Marrapodi Maria Maddalena, Mascolo Annamaria, di Mauro Gabriella, Mondillo Gianluca, Pota Elvira, Rossi Francesca
Department of Woman, Child and General and Specialist Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy.
Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.
Front Pediatr. 2022 Jul 22;10:929122. doi: 10.3389/fped.2022.929122. eCollection 2022.
Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that has proven efficacy in children with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Despite its efficacy, it has also been associated with the development of potentially serious adverse events such as the cytokine release syndrome (CRS) and neurologic events. The present meta-analysis aimed to assess the safety profile of blinatumomab in terms of serious adverse events, CRS, and neurologic events (such as seizure and encephalopathy) in pediatric patients with B-cell ALL.
A systematic review was conducted in Pubmed up to December 10, 2021 to retain pediatric clinical trials on blinatumomab. A random effect meta-analysis approach was used. This study followed the PRISMA statement. Four out of the 255 initial references were selected, of which 2 were phase 1/2 clinical trials and 2 phase 3 clinical trials. Blinatumomab was associated with a lower risk of serious adverse events (Risk ratio RR, 0.56; 95% CI, 0.32-0.99), febrile neutropenia (RR, 0.13; 95% CI, 0.06-0.26), infection (RR, 0.40; 95% CI, 0.29-0.56), and grade ≥ 3 adverse events (RR, 0.79; 95% CI, 0.67-0.93) compared to chemotherapy. No difference in the risk of CRS (RR, 8.37; 95% CI, 0.27-260.97) and seizure (RR, 6.43; 95% CI, 0.79-53.08) was observed between groups, while for encephalopathy a higher risk was associated with blinatumomab compared to chemotherapy (RR, 8.90; 95% CI, 1.08-73.29).
Our data support the good safety profile of bliantumomab in treating pediatric patients with B-ALL.
博纳吐单抗是一种双特异性CD19导向的CD3 T细胞衔接器，已被证明对复发或难治性B细胞急性淋巴细胞白血病（ALL）患儿有效。尽管其疗效显著，但它也与潜在的严重不良事件的发生有关，如细胞因子释放综合征（CRS）和神经系统事件。本荟萃分析旨在评估博纳吐单抗在B细胞ALL患儿中严重不良事件、CRS和神经系统事件（如癫痫和脑病）方面的安全性。
截至2021年12月10日在PubMed上进行了系统评价，以保留关于博纳吐单抗的儿科临床试验。采用随机效应荟萃分析方法。本研究遵循PRISMA声明。从255篇初始参考文献中筛选出4篇，其中2篇为1/2期临床试验，2篇为3期临床试验。与化疗相比，博纳吐单抗与严重不良事件（风险比RR，0.56；95%可信区间，0.32-0.99）、发热性中性粒细胞减少（RR，
