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.
Methods and findings: 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).
Conclusion: Our data support the good safety profile of bliantumomab in treating pediatric patients with B-ALL.