尼赛珠单抗与 RSV 毛细支气管炎住院治疗。
Nirsevimab and Hospitalization for RSV Bronchiolitis.
机构信息
From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology (M.G.-M.), the Neonatal Intensive Care Unit (V.B.), and the Unit of Clinical Epidemiology, INSERM Unité 1123 and Epidémiologie Clinique du Centre d'Investigation Clinique 1426 (K.D., O.A.), Robert-Debré University Hospital, Paris Cité University (Z.A., C.S., A.G., Z.V., M.B., J.F.C., J.T., M.L., P.S., L.L., M.G.-M., V.B., K.D., O.A.), the Departments of General Pediatrics (A.-S.R., M. Lorrot, C.F.) and Pediatric Pulmonology (A.-S.R., M. Lorrot), Armand Trousseau University Hospital, Sorbonne University (A.-S.R., M. Lorrot), the Pediatric Emergency Department (C.S.), the Pediatric Intensive Care Unit (M.B.), and the Department of General Pediatrics and Pediatric Infectious Diseases (C.S., J.F.C., J.T.), Necker-Enfants Malades University Hospital, Saint-Antoine Research Center, INSERM Unité Mixte de Recherche (UMR) S938 (H.C., B.P.), and Assistance Publique-Hôpitaux de Paris (AP-HP), Infection, Antimicrobials, Modeling, and Evolution (IAME) Research Unit, INSERM UMR 1137 (Z.A., L.L., M.G.-M., N.O.), Épidémiologie Clinique et Évaluation Économique Appliqué aux Populations Vulnérables, INSERM UMR 1123 (C.A.), the Center of Research in Epidemiology and Statistics, INSERM UMR 1153 (J.F.C.), and Biodiversity and Epidemiology of Bacterial Pathogens Research Unit, Institut Pasteur (J.T.), Paris Cité University, Paris, Groupe de Pathologie Infectieuse Pédiatrique, Nice (Z.A., M. Lorrot, R.C., C.L., N.O.), the Pediatric Emergency Department (C.A.) and the Department of General Pediatrics (L.P., C.F.D.), Jean Verdier University Hospital, AP-HP de Paris, Bondy, the Department of General Pediatrics, Centre Hospitalier Intercommunal de Créteil (M.S., C.J.), Association Clinique et Thérapeutique Infantile du Val-de-Marne France (R.C., C.L.), Institut Mondor de Recherche Biomédicale-Groupe de Recherche Clinique Groupe d'Étude des Maladies Infectieuses Néonatales et Infantiles, Université Paris Est (R.C., C.L., C.J.), and the Clinical Research Center (M.M.E.H., C.J.) and the Neonatal Intensive Care Unit (X.D.), Centre Hospitalier Intercommunal de Créteil, Université Paris Est Créteil, Faculté de Santé de Créteil, Créteil, Association Française de Pédiatrie Ambulatoire, Orleans (R.C., C.L.), and the Departments of Pediatric Pulmonology and Allergology (G.L., N.C.) and General Pediatrics (B.H., O.M., C.B.), Children's Hospital, Toulouse University Hospital, Toulouse - all in France; and the Department of Pediatrics, Department Woman-Mother-Child, Lausanne University Hospital, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (F.A.).
出版信息
N Engl J Med. 2024 Jul 11;391(2):144-154. doi: 10.1056/NEJMoa2314885.
BACKGROUND
Respiratory syncytial virus (RSV) is the leading cause of bronchiolitis, resulting in 3 million hospitalizations each year worldwide. Nirsevimab is a monoclonal antibody against RSV that has an extended half-life. Its postlicensure real-world effectiveness against RSV-associated bronchiolitis is unclear.
METHODS
We conducted a prospective, multicenter, matched case-control study to analyze the effectiveness of nirsevimab therapy against hospitalization for RSV-associated bronchiolitis in infants younger than 12 months of age. Case patients were infants younger than 12 months of age who were hospitalized for RSV-associated bronchiolitis between October 15 and December 10, 2023. Control patients were infants with clinical visits to the same hospitals for conditions unrelated to RSV infection. Case patients were matched to control patients in a 2:1 ratio on the basis of age, date of hospital visit, and study center. We calculated the effectiveness of nirsevimab therapy against hospitalization for RSV-associated bronchiolitis (primary outcome) by means of a multivariate conditional logistic-regression model with adjustment for confounders. Several sensitivity analyses were performed.
RESULTS
The study included 1035 infants, of whom 690 were case patients (median age, 3.1 months; interquartile range, 1.8 to 5.3) and 345 were matched control patients (median age, 3.4 months; interquartile range, 1.6 to 5.6). Overall, 60 case patients (8.7%) and 97 control patients (28.1%) had received nirsevimab previously. The estimated adjusted effectiveness of nirsevimab therapy against hospitalization for RSV-associated bronchiolitis was 83.0% (95% confidence interval [CI], 73.4 to 89.2). Sensitivity analyses gave results similar to those of the primary analysis. The effectiveness of nirsevimab therapy against RSV-associated bronchiolitis resulting in critical care was 69.6% (95% CI, 42.9 to 83.8) (27 of 193 case patients [14.0%] vs. 47 of 146 matched control patients [32.2%]) and against RSV-associated bronchiolitis resulting in ventilatory support was 67.2% (95% CI, 38.6 to 82.5) (27 of 189 case patients [14.3%] vs. 46 of 151 matched control patients [30.5%]).
CONCLUSIONS
In a real-world setting, nirsevimab therapy was effective in reducing the risk of hospitalized RSV-associated bronchiolitis. (Funded by the National Agency for AIDS Research-Emerging Infectious Disease and others; ENVIE ClinicalTrials.gov number, NCT06030505.).
背景
呼吸道合胞病毒（RSV）是毛细支气管炎的主要病因，导致全球每年有 300 万人住院。尼尔斯维拉单抗是一种针对 RSV 的单克隆抗体，具有延长的半衰期。其上市后预防 RSV 相关毛细支气管炎的真实世界效果尚不清楚。
方法
我们进行了一项前瞻性、多中心、匹配病例对照研究，以分析尼尔斯维拉单抗治疗对 12 个月以下婴儿因 RSV 相关毛细支气管炎住院的效果。病例组为 12 个月以下因 RSV 相关毛细支气管炎住院的婴儿。对照组为在同一医院因与 RSV 感染无关的疾病就诊的婴儿。根据年龄、就诊日期和研究中心，病例组与对照组以 2:1 的比例进行匹配。我们通过多变量条件逻辑回归模型计算了尼尔斯维拉单抗治疗对 RSV 相关毛细支气管炎住院的效果（主要结局），并进行了混杂因素调整。进行了几次敏感性分析。
结果
该研究纳入了 1035 名婴儿，其中 690 名为病例组（中位年龄为 3.1 个月；四分位间距为 1.8 至 5.3），345 名为匹配的对照组（中位年龄为 3.4 个月；四分位间距为 1.6 至 5.6）。总体而言，60 名病例组（8.7%）和 97 名对照组（28.1%）之前接受过尼尔斯维拉单抗治疗。尼尔斯维拉单抗治疗对 RSV 相关毛细支气管炎住院的估计调整效果为 83.0%（95%置信区间[CI]，73.4 至 89.2）。敏感性分析得出的结果与主要分析相似。尼尔斯维拉单抗治疗对需要重症监护的 RSV 相关毛细支气管炎的效果为 69.6%（95%CI，42.9 至 83.8）（27/193 例病例患者[14.0%] vs. 47/146 例匹配对照组患者[32.2%]），对需要通气支持的 RSV 相关毛细支气管炎的效果为 67.2%（95%CI，38.6 至 82.5）（27/189 例病例患者[14.3%] vs. 46/151 例匹配对照组患者[30.5%]）。
结论
在真实环境中，尼尔斯维拉单抗治疗可有效降低 RSV 相关毛细支气管炎住院的风险。（由美国国立艾滋病研究署-新发传染病和其他机构资助；ENVIE ClinicalTrials.gov 编号，NCT06030505。）
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