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May 19, 2026Open Access

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

MKMasataka KuwanaKeio University TYToshiki Yabe‐WadaKanazawa Medical University THTakehiro HiraiAstraZeneca (Japan)

Key Points

To examine the real-world incidence of serious infections, herpes zoster, and hepatitis B virus reactivation in patients with systemic lupus erythematosus (SLE).
Retrospective, non-interventional cohort study using an insurance claims database in Japan from April 2017 to March 2021.
Calculated incidence rates of infections requiring hospitalization and performed exploratory analyses adjusting for age and sex.
Involved 10,865 patients with SLE, predominantly female (83.1%), with a median age of 53.0 years.
Incidence rates for serious infections, herpes zoster, 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) per 100 patient-years respectively.
For patients with no previous complications, 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).
In patients with a history of serious infection, incidence rates increased significantly, with a rate of 64.23 per 100 patient-years for serious infections under glucocorticoid pulse therapy.

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.

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