{
  "abstract": "Objectives Although anifrolumab and belimumab are both approved for the treatment of systemic lupus erythematosus (SLE), their comparative infection-related safety profiles in real-world clinical practice remain insufficiently characterized.Methods We conducted a retrospective cohort study using the TriNetX US research network. Patients with SLE (>2 diagnosis codes) who newly initiated anifrolumab or belimumab between August 1, 2021, and June 30, 2025 were identified. Those with composite infection outcomes or death within 1 year before index were excluded. Propensity score matching balanced baseline characteristics. Cox models estimated hazard ratios (HRs) with 95% CIs and Kaplan–Meier curves assessed cumulative incidence. The primary outcome was infection occurrence (including herpes zoster, influenza, pneumonia, tuberculosis, sepsis, urinary tract infection, and COVID-19); secondary outcomes were mortality and inpatient utilization. Follow-up was up to 4 years, with prespecified subgroup and sensitivity analyses.Results After matching, 1,038 patients were included in each group. Overall serious infection risk was similar between anifrolumab and belimumab (HR 1.020, 95% CI 0.861–1.207), with no significant difference in 4-year cumulative incidence. However, sepsis risk was higher with anifrolumab (HR 2.593, 95% CI 1.466–4.588). Sensitivity analyses consistently showed increased influenza risk with anifrolumab across restricted follow-up windows and stricter exposure definitions, including exclusion of prior rituximab/other biologics. No meaningful differences were observed for COVID-19, herpes zoster, urinary tract infection, pneumonia, or other infection subtypes. Subgroup analyses showed no effect modification, and time-dependent analyses suggested influenza risk may increase with longer treatment duration. Mortality and inpatient utilization were comparable.Abstract LBA:01:08 Table 1Hazard ratio and 95% CIs for the risk of various infectionConclusions Anifrolumab was associated with higher risks of certain infections, most notably sepsis and influenza, when compared with belimumab, and these differences became more evident with longer exposure. Because the findings are exploratory, confirmation through randomized or prospective studies is still needed. Overall, the results emphasize the importance of close infection monitoring and may assist clinicians in choosing biologic therapy and discussing treatment options with patients in routine SLE care.",
  "authors": [
    {
      "affiliations": [
        "Department of Allergy*, Immunology and Rheumatology, Wuri Lin Shin Hospital, Taichung, Taiwan, Taichung, * OTHER",
        "College of Health Care and Management, Chung Shan Medical University, Taichung, Taiwan, Taichung, * OTHER"
      ],
      "name": "Teng-Chieh Hsu"
    },
    {
      "affiliations": [
        "Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, Taichung, * OTHER",
        "Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taichung, * OTHER"
      ],
      "name": "Po-Cheng Shih"
    },
    {
      "affiliations": [
        "Department of Allergy and Immunology, China Medical University Children’s Hospital, Taichung, Taiwan., Taichung, * OTHER",
        "Research Center for Allergy, Immunology, and Microbiome (A.I.M.), China Medical University Hospital, Taichung, Taiwan., Taichung, * OTHER"
      ],
      "name": "Su-Boon Yong"
    },
    {
      "affiliations": [
        "Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, Taichung, * OTHER",
        "Division of Allergy, Immunology and Rheumatology, Chung Shan Medical University Hospital, Taichung, Taiwan, Taichung, * OTHER"
      ],
      "name": "An-Ping Huo"
    },
    {
      "affiliations": [
        "Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, Taichung, * OTHER"
      ],
      "name": "Pei-Lun Liao"
    },
    {
      "affiliations": [
        "Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, Taichung, * OTHER",
        "Division of Allergy, Immunology and Rheumatology, Chung Shan Medical University Hospital, Taichung, Taiwan, Taichung, * OTHER"
      ],
      "name": "Pui-Ying Leong"
    },
    {
      "affiliations": [
        "Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, Taichung, * OTHER",
        "Division of Allergy, Immunology and Rheumatology, Chung Shan Medical University Hospital, Taichung, Taiwan, Taichung, * OTHER"
      ],
      "name": "James Cheng-Chu Wei"
    }
  ],
  "title": "LBA:01:08 Comparative risk of infection-related complications in systemic lupus erythematosus patients treated with anifrolumab versus belimumab: an emulated target trial",
  "uid": "788fa42f-927e-5763-98cd-35e3b784bc8a"
}