herpes zoster and hepatitis B virus reactivation among patients with SLE: a cohort study using a health claims database in Japan

Clinical Snapshot

Key Findings

• P Value: Not reported in abstract

• Effect Size: Serious infection incidence 37.93 per 100 patient-years in those with previous infection history

• Primary Outcome: Incidence rates per 100 patient-years for serious infections (4.80), herpes zoster (0.52), and HBV reactivation (0.37)

• Nnt Or Sensitivity: Hazard ratios estimated for patient characteristics but specific values not provided in abstract

• Confidence Interval: 95% CI for serious infections: 4.53 to 5.08 per 100 patient-years

Clinical Application

Findings applicable to routine clinical practice for infection risk assessment Relevant for Australian rheumatologists managing SLE patients; may inform PBS criteria for prophylactic treatments and monitoring protocols aligned with RACGP chronic disease management Patients with established SLE, particularly relevant for Asian populations

Abstract

OBJECTIVES: To investigate the real-world incidence of serious infections (SI), herpes zoster (HZ) and hepatitis B virus (HBV) reactivation among patients with SLE. METHODS: This retrospective, non-interventional cohort study used an insurance claims database in Japan to calculate the incidence of SI requiring hospitalisation, HZ and HBV reactivation in patients with SLE from 1 April 2017 to 31 March 2021. As an exploratory analysis, HRs and 95% CIs were estimated for clinically relevant patient characteristics for SI and HZ, adjusting for age and sex. RESULTS: Among 10 865 patients with SLE (female: 83.1%, median age: 53.0 years), including those who had previously experienced each complication, the incidence rates (per 100 patient-years) for SI, HZ and HBV reactivation were 4.80 (95% CI 4.53 to 5.08), 0.52 (0.44 to 0.61) and 0.37 (0.30 to 0.45), respectively. For those who had no previous history of each complication, incidence rates were 3.67 (3.44 to 3.92), 0.48 (0.40 to 0.58) and 0.25 (0.20 to 0.32), respectively. Incidence rates in specific subgroups were as follows: history of each complication (SI: 37.93, HZ: 4.19, HBV reactivation: 72.01), history of SI (HZ: 1.51, HBV reactivation: 1.75) and glucocorticoid pulse therapy during follow-up (SI: 64.23, HZ: 3.10, HBV reactivation: 4.85). CONCLUSIONS: These results provide data on the occurrence of selected infections in SLE and may inform safety management.

References

1. 1.Kuwana, M., Yabe-Wada, T., Hirai, T., Kato, Y., & Yamaguchi, Y. (2026). Incidence of serious infections, herpes zoster and hepatitis B virus reactivation among patients with SLE: a cohort study using a health claims database in Japan. Lupus Science & Medicine. https://doi.org/10.1136/lupus-2025-001879