{
    "abstract": "Although belimumab has been widely used in patients with systemic lupus erythematosus (SLE) globally, real-world safety data among Chinese patients are limited, particularly for children. This study assessed the safety and tolerability of belimumab in adult and paediatric patients with SLE in China in real-world clinical practice.\nThis Phase 4, multicentre, prospective, observational study enrolled patients prescribed intravenous belimumab by their physicians in tertiary hospitals, independent of a clinical study, during routine clinical visits between May 2021 and May 2022. Patients could have been receiving belimumab prior to enrolment. The primary objective was to describe the incidence of adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs) and AEs of special interest (AESIs) over the 24-week follow-up period. Data were collected at enrolment and approximately 4, 12 and 24\u00a0weeks post-enrolment, during routine clinical visits. AEs, ADRs and SAEs were collected as independent events. The safety population comprised patients who received \u22651 dose of belimumab and completed \u22651 follow-up visit.\nOverall, 417 patients were included in the analysis (safety population); 89.2% were female and mean (standard deviation) age was 35.5 (11.9) years. AEs were reported in 158 patients (37.9%) and were mostly mild (79.1%). The most common AEs were upper respiratory tract infections (\nBelimumab was generally well tolerated in adult and paediatric patients with SLE in this real-world setting in China, with no new safety signals identified. Future assessment of long-term belimumab safety in China beyond 24\u00a0weeks will extend this current body of evidence.",
    "authors": [
        {
            "affiliation": "Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, China.",
            "firstname": "Zhuoli",
            "initials": "Z",
            "lastname": "Zhang"
        },
        {
            "affiliation": "Department of Rheumatology, Shenzhen Futian District Rheumatology College Hospital, Shenzhen, China.",
            "firstname": "Zhizhong",
            "initials": "Z",
            "lastname": "Ye"
        },
        {
            "affiliation": "Department of Rheumatology, Zhongshan City People Hospital, Guangdong Province, China.",
            "firstname": "Shanzhi",
            "initials": "S",
            "lastname": "He"
        },
        {
            "affiliation": "Department of Rheumatology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.",
            "firstname": "Lin",
            "initials": "L",
            "lastname": "Tang"
        },
        {
            "affiliation": "Department of Rheumatology, Affiliated Hospital of North Sichuan Medical College, Nanchong City, China.",
            "firstname": "Chuanmei",
            "initials": "C",
            "lastname": "Xie"
        },
        {
            "affiliation": "Department of Rheumatology, The Affiliated Stomatological Hospital of Xuzhou Medical University, Xuzhou, China.",
            "firstname": "Songlou",
            "initials": "S",
            "lastname": "Yin"
        },
        {
            "affiliation": "Department of Rheumatology, Ningxia Medical University General Hospital, Yinchuan, China.",
            "firstname": "Shuhong",
            "initials": "S",
            "lastname": "Chi"
        },
        {
            "affiliation": "Department of Rheumatology, Mianyang Central Hospital, Sichuan, China.",
            "firstname": "Jing",
            "initials": "J",
            "lastname": "Yang"
        },
        {
            "affiliation": "Department of Rheumatology, Zhujiang Hospital of Southern Medical University, Guangzhou, China.",
            "firstname": "Qinghong",
            "initials": "Q",
            "lastname": "Yu"
        },
        {
            "affiliation": "Department of Rheumatology, Nanfang Hospital, Southern Medical University, Guangzhou, China.",
            "firstname": "Min",
            "initials": "M",
            "lastname": "Yang"
        },
        {
            "affiliation": "China Clinical Development, GSK, Shanghai, China.",
            "firstname": "Xuefeng",
            "initials": "X",
            "lastname": "Zhao"
        },
        {
            "affiliation": "Biostatistics, China Clinical Development, GSK, Shanghai, China.",
            "firstname": "Yifan",
            "initials": "Y",
            "lastname": "He"
        },
        {
            "affiliation": "China Clinical Development, GSK, Shanghai, China.",
            "firstname": "Jingwen",
            "initials": "J",
            "lastname": "Hu"
        },
        {
            "affiliation": "China Clinical Development, GSK, Shanghai, China.",
            "firstname": "Weibo",
            "initials": "W",
            "lastname": "Wang"
        },
        {
            "affiliation": "Pharmacovigilance, Medical Department, GSK, Shanghai, China.",
            "firstname": "Annie",
            "initials": "A",
            "lastname": "Tung"
        }
    ],
    "conclusions": "Belimumab was generally well tolerated in adult and paediatric patients with SLE in this real-world setting in China, with no new safety signals identified. Future assessment of long-term belimumab safety in China beyond 24\u00a0weeks will extend this current body of evidence.",
    "copyrights": null,
    "doi": "10.1177/09612033241299175\n10.1093/rheumatology/kead629",
    "journal": "Lupus",
    "keywords": [
        "Adverse drug reactions",
        "China",
        "belimumab",
        "post-authorisation",
        "systemic lupus erythematosus"
    ],
    "methods": null,
    "publication_date": "2024-11-13",
    "pubmed_id": "39517123\n24834926\n18237382\n36241363\n23963101\n37781683\n22052624\n37827694\n36465077\n34238087\n21296403\n22127708\n28118533\n29295825\n35428697\n33206344\n32275125\n38279368\n36979944\n37497208\n9324032\n7138600\n22553077\n30926722\n26537534\n38011668\n32699034\n30771238",
    "results": "Overall, 417 patients were included in the analysis (safety population); 89.2% were female and mean (standard deviation) age was 35.5 (11.9) years. AEs were reported in 158 patients (37.9%) and were mostly mild (79.1%). The most common AEs were upper respiratory tract infections (",
    "title": "Belimumab safety in adult and paediatric Chinese patients with systemic lupus erythematosus: A Phase 4, multicentre, observational study.",
    "xml": "<Element 'PubmedArticle' at 0x7885036eb880>"
}