METHODS: Participants (randomized 2:1) received a single intramuscular dose of nirsevimab or comparator (placebo, Phase 2b/MELODY; 5× once-monthly palivizumab, MEDLEY) before their first RSV season (recipients < 5 kg, nirsevimab 50 mg; ≥5 kg, nirsevimab 100 mg). In MEDLEY, children with CHD/CLD continued to a second RSV season: first-season nirsevimab recipients received nirsevimab 200 mg; first-season palivizumab recipients were re-randomized 1:1 to receive nirsevimab 200 mg or 5× once-monthly palivizumab.
RESULTS: The incidence, severity, and nature of AEs were similar across treatments (nirsevimab, n = 3184; placebo, n = 1284; palivizumab, n = 304). Most AEs were mild to moderate in severity, with ≥98% unrelated to treatment. AEs of special interest occurred infrequently (<1%): no anaphylaxis or thrombocytopenia were treatment-related, and no immune complex disease was reported. Deaths (incidence < 1.0%) were all unrelated to treatment.
CONCLUSIONS: A single dose per season of nirsevimab for the prevention of RSV disease had a favorable safety profile, irrespective of wGA or comorbidities.
方法:参与者(随机2:1)接受单次肌内剂量的nirsevimab或比较剂(安慰剂,2b期/MELODY;5×每月一次帕利珠单抗,MEDLEY)在他们的第一个RSV赛季之前(接受者<5公斤,nirsevimab50mg;≥5kg,nirsevimab100毫克)。在Medley,CHD/CLD患儿持续到第二个RSV季节:第一个季节的nirsevimab接受者接受了200mg的nirsevimab;第一个季节的palivizumab接受者被1:1重新随机分配接受200mg的nirsevimab或5次每月一次的palivizumab.
结果:发病率,严重程度,和AE的性质在不同的治疗中相似(nirsevimab,n=3184;安慰剂,n=1284;帕利珠单抗,n=304)。大多数不良事件的严重程度为轻度至中度,≥98%与治疗无关。特别关注的AE很少发生(<1%):没有过敏反应或血小板减少症与治疗相关,没有免疫复合物疾病的报道。死亡(发生率<1.0%)均与治疗无关。
结论:每个季节单剂量的尼尔塞维玛用于预防RSV疾病具有良好的安全性。无论WGA或合并症。